Issuance of Multiple Prescriptions for Schedule II Controlled Substances, 64921-64930 [E7-22558]
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Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Rules and Regulations
Appendix: Basic Commission
Enforcement Procedure
The Commission’s enforcement procedures
are set forth at 11 CFR part 111. An
enforcement matter may be initiated by a
complaint or on the basis of information
ascertained by the Commission in the normal
course of carrying out its supervisory
responsibilities. 11 CFR 111.3. If a complaint
substantially complies with certain
requirements set forth in 11 CFR 111.4,
within five days of receipt the Office of
General Counsel notifies each party
determined to be a respondent that a
complaint has been filed, provides a copy of
the complaint, and advises each respondent
of Commission compliance procedures. 11
CFR 111.5. A respondent then has 15 days
from receipt of the notification from the
Office of General Counsel to submit a letter
or memorandum to the Commission setting
forth reasons why the Commission should
take no action on the basis of the complaint.
11 CFR 111.6.
Following receipt of such letter or
memorandum, or expiration of the 15-day
period, the Office of General Counsel may
recommend to the Commission whether or
not it should find ‘‘reason to believe’’ that a
respondent has committed or is about to
commit a violation of the Act or Commission
regulations. 11 CFR 111.7(a).4 With respect to
internally-generated matters (e.g., referrals
from the Commission’s Audit or Reports
Analysis Divisions), the Office of General
Counsel may recommend that the
Commission find ‘‘reason to believe’’ that a
respondent has committed or is about to
commit a violation of the Act or Commission
regulations on the basis of information
ascertained by the Commission in the normal
course of carrying out its supervisory
responsibilities, or on the basis of a referral
from an agency of the United States or any
state. If the Commission determines by an
affirmative vote of four members that it has
‘‘reason to believe’’ that a respondent
violated the Act or Commission regulations,
the respondent must be notified by letter of
the Commission’s finding(s). 11 CFR
111.9(a).5 The Office of General Counsel will
also provide the respondent with a Factual
and Legal Analysis, which will set forth the
bases for the Commission’s finding of reason
to believe.
After the Commission makes a ‘‘reason to
believe’’ finding, an investigation is
conducted by the Office of General Counsel,
in which the Commission may undertake
field investigations, audits, and other
methods of information-gathering. 11 CFR
111.10. Additionally, the Commission may
issue subpoenas to order any person to
submit sworn written answers to written
questions, to provide documents, or to
appear for a deposition. 11 CFR 111.11–
111.12. Any person who is subpoenaed may
submit a motion to the Commission for it to
be quashed or modified. 11 CFR 111.15.
Following a ‘‘reason to believe’’ finding,
the Commission may attempt to reach a
conciliation agreement with the
respondent(s) prior to reaching the ‘‘probable
cause’’ stage of enforcement (i.e., a preprobable cause conciliation agreement). See
11 CFR 111.18(d). If the Commission is
unable to reach a pre-probable cause
conciliation agreement with the respondent,
or determines that such a conciliation
agreement would not be appropriate, upon
completion of the investigation referenced in
the preceding paragraph, the Office of
General Counsel prepares a brief setting forth
its position on the factual and legal issues of
the matter and containing a recommendation
on whether or not the Commission should
find ‘‘probable cause to believe’’ that a
violation has occurred or is about to occur.
11 CFR 111.16(a).
The Office of General Counsel notifies the
respondent(s) of this recommendation and
provides a copy of the probable cause brief.
11 CFR 111.16(b). The respondent(s) may file
a written response to the probable cause brief
within fifteen days of receiving said brief. 11
CFR 111.16(c). After reviewing this response,
the Office of General Counsel shall advise the
Commission in writing whether it intends to
proceed with the recommendation or to
withdraw the recommendation from
Commission consideration. 11 CFR
111.16(d).
If the Commission determines by an
affirmative vote of four members that there is
‘‘probable cause to believe’’ that a respondent
has violated the Act or Commission
regulations, the Commission authorizes the
Office of General Counsel to notify the
respondent by letter of this determination. 11
CFR 111.17(a). Upon a Commission finding
of ‘‘probable cause to believe,’’ the
Commission must attempt to reach a
conciliation agreement with the respondent.
11 CFR 111.18(a). If no conciliation
agreement is finalized within the time period
specified in 11 CFR 111.18(c), the Office of
General Counsel may recommend to the
Commission that it authorize a civil action
for relief in the appropriate court. 11 CFR
111.19(a). Commencement of such civil
action requires an affirmative vote of four
members of the Commission. 11 CFR
111.19(b). The Commission may enter into a
conciliation agreement with respondent after
authorizing a civil action. 11 CFR 111.19(c).
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4 The Office of General Counsel may also
recommend that the Commission find no ‘‘reason to
believe’’ that a violation has been committed to is
about to be committed, or that the Commission
otherwise dismiss a complaint without regard to the
provisions of 11 CFR 111.6(a). 11 CFR 111.7(b).
5 If the Commission finds no ‘‘reason to believe,’’
or otherwise terminates its proceedings, the Office
of General Counsel shall advise the complainant
and respondent(s) by letter. 11 CFR 111.9(b).
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA–287F]
RIN 1117–AB01
Issuance of Multiple Prescriptions for
Schedule II Controlled Substances
Drug Enforcement
Administration (DEA), Department of
Justice
ACTION: Final rule.
AGENCY:
SUMMARY: The Drug Enforcement
Administration (DEA) is finalizing a
Notice of Proposed Rulemaking
published on September 6, 2006 (71 FR
52724). In that document, DEA
proposed to amend its regulations to
allow practitioners to provide
individual patients with multiple
prescriptions, to be filled sequentially,
for the same schedule II controlled
substance, with such multiple
prescriptions having the combined
effect of allowing a patient to receive
over time up to a 90-day supply of that
controlled substance.
DATES: Effective Date: This rule is
effective December 19, 2007.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Telephone (202) 307–7297.
SUPPLEMENTARY INFORMATION:
Background
On September 6, 2006, the Drug
Enforcement Administration (DEA)
published in the Federal Register a
Notice of Proposed Rulemaking (NPRM)
(71 FR 52724) proposing to amend its
regulations to allow practitioners to
provide individual patients with
multiple prescriptions, to be filled
sequentially, for the same schedule II
controlled substance, with such
multiple prescriptions having the
combined effect of allowing a patient to
receive over time up to a 90-day supply
of that controlled substance.
Comments Received
DEA received 264 comments
regarding the NPRM. Two hundred
thirty-one commenters supported the
NPRM, 33 commenters opposed the
rulemaking. Commenters supporting the
NPRM included six physician
associations, including those
representing anesthesiologists,
pediatricians, and psychiatrists, and
three state level licensing organizations;
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five nursing associations, including
several nursing specialty associations; 3
pharmacy associations and 6 state
boards of pharmacy; 17 organizations
focusing on the treatment of pain and
end of life issues; 8 other organizations;
and individual commenters including
73 pain patients, 65 physicians or
physicians’ offices, 31 parents of
children with attention deficit disorder
(ADD) or attention deficit hyperactivity
disorder (ADHD), 30 individual citizens,
16 pharmacists, 5 nurses, and 2
physician’s assistants. Commenters
opposing the NPRM included 1
organization focusing on the treatment
of pain; 17 individual citizens; 8
physicians; 3 pharmacists or pharmacy
workers; 2 parents of pain patients; 1
nurse; and 1 physician’s assistant.
The vast majority of commenters
supported the rulemaking as proposed,
although some commenters suggested
various changes or requested
clarification of certain issues. DEA has
carefully considered all comments
received. An in-depth discussion of the
issues raised by commenters and DEA’s
responses to those comments follows.
Discussion of Comments
Of the 264 comments DEA received,
166 expressed approval of the proposed
rule without change. The remainder of
the comments either objected to the
proposed rule or suggested
modifications thereto. The major issues
raised by the commenters are addressed
below.
Comments expressing approval of the
proposed rule without change:
Commenters who expressed support for
this rule represented a broad variety of
interest groups, medical professionals,
pharmacists, and patients. General
comments regarding the support for this
rule and the benefits commenters
believed it will have appear below.
Patients being treated for pain:
Commenters who described themselves
as patients who receive controlled
substances for the treatment of pain
were very supportive of implementation
of the rule as proposed. These
commenters noted that the allowance
for multiple prescriptions would reduce
the number of visits they would need to
make to practitioners, which would be
beneficial financially. Many of these
patients indicated they are unemployed
or underemployed due to their medical
conditions, and each additional visit to
practitioners for the purpose of
receiving another prescription takes a
financial toll on them.
Among the patients who commented
in support of the rule were those who
indicated that they live in rural areas.
These commenters explained that,
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currently, they must either drive to their
practitioners, which is difficult for
them, or must find someone to drive
them because they cannot drive
themselves due to their condition. They
noted that arranging rides is often
difficult and that the drive to a
practitioner may be several hours each
way. Some also stated that the trip is
expensive and that the length of the trip
exacerbates their conditions. According
to these commenters, implementation of
the proposed rule would enable them to
visit their prescribing practitioners less
frequently, thereby lessening the
foregoing difficulties.
Parents of children receiving
controlled substances: Commenters who
described themselves as parents of
children with ADD or ADHD welcomed
the proposed rule. In their view, if the
proposed rule is implemented, they no
longer will have to take their children
to their prescribing practitioners every
month. As a result, they indicated they
will be able to take less time off from
work and their children will have fewer
absences from school. Many of these
commenters also noted that having to
make monthly visits to practitioners is
especially burdensome to single parents.
These commenters also identified
reduced costs as a reason for their
support of the proposed rule.
Prescribing practitioners: Commenters
who identified themselves as
practitioners who prescribe controlled
substances were, for the most part,
strongly supportive of the proposed
rule. Many of these commenters
expressed the view that allowing the
issuance of multiple sequential
prescriptions for schedule II controlled
substances will drastically reduce the
work of the practitioners’ offices and
free up valuable practitioner-patient
time. Many also expressed the view that
for some of their patients whom they
characterized as ‘‘stable’’ (including
certain patients with chronic pain and
ADD or ADHD), they believe there is no
medical need to see such patients every
month. In such cases, some of these
commenters added they believe having
to make monthly visits to the
practitioner is a hardship to patients
who are already suffering. It should be
noted that some commenters who
identified themselves as practitioners
expressed a sharply contrasting view,
asserting that patients who receive
schedule II controlled substances
should be seen in person at least once
a month to ensure proper medical
supervision and to lessen the likelihood
of drug addiction and abuse. This latter
perspective of some commenting
practitioners is addressed further below.
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Pharmacists: Commenters who
identified themselves as pharmacists
were, for the most part, supportive of
the proposed rule. These commenters
stated that issuing multiple
prescriptions for sequential filling for
schedule II controlled substances would
reduce the quantity of those controlled
substances dispensed to a patient at any
one time. They argued that this reduced
quantity could reduce the potential for
abuse or diversion of these controlled
substances. Some pharmacists indicated
they would be more comfortable
dispensing these prescriptions because
of the more limited quantities
dispensed.
90-day supply at one time: Sixteen
commenters who supported the NPRM,
and six commenters who disagreed with
the NPRM, believed that the entire 90day supply of controlled substances was
available at one time instead of in
sequential prescriptions. Commenters
who supported the rule but believed
that DEA is advocating the dispensing of
a 90-day supply of controlled
substances at one time cited the ease of
filling prescriptions and obtaining
reimbursement as reasons for their
support. Those who objected to the rule
on this ground believed it would be
more difficult to monitor patients.
DEA response: In view of these
comments, DEA wishes to make clear
that the NPRM did not advocate that
physicians prescribe a 90-day supply of
controlled substances with a single
prescription. Rather, the NPRM stated
that if a physician determines it is
medically appropriate to issue multiple
schedule II prescriptions, the physician
may provide for up to a 90-day supply
through the use of multiple schedule II
prescriptions under the conditions
specified in the proposed rule.
As to the comment that DEA should
allow multiple schedule II prescriptions
for unlimited days’ worth of schedule II
controlled substances, as DEA explained
in the NPRM, for the proposed rule to
be legally permissible, it must be
consistent with the text, structure, and
purposes of the Controlled Substances
Act (CSA). In this regard, 21 U.S.C.
829(a) states: ‘‘No prescription for a
controlled substance in schedule II may
be refilled.’’ By comparison, subsection
829(b) states that, for a schedule III or
IV controlled substance, a prescription
may be refilled up to five times within
six months after the date the
prescription was issued. Thus, Congress
clearly mandated greater prescription
controls for schedule II substances than
for schedule III and IV substances. For
example, a physician may—consistent
with the statute—issue a prescription
for a schedule III or IV controlled
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substance and indicate on the
prescription a certain number of refills.
In this manner, a physician may provide
a patient with up to a six-month supply
of a schedule III or IV controlled
substance with a single prescription
indicating five refills. The same cannot
be done with a schedule II controlled
substance since section 829(a) prohibits
refills. The statute requires a separate
prescription if the physician wishes to
authorize a continuation of the patient’s
use of a schedule II drug beyond the
amount specified on the first
prescription. Thus, if DEA were to allow
multiple prescriptions for an unlimited
days’ worth of schedule II controlled
substances, the controls for prescribing
schedule II controlled substances would
be less stringent than for schedule III
and IV controlled substances—a result
that would conflict with the purpose
and structure of the CSA. DEA believes
that the 90-day limit, under the terms
specified in the proposed rule, strikes a
fair balance that takes into account the
limitation imposed by Congress under
section 829 as well as the general
structure of the statute, which imposes
greater controls for schedule II
substances than those in lower
schedules.
Sequential filling of prescriptions,
‘‘refills’’: One commenter opposed the
NPRM because the commenter believed
that sequential prescriptions were
‘‘refills’’ which are not permitted by
law. Two commenters suggested writing
all sequential prescriptions, which the
commenters referred to as ‘‘refills,’’ on
one prescription. They believed this
would prevent the patient from
changing the dates or using multiple
pharmacies to fill the prescriptions.
Commenters also believed this would
eliminate the possibility of the patient
claiming that the original prescription
had been lost and requesting
replacement prescriptions. Two
commenters recommended allowing 90day sequential prescriptions on one
prescription blank, but allowing the
practitioner to prescribe the intervals at
which it would be filled, rather than
only permitting 30-day interval
sequential fillings.
One commenter suggested writing a
single prescription with two ‘‘refills’’
with the annotation ‘‘Do not fill more
frequently than once a month.’’ One
commenter suggested permitting not
more than two ‘‘refills’’ of a schedule II
prescription, but requiring the use of
triplicate prescription blanks with one
copy being sent to the state and the
second copy being sent to DEA. The
commenter then suggested that if a
practitioner chose not to agree to this
system, then the practitioner would not
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be permitted to sequentially prescribe
any schedule II prescription. The
commenter believed that this system
would prevent theft and loss.
DEA response: As discussed above,
DEA believes that the proposed rule
takes into account the CSA prohibition
on refilling prescriptions for schedule II
controlled substances in a manner
consistent with the overall framework of
the Act. The use of multiple
prescriptions for the dispensing of
schedule II controlled substances, under
the conditions set forth in this Final
Rule, ensures that the prescriptions are
treated as separate dispensing
documents, not refills of an original
prescription. As this Final Rule
indicates, each separate prescription
must be written for a legitimate medical
purpose by a practitioner acting in the
usual course of professional practice,
and the practitioner must provide
written instructions on each separate
prescription regarding the filling of that
prescription.
Regarding the comment that suggested
allowing the writing of a single
prescription with two ‘‘refills’’ with the
annotation ‘‘Do not fill more frequently
than once a month,’’ this would conflict
with the CSA, which, as explained
above, disallows the refilling of
schedule II prescriptions. As indicated
in this Final Rule, when issuing
multiple prescriptions for a schedule II
controlled substance, each of the
prescriptions to be filled sequentially
must be written on a separate
prescription blank and must contain the
information specified in this Final Rule.
As for the suggestion that DEA require
the use of triplicate prescription blanks,
DEA has never required triplicate
prescription blanks for prescriptions
and believes, at this time, that the
requirements contained in this Final
Rule provide adequate safeguards
against diversion, which render
unnecessary the use of triplicate
prescription blanks. However, as with
all newly promulgated regulations, DEA
will continue to monitor the situation to
determine whether additional
modifications are needed to safeguard
against diversion. DEA recognizes that
some states require the use of triplicate
prescriptions for some or all controlled
substances. DEA supports the efforts of
states to take the specific action they
deem necessary to prevent the diversion
of controlled substances within their
jurisdictions. This Final Rule expressly
requires practitioners to comply with all
applicable provisions of state law when
issuing multiple schedule II
prescriptions.
Federal law and schedule II
controlled substances: Five commenters
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64923
requested written clarification that this
rule is not intended to change existing
Federal law which does not limit the
length of time for which an individual
prescription may be written or the total
quantity, including the number of
dosage units, that may be prescribed at
one time. Further, two commenters
suggested that DEA state, in the Final
Rule, that federal law does not address
how frequently a practitioner must see
his patient, and that it remains within
the practitioner’s reasonable medical
judgment as to how frequently the
practitioner sees a patient.
Commenters requested that DEA
clarify that the practitioner is not
required to see the patient every 30 days
or at the end of 90 days. One commenter
requested that DEA clarify whether a
practitioner is required to see a patient
after 90 days. Alternatively, the
commenter inquired as to whether the
practitioner is permitted to write a new
prescription with ‘‘Do not fill until’’ and
mail it to the patient or have the patient
pick it up if, in the prescribing
practitioner’s medical judgment, the
patient does not need to see the
practitioner. One commenter
recommended DEA clarify whether it is
DEA’s intent to limit any schedule II
controlled substance prescription to
only a 90-day supply or, alternatively, to
limit sequential schedule II
prescriptions written on the same day to
a 90-day supply. One commenter
requested clarification as to whether the
regulation limits the supply to 90 days
when only a single schedule II
controlled substance prescription is
issued.
DEA response: As the NPRM made
clear, the proposed rule in no way
changes longstanding federal law
governing the issuance of prescriptions
for controlled substances. As stated in
the NPRM: ‘‘What is required, in each
instance where a physician issues a
prescription for any controlled
substance, is that the physician properly
determine there is a legitimate medical
purpose for the patient to be prescribed
that controlled substance and that the
physician be acting in the usual course
of professional practice.’’ (71 FR 52725,
September 6, 2006). Further, this Final
Rule itself contains the following
statement:
Nothing in this subsection shall be
construed as mandating or encouraging
individual practitioners to issue multiple
prescriptions or to see their patients only
once every 90 days when prescribing
Schedule II controlled substances. Rather,
individual practitioners must determine on
their own, based on sound medical judgment,
and in accordance with established medical
standards, whether it is appropriate to issue
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multiple prescriptions and how often to see
their patients when doing so.
In addition, in the August 26, 2005,
‘‘Clarification of Existing Requirements
Under the Controlled Substances Act for
Prescribing Controlled Substances’’ (70
FR 50408), DEA stated the following:
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The CSA and DEA regulations contain no
specific limit on the number of days worth
of a schedule II controlled substance that a
physician may authorize per prescription.
Some states, however, do impose specific
limits on the amount of a schedule II
controlled substance that may be prescribed.
Any limitations imposed by state law apply
in addition to the corresponding
requirements under Federal law, so long as
the state requirements do not conflict with or
contravene the Federal requirements. 21
U.S.C. 903. Again, the essential requirement
under Federal law is that the prescription for
a controlled substance be issued for a
legitimate medical purpose in the usual
course of professional practice. In addition,
physicians and pharmacies have a duty as
DEA registrants to ensure that their
prescribing and dispensing of controlled
substances occur in a manner consistent with
effective controls against diversion and
misuse, taking into account the nature of the
drug being prescribed. 21 U.S.C. 823(f).
This Final Rule does not change any
of the foregoing principles of the CSA
and DEA regulations.
Effective date of prescription: Two
commenters requested that DEA clarify
the effective date of a sequential
prescription for a schedule II controlled
substance. Some commenters pointed
out that some states stipulate ‘‘effective
dates’’ for prescriptions, noting that
these states have laws which require
that, to be valid, prescriptions must be
filled within a certain time after they are
written, and that these time limits differ
by state. Some commenters noted that if
the time limit starts on the date all the
sequential prescriptions are written,
then it cannot be used in some states. If
the effective date starts on the ‘‘Do not
fill until’’ date on the second and third
prescriptions, then it will be valid in
many more states.
Three commenters requested
clarification as to whether it is legally
permissible for a practitioner to issue a
single prescription with ‘‘Do not fill
before [date],’’ in which the ‘‘Do not
fill’’ date is, for example, 7–10 days in
the future.
DEA response: Neither the CSA nor
the DEA regulations use the term
‘‘effective date’’ for a prescription. The
DEA regulations require that all
prescriptions for controlled substances
‘‘be dated as of, and signed on, the day
when issued.’’ 21 CFR 1306.05(a). This
Final Rule does not amend the
regulations regarding the date of
issuance of a prescription.
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Under longstanding federal law and
DEA regulations, there is no express
requirement that a prescription be filled
within a certain time after it was issued.
The proposed rule likewise contained
no such express requirement, as DEA
believes that the requirements contained
in the proposed rule provided adequate
safeguards against diversion. At the
same time, the proposed rule made clear
that the issuance of multiple
prescriptions is permissible only if ‘‘the
individual practitioner complies fully
with all other applicable requirements
under the [CSA] and [DEA] regulations
as well as any additional requirements
under state law.’’ (71 FR 52726). To
make this point unambiguous, the
NPRM also stated that ‘‘nothing in this
proposed rule changes the requirement
that physicians must also abide by the
laws of the states in which they practice
and any additional requirements
imposed by their state medical boards
with respect to proper prescribing
practices and what constitutes a bona
fide physician-patient relationship.’’ (71
FR 52725).
The proposed rule did not address
whether a single prescription with ‘‘Do
not fill before [date]’’ instructions is
permissible. Nor does any existing
provision of the CSA or DEA regulations
address this type of prescribing.
Accordingly, there is no prohibition on
doing so under the CSA or DEA
regulations, provided the practitioner
otherwise complies fully with all
applicable requirements of federal and
state law.
Insurance reimbursement
considerations: Four commenters
requested further relaxation of the
regulations to allow a 90-day supply of
schedule II controlled substances to be
dispensed at one time because, these
commenters asserted, this would
significantly decrease the cost of the
medications to the patients through
their health insurance. One commenter
also recommended permitting the
pharmacy to dispense a 90-day supply
on one prescription, making it available
in 30-day intervals, but allowing the
patient to pay for the entire supply at
one time to save on the cost of the
medication.
DEA response: It is beyond the scope
of DEA’s authority under the CSA to
take regulatory action for the specific
purpose of affecting the manner in
which patients pay for the medications
or the manner in which insurance
providers reimburse patients for such
costs. As mentioned previously, the
CSA and DEA regulations contain no
specific limit on the number of days’
worth of a schedule II controlled
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substance that a practitioner may
authorize per prescription.
Limitations regarding certain
medications: Three commenters
supported the use of sequential
prescriptions specifically for schedule II
controlled substances used to treat ADD
or ADHD, but disagreed with the use of
sequential prescriptions for schedule II
controlled substances used in the
treatment of pain. Commenters believed
pain patients should be seen and
evaluated every 30 days and have
medications prescribed at that time. One
commenter requested that DEA include
explicit language indicating that this
regulation is applicable to all patients
being treated for ADHD with stimulant
medications.
Conversely, one commenter
supported the use of sequential
prescriptions only for narcotic schedule
II controlled substances, or pain
medications.
Another commenter suggested
rescheduling methylphenidate and
amphetamines, except
methamphetamine, to separate them
from pain medications because the two
populations for ADHD medications and
pain medications are different.
DEA response: This rule pertains to
all schedule II controlled substances,
not just those substances intended or
approved to treat certain conditions. As
DEA stated in the September 6, 2006,
Policy Statement published in
conjunction with the Notice of Proposed
Rulemaking (71 FR 52716), it is
certainly appropriate for prescribing
practitioners and medical oversight
boards to explore questions regarding
appropriate treatment regimens for
particular categories of controlled
substances. Moreover, it might indeed
be beneficial toward preventing
diversion and abuse of controlled
substances for prescribing practitioners
to see patients at regular intervals when
prescribing certain controlled
substances for certain medical
conditions. However, as the Policy
Statement made clear, DEA does not
regulate the general practice of medicine
and the agency lacks the authority to
issue guidelines that constitute advice
on the general practice of medicine.
DEA wishes to reiterate the general
principle that the prescribing
practitioner must properly determine
there is a legitimate medical purpose for
the patient to be prescribed the
controlled substance and must be acting
in the usual course of professional
practice. Similarly, a pharmacy has a
corresponding responsibility in this
regard.
Regarding the comment suggesting the
rescheduling of certain schedule II
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controlled substances based on the
conditions and populations which they
are intended to treat, DEA notes that
scheduling of controlled substances is
based on scientific determinations
regarding the substance’s potential for
abuse, its potential for psychological
and physical dependence, and whether
the substance has a currently accepted
medical use in treatment in the United
States (21 U.S.C. 812(b)). DEA may not
reschedule a substance merely based on
the population it is intended or
approved to treat.
Language on sequential prescriptions:
Two commenters suggested not limiting
the language on the prescription to ‘‘Do
not fill before [date].’’ These
commenters suggested other alternatives
including ‘‘Do not fill until xx/xx/
xxxx,’’ and ‘‘Fill on xx/xx/xxxx.’’ Five
commenters requested that DEA provide
examples of acceptable language in the
Final Rule. One commenter suggested
requiring a standardized method for
dating prescriptions, and considering
prescriptions void if that standard is not
adhered to. Another commenter
recommended that specific indication
should be provided regarding sequential
prescriptions by including ‘‘1 of 3,’’ ‘‘2
of 3,’’ and ‘‘3 of 3’’ on the prescriptions.
DEA response: The Final Rule states
that the individual practitioner must
‘‘[provide] written instructions on each
prescription (other than the first
prescription, if the prescribing
practitioner intends for that prescription
to be filled immediately) indicating the
earliest date on which a pharmacy may
fill each prescription.’’ The commenters
have correctly observed that this
provision does not mandate that the
practitioner use any particular language
in the instructions on the sequential
prescriptions, so long as such
instructions make clear what is the
earliest date on which the pharmacy
may fill each prescription. DEA believes
this is a sufficiently clear rule that
practitioners will be able to understand
and carry it out and, therefore, it is
unnecessary to insist on a particular
scripted approach. Likewise, under this
Final Rule, a practitioner may—but is
not required to—do as the commenter
suggested and write on the sequential
prescriptions, ‘‘1 of 3,’’ ‘‘2 of 3,’’ and ‘‘3
of 3’’, so long as each prescription
complies fully with all the requirements
of this Final Rule, including that it
contains specific instructions regarding
the earliest date on which the sequential
prescription may be filled.
One commenter recommended that
the practitioner write in his/her own
handwriting in blue ink ‘‘Do not fill
until [date].’’
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DEA response: DEA appreciates that
the underlying intent of this comment is
to ensure that the ‘‘Do not fill until
[date]’’ instructions were actually
written by the practitioner, as opposed
to being the result of forgery. While DEA
supports all efforts of practitioners to
take steps to prevent forgery in the
context of prescriptions, the agency
believes it is unnecessary to adopt the
particular added requirement suggested
by this commenter.
One commenter recommended that
certain diagnostic codes, known as ICD–
9 codes, should be written by the
practitioner in their own handwriting
on the face of the prescription.
DEA response: DEA has not
previously required that prescriptions
contain such diagnostic information,
and the agency does not believe that
such requirement is necessary to
prevent diversion and abuse of
controlled substances when issuing
multiple prescriptions in accordance
with the rule being issued today.
Post-dating of prescriptions: One
commenter recommended allowing
post-dated prescriptions so the
practitioner does not have to use space
on the prescription blank for the phrase
‘‘Do not fill before [date].’’
DEA response: The DEA regulations
have always required that all
prescriptions for controlled substances
‘‘be dated as of, and signed on, the day
when issued.’’ 21 CFR 1306.05(a). This
requirement is essential to monitor
compliance with all provisions of the
CSA and DEA regulations relating to the
prescribing and dispensing of controlled
substances, including (but not limited
to) the requirement that a controlled
substance be dispensed, including
prescribed, only for a legitimate medical
purpose by a practitioner acting in the
usual course of professional practice.
Accordingly, it would be inappropriate
to allow post-dating of prescriptions
under any circumstance, including
when issuing multiple prescriptions
under the Final Rule being issued today.
Return of unfilled prescriptions: One
commenter suggested that a patient
return to the practitioner unfilled
prescriptions (if issued for sequential
dispensing) if the practitioner changes
the medication and before the patient
can receive a new prescription, as
compared with simply destroying the
previous prescriptions. The commenter
asserted this would help to ensure that
the previously-issued prescriptions will
not be filled and diverted.
DEA response: Neither the CSA nor
the DEA regulations address what a
patient should do with an unfilled
prescription for a controlled substance.
Thus, regardless of whether the
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practitioner writes a single prescription
or issues multiple prescriptions at the
same time under the Final Rule being
issued today, there is no mandatory
procedure for handling unfilled
prescriptions. In all situations, however,
practitioners should use common sense
in determining what steps are
appropriate to prevent diversion in view
of the particular patient’s
circumstances. While not required
under the CSA or DEA regulations, it
would be acceptable—and may even be
the preferred practice—for a practitioner
to ask the patient to return unfilled
prescriptions for controlled substances,
or for a patient to voluntarily do so.
Pharmacies and dispensing of
sequential prescriptions: One
commenter recommended that DEA
clarify what a pharmacy is permitted to
do if a prescription is written for 30
days and the month has 31 days (e.g., a
prescription for 30 days with ‘‘Do not
fill’’ before dates of 10/18/yy, 11/18/yy,
12/18/yy, but October has 31 days). The
commenter also asked whether a
pharmacist who fills a sequential
prescription a day before the date stated
because the pharmacy will be closed on
the date the sequential prescription may
be filled (e.g., Sunday) would be
violating the regulation. Other
commenters asked similar questions as
to whether a pharmacist may fill
sequential prescriptions earlier than the
date specified by the prescribing
practitioner. One commenter requested
that DEA allow some language for a
pharmacist’s ‘‘good judgment’’ rather
than having as an absolute that
sequential prescriptions cannot be filled
before the ‘‘Do not fill’’ date. At the very
least, the commenter recommended that
DEA include a statement of its intent to
use enforcement discretion in these
cases. Two commenters recommended
that DEA clarify whether pharmacists
can fill a sequential prescription before
the ‘‘Do not fill’’ date (1) if the
practitioner has not been contacted and
(2) if the practitioner has been
contacted. Three commenters requested
that DEA clarify whether pharmacies are
held accountable for filling the
sequential prescriptions before the
indicated date. Two commenters
suggested that the Final Rule clarify any
implications or responsibilities for the
dispensing pharmacy.
DEA response: As explained in the
NPRM, the requirements contained in
the proposed rule were included to
ensure that the rule can be reconciled
with the text, purpose, and structure of
the CSA. This includes, but is not
limited to, adherence to the principles
of requiring a written prescription for a
schedule II controlled substance,
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maintaining clear accountability by
practitioners when prescribing
controlled substances, and ensuring
adequate safeguards to prevent
diversion and abuse. The Final Rule
being issued today states expressly that,
where a practitioner has issued multiple
prescriptions in accordance with the
rule, no pharmacist may fill any
prescription before the date specified by
the practitioner. The rule contains no
exceptions to this requirement. In
addition, because the CSA states that
prescriptions for schedule II controlled
substances must be written (21 U.S.C.
829(a)), the essential elements of the
prescription written by the practitioner
(such as the name of the controlled
substance, strength, dosage form, and
quantity prescribed, and—in the case of
multiple prescriptions under this Final
Rule—the earliest date on which the
prescription may be filled) may not be
modified orally.
Changes to Regulatory Text
Section 1306.12: Some commenters
suggested revising the proposed rule to
state that multiple prescriptions do not
constitute refills.
DEA response: DEA believes such a
revision is unnecessary as it is clear
from the text of the rule that it is
permissible to issue multiple
prescriptions in the manner specified in
the rule.
Use of the term ‘‘properly’’: Section
1306.12(b)(1)(i) of the proposed rule
read: ‘‘The individual practitioner
properly determines there is a legitimate
medical purpose for the patient to be
prescribed that controlled substance and
the individual practitioner is acting in
the usual course of professional
practice.’’ Several commenters
suggested removing the word
‘‘properly’’ here, asserting that the use
of the word ‘‘properly’’ in this context
is unclear or modifies the meaning of
the longstanding requirement that a
controlled substance be dispensed for a
legitimate medical purpose by a
practitioner acting in the usual course of
professional practice.
DEA response: Although the language
of the proposed rule was meant simply
to reiterate (and not modify) the
meaning of the longstanding
requirement that a controlled substance
be dispensed for a legitimate medical
purpose by a practitioner acting in the
usual course of professional practice,
DEA has decided to revise section
1306.12(b)(1)(i) in view of the
comments. Specifically, DEA has
revised this paragraph to more closely
track the pertinent language contained
in the longstanding regulation 21 CFR
1306.04(a). The paragraph being
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finalized today reads: ‘‘Each separate
prescription is issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
professional practice.’’
Section 1306.12(b)(1)(iii): Section
1306.12(b)(1)(iii) of the proposed rule
stated: ‘‘The individual practitioner
concludes that providing the patient
with multiple prescriptions in this
manner does not create an undue risk of
diversion or abuse.’’ Several
commenters objected to this provision,
asserting that its meaning is unclear or
that it imposes an undue burden on
practitioners to prevent diversion and
abuse. One commenter requested that
DEA state whether this imposes a new
standard on practitioners.
Eleven commenters recommended
deleting the paragraph in its entirety.
Commenters believed that the
practitioner cannot account for all
possible scenarios in making this
conclusion. Commenters stated that the
potential liability problem for
practitioners is that their conclusions
and prescribing actions could come into
question any time a patient was
implicated in abuse or diversion.
Commenters believed that practitioners
will waste valuable patient time
documenting why issuing sequential
prescriptions does not cause undue risk.
Commenters believed it could also
cause the unintended consequences of
practitioners avoiding prescribing a
medication the patient needs for fear of
liability in court. Commenters argued
that sequential prescriptions, in limiting
the quantity of controlled substances
prescribed at one time, supposedly
decrease the potential for abuse/
diversion.
DEA response: Since the inception of
the CSA, it has always been a
requirement that all DEA registrants
(manufacturers, distributors,
practitioners, pharmacies, researchers,
importers and exporters) take reasonable
steps to prevent their DEA registrations
from being used in a manner that results
in an undue risk of diversion. This
requirement is inherent in the CSA
registration provisions (21 U.S.C. 823)
as well as the DEA regulations. For
example, 21 CFR 1301.71 states: ‘‘All
* * * registrants shall provide effective
controls to guard against theft and
diversion of controlled substances.’’ It
bears emphasis that the Final Rule being
issued today in no way changes this
requirement. Under this Final Rule,
practitioners who prescribe controlled
substances are subject to the same
standard in preventing diversion as they
always have been under the CSA and
DEA regulations. Section
1306.12(b)(1)(iii) of this Final Rule is
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intended to make clear that a
practitioner may not simply comply
with the other requirements of this Final
Rule while turning a blind eye to
circumstances that might be indicative
of diversion. Thus, section
1306.12(b)(1)(iii) merely underscores
that the longstanding requirement of
providing effective controls against
diversion remains in effect when issuing
multiple schedule II prescriptions in
accordance with this Final Rule.
Further, as DEA stated in the Policy
Statement (71 FR 52716), published
alongside the NPRM, ‘‘one cannot
provide an exhaustive and foolproof list
of ‘dos and don’ts’ when it comes to
prescribing controlled substances for
pain or any other medical purpose.’’ Just
as DEA cannot provide an exhaustive
list of ‘‘dos and don’ts’’ to elaborate on
the phrase ‘‘legitimate medical purpose
in the usual course of professional
practice,’’ the agency cannot expand
upon the general requirement that
practitioners take reasonable steps to
prevent diversion by setting forth a list
of every hypothetical scenario a
practitioner might encounter along with
specific instructions on how the
practitioner should handle the situation.
DEA has an obligation to carry out all
regulatory requirements in a reasonable
manner, consistent with the governing
statutes enacted by Congress, and to
take into account all circumstances of
the particular case at issue. The agency
will do so with regard to all aspects of
this Final Rule, including section
1306.12(b)(1)(iii).
Section 1306.12(b)(2): Section
1306.12(b)(2) of the proposed rule
contained the statement:
Nothing in this paragraph (b) shall be
construed as mandating or encouraging
individual practitioners to issue multiple
prescriptions or to see their patients only
once every 90 days when prescribing
Schedule II controlled substances. Rather,
individual practitioners must determine on
their own, based on sound medical judgment,
and in accordance with established medical
standards, whether it is appropriate to issue
multiple prescriptions and how often to see
their patients when doing so.
In this context, two commenters
suggested deleting the words ‘‘in
accordance with established medical
standards.’’ The commenters indicated
they were not aware of any standards
that a practitioner could use to
determine whether it is appropriate to
issue multiple prescriptions.
DEA response: The requirement that a
prescription for a controlled substance
be issued in accordance with
established medical standards has been
an integral part of federal law for
decades and has been upheld by the
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United States Supreme Court.1 This
requirement applies to all controlled
substances and applies regardless of
whether a practitioner issues a single
prescription or multiple prescriptions in
accordance with this Final Rule.
Pharmacies and dispensing of
sequential prescriptions: In section
1306.14, Labeling of substances and
filling of prescriptions, DEA proposed
the following new paragraph (e):
‘‘Where a prescription that has been
prepared in accordance with section
1306.12(b) contains instructions from
the prescribing practitioner indicating
that the prescription shall not be filled
until a certain date, no pharmacist may
fill the prescription before that date.’’
One commenter suggested the
following additional language to section
1306.14(e): ‘‘No pharmacist or pharmacy
including mail order operations may
auto-fill any additional prescriptions for
schedule II drugs before verifying that
the patient is still in need of each
prescription refill.’’
DEA response: It has always been the
case under the CSA and DEA
regulations that a pharmacist who fills
a prescription for a controlled substance
has a corresponding responsibility to
ensure that the prescription was issued
for a legitimate medical purpose by an
individual practitioner acting in the
usual course of professional practice.
This requirement, which is set forth in
21 CFR 1306.04(a), is one of the primary
legal bases upon which pharmacists are
held accountable under the CSA. DEA
believes it is not necessary to modify or
expand upon this longstanding
requirement in the context of multiple
schedule II prescriptions, so long as the
prescribing and filling of such
prescriptions takes place in accordance
with all the provisions of this Final
Rule.
Other Issues
Electronically transmitted
prescriptions: Four commenters
recommended DEA allow electronically
transmitted prescriptions for controlled
substances.
DEA response: DEA notes that the
electronic prescribing of controlled
substances is outside the scope of this
rulemaking. DEA intends to address
electronic prescribing of controlled
substances in a separate future
rulemaking.
Authorization to use sequential
prescriptions prior to publication of
Final Rule: Two commenters requested
that DEA allow practitioners to begin
issuing multiple schedule II
1 United States v. Moore, 423 U.S. 122, 139–142
(1975).
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prescriptions based on the issuance of
the NPRM (without waiting for a Final
Rule to be published and to take effect).
DEA response: Under the
Administrative Procedure Act (APA),
when an agency seeks to impose a new
substantive rule that modifies legal
obligations of members of the public,
the agency must first engage in noticeand-comment rulemaking (5 U.S.C.
553(b)). The APA further provides that
substantive rules may not take effect
until at least 30 days after publication
of the final rule (5 U.S.C. 553(d)).
Exceptions to these procedural
requirements can be made only ‘‘when
the agency for good cause finds (and
incorporates the finding and a brief
statement of reasons therefor in the
rules issued) that notice and public
procedure thereon are impracticable,
unnecessary, or contrary to the public
interest’’ (5 U.S.C. 553(b)(B)). DEA has
not found that there is such a legal
justification to exempt this Final Rule
from the basic procedural requirements
of the APA. Accordingly, this Final Rule
does not take effect until the effective
date indicated herein (December 19,
2007).
Long Term Care Facilities: One
commenter asked if this rule will apply
to patients in long term care facilities.
DEA response: The DEA regulations
contain a variety of provisions relating
to the dispensing of controlled
substances at long term care facilities.
These provisions are unaltered by this
Final Rule. This Final Rule may be
utilized in the context of a long term
care facility, provided such activity
complies with any other applicable
provisions of the DEA regulations.
Miscellaneous: One commenter
recommended that DEA make one
federal rule regarding prescriptions to
supersede the many different state laws.
DEA response: Under the CSA,
Congress envisioned that the Federal
and State Governments would work in
tandem to regulate activities relating to
controlled substances. This is reflected
in 21 U.S.C. 903, which indicates that
Congress did not intend to preempt state
controlled substance laws, so long as
such state laws do not conflict with
federal law. Thus, each state may enact
controlled substance laws that go
beyond the requirements of the CSA,
provided such laws do not conflict with
the CSA. Given this aspect of the CSA,
it would not be appropriate for DEA to
seek to preempt or supersede state laws
relating to the prescribing of controlled
substances, provided such laws do not
conflict with the CSA or DEA
regulations.
One commenter suggested DEA work
with other federal agencies and national
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64927
professional medical societies to be
certain doctors are screening for
alcoholism and drug addiction in their
private medical practices as they are
prescribing schedule II controlled
substances in the treatment of legitimate
medical illnesses.
DEA response: DEA firmly supports
all efforts of practitioners to screen for
factors that might be indicative of
whether the patient may be likely to
seek controlled substances for purposes
of abuse or to satisfy an addiction.
However, such a consideration is
beyond the scope of this Final Rule.
Persons interested in such
considerations might wish to review the
Policy Statement, which was published
in the Federal Register alongside the
NPRM (71 FR 52716).
Three commenters recommended that
DEA explain existing law and the
impact of the new rule to health care
professionals, state attorneys general,
drug control officials, and professional
licensing and regulatory boards.
DEA response: DEA works
cooperatively with a wide variety of
organizations who have an interest in
the CSA and DEA regulations and
policies, including, but not limited to:
State Boards of Medicine and Boards of
Pharmacy; law enforcement; regulatory
and professional licensing authorities
and agencies; the pharmaceutical
industry; and professional organizations
representing prescribing and dispensing
practitioners. DEA meets regularly with
these organizations to discuss matters of
mutual concern. Included in these
meetings are discussions of DEA legal
and regulatory activities.
One commenter suggested allowing
partial filling of schedule II
prescriptions so as not to constitute a
refill.
DEA response: The DEA regulations
delineate the circumstances under
which the partial filling of a
prescription for a controlled substance
in schedule II is permissible (21 CFR
1306.13). Adherence to this aspect of
the DEA regulations serves a critical
function in preventing diversion of
schedule II controlled substances.
Accordingly, this Final Rule does not
modify the requirements of the DEA
regulations relating to the partial filling
of prescriptions.
Objections to Notice of Proposed
Rulemaking
Treatment of Pain Patients: Nineteen
commenters opposed the NPRM because
they believed that, for a patient who is
receiving controlled substances for the
treatment of pain, the practitioner
should see the patient more than once
every 90 days to properly monitor the
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patient’s condition and whether that
patient is responding well to the
medication. These commenters asserted
that such a patient should see the
practitioner every 30 days because
treatment for pain does not consist of
medication alone.
One commenter stated that he had a
family member who became addicted to
schedule II controlled substances that
were prescribed for pain and whose
quality of life diminished significantly
as a result. This commenter therefore
objected to ‘‘slackening the restrictions
on these highly addictive and
destructive drugs.’’
DEA response: DEA recognizes, as
these comments reflect, that some
practitioners believe that seeing a
patient who is receiving controlled
substances only once every 90 days is
inadequate. However, the CSA does not
expressly address how frequently a
practitioner must see a patient when
prescribing controlled substances. At
the same time, practitioners who
prescribe controlled substances must
see their patients in an appropriate time
and manner so as to meet their
obligation to prescribe only for a
legitimate medical purpose in the usual
course of professional practice and to
thereby minimize the likelihood that
patients will abuse, or become addicted
to, the controlled substances. In this
regard, section 1306.12(b)(2) of this
Final Rule states:
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Nothing in this section shall be construed
as mandating or encouraging individual
practitioners to issue multiple prescriptions
or to see their patients only once every 90
days when prescribing Schedule II controlled
substances. Rather, individual practitioners
must determine on their own, based on
sound medical judgment, and in accordance
with established medical standards, whether
it is appropriate to issue multiple
prescriptions and how often to see their
patients when doing so.
Diversion: One commenter opposed
the NPRM, asserting that a practitioner
cannot always tell whether he or she is
‘‘getting scammed’’ by a patient seeking
drugs for abuse. This commenter
suggested that, if a practitioner is being
deceived by such a patient, the harm
will be less if the prescription is only for
a 30-day supply of a controlled
substance (rather than a 90-day supply).
Another commenter opposed the NPRM
because the commenter believed that
drug abusers will change the dates on
the multiple prescriptions and have all
the multiple prescriptions filled at once
by different pharmacies. Another
commenter, who indicated she worked
in a pharmacy, expressed the view that
drug addicts will see multiple
practitioners in a 90-day period to
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obtain overlapping 90-day supplies of
schedule II controlled substances.
DEA response: It is true that, other
factors being equal, the diversion of a
90-day supply of controlled substances
causes greater harm than the diversion
of a 30-day supply. Likewise, the
adverse effects of any improper conduct
on the part of a drug-seeking patient
(such as ‘‘doctor shopping’’ or seeing
multiple prescribing practitioners) will
be magnified if the patient is receiving
a 90-day supply of a schedule II
controlled substance as opposed to a 30day supply. However, for the reasons
provided in responding to the preceding
comments, DEA believes it is
appropriate to allow for up to a 90-day
supply of schedule II controlled
substances under the conditions set
forth in this Final Rule—with the
understanding that 90 days is the upper
limit and by no means mandatory. To
the contrary, as this Final Rule
indicates, the practitioner must
determine on his/her own, on a case-bycase basis, based on sound medical
judgment, and in accordance with
established medical standards, the
appropriate amounts of schedule II
controlled substances to prescribe.
Possibility of increased pressure on
prescribing practitioners: Some
commenters expressed the view that
implementation of the proposed rule
will result in practitioners receiving an
increased number of ‘‘demands’’ by
patients to receive a 90-day supply of
controlled substances. As a result, these
commenters asserted practitioners might
feel undue pressure to prescribe a 90day supply of controlled substances at
each office visit.
DEA response: Given this important
concern, DEA repeats for emphasis the
following statement in this Final Rule:
Nothing in this [Final Rule] shall be
construed as mandating or encouraging
individual practitioners to issue multiple
prescriptions or to see their patients only
once every 90 days when prescribing
Schedule II controlled substances. Rather,
individual practitioners must determine on
their own, based on sound medical judgment,
and in accordance with established medical
standards, whether it is appropriate to issue
multiple prescriptions and how often to see
their patients when doing so.
It is indeed essential that practitioners
adhere to the above-quoted provision
and not simply—based on pressure from
patients or any other improper reason—
feel obligated to provide multiple
prescriptions totaling a 90-day supply of
schedule II controlled substances.
Toward this end, practitioners may wish
to refer their patients to the abovequoted provision if they believe doing
so will be beneficial.
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Appropriateness of this rule in view of
the extent of prescription controlled
substance abuse in the United States:
Among those commenters who objected
to the proposed rule, many pointed to
the alarming increase in prescription
controlled substance abuse in the
United States and resulting deaths and
harm to the public welfare. Such
commenters expressed the view that the
proposed rule—or any other lessening of
drug controls—will exacerbate the
problem.
DEA response: DEA shares the
concerns of those who are deeply
troubled by the increasing levels of
prescription controlled substance abuse
in the United States and the resulting
detriment to the public health and
welfare of the American people. DEA
addressed these concerns in depth in
the September 6, 2006, Policy Statement
that was published in conjunction with
the proposed rule, and the agency
encourages those interested in this topic
to review that document. To minimize
the likelihood that this Final Rule will
exacerbate the extensive problem of
prescription controlled substance abuse
in the United States, DEA has reiterated
in the text of the regulation several
important and longstanding legal
principles. Among these are the
requirements that ‘‘Each separate
prescription is issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
professional practice’’ and that ‘‘The
individual practitioner concludes that
providing the patient with multiple
prescriptions in this manner does not
create an undue risk of diversion or
abuse.’’ In addition, as stated repeatedly
above, nothing in this Final Rule shall
be construed as mandating or
encouraging individual practitioners to
issue multiple prescriptions or to see
their patients only once every 90 days
when prescribing schedule II controlled
substances; rather, individual
practitioners must determine on their
own, based on sound medical judgment,
and in accordance with established
medical standards, whether it is
appropriate to issue multiple
prescriptions and how often to see their
patients when doing so. It is with the
understanding that adherence to all of
these principles is essential that DEA
has concluded that implementation of
this Final Rule is consistent with the
overall structure of the CSA and DEA’s
mission.
Methadone: Among the commenters
who objected to the proposed rule,
several mentioned the prescribing of
methadone in particular and the
significant number of deaths that have
resulted from methadone abuse. These
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commenters expressed concern that the
proposed rule would lead to even more
deaths from methadone abuse.
DEA response: DEA shares the
concerns of those commenters who
pointed to the unique and significant
problems associated with methadone
abuse. In view of these concerns, DEA
repeats the following statement from the
September 6, 2006, Policy Statement
that was published in conjunction with
the proposed rule:
Methadone, a schedule II controlled
substance, has been approved by the [Food
and Drug Administration (FDA)] as an
analgesic. While a physician must have a
separate DEA registration to dispense
methadone for maintenance or detoxification,
no separate registration is required to
prescribe methadone for pain. However, in a
document entitled ‘‘Methadone-Associated
Mortality: Report of a National Assessment,’’
[The Department of Health and Human
Services, Substance Abuse and Mental
Health Services Administration] recently
recommended that ‘‘physicians need to
understand methadone’s pharmacology and
appropriate use, as well as specific
indications and cautions to consider when
deciding whether to use this medication in
the treatment of pain.’’ 2 This
recommendation was made in light of
mortality rates associated with methadone.
Since 2003, the FDA has issued
revised labeling for methadone
analgesic products, and physician
education and training curricula have
been developed for methadone
treatment.3 In 2007, SAMHSA convened
an expert panel to consider the
implications of methadone mortality.
Conclusion
As DEA discussed at the beginning of
this document, the vast majority of
comments received regarding this
rulemaking were supportive of its
adoption. Two hundred thirty-one of the
264 comments received supported this
action. As DEA noted previously, this
rulemaking was supported by a wide
variety of individuals and
organizations—medical professionals,
patient advocacy organizations, and
patients themselves. To reiterate, the
majority of commenters believed this
Final Rule would be beneficial from
both physical and financial
perspectives, citing the time and money
saved due to less frequent visits to
prescribing practitioners, and the
reduced physical toll resulting from the
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2 CSAT
Publication No. 28–03. Available at
https://dpt.samhsa.gov/medications/
methreports.aspx.
3 The FDA health advisory can be found at https://
www.fda.gov/cder/drug/advisory/methadone.htm
and the package insert can be found at https://
www.fda.gov/cder/foi/label/2006/
006134s028lbl.pdf.
VerDate Aug<31>2005
15:24 Nov 16, 2007
Jkt 214001
reduced visits. While many commenters
sought clarification regarding various
aspects of this rulemaking, it is
important to reiterate the
overwhelmingly positive reaction this
rule generated.
DEA, state authorities, practitioners,
and pharmacists all share a common
interest in ensuring that controlled
substances are prescribed for legitimate
medical purposes by prescribing
practitioners acting in the usual course
of professional practice. As discussed
throughout this document, DEA,
through its enforcement of the CSA and
its implementing regulations, must
prevent the diversion and abuse of
controlled substances while ensuring
that there is an adequate supply for
legitimate medical purposes. DEA
supports the intent of this Final Rule to
address patients’ needs for schedule II
controlled substances while preventing
the diversion of those substances. DEA
believes that this Final Rule provides an
option for practitioners to treat their
patients, which is legally permissible
and consistent with the text, structure,
and purposes of the CSA.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612), has reviewed this regulation,
and by approving it certifies that this
regulation will not have a significant
economic impact on a substantial
number of small entities. This rule
provides an additional option that
practitioners may utilize when
prescribing schedule II controlled
substances under certain circumstances.
The rule will not mandate any new
procedures. Therefore, a regulatory
flexibility analysis is not required for
this rule.
Executive Order 12866
The Deputy Administrator further
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866,
Regulatory Planning and Review,
Section 1(b). This rule has been deemed
a ‘‘significant regulatory action.’’
Accordingly, this rule has been
reviewed by the Office of Management
and Budget.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
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64929
Executive Order 13132
This rule does not preempt or modify
any provision of state law; nor does it
impose enforcement responsibilities on
any state; nor does it diminish the
power of any state to enforce its own
laws. Accordingly, this rulemaking does
not have federalism implications
warranting the application of Executive
Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act (Congressional Review
Act). This rule will not result in an
annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1306
Drug traffic control, Prescription
drugs.
I Pursuant to the authority vested in the
Attorney General under sections 201,
202, and 501(b) of the CSA (21 U.S.C.
811, 812, and 871(b)), delegated to the
Deputy Administrator pursuant to
section 501(a) (21 U.S.C. 871(a)) and as
specified in 28 CFR 0.100 and 0.104,
Appendix to Subpart R, the Deputy
Administrator hereby orders that Title
21 of the Code of Federal Regulations,
Part 1306, be amended as follows:
PART 1306—PRESCRIPTIONS
1. The authority citation for part 1306
continues to read as follows:
I
Authority: 21 U.S.C. 821, 829, 871(b),
unless otherwise noted.
2. Section 1306.12 is revised to read
as follows:
I
§ 1306.12 Refilling prescriptions; issuance
of multiple prescriptions.
(a) The refilling of a prescription for
a controlled substance listed in
Schedule II is prohibited.
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Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Rules and Regulations
(b)(1) An individual practitioner may
issue multiple prescriptions authorizing
the patient to receive a total of up to a
90-day supply of a Schedule II
controlled substance provided the
following conditions are met:
(i) Each separate prescription is
issued for a legitimate medical purpose
by an individual practitioner acting in
the usual course of professional
practice;
(ii) The individual practitioner
provides written instructions on each
prescription (other than the first
prescription, if the prescribing
practitioner intends for that prescription
to be filled immediately) indicating the
earliest date on which a pharmacy may
fill each prescription;
(iii) The individual practitioner
concludes that providing the patient
with multiple prescriptions in this
manner does not create an undue risk of
diversion or abuse;
(iv) The issuance of multiple
prescriptions as described in this
section is permissible under the
applicable state laws; and
(v) The individual practitioner
complies fully with all other applicable
requirements under the Act and these
regulations as well as any additional
requirements under state law.
(2) Nothing in this paragraph (b) shall
be construed as mandating or
encouraging individual practitioners to
issue multiple prescriptions or to see
their patients only once every 90 days
when prescribing Schedule II controlled
substances. Rather, individual
practitioners must determine on their
own, based on sound medical judgment,
and in accordance with established
medical standards, whether it is
appropriate to issue multiple
prescriptions and how often to see their
patients when doing so.
3. Section 1306.14 is amended by
adding a new paragraph (e) to read as
follows:
I
§ 1306.14 Labeling of substances and
filling of prescriptions.
*
*
*
*
(e) Where a prescription that has been
prepared in accordance with section
1306.12(b) contains instructions from
the prescribing practitioner indicating
that the prescription shall not be filled
until a certain date, no pharmacist may
fill the prescription before that date.
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*
Dated: November 7, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–22558 Filed 11–16–07; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF STATE
22 CFR Part 51
[Public Notice: 5991]
RIN 1400–AC28
Passports
Department of State.
Final rule.
AGENCY:
ACTION:
SUMMARY: This rule reorganizes,
restructures, and updates passport
regulations in order to make them easier
for users to access information, to better
reflect current practice and changes in
statutory authority, and to remove
outdated provisions. In general, the
revisions do not mark a departure from
current policy. Rather, the Department’s
intent is to bring greater clarity to
current passport policy and practice and
to present it in a less cumbersome way.
DATES: This rule becomes effective
February 1, 2008.
FOR FURTHER INFORMATION CONTACT:
Consuelo Pachon, Office of Passport
Policy, (202) 663–2662. Hearing- or
speech-impaired persons may use the
Telecommunications Devices for the
Deaf (TDD) by contacting the Federal
Information Relay Service at 1–800–
877–8339.
SUPPLEMENTARY INFORMATION: The
Department published a proposed rule,
with a request for comments, amending
and updating numerous sections of Part
51 of Title 22 of the Code of Federal
Regulations. The rule was discussed in
detail in Public Notice 5712, as were the
Department’s reasons for changes in the
regulation (Federal Register, March 7,
2007, 72 FR 10095). The comment
period closed on May 7, 2007. The
Department of State is now
promulgating its final rule. Some of the
more notable changes in the regulations
include: Changes regarding minors,
extending the two-parent consent and
personal appearance requirements to
minors under the age of 16; changes
regarding Passport Agents and Passport
Acceptance Agents, codifying the
definitions and clarifying their
qualifications and responsibilities,
including the requirement that they be
U.S. citizens or U.S. nationals
respectively; changes on denial,
revocation and restriction of passports
to permit the Department to deny a
passport, for example, to applicants who
are the subject of an outstanding State,
local, or foreign warrant of arrest for a
felony, intended to enhance U.S. law
enforcement and cooperation; and
changes regarding change of names on
passports, intended to clarify what is
required of an applicant whose name
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Frm 00012
Fmt 4700
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has changed and to reflect more
accurately Department practice in this
regard.
Subpart F remains under review and
may be addressed in a future
rulemaking. Public Notice 5712 further
advised that a separate rulemaking was
underway to amend Part 51 to introduce
the passport card and that comments
regarding the passport card would be
considered in that separate rulemaking,
which is ongoing. The final rule for the
passport card will include any
necessary renumbering of its sections
for compatibility with the numbering of
this overall revision, as well as language
modifications to take into account the
changes made in this Final Rule.
Analysis of Comments: The
Department received four (4) comments.
One comment expressed support of the
change to increase the maximum age
requiring two-parent consent for minors
from under 14 to under 16. A second
comment, addressed in detail below,
underscored the importance of
competent adjudicators, recommended
the Department always require
applicants to appear in person (rather
than permit mail-in procedures), and
suggested passport fees should be
considerably increased. The two
remaining comments concerned
passport fees and the proposed passport
card. Because issues regarding passport
fees and the passport card are addressed
in a separate rulemaking, the
Department will respond to these
comments at a later time.
One comment suggested that the
Department should always require that
a passport application be executed
personally rather than allowing
renewals by mail. The comment also
seemed to misunderstand the role of the
U.S. Postal Service and clerks of court,
who act as passport acceptance agents
but do not have the ability to adjudicate
and issue passports. The commenter
also opined that the passport
application process should be made
more difficult because passports are ‘‘as
easy to get as turning on a water faucet.’’
The passport application process for
first time passport applicants is
designed to verify the citizenship and
identity of the applicant. A U.S.
passport is, by definition, a citizenship
and identity document. U.S. citizens
may apply for subsequent passports by
mail within certain parameters
described in the regulations. This is an
acceptable practice because the
Department has previously thoroughly
reviewed and verified the applicant’s
citizenship and ensured that the
applicant’s identity is genuine.
Furthermore, fraud prevention measures
allow the Department to instantly
E:\FR\FM\19NOR1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Rules and Regulations]
[Pages 64921-64930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22558]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-287F]
RIN 1117-AB01
Issuance of Multiple Prescriptions for Schedule II Controlled
Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing a
Notice of Proposed Rulemaking published on September 6, 2006 (71 FR
52724). In that document, DEA proposed to amend its regulations to
allow practitioners to provide individual patients with multiple
prescriptions, to be filled sequentially, for the same schedule II
controlled substance, with such multiple prescriptions having the
combined effect of allowing a patient to receive over time up to a 90-
day supply of that controlled substance.
DATES: Effective Date: This rule is effective December 19, 2007.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
On September 6, 2006, the Drug Enforcement Administration (DEA)
published in the Federal Register a Notice of Proposed Rulemaking
(NPRM) (71 FR 52724) proposing to amend its regulations to allow
practitioners to provide individual patients with multiple
prescriptions, to be filled sequentially, for the same schedule II
controlled substance, with such multiple prescriptions having the
combined effect of allowing a patient to receive over time up to a 90-
day supply of that controlled substance.
Comments Received
DEA received 264 comments regarding the NPRM. Two hundred thirty-
one commenters supported the NPRM, 33 commenters opposed the
rulemaking. Commenters supporting the NPRM included six physician
associations, including those representing anesthesiologists,
pediatricians, and psychiatrists, and three state level licensing
organizations;
[[Page 64922]]
five nursing associations, including several nursing specialty
associations; 3 pharmacy associations and 6 state boards of pharmacy;
17 organizations focusing on the treatment of pain and end of life
issues; 8 other organizations; and individual commenters including 73
pain patients, 65 physicians or physicians' offices, 31 parents of
children with attention deficit disorder (ADD) or attention deficit
hyperactivity disorder (ADHD), 30 individual citizens, 16 pharmacists,
5 nurses, and 2 physician's assistants. Commenters opposing the NPRM
included 1 organization focusing on the treatment of pain; 17
individual citizens; 8 physicians; 3 pharmacists or pharmacy workers; 2
parents of pain patients; 1 nurse; and 1 physician's assistant.
The vast majority of commenters supported the rulemaking as
proposed, although some commenters suggested various changes or
requested clarification of certain issues. DEA has carefully considered
all comments received. An in-depth discussion of the issues raised by
commenters and DEA's responses to those comments follows.
Discussion of Comments
Of the 264 comments DEA received, 166 expressed approval of the
proposed rule without change. The remainder of the comments either
objected to the proposed rule or suggested modifications thereto. The
major issues raised by the commenters are addressed below.
Comments expressing approval of the proposed rule without change:
Commenters who expressed support for this rule represented a broad
variety of interest groups, medical professionals, pharmacists, and
patients. General comments regarding the support for this rule and the
benefits commenters believed it will have appear below.
Patients being treated for pain: Commenters who described
themselves as patients who receive controlled substances for the
treatment of pain were very supportive of implementation of the rule as
proposed. These commenters noted that the allowance for multiple
prescriptions would reduce the number of visits they would need to make
to practitioners, which would be beneficial financially. Many of these
patients indicated they are unemployed or underemployed due to their
medical conditions, and each additional visit to practitioners for the
purpose of receiving another prescription takes a financial toll on
them.
Among the patients who commented in support of the rule were those
who indicated that they live in rural areas. These commenters explained
that, currently, they must either drive to their practitioners, which
is difficult for them, or must find someone to drive them because they
cannot drive themselves due to their condition. They noted that
arranging rides is often difficult and that the drive to a practitioner
may be several hours each way. Some also stated that the trip is
expensive and that the length of the trip exacerbates their conditions.
According to these commenters, implementation of the proposed rule
would enable them to visit their prescribing practitioners less
frequently, thereby lessening the foregoing difficulties.
Parents of children receiving controlled substances: Commenters who
described themselves as parents of children with ADD or ADHD welcomed
the proposed rule. In their view, if the proposed rule is implemented,
they no longer will have to take their children to their prescribing
practitioners every month. As a result, they indicated they will be
able to take less time off from work and their children will have fewer
absences from school. Many of these commenters also noted that having
to make monthly visits to practitioners is especially burdensome to
single parents. These commenters also identified reduced costs as a
reason for their support of the proposed rule.
Prescribing practitioners: Commenters who identified themselves as
practitioners who prescribe controlled substances were, for the most
part, strongly supportive of the proposed rule. Many of these
commenters expressed the view that allowing the issuance of multiple
sequential prescriptions for schedule II controlled substances will
drastically reduce the work of the practitioners' offices and free up
valuable practitioner-patient time. Many also expressed the view that
for some of their patients whom they characterized as ``stable''
(including certain patients with chronic pain and ADD or ADHD), they
believe there is no medical need to see such patients every month. In
such cases, some of these commenters added they believe having to make
monthly visits to the practitioner is a hardship to patients who are
already suffering. It should be noted that some commenters who
identified themselves as practitioners expressed a sharply contrasting
view, asserting that patients who receive schedule II controlled
substances should be seen in person at least once a month to ensure
proper medical supervision and to lessen the likelihood of drug
addiction and abuse. This latter perspective of some commenting
practitioners is addressed further below.
Pharmacists: Commenters who identified themselves as pharmacists
were, for the most part, supportive of the proposed rule. These
commenters stated that issuing multiple prescriptions for sequential
filling for schedule II controlled substances would reduce the quantity
of those controlled substances dispensed to a patient at any one time.
They argued that this reduced quantity could reduce the potential for
abuse or diversion of these controlled substances. Some pharmacists
indicated they would be more comfortable dispensing these prescriptions
because of the more limited quantities dispensed.
90-day supply at one time: Sixteen commenters who supported the
NPRM, and six commenters who disagreed with the NPRM, believed that the
entire 90-day supply of controlled substances was available at one time
instead of in sequential prescriptions. Commenters who supported the
rule but believed that DEA is advocating the dispensing of a 90-day
supply of controlled substances at one time cited the ease of filling
prescriptions and obtaining reimbursement as reasons for their support.
Those who objected to the rule on this ground believed it would be more
difficult to monitor patients.
DEA response: In view of these comments, DEA wishes to make clear
that the NPRM did not advocate that physicians prescribe a 90-day
supply of controlled substances with a single prescription. Rather, the
NPRM stated that if a physician determines it is medically appropriate
to issue multiple schedule II prescriptions, the physician may provide
for up to a 90-day supply through the use of multiple schedule II
prescriptions under the conditions specified in the proposed rule.
As to the comment that DEA should allow multiple schedule II
prescriptions for unlimited days' worth of schedule II controlled
substances, as DEA explained in the NPRM, for the proposed rule to be
legally permissible, it must be consistent with the text, structure,
and purposes of the Controlled Substances Act (CSA). In this regard, 21
U.S.C. 829(a) states: ``No prescription for a controlled substance in
schedule II may be refilled.'' By comparison, subsection 829(b) states
that, for a schedule III or IV controlled substance, a prescription may
be refilled up to five times within six months after the date the
prescription was issued. Thus, Congress clearly mandated greater
prescription controls for schedule II substances than for schedule III
and IV substances. For example, a physician may--consistent with the
statute--issue a prescription for a schedule III or IV controlled
[[Page 64923]]
substance and indicate on the prescription a certain number of refills.
In this manner, a physician may provide a patient with up to a six-
month supply of a schedule III or IV controlled substance with a single
prescription indicating five refills. The same cannot be done with a
schedule II controlled substance since section 829(a) prohibits
refills. The statute requires a separate prescription if the physician
wishes to authorize a continuation of the patient's use of a schedule
II drug beyond the amount specified on the first prescription. Thus, if
DEA were to allow multiple prescriptions for an unlimited days' worth
of schedule II controlled substances, the controls for prescribing
schedule II controlled substances would be less stringent than for
schedule III and IV controlled substances--a result that would conflict
with the purpose and structure of the CSA. DEA believes that the 90-day
limit, under the terms specified in the proposed rule, strikes a fair
balance that takes into account the limitation imposed by Congress
under section 829 as well as the general structure of the statute,
which imposes greater controls for schedule II substances than those in
lower schedules.
Sequential filling of prescriptions, ``refills'': One commenter
opposed the NPRM because the commenter believed that sequential
prescriptions were ``refills'' which are not permitted by law. Two
commenters suggested writing all sequential prescriptions, which the
commenters referred to as ``refills,'' on one prescription. They
believed this would prevent the patient from changing the dates or
using multiple pharmacies to fill the prescriptions. Commenters also
believed this would eliminate the possibility of the patient claiming
that the original prescription had been lost and requesting replacement
prescriptions. Two commenters recommended allowing 90-day sequential
prescriptions on one prescription blank, but allowing the practitioner
to prescribe the intervals at which it would be filled, rather than
only permitting 30-day interval sequential fillings.
One commenter suggested writing a single prescription with two
``refills'' with the annotation ``Do not fill more frequently than once
a month.'' One commenter suggested permitting not more than two
``refills'' of a schedule II prescription, but requiring the use of
triplicate prescription blanks with one copy being sent to the state
and the second copy being sent to DEA. The commenter then suggested
that if a practitioner chose not to agree to this system, then the
practitioner would not be permitted to sequentially prescribe any
schedule II prescription. The commenter believed that this system would
prevent theft and loss.
DEA response: As discussed above, DEA believes that the proposed
rule takes into account the CSA prohibition on refilling prescriptions
for schedule II controlled substances in a manner consistent with the
overall framework of the Act. The use of multiple prescriptions for the
dispensing of schedule II controlled substances, under the conditions
set forth in this Final Rule, ensures that the prescriptions are
treated as separate dispensing documents, not refills of an original
prescription. As this Final Rule indicates, each separate prescription
must be written for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice, and the
practitioner must provide written instructions on each separate
prescription regarding the filling of that prescription.
Regarding the comment that suggested allowing the writing of a
single prescription with two ``refills'' with the annotation ``Do not
fill more frequently than once a month,'' this would conflict with the
CSA, which, as explained above, disallows the refilling of schedule II
prescriptions. As indicated in this Final Rule, when issuing multiple
prescriptions for a schedule II controlled substance, each of the
prescriptions to be filled sequentially must be written on a separate
prescription blank and must contain the information specified in this
Final Rule.
As for the suggestion that DEA require the use of triplicate
prescription blanks, DEA has never required triplicate prescription
blanks for prescriptions and believes, at this time, that the
requirements contained in this Final Rule provide adequate safeguards
against diversion, which render unnecessary the use of triplicate
prescription blanks. However, as with all newly promulgated
regulations, DEA will continue to monitor the situation to determine
whether additional modifications are needed to safeguard against
diversion. DEA recognizes that some states require the use of
triplicate prescriptions for some or all controlled substances. DEA
supports the efforts of states to take the specific action they deem
necessary to prevent the diversion of controlled substances within
their jurisdictions. This Final Rule expressly requires practitioners
to comply with all applicable provisions of state law when issuing
multiple schedule II prescriptions.
Federal law and schedule II controlled substances: Five commenters
requested written clarification that this rule is not intended to
change existing Federal law which does not limit the length of time for
which an individual prescription may be written or the total quantity,
including the number of dosage units, that may be prescribed at one
time. Further, two commenters suggested that DEA state, in the Final
Rule, that federal law does not address how frequently a practitioner
must see his patient, and that it remains within the practitioner's
reasonable medical judgment as to how frequently the practitioner sees
a patient.
Commenters requested that DEA clarify that the practitioner is not
required to see the patient every 30 days or at the end of 90 days. One
commenter requested that DEA clarify whether a practitioner is required
to see a patient after 90 days. Alternatively, the commenter inquired
as to whether the practitioner is permitted to write a new prescription
with ``Do not fill until'' and mail it to the patient or have the
patient pick it up if, in the prescribing practitioner's medical
judgment, the patient does not need to see the practitioner. One
commenter recommended DEA clarify whether it is DEA's intent to limit
any schedule II controlled substance prescription to only a 90-day
supply or, alternatively, to limit sequential schedule II prescriptions
written on the same day to a 90-day supply. One commenter requested
clarification as to whether the regulation limits the supply to 90 days
when only a single schedule II controlled substance prescription is
issued.
DEA response: As the NPRM made clear, the proposed rule in no way
changes longstanding federal law governing the issuance of
prescriptions for controlled substances. As stated in the NPRM: ``What
is required, in each instance where a physician issues a prescription
for any controlled substance, is that the physician properly determine
there is a legitimate medical purpose for the patient to be prescribed
that controlled substance and that the physician be acting in the usual
course of professional practice.'' (71 FR 52725, September 6, 2006).
Further, this Final Rule itself contains the following statement:
Nothing in this subsection shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions
or to see their patients only once every 90 days when prescribing
Schedule II controlled substances. Rather, individual practitioners
must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is
appropriate to issue
[[Page 64924]]
multiple prescriptions and how often to see their patients when
doing so.
In addition, in the August 26, 2005, ``Clarification of Existing
Requirements Under the Controlled Substances Act for Prescribing
Controlled Substances'' (70 FR 50408), DEA stated the following:
The CSA and DEA regulations contain no specific limit on the
number of days worth of a schedule II controlled substance that a
physician may authorize per prescription. Some states, however, do
impose specific limits on the amount of a schedule II controlled
substance that may be prescribed. Any limitations imposed by state
law apply in addition to the corresponding requirements under
Federal law, so long as the state requirements do not conflict with
or contravene the Federal requirements. 21 U.S.C. 903. Again, the
essential requirement under Federal law is that the prescription for
a controlled substance be issued for a legitimate medical purpose in
the usual course of professional practice. In addition, physicians
and pharmacies have a duty as DEA registrants to ensure that their
prescribing and dispensing of controlled substances occur in a
manner consistent with effective controls against diversion and
misuse, taking into account the nature of the drug being prescribed.
21 U.S.C. 823(f).
This Final Rule does not change any of the foregoing principles of
the CSA and DEA regulations.
Effective date of prescription: Two commenters requested that DEA
clarify the effective date of a sequential prescription for a schedule
II controlled substance. Some commenters pointed out that some states
stipulate ``effective dates'' for prescriptions, noting that these
states have laws which require that, to be valid, prescriptions must be
filled within a certain time after they are written, and that these
time limits differ by state. Some commenters noted that if the time
limit starts on the date all the sequential prescriptions are written,
then it cannot be used in some states. If the effective date starts on
the ``Do not fill until'' date on the second and third prescriptions,
then it will be valid in many more states.
Three commenters requested clarification as to whether it is
legally permissible for a practitioner to issue a single prescription
with ``Do not fill before [date],'' in which the ``Do not fill'' date
is, for example, 7-10 days in the future.
DEA response: Neither the CSA nor the DEA regulations use the term
``effective date'' for a prescription. The DEA regulations require that
all prescriptions for controlled substances ``be dated as of, and
signed on, the day when issued.'' 21 CFR 1306.05(a). This Final Rule
does not amend the regulations regarding the date of issuance of a
prescription.
Under longstanding federal law and DEA regulations, there is no
express requirement that a prescription be filled within a certain time
after it was issued. The proposed rule likewise contained no such
express requirement, as DEA believes that the requirements contained in
the proposed rule provided adequate safeguards against diversion. At
the same time, the proposed rule made clear that the issuance of
multiple prescriptions is permissible only if ``the individual
practitioner complies fully with all other applicable requirements
under the [CSA] and [DEA] regulations as well as any additional
requirements under state law.'' (71 FR 52726). To make this point
unambiguous, the NPRM also stated that ``nothing in this proposed rule
changes the requirement that physicians must also abide by the laws of
the states in which they practice and any additional requirements
imposed by their state medical boards with respect to proper
prescribing practices and what constitutes a bona fide physician-
patient relationship.'' (71 FR 52725).
The proposed rule did not address whether a single prescription
with ``Do not fill before [date]'' instructions is permissible. Nor
does any existing provision of the CSA or DEA regulations address this
type of prescribing. Accordingly, there is no prohibition on doing so
under the CSA or DEA regulations, provided the practitioner otherwise
complies fully with all applicable requirements of federal and state
law.
Insurance reimbursement considerations: Four commenters requested
further relaxation of the regulations to allow a 90-day supply of
schedule II controlled substances to be dispensed at one time because,
these commenters asserted, this would significantly decrease the cost
of the medications to the patients through their health insurance. One
commenter also recommended permitting the pharmacy to dispense a 90-day
supply on one prescription, making it available in 30-day intervals,
but allowing the patient to pay for the entire supply at one time to
save on the cost of the medication.
DEA response: It is beyond the scope of DEA's authority under the
CSA to take regulatory action for the specific purpose of affecting the
manner in which patients pay for the medications or the manner in which
insurance providers reimburse patients for such costs. As mentioned
previously, the CSA and DEA regulations contain no specific limit on
the number of days' worth of a schedule II controlled substance that a
practitioner may authorize per prescription.
Limitations regarding certain medications: Three commenters
supported the use of sequential prescriptions specifically for schedule
II controlled substances used to treat ADD or ADHD, but disagreed with
the use of sequential prescriptions for schedule II controlled
substances used in the treatment of pain. Commenters believed pain
patients should be seen and evaluated every 30 days and have
medications prescribed at that time. One commenter requested that DEA
include explicit language indicating that this regulation is applicable
to all patients being treated for ADHD with stimulant medications.
Conversely, one commenter supported the use of sequential
prescriptions only for narcotic schedule II controlled substances, or
pain medications.
Another commenter suggested rescheduling methylphenidate and
amphetamines, except methamphetamine, to separate them from pain
medications because the two populations for ADHD medications and pain
medications are different.
DEA response: This rule pertains to all schedule II controlled
substances, not just those substances intended or approved to treat
certain conditions. As DEA stated in the September 6, 2006, Policy
Statement published in conjunction with the Notice of Proposed
Rulemaking (71 FR 52716), it is certainly appropriate for prescribing
practitioners and medical oversight boards to explore questions
regarding appropriate treatment regimens for particular categories of
controlled substances. Moreover, it might indeed be beneficial toward
preventing diversion and abuse of controlled substances for prescribing
practitioners to see patients at regular intervals when prescribing
certain controlled substances for certain medical conditions. However,
as the Policy Statement made clear, DEA does not regulate the general
practice of medicine and the agency lacks the authority to issue
guidelines that constitute advice on the general practice of medicine.
DEA wishes to reiterate the general principle that the prescribing
practitioner must properly determine there is a legitimate medical
purpose for the patient to be prescribed the controlled substance and
must be acting in the usual course of professional practice. Similarly,
a pharmacy has a corresponding responsibility in this regard.
Regarding the comment suggesting the rescheduling of certain
schedule II
[[Page 64925]]
controlled substances based on the conditions and populations which
they are intended to treat, DEA notes that scheduling of controlled
substances is based on scientific determinations regarding the
substance's potential for abuse, its potential for psychological and
physical dependence, and whether the substance has a currently accepted
medical use in treatment in the United States (21 U.S.C. 812(b)). DEA
may not reschedule a substance merely based on the population it is
intended or approved to treat.
Language on sequential prescriptions: Two commenters suggested not
limiting the language on the prescription to ``Do not fill before
[date].'' These commenters suggested other alternatives including ``Do
not fill until xx/xx/xxxx,'' and ``Fill on xx/xx/xxxx.'' Five
commenters requested that DEA provide examples of acceptable language
in the Final Rule. One commenter suggested requiring a standardized
method for dating prescriptions, and considering prescriptions void if
that standard is not adhered to. Another commenter recommended that
specific indication should be provided regarding sequential
prescriptions by including ``1 of 3,'' ``2 of 3,'' and ``3 of 3'' on
the prescriptions.
DEA response: The Final Rule states that the individual
practitioner must ``[provide] written instructions on each prescription
(other than the first prescription, if the prescribing practitioner
intends for that prescription to be filled immediately) indicating the
earliest date on which a pharmacy may fill each prescription.'' The
commenters have correctly observed that this provision does not mandate
that the practitioner use any particular language in the instructions
on the sequential prescriptions, so long as such instructions make
clear what is the earliest date on which the pharmacy may fill each
prescription. DEA believes this is a sufficiently clear rule that
practitioners will be able to understand and carry it out and,
therefore, it is unnecessary to insist on a particular scripted
approach. Likewise, under this Final Rule, a practitioner may--but is
not required to--do as the commenter suggested and write on the
sequential prescriptions, ``1 of 3,'' ``2 of 3,'' and ``3 of 3'', so
long as each prescription complies fully with all the requirements of
this Final Rule, including that it contains specific instructions
regarding the earliest date on which the sequential prescription may be
filled.
One commenter recommended that the practitioner write in his/her
own handwriting in blue ink ``Do not fill until [date].''
DEA response: DEA appreciates that the underlying intent of this
comment is to ensure that the ``Do not fill until [date]'' instructions
were actually written by the practitioner, as opposed to being the
result of forgery. While DEA supports all efforts of practitioners to
take steps to prevent forgery in the context of prescriptions, the
agency believes it is unnecessary to adopt the particular added
requirement suggested by this commenter.
One commenter recommended that certain diagnostic codes, known as
ICD-9 codes, should be written by the practitioner in their own
handwriting on the face of the prescription.
DEA response: DEA has not previously required that prescriptions
contain such diagnostic information, and the agency does not believe
that such requirement is necessary to prevent diversion and abuse of
controlled substances when issuing multiple prescriptions in accordance
with the rule being issued today.
Post-dating of prescriptions: One commenter recommended allowing
post-dated prescriptions so the practitioner does not have to use space
on the prescription blank for the phrase ``Do not fill before [date].''
DEA response: The DEA regulations have always required that all
prescriptions for controlled substances ``be dated as of, and signed
on, the day when issued.'' 21 CFR 1306.05(a). This requirement is
essential to monitor compliance with all provisions of the CSA and DEA
regulations relating to the prescribing and dispensing of controlled
substances, including (but not limited to) the requirement that a
controlled substance be dispensed, including prescribed, only for a
legitimate medical purpose by a practitioner acting in the usual course
of professional practice. Accordingly, it would be inappropriate to
allow post-dating of prescriptions under any circumstance, including
when issuing multiple prescriptions under the Final Rule being issued
today.
Return of unfilled prescriptions: One commenter suggested that a
patient return to the practitioner unfilled prescriptions (if issued
for sequential dispensing) if the practitioner changes the medication
and before the patient can receive a new prescription, as compared with
simply destroying the previous prescriptions. The commenter asserted
this would help to ensure that the previously-issued prescriptions will
not be filled and diverted.
DEA response: Neither the CSA nor the DEA regulations address what
a patient should do with an unfilled prescription for a controlled
substance. Thus, regardless of whether the practitioner writes a single
prescription or issues multiple prescriptions at the same time under
the Final Rule being issued today, there is no mandatory procedure for
handling unfilled prescriptions. In all situations, however,
practitioners should use common sense in determining what steps are
appropriate to prevent diversion in view of the particular patient's
circumstances. While not required under the CSA or DEA regulations, it
would be acceptable--and may even be the preferred practice--for a
practitioner to ask the patient to return unfilled prescriptions for
controlled substances, or for a patient to voluntarily do so.
Pharmacies and dispensing of sequential prescriptions: One
commenter recommended that DEA clarify what a pharmacy is permitted to
do if a prescription is written for 30 days and the month has 31 days
(e.g., a prescription for 30 days with ``Do not fill'' before dates of
10/18/yy, 11/18/yy, 12/18/yy, but October has 31 days). The commenter
also asked whether a pharmacist who fills a sequential prescription a
day before the date stated because the pharmacy will be closed on the
date the sequential prescription may be filled (e.g., Sunday) would be
violating the regulation. Other commenters asked similar questions as
to whether a pharmacist may fill sequential prescriptions earlier than
the date specified by the prescribing practitioner. One commenter
requested that DEA allow some language for a pharmacist's ``good
judgment'' rather than having as an absolute that sequential
prescriptions cannot be filled before the ``Do not fill'' date. At the
very least, the commenter recommended that DEA include a statement of
its intent to use enforcement discretion in these cases. Two commenters
recommended that DEA clarify whether pharmacists can fill a sequential
prescription before the ``Do not fill'' date (1) if the practitioner
has not been contacted and (2) if the practitioner has been contacted.
Three commenters requested that DEA clarify whether pharmacies are held
accountable for filling the sequential prescriptions before the
indicated date. Two commenters suggested that the Final Rule clarify
any implications or responsibilities for the dispensing pharmacy.
DEA response: As explained in the NPRM, the requirements contained
in the proposed rule were included to ensure that the rule can be
reconciled with the text, purpose, and structure of the CSA. This
includes, but is not limited to, adherence to the principles of
requiring a written prescription for a schedule II controlled
substance,
[[Page 64926]]
maintaining clear accountability by practitioners when prescribing
controlled substances, and ensuring adequate safeguards to prevent
diversion and abuse. The Final Rule being issued today states expressly
that, where a practitioner has issued multiple prescriptions in
accordance with the rule, no pharmacist may fill any prescription
before the date specified by the practitioner. The rule contains no
exceptions to this requirement. In addition, because the CSA states
that prescriptions for schedule II controlled substances must be
written (21 U.S.C. 829(a)), the essential elements of the prescription
written by the practitioner (such as the name of the controlled
substance, strength, dosage form, and quantity prescribed, and--in the
case of multiple prescriptions under this Final Rule--the earliest date
on which the prescription may be filled) may not be modified orally.
Changes to Regulatory Text
Section 1306.12: Some commenters suggested revising the proposed
rule to state that multiple prescriptions do not constitute refills.
DEA response: DEA believes such a revision is unnecessary as it is
clear from the text of the rule that it is permissible to issue
multiple prescriptions in the manner specified in the rule.
Use of the term ``properly'': Section 1306.12(b)(1)(i) of the
proposed rule read: ``The individual practitioner properly determines
there is a legitimate medical purpose for the patient to be prescribed
that controlled substance and the individual practitioner is acting in
the usual course of professional practice.'' Several commenters
suggested removing the word ``properly'' here, asserting that the use
of the word ``properly'' in this context is unclear or modifies the
meaning of the longstanding requirement that a controlled substance be
dispensed for a legitimate medical purpose by a practitioner acting in
the usual course of professional practice.
DEA response: Although the language of the proposed rule was meant
simply to reiterate (and not modify) the meaning of the longstanding
requirement that a controlled substance be dispensed for a legitimate
medical purpose by a practitioner acting in the usual course of
professional practice, DEA has decided to revise section
1306.12(b)(1)(i) in view of the comments. Specifically, DEA has revised
this paragraph to more closely track the pertinent language contained
in the longstanding regulation 21 CFR 1306.04(a). The paragraph being
finalized today reads: ``Each separate prescription is issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of professional practice.''
Section 1306.12(b)(1)(iii): Section 1306.12(b)(1)(iii) of the
proposed rule stated: ``The individual practitioner concludes that
providing the patient with multiple prescriptions in this manner does
not create an undue risk of diversion or abuse.'' Several commenters
objected to this provision, asserting that its meaning is unclear or
that it imposes an undue burden on practitioners to prevent diversion
and abuse. One commenter requested that DEA state whether this imposes
a new standard on practitioners.
Eleven commenters recommended deleting the paragraph in its
entirety. Commenters believed that the practitioner cannot account for
all possible scenarios in making this conclusion. Commenters stated
that the potential liability problem for practitioners is that their
conclusions and prescribing actions could come into question any time a
patient was implicated in abuse or diversion. Commenters believed that
practitioners will waste valuable patient time documenting why issuing
sequential prescriptions does not cause undue risk. Commenters believed
it could also cause the unintended consequences of practitioners
avoiding prescribing a medication the patient needs for fear of
liability in court. Commenters argued that sequential prescriptions, in
limiting the quantity of controlled substances prescribed at one time,
supposedly decrease the potential for abuse/diversion.
DEA response: Since the inception of the CSA, it has always been a
requirement that all DEA registrants (manufacturers, distributors,
practitioners, pharmacies, researchers, importers and exporters) take
reasonable steps to prevent their DEA registrations from being used in
a manner that results in an undue risk of diversion. This requirement
is inherent in the CSA registration provisions (21 U.S.C. 823) as well
as the DEA regulations. For example, 21 CFR 1301.71 states: ``All * * *
registrants shall provide effective controls to guard against theft and
diversion of controlled substances.'' It bears emphasis that the Final
Rule being issued today in no way changes this requirement. Under this
Final Rule, practitioners who prescribe controlled substances are
subject to the same standard in preventing diversion as they always
have been under the CSA and DEA regulations. Section 1306.12(b)(1)(iii)
of this Final Rule is intended to make clear that a practitioner may
not simply comply with the other requirements of this Final Rule while
turning a blind eye to circumstances that might be indicative of
diversion. Thus, section 1306.12(b)(1)(iii) merely underscores that the
longstanding requirement of providing effective controls against
diversion remains in effect when issuing multiple schedule II
prescriptions in accordance with this Final Rule.
Further, as DEA stated in the Policy Statement (71 FR 52716),
published alongside the NPRM, ``one cannot provide an exhaustive and
foolproof list of `dos and don'ts' when it comes to prescribing
controlled substances for pain or any other medical purpose.'' Just as
DEA cannot provide an exhaustive list of ``dos and don'ts'' to
elaborate on the phrase ``legitimate medical purpose in the usual
course of professional practice,'' the agency cannot expand upon the
general requirement that practitioners take reasonable steps to prevent
diversion by setting forth a list of every hypothetical scenario a
practitioner might encounter along with specific instructions on how
the practitioner should handle the situation. DEA has an obligation to
carry out all regulatory requirements in a reasonable manner,
consistent with the governing statutes enacted by Congress, and to take
into account all circumstances of the particular case at issue. The
agency will do so with regard to all aspects of this Final Rule,
including section 1306.12(b)(1)(iii).
Section 1306.12(b)(2): Section 1306.12(b)(2) of the proposed rule
contained the statement:
Nothing in this paragraph (b) shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions
or to see their patients only once every 90 days when prescribing
Schedule II controlled substances. Rather, individual practitioners
must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see
their patients when doing so.
In this context, two commenters suggested deleting the words ``in
accordance with established medical standards.'' The commenters
indicated they were not aware of any standards that a practitioner
could use to determine whether it is appropriate to issue multiple
prescriptions.
DEA response: The requirement that a prescription for a controlled
substance be issued in accordance with established medical standards
has been an integral part of federal law for decades and has been
upheld by the
[[Page 64927]]
United States Supreme Court.\1\ This requirement applies to all
controlled substances and applies regardless of whether a practitioner
issues a single prescription or multiple prescriptions in accordance
with this Final Rule.
---------------------------------------------------------------------------
\1\ United States v. Moore, 423 U.S. 122, 139-142 (1975).
---------------------------------------------------------------------------
Pharmacies and dispensing of sequential prescriptions: In section
1306.14, Labeling of substances and filling of prescriptions, DEA
proposed the following new paragraph (e): ``Where a prescription that
has been prepared in accordance with section 1306.12(b) contains
instructions from the prescribing practitioner indicating that the
prescription shall not be filled until a certain date, no pharmacist
may fill the prescription before that date.''
One commenter suggested the following additional language to
section 1306.14(e): ``No pharmacist or pharmacy including mail order
operations may auto-fill any additional prescriptions for schedule II
drugs before verifying that the patient is still in need of each
prescription refill.''
DEA response: It has always been the case under the CSA and DEA
regulations that a pharmacist who fills a prescription for a controlled
substance has a corresponding responsibility to ensure that the
prescription was issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of professional
practice. This requirement, which is set forth in 21 CFR 1306.04(a), is
one of the primary legal bases upon which pharmacists are held
accountable under the CSA. DEA believes it is not necessary to modify
or expand upon this longstanding requirement in the context of multiple
schedule II prescriptions, so long as the prescribing and filling of
such prescriptions takes place in accordance with all the provisions of
this Final Rule.
Other Issues
Electronically transmitted prescriptions: Four commenters
recommended DEA allow electronically transmitted prescriptions for
controlled substances.
DEA response: DEA notes that the electronic prescribing of
controlled substances is outside the scope of this rulemaking. DEA
intends to address electronic prescribing of controlled substances in a
separate future rulemaking.
Authorization to use sequential prescriptions prior to publication
of Final Rule: Two commenters requested that DEA allow practitioners to
begin issuing multiple schedule II prescriptions based on the issuance
of the NPRM (without waiting for a Final Rule to be published and to
take effect).
DEA response: Under the Administrative Procedure Act (APA), when an
agency seeks to impose a new substantive rule that modifies legal
obligations of members of the public, the agency must first engage in
notice-and-comment rulemaking (5 U.S.C. 553(b)). The APA further
provides that substantive rules may not take effect until at least 30
days after publication of the final rule (5 U.S.C. 553(d)). Exceptions
to these procedural requirements can be made only ``when the agency for
good cause finds (and incorporates the finding and a brief statement of
reasons therefor in the rules issued) that notice and public procedure
thereon are impracticable, unnecessary, or contrary to the public
interest'' (5 U.S.C. 553(b)(B)). DEA has not found that there is such a
legal justification to exempt this Final Rule from the basic procedural
requirements of the APA. Accordingly, this Final Rule does not take
effect until the effective date indicated herein (December 19, 2007).
Long Term Care Facilities: One commenter asked if this rule will
apply to patients in long term care facilities.
DEA response: The DEA regulations contain a variety of provisions
relating to the dispensing of controlled substances at long term care
facilities. These provisions are unaltered by this Final Rule. This
Final Rule may be utilized in the context of a long term care facility,
provided such activity complies with any other applicable provisions of
the DEA regulations.
Miscellaneous: One commenter recommended that DEA make one federal
rule regarding prescriptions to supersede the many different state
laws.
DEA response: Under the CSA, Congress envisioned that the Federal
and State Governments would work in tandem to regulate activities
relating to controlled substances. This is reflected in 21 U.S.C. 903,
which indicates that Congress did not intend to preempt state
controlled substance laws, so long as such state laws do not conflict
with federal law. Thus, each state may enact controlled substance laws
that go beyond the requirements of the CSA, provided such laws do not
conflict with the CSA. Given this aspect of the CSA, it would not be
appropriate for DEA to seek to preempt or supersede state laws relating
to the prescribing of controlled substances, provided such laws do not
conflict with the CSA or DEA regulations.
One commenter suggested DEA work with other federal agencies and
national professional medical societies to be certain doctors are
screening for alcoholism and drug addiction in their private medical
practices as they are prescribing schedule II controlled substances in
the treatment of legitimate medical illnesses.
DEA response: DEA firmly supports all efforts of practitioners to
screen for factors that might be indicative of whether the patient may
be likely to seek controlled substances for purposes of abuse or to
satisfy an addiction. However, such a consideration is beyond the scope
of this Final Rule. Persons interested in such considerations might
wish to review the Policy Statement, which was published in the Federal
Register alongside the NPRM (71 FR 52716).
Three commenters recommended that DEA explain existing law and the
impact of the new rule to health care professionals, state attorneys
general, drug control officials, and professional licensing and
regulatory boards.
DEA response: DEA works cooperatively with a wide variety of
organizations who have an interest in the CSA and DEA regulations and
policies, including, but not limited to: State Boards of Medicine and
Boards of Pharmacy; law enforcement; regulatory and professional
licensing authorities and agencies; the pharmaceutical industry; and
professional organizations representing prescribing and dispensing
practitioners. DEA meets regularly with these organizations to discuss
matters of mutual concern. Included in these meetings are discussions
of DEA legal and regulatory activities.
One commenter suggested allowing partial filling of schedule II
prescriptions so as not to constitute a refill.
DEA response: The DEA regulations delineate the circumstances under
which the partial filling of a prescription for a controlled substance
in schedule II is permissible (21 CFR 1306.13). Adherence to this
aspect of the DEA regulations serves a critical function in preventing
diversion of schedule II controlled substances. Accordingly, this Final
Rule does not modify the requirements of the DEA regulations relating
to the partial filling of prescriptions.
Objections to Notice of Proposed Rulemaking
Treatment of Pain Patients: Nineteen commenters opposed the NPRM
because they believed that, for a patient who is receiving controlled
substances for the treatment of pain, the practitioner should see the
patient more than once every 90 days to properly monitor the
[[Page 64928]]
patient's condition and whether that patient is responding well to the
medication. These commenters asserted that such a patient should see
the practitioner every 30 days because treatment for pain does not
consist of medication alone.
One commenter stated that he had a family member who became
addicted to schedule II controlled substances that were prescribed for
pain and whose quality of life diminished significantly as a result.
This commenter therefore objected to ``slackening the restrictions on
these highly addictive and destructive drugs.''
DEA response: DEA recognizes, as these comments reflect, that some
practitioners believe that seeing a patient who is receiving controlled
substances only once every 90 days is inadequate. However, the CSA does
not expressly address how frequently a practitioner must see a patient
when prescribing controlled substances. At the same time, practitioners
who prescribe controlled substances must see their patients in an
appropriate time and manner so as to meet their obligation to prescribe
only for a legitimate medical purpose in the usual course of
professional practice and to thereby minimize the likelihood that
patients will abuse, or become addicted to, the controlled substances.
In this regard, section 1306.12(b)(2) of this Final Rule states:
Nothing in this section shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions
or to see their patients only once every 90 days when prescribing
Schedule II controlled substances. Rather, individual practitioners
must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see
their patients when doing so.
Diversion: One commenter opposed the NPRM, asserting that a
practitioner cannot always tell whether he or she is ``getting
scammed'' by a patient seeking drugs for abuse. This commenter
suggested that, if a practitioner is being deceived by such a patient,
the harm will be less if the prescription is only for a 30-day supply
of a controlled substance (rather than a 90-day supply). Another
commenter opposed the NPRM because the commenter believed that drug
abusers will change the dates on the multiple prescriptions and have
all the multiple prescriptions filled at once by different pharmacies.
Another commenter, who indicated she worked in a pharmacy, expressed
the view that drug addicts will see multiple practitioners in a 90-day
period to obtain overlapping 90-day supplies of schedule II controlled
substances.
DEA response: It is true that, other factors being equal, the
diversion of a 90-day supply of controlled substances causes greater
harm than the diversion of a 30-day supply. Likewise, the adverse
effects of any improper conduct on the part of a drug-seeking patient
(such as ``doctor shopping'' or seeing multiple prescribing
practitioners) will be magnified if the patient is receiving a 90-day
supply of a schedule II controlled substance as opposed to a 30-day
supply. However, for the reasons provided in responding to the
preceding comments, DEA believes it is appropriate to allow for up to a
90-day supply of schedule II controlled substances under the conditions
set forth in this Final Rule--with the understanding that 90 days is
the upper limit and by no means mandatory. To the contrary, as this
Final Rule indicates, the practitioner must determine on his/her own,
on a case-by-case basis, based on sound medical judgment, and in
accordance with established medical standards, the appropriate amounts
of schedule II controlled substances to prescribe.
Possibility of increased pressure on prescribing practitioners:
Some commenters expressed the view that implementation of the proposed
rule will result in practitioners receiving an increased number of
``demands'' by patients to receive a 90-day supply of controlled
substances. As a result, these commenters asserted practitioners might
feel undue pressure to prescribe a 90-day supply of controlled
substances at each office visit.
DEA response: Given this important concern, DEA repeats for
emphasis the following statement in this Final Rule:
Nothing in this [Final Rule] shall be construed as mandating or
encouraging individual practitioners to issue multiple prescriptions
or to see their patients only once every 90 days when prescribing
Schedule II controlled substances. Rather, individual practitioners
must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is
appropriate to issue multiple prescriptions and how often to see
their patients when doing so.
It is indeed essential that practitioners adhere to the above-
quoted provision and not simply--based on pressure from patients or any
other improper reason--feel obligated to provide multiple prescriptions
totaling a 90-day supply of schedule II controlled substances. Toward
this end, practitioners may wish to refer their patients to the above-
quoted provision if they believe doing so will be beneficial.
Appropriateness of this rule in view of the extent of prescription
controlled substance abuse in the United States: Among those commenters
who objected to the proposed rule, many pointed to the alarming
increase in prescription controlled substance abuse in the United
States and resulting deaths and harm to the public welfare. Such
commenters expressed the view that the proposed rule--or any other
lessening of drug controls--will exacerbate the problem.
DEA response: DEA shares the concerns of those who are deeply
troubled by the increasing levels of prescription controlled substance
abuse in the United States and the resulting detriment to the public
health and welfare of the American people. DEA addressed these concerns
in depth in the September 6, 2006, Policy Statement that was published
in conjunction with the proposed rule, and the agency encourages those
interested in this topic to review that document. To minimize the
likelihood that this Final Rule will exacerbate the extensive problem
of prescription controlled substance abuse in the United States, DEA
has reiterated in the text of the regulation several important and
longstanding legal principles. Among these are the requirements that
``Each separate prescription is issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of
professional practice'' and that ``The individual practitioner
concludes that providing the patient with multiple prescriptions in
this manner does not create an undue risk of diversion or abuse.'' In
addition, as stated repeatedly above, nothing in this Final Rule shall
be construed as mandating or encouraging individual practitioners to
issue multiple prescriptions or to see their patients only once every
90 days when prescribing schedule II controlled substances; rather,
individual practitioners must determine on their own, based on sound
medical judgment, and in accordance with established medical standards,
whether it is appropriate to issue multiple prescriptions and how often
to see their patients when doing so. It is with the understanding that
adherence to all of these principles is essential that DEA has
concluded that implementation of this Final Rule is consistent with the
overall structure of the CSA and DEA's mission.
Methadone: Among the commenters who objected to the proposed rule,
several mentioned the prescribing of methadone in particular and the
significant number of deaths that have resulted from methadone abuse.
These
[[Page 64929]]
commenters expressed concern that the proposed rule would lead to even
more deaths from methadone abuse.
DEA response: DEA shares the concerns of those commenters who
pointed to the unique and significant problems associated with
methadone abuse. In view of these concerns, DEA repeats the following
statement from the September 6, 2006, Policy Statement that was
published in conjunction with the proposed rule:
Methadone, a schedule II controlled substance, has been approved
by the [Food and Drug Administration (FDA)] as an analgesic. While a
physician must have a separate DEA registration to dispense
methadone for maintenance or detoxification, no separate
registration is required to prescribe methadone for pain. However,
in a document entitled ``Methadone-Associated Mortality: Report of a
National Assessment,'' [The Department of Health and Human Services,
Substance Abuse and Mental Health Services Administration] recently
recommended that ``physicians need to understand methadone's
pharmacology and appropriate use, as well as specific indications
and cautions to consider when deciding whether to use this
medication in the treatment of pain.'' \2\ This recommendation was
made in light of mortality rates associated with methadone.
---------------------------------------------------------------------------
\2\ CSAT Publication No. 28-03. Available at https://
dpt.samhsa.gov/medications/methreports.aspx.
Since 2003, the FDA has issued revised labeling for methadone
analgesic products, and physician education and training curricula have
been developed for methadone treatment.\3\ In 2007, SAMHSA convened an
expert panel to consider the implications of methadone mortality.
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\3\ The FDA health advisory can be found at https://www.fda.gov/
cder/drug/advisory/methadone.htm and the package insert can be found
at https://www.fda.gov/cder/foi/label/2006/006134s028lbl.pdf.
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Conclusion
As DEA discussed at the beginning of this document, the vast
majority of comments received regarding this rulemaking were supportive
of its adoption. Two hundred thirty-one of the 264 comments received
supported this action. As DEA noted previously, this rulemaking was
supported by a wide variety of individuals and organizations--medical
professionals, patient advocacy organizations, and patients themselves.
To reiterate, the majority of commenters believed this Final Rule would
be beneficial from both physical and financial perspectives, citing the
time and money saved due to less frequent visits to prescribing
practitioners, and the reduced physical toll resulting from the reduced
visits. While many commenters sought clarification regarding various
aspects of this rulemaking, it is important to reiterate the
overwhelmingly positive reaction this rule generated.
DEA, state authorities, practitioners, and pharmacists all share a
common interest in ensuring that controlled substances are prescribed
for legitimate medical purposes by prescribing practitioners acting in
the usual course of professional practice. As discussed throughout this
document, DEA, through its enforcement of the CSA and its implementing
regulations, must prevent the diversion and abuse of controlled
substances while ensuring that there is an adequate supply for
legitimate medical purposes. DEA supports the intent of this Final Rule
to address patients' needs for schedule II controlled substances while
preventing the diversion of those substances. DEA believes that this
Final Rule provides an option for practitioners to treat their
patients, which is legally permissible and consistent with the text,
structure, and purposes of the CSA.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. This rule provides an
additional option that practitioners may utilize when prescribing
schedule II controlled substances under certain circumstances. The rule
will not mandate any new procedures. Therefore, a regulatory
flexibility analysis is not required for this rule.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order
12866, Regulatory Planning and Review, Section 1(b). This rule has been
deemed a ``significant regulatory action.'' Accordingly, this rule has
been reviewed by the Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rule does not preempt or modify any provision of state law;
nor does it impose enforcement responsibilities on any state; nor does
it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act (Congressional
Review Act). This rule will not result in an annual effect on the
economy of $100,000,000 or more; a major increase in costs or prices;
or significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
companies to compete with foreign-based companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1306
Drug traffic control, Prescription drugs.
0
Pursuant to the authority vested in the Attorney General under sections
201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)),
delegated to the Deputy Administrator pursuant to section 501(a) (21
U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, Appendix to
Subpart R, the Deputy Administrator hereby orders that Title 21 of the
Code of Federal Regulations, Part 1306, be amended as follows:
PART 1306--PRESCRIPTIONS
0
1. The authority citation for part 1306 continues to read as follows:
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
0
2. Section 1306.12 is revised to read as follows:
Sec. 1306.12 Refilling prescriptions; issuance of multiple
prescriptions.
(a) The refilling of a prescription for a controlled substance
listed in Schedule II is prohibited.
[[Page 64930]]
(b)(1) An individual practitioner may issue multiple prescriptions
authorizing the patient to receive a total of up to a 90-day supply of
a Schedule II controlled substance provided the following conditions
are met:
(i) Each separate prescription is issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of
professional practice;
(ii) The individual practitioner provides written instructions on
each prescription (other than the first prescription, if the
prescribing practitioner intends for that prescription to be filled
immediately) indicating the earliest date on which a pharmacy may fill
each prescription;
(iii) The individual practitioner concludes that providing the
patient with multiple prescriptions in this manner does not create an
undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this
section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other
applicable requirements under the Act and these regulations as well as
any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating
or encouraging individual practitioners to issue multiple prescriptions
or to see their patients only once every 90 days when prescribing
Sche
