Dispensing of Controlled Substances to Residents at Long Term Care Facilities, 37463-37470 [2010-15757]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Notices]
[Pages 37463-37470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15757]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-337N]


Dispensing of Controlled Substances to Residents at Long Term 
Care Facilities

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice; solicitation of information.

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[[Page 37464]]

SUMMARY: To analyze ongoing issues related to the dispensing of 
controlled substances to residents residing at long term care 
facilities (LTCFs), DEA is soliciting information on this subject from 
practitioners, pharmacists, LTCFs, nurses, residents and family of 
residents in long term care facilities, State regulatory agencies, and 
other interested members of the public. Specifically, DEA is exploring 
whether--while adhering to the framework of the Controlled Substances 
Act--any further revisions to the DEA regulations are feasible and 
warranted toward the goal of making it easier for residents of LTCFs to 
receive controlled substance medications. This notice recites the 
pertinent statutory considerations and contains a series of questions 
designed to elicit public comment that will assist DEA in making this 
evaluation.

DATES: Written comments must be postmarked and electronic comments must 
be submitted on or before August 30, 2010. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-337'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to the Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
dea.diversion.policy@usdoj.gov. DEA will accept attachments to 
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file formats other than 
those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern Time on the day the comment period 
closes because https://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern Time on the day the 
comment period closes. Commenters in time zones other than Eastern Time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at https://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

    In enacting the Controlled Substances Act (CSA) in 1970, Congress 
recognized at the outset of the Act that while ``[m]any of the drugs 
included with [the Act] have a useful and legitimate medical purpose 
and are necessary to maintain the health and general welfare of the 
American people, * * * [t]he illegal * * * distribution, and possession 
and improper use of controlled substances have a substantial and 
detrimental impact on the health and general welfare of the American 
people.'' 21 U.S.C. 801. To minimize the likelihood that pharmaceutical 
controlled substances would be diverted into illicit channels, Congress 
established under the CSA a ``closed system of drug distribution'' for 
legitimate handlers of controlled substances. This system is comprised 
of a series of statutory provisions designed to ensure that all persons 
in the legitimate distribution chain are registered and keep records 
with respect to all transfers of controlled substances. Another key 
element of the CSA regulatory scheme is the requirement (first 
established under Federal law in 1914) that controlled substances only 
be dispensed for a legitimate medical purpose by DEA-registered 
practitioners acting in the usual course of their professional 
practice.
    As the agency responsible for enforcing the CSA and administering 
the regulatory provisions of the Act, DEA has continually sought to 
reevaluate the regulations within the statutory framework. That is, any 
DEA regulation must maintain the statutory requirements of the CSA. 
Also, whenever DEA is evaluating whether to revise the regulations, the 
agency must take into account the dual aims of facilitating the 
delivery of controlled substance medications to patients for legitimate 
medical purposes and safeguarding against the diversion of these drugs 
into illicit channels.

Controlled Substances

    DEA regulates controlled substances which account for between 10 
percent and 11 percent of all prescriptions written in the United 
States. Controlled substances are drugs and other substances that have 
a potential for abuse and psychological and physical dependence; these 
include opioids, stimulants, depressants, hallucinogens, anabolic 
steroids, and drugs that are immediate precursors of these classes of 
substances. The CSA and implementing regulations at 21 CFR 1308 list 
controlled substances and place them in five schedules based on whether 
they have an accepted medical use in the United States and their 
relative abuse potential and likelihood of causing dependence when 
abused. The degree of restriction under the CSA depends upon the 
schedule of a given controlled substance. The intent of the statute and 
regulations is to protect the public health and safety by ensuring that 
there is a sufficient supply of controlled

[[Page 37465]]

substances for medical, scientific, and other legitimate purposes while 
preventing and deterring the diversion of controlled substances to 
illegal purposes.
    Schedule I substances have a high potential for abuse and have no 
accepted medical use in treatment in the United States. 21 U.S.C. 
812(b)(1). These substances may only be used for research, chemical 
analysis, or manufacture of other drugs. Schedule II controlled 
substances have accepted medical use in treatment in the United States 
while having a high potential for abuse and having the greatest 
potential for physical and psychological dependence of the FDA-approved 
pharmaceutical controlled substances. 21 U.S.C. 812(b)(2). For this 
reason, Schedule II controlled substances are subject to the highest 
levels of controls among FDA-approved controlled substances. Examples 
of schedule II narcotics include morphine, codeine, and opium. Some 
common brand names include hydromorphone (Dilaudid[supreg]), methadone 
(Dolophine[supreg]), meperidine (Demerol[supreg]), oxycodone 
(OxyContin[supreg]), and fentanyl (Sublimaze[supreg] or 
Duragesic[supreg]). Schedule II narcotics are commonly prescribed for 
the treatment of moderate to severe pain.
    Controlled substances in Schedules III-V have an accepted medical 
use in the United States and have a lower dependence and abuse 
potential than Schedule II substances. 21 U.S.C. 812(b)(3), (4), (5). 
Thus, the statutory and regulatory restrictions on Schedule III-V 
substances, while significant, are not as extensive as those for 
Schedule II substances. Examples of schedule III narcotics include 
combination products containing less than 15 milligrams of hydrocodone 
per dosage unit (Vicodin[supreg], Lorcet[supreg], and Lortab[supreg]) 
and products containing not more than 90 milligrams of codeine per 
dosage unit (i.e., Tylenol with codeine[supreg]). Schedule III 
narcotics are commonly prescribed for moderate pain. Substances in this 
schedule have a lower potential for abuse relative to substances in 
Schedule II.
    Examples of Schedule IV substances include propoxyphene 
(Darvon[supreg] and Darvocet-N 100[supreg]), alprazolam 
(Xanax[supreg]), clonazepam (Klonopin[supreg]), and triazolam 
(Halcion[supreg]). Examples of Schedule V substances are cough 
preparations containing not more than 200 milligrams of codeine per 100 
milliliters or per 100 grams (Robitussin AC[supreg], and Phenergan with 
Codeine[supreg]).

Long Term Care Facilities

    With specific regard to nursing homes and other Long Term Care 
Facilities (LTCFs), DEA has made a number of revisions to the 
regulations over the years to make it easier for residents of these 
facilities to receive controlled substance medications, including the 
following:
     For schedule II controlled substances, a practitioner or a 
practitioner's agent may fax to a pharmacy a prescription written by 
the practitioner for a LTCF resident. 21 CFR 1306.11(f). This 
accommodation obviates the need to physically deliver a hard copy of 
the original written prescription to the pharmacy. It should be noted 
that allowance for faxing prescriptions for schedule II controlled 
substances is not permissible as a general rule in non-LTCF settings.
     Pharmacies may install at a LTCF (but in no other setting) 
an automated dispensing system (ADS). 21 CFR 1301.27. As with all 
dispensing of controlled substances by pharmacies, such dispensing must 
still be pursuant to valid prescription, but these machines can 
alleviate certain burdens in the LTCF setting by placing the supply of 
controlled substances directly on site for convenient dispensing to a 
resident. Once a pharmacy receives a valid prescription issued by the 
practitioner, the pharmacy initiates the release of the prescribed 
drugs from the automated dispensing system at the LTCF by remotely 
entering a code. Thereafter, a practitioner or authorized nurse at the 
LTCF enters another code that completes release of the drugs from the 
machine. In this manner, pharmacies may, in their discretion, dispense 
small amounts of the drugs (e.g., daily doses) rather than the entire 
amount indicated on the prescription at one time. The automated 
dispensing systems may be used in both emergency and nonemergency 
situations. The automated dispensing systems thereby provide at least 
two benefits: (1) They allow for immediate dispensing of controlled 
substances in emergency situations and (2) they help to prevent 
accumulation of unused medications at the LTCF.
     The regulations make a special allowance in the LTCF 
setting for partial filling by pharmacists of prescriptions for 
schedule II controlled substances. 21 CFR 1306.13(b). Under this 
provision, where the patient is a resident of a LTCF (or is terminally 
ill), such partial filling may occur as long as the amount dispensed 
does not exceed the total prescribed and occurs within 60 days of the 
date that the prescription was written. This lessens the extent to 
which LTCFs accumulate unused controlled substances.
     Although the CSA prohibits the refilling of prescriptions 
for schedule II controlled substances (21 U.S.C. 829(a)), DEA has 
issued a regulation that allows practitioners to issue multiple 
sequential prescriptions authorizing a patient to receive up to a 90-
day supply for these substances. 21 CFR 1306.12. This accommodation 
applies to all practitioners, not just those with patients in LTCFs, 
but it can be particularly useful in the LTCF setting where physicians 
sometimes visit the residents only once every 30 or 60 days.
     To facilitate the dispensing of controlled substances in 
emergencies, DEA has allowed pharmacies to place in LTCFs ``emergency 
kits'' that are routinely stocked with commonly dispensed controlled 
substances (45 FR 24128, April 9, 1980). These kits are considered 
extensions of the pharmacy and are controlled under the pharmacy's DEA 
registration. Again, the same requirement of a valid prescription 
delivered to the pharmacy prior to dispensing applies with respect to 
these kits; however, they provide an immediate supply of the drugs in 
emergencies and eliminate the need to wait for a delivery from the 
pharmacy in such circumstances.
    DEA is continuing to evaluate whether further regulatory changes 
are warranted for the LTCF setting and is seeking public comment on 
this topic. As indicated, the dispensing of controlled substances to 
residents of LTCFs--as with the dispensing of controlled substances to 
patients in any other setting--must take place in accordance with the 
CSA. Thus, in order to consider what types of controlled substance 
dispensing practices might be permissible in a LTCF setting, and 
whether any revisions to the DEA regulations might be warranted to 
accommodate such practices, the provisions of the CSA governing the 
dispensing of controlled substances must be considered. The following 
is a brief summary of these provisions, which have remained consistent 
since the enactment of the CSA in 1970.
    The registration requirement--As set forth in 21 U.S.C. 822(a), 
every person who dispenses any controlled substance must obtain a DEA 
registration issued in accordance with the agency regulations. The 
regulations governing registration are set forth in 21 CFR Part 1301. 
Persons registered with DEA are authorized to dispense controlled 
substances only to the extent authorized by their registration and in 
conformity with the CSA. 21 U.S.C. 822(b). In addition, to be eligible 
under the CSA to obtain a registration to dispense controlled 
substances, a practitioner--which could be an individual (such as

[[Page 37466]]

a physician), an institution (such as a hospital), or a pharmacy--must 
be licensed or otherwise authorized to dispense controlled substances 
under the laws of the State in which the practitioner practices. 21 
U.S.C. 802(21), 823(f), 824(a)(3).
    The recordkeeping requirement--As set forth in 21 U.S.C. 827(a), 
every registrant authorized to dispense controlled substances must 
maintain, on a current basis, a complete and accurate record of each 
such substance dispensed.
    The prescription requirement--The requirement of a prescription is 
set forth in 21 U.S.C. 829. For schedule II controlled substances, this 
provision states, in pertinent part:

    Except when dispensed directly by a practitioner, other than a 
pharmacist, to an ultimate user, no controlled substance in schedule 
II, which is a prescription drug * * *, may be dispensed without the 
written prescription of a practitioner, except that in emergency 
situations * * *, such drug may be dispensed upon oral prescription 
in accordance with [21 U.S.C. 353(b)].

    21 U.S.C. 829(a).

    For schedule III and IV controlled substances, the pertinent part 
of the statute states:

    Except when dispensed directly by a practitioner, other than a 
pharmacist, to an ultimate user, no controlled substance in schedule 
III or IV, which is a prescription drug * * * may be dispensed 
without a written or oral prescription in conformity with [21 U.S.C. 
353(b)].

    21 U.S.C. 829(b).

    Prescriptions are required to contain specific information 
including: patient name and address; drug name, strength, dosage form, 
quantity prescribed, directions for use; and name, address, and DEA 
number of the issuing practitioner. 21 CFR 1306.05(a). All 
prescriptions for controlled substances must be dated as of, and signed 
on, the day when issued.
    Two aspects of these statutory provisions bear emphasis here. 
First, in those situations in which a controlled substance is not 
dispensed directly by a practitioner (e.g., it is dispensed by a 
pharmacy), the dispensing must be pursuant to a prescription issued by 
a practitioner. Second, the prescription must be issued in writing by 
the practitioner if the drug is a schedule II controlled substance 
(except in an emergency, in which an oral prescription issued by the 
practitioner is permitted); whereas the prescription may be issued in 
writing or orally by the practitioner if the drug is a schedule III or 
IV controlled substance.
    The requirement of a legitimate medical purpose in the usual course 
of professional practice--As the United States Supreme Court explained 
in United States v. Moore, 423 U.S. 122, 136-138 (1975), implicit in 
the CSA is the requirement that every prescription for a controlled 
substance must be issued for a legitimate medical purpose by an 
individual practitioner acting in the usual course of his professional 
practice. As the Supreme Court stated in Moore, id., this implicit 
requirement of the CSA is made explicit in a provision of the DEA 
regulations, 21 CFR 1306.04(a), which states:

    A prescription for a controlled substance to be effective must 
be issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional 
practice. The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but a corresponding responsibility rests with the 
pharmacist who fills the prescription. An order purporting to be a 
prescription issued not in the usual course of professional 
treatment or in legitimate and authorized research is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and 
the person knowingly filling such a purported prescription, as well 
as the person issuing it, shall be subject to the penalties provided 
for violations of the provisions of law relating to controlled 
substances.

    The Moore decision also makes clear that, under the CSA, the 
requirement of a legitimate medical purpose in the usual course of 
professional practice is tied to the concept of registration. The 
Supreme Court stated, with respect to the prescribing and dispensing of 
controlled substances, ``only the lawful acts of registrants are 
exempted'' from the CSA's general prohibition on dispensing controlled 
substances. Id. at 131 (emphasis added). Further, the Court stated that 
the CSA was intended ``to limit a registered physician's dispensing 
authority to the course of his `professional practice' '' and that the 
registration of a practitioner ``is limited to the dispensing and use 
of drugs `in the course of professional practice * * *.' '' Id. at 140-
141.
    The foregoing aspects of the CSA, viewed collectively, can be 
reiterated as setting forth the following principles:
     To lawfully dispense a controlled substance to a patient, 
the dispenser must be in one of the following two categories: (1) A 
practitioner authorized to dispense controlled substances directly to 
patients (such as a physician or a hospital) or (2) a pharmacy or other 
entity authorized to dispense controlled substances pursuant to a 
prescription issued by a practitioner.
     For either of the foregoing two categories of dispensers, 
the dispenser must be licensed or otherwise authorized under State law 
to engage in such activity and also have a DEA registration authorizing 
such activity.
     Because controlled substances may only be dispensed for a 
legitimate medical purpose by a practitioner acting in the usual course 
of professional practice, and only a DEA-registered practitioner may 
make the determination there is such a legitimate medical purpose for a 
given instance of dispensing, a DEA registrant may not delegate to a 
subordinate the medical decision making that must underlie each 
instance of dispensing.
    Accordingly, to be consistent with the CSA, any type of arrangement 
under which controlled substances would be dispensed to patients who 
reside in LTCFs must adhere to the foregoing principles.

Note Regarding Electronic Prescribing of Controlled Substances

    DEA revised its regulations effective June 1, 2010 to provide 
practitioners with the option of writing prescriptions for controlled 
substances electronically. 75 FR 16236, March 31, 2010. The regulations 
also permit pharmacies to receive, dispense, and archive these 
electronic prescriptions. This rule provides another tool for 
practitioners to use when prescribing a controlled substance for their 
patients, including those who reside in a LTCF. This rule allows a 
practitioner to use a computer, laptop or personal digital assistant 
(PDA) to send a prescription to a pharmacy from a remote location 
instantaneously. The basic framework of the CSA outlined above remains 
in effect with respect to the issuance of electronic prescriptions.

Note Regarding Authority of Agents of Individual Practitioners

    While a prescription for a controlled substance must always be 
issued by a DEA-registered practitioner (rather than the agent of a 
practitioner), an agent may, under certain circumstances, be involved 
in the transmission of the prescription to the pharmacy. The general 
statutory requirements, as implemented through regulations, are 
described below.
    The CSA provides that--except in emergency situations--a controlled 
substance in schedule II may only be dispensed by a pharmacy pursuant 
to a written prescription signed by a practitioner. 21 U.S.C. 829(a). 
The written prescription generally must be directly, physically 
provided to the pharmacist.\1\ Where the patient is a

[[Page 37467]]

resident of a LTCF, and the drug being dispensed is a schedule II 
controlled substance, the DEA regulations permit an individual 
practitioner, or his agent where a valid agency relationship exists, to 
transmit by facsimile to the pharmacy a written prescription that has 
been issued and signed by the practitioner. 21 CFR 1306.11(f).
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    \1\ As stated above, DEA has recently issued regulations 
allowing for the electronic prescribing of controlled substances. 
Where a practitioner issues an electronic prescription in accordance 
with these regulations, such a prescription constitutes a written 
prescription within the meaning of the CSA. When such an electronic 
prescription is used, the prescription information is conveyed 
electronically from the practitioner to the pharmacy, rather than 
through the delivery to the pharmacy of a hard copy of the 
prescription that was signed by the practitioner.
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    As indicated, the CSA contains an exception that allows 
practitioners to issue oral prescriptions for schedule II controlled 
substances in an emergency. 21 U.S.C. 829(a). In this context, Congress 
assigned to the Secretary of HHS, in consultation with the Attorney 
General, responsibility for defining the term ``emergency'' by 
regulation. The Secretary delegated this responsibility to the Food and 
Drug Administration, which set forth the definition of ``emergency'' in 
21 CFR 290.10. Assuming the situation constitutes a bona fide emergency 
within the meaning of the FDA regulation, and a practitioner determines 
that such emergency warrants the dispensing of a schedule II controlled 
substance, a pharmacy may dispense the medication upon receiving oral 
authorization from the practitioner in accordance with 21 CFR 
1306.11(d). That regulation requires, among other things, that the 
quantity prescribed and dispensed be limited to the amount adequate to 
treat the patient during the emergency period, and that the 
practitioner follow up within 7 days with a written prescription to the 
dispensing pharmacy. 21 CFR 1306.11(d). The regulation further requires 
the pharmacy to make a reasonable effort to determine that the oral 
authorization came from the practitioner, which may include a callback 
to the practitioner using his phone number as listed in the telephone 
directory.
    For controlled substances in schedules III-V, the CSA provides that 
a pharmacy may dispense pursuant to a ``written or oral prescription.'' 
21 U.S.C. 829(b). Where an oral prescription is permitted by the CSA, 
the DEA regulations also provide that a practitioner may transmit to 
the pharmacy a facsimile of a written, manually signed prescription in 
lieu of an oral prescription. 21 CFR 1306.21(a). As a result, a 
prescription issued by a practitioner for substance in schedules III-V 
may be transmitted to a pharmacy in the following ways: (1) By delivery 
to the pharmacy of the original, written prescription signed by the 
practitioner; (2) by the practitioner or his agent (where a valid 
agency relationship exists) faxing the written prescription signed by 
the practitioner; or (3) by the practitioner or his agent (where a 
valid agency relationship exists) orally transmitting the prescription 
to a pharmacy, where it is promptly reduced to writing by the 
pharmacist prior to dispensing. 21 CFR 1306.21(a) and 1306.03(b).
    As previously discussed, the CSA does not permit the prescribing 
practitioner to delegate to an agent or any other person the 
practitioner's authority to issue a prescription for a controlled 
substance. Thus, the determination of a legitimate medical purpose must 
be made by the practitioner acting in the usual course of their 
professional practice; the determination may not be made by the agent. 
Likewise, the required elements of the prescription (set forth in 21 
CFR Part 1306) must be specified by the prescribing practitioner--not 
the agent. The pharmacist who fills a prescription for a controlled 
substance has a corresponding responsibility to ensure that these 
requirements have been met. 21 CFR 1306.04(a), 1306.05(a).

Other Considerations Regarding State Licensure

    As indicated, to be eligible for a DEA registration, a practitioner 
must be licensed or otherwise authorized by the State in which he 
practices to carry out the specific activity for which he seeks a 
registration. This typically entails a determination by the applicable 
State regulatory body that the practitioner meets certain 
qualifications. For example, to practice medicine, States generally 
require that a physician obtain a medical license issued by the State 
medical board, which typically requires the physician to demonstrate 
the completion of certain education and training, to pass an 
examination demonstrating competency to practice medicine, and to 
undergo a background check to verify professional competence, ethics, 
and character. To operate a hospital, States generally require, at a 
minimum, that the facility obtain a license from the State public 
health department, which typically requires the facility to demonstrate 
that it has appropriate levels of qualified healthcare professional 
staff (physicians, nurses, etc.) and facilities to provide a proper 
standard of hospital service to the community. As part of the licensure 
process, States may also require that the hospital demonstrate specific 
qualifications to provide particular types of services. In addition, 
some States may require hospitals to obtain accreditation and/or 
certification from public and private agencies. To operate a pharmacy, 
States generally require the pharmacy to obtain a license from the 
State board of pharmacy, which also typically requires a showing of 
properly qualified staff and facilities.
    Thus, by requiring practitioners to obtain a State license or other 
State authorization as a prerequisite to obtaining a DEA registration, 
the CSA ensures that controlled substances are only dispensed by those 
persons who have appropriate professional qualifications and who follow 
professional standards.
    Accordingly, to remain consistent with the CSA, if a LTCF were to 
be eligible to obtain a DEA registration, it would need to have the 
requisite State license or other State authorization that is 
commensurate with the extent of the qualifications of its staff and 
with its ability to adhere to applicable professional standards for 
dispensing controlled substances to patients.

Distinctions Between LTCFs and Hospitals

    An important distinction between LTCFs and hospitals is that States 
authorize hospitals to have independent controlled substances authority 
and accordingly hospitals may register with DEA. This means, among 
other things, that hospitals are authorized to maintain common stocks 
of controlled substances for immediate dispensing or administration 
pursuant to a practitioner's medication order and are subject to DEA 
regulatory oversight and inspection. LTCFs, on the other hand, 
typically have no independent State controlled substances authority and 
accordingly are not eligible to become DEA registrants, as explained 
above. This means they may not maintain common stocks of controlled 
substances. Therefore, any prescribed controlled substance medication 
in a LTCF is deemed, for CSA purposes, to be possessed by the resident 
and not the facility. A further consequence of their lack of DEA 
registration is that LTCFs are not subject to direct DEA regulatory 
oversight and inspection, security and recordkeeping requirements, or 
administrative action (suspension or revocation of registration).
    There are a variety of reasons that States may currently treat 
LTCFs differently than hospitals. For example, although LTCFs provide 
care for residents, the nature of their practice is not the same as 
that of a hospital. LTCF

[[Page 37468]]

residents typically reside in these facilities for long periods of time 
and have health issues and disorders that require long-term medical 
attention. Generally, they do not receive daily care from an on-site 
physician; and, indeed, many facilities do not employ a physician as 
part of their staff 24 hours a day. Likewise, the extent to which 
registered nurses (rather than licensed practical nurses or nursing 
assistants) are involved in resident care is generally less in LTCFs 
than in hospitals. Also, in contrast to the length of stays of 
residents of LTCFs, patients in hospitals are typically there for short 
periods of time and are regularly monitored by their attending 
physician or hospital staff physicians.

Note Regarding Chart Orders

    As explained above, because a DEA-registered hospital is a 
``practitioner'' within the meaning of the CSA, it is permissible under 
the Act for such a hospital to dispense controlled substances directly 
to patients without a prescription. 21 U.S.C. 829(a), (b). Because of 
this, in a hospital setting, a hospital may dispense a controlled 
substance, for immediate administration to a patient, pursuant to an 
order for medication made by a physician (or other individual 
practitioner) who is an employee or agent of the hospital. 21 CFR 
1306.11(c). This may occur, for example, through the issuance of a 
``chart order'' by a hospital physician. In this context, the term 
``chart order'' should be distinguished from the term ``prescription.'' 
A prescription--unlike a chart order--must contain all the information 
specified in 21 CFR 1306.05 (including, among other things, the 
signature of the physician).\2\
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    \2\ If a physician wrote all the elements of a prescription 
specified in 21 CFR 1306.05(a) on a patient's chart, including the 
signature on the date when issued, this would be considered a valid 
``prescription'' within the meaning of the CSA and DEA regulations, 
and such document containing all the required elements could be 
delivered to a pharmacy for dispensing in accordance with 21 U.S.C. 
829.
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    It bears emphasis that regardless of whether the controlled 
substance is dispensed by a pharmacy pursuant to a prescription or 
hospital pursuant to a chart order, the person who issues the 
prescription or order must be authorized under the CSA to make the 
medical determination, while acting in the usual course of professional 
practice, that there is a legitimate medical purpose for the drugs to 
be dispensed to the patient. The CSA ensures this condition is 
satisfied by allowing only those practitioners who have obtained the 
requisite State licensure and DEA registration to make such medical 
determination and issue the corresponding prescription or chart order. 
Another point worth noting is that, in the hospital setting, where a 
physician issues a chart order for a controlled substance, the 
physician, as well as the nursing staff and hospital pharmacy staff who 
take certain steps in carrying out the order, are all acting as 
employees or agents of the DEA-registered hospital and thus are 
collectively viewed as the ``practitioner'' within the meaning of the 
CSA. The physician who issues the chart order is doing so under the 
hospital's DEA registration number in accordance with the requirements 
of 21 CFR 1301.22(c). The hospital is, therefore, responsible for 
ensuring that all such persons are acting in accordance with the CSA 
and DEA regulations, and any failure to do so may result in criminal or 
civil liability on the part of the hospital or loss of the hospital's 
DEA registration. These legal consequences are part of the fabric of 
the CSA that promotes compliance with the Act.
    As indicated, most LTCFs are not licensed by the State as hospitals 
or other practitioners authorized to dispense controlled substances 
directly to patients, and thus they are not eligible under the CSA for 
registration as practitioners.

Other Federal Regulations Governing Long Term Care Facilities

    For purposes of the CSA, DEA defines the term ``long term care 
facility'' (LTCF) as ``a nursing home, retirement care, mental care, or 
other facility or institution which provides extended health care to 
resident patients.'' 21 CFR 1300.01(b)(25). The Secretary of Health and 
Human Services (HHS) applies more specific definitions for purposes of 
defining facilities eligible to participate in Medicare and Medicaid. 
42 CFR 483.5.
    HHS establishes requirements deemed necessary for the health and 
safety of individuals to whom services are furnished in nursing 
facilities participating in Medicare and Medicaid. 42 CFR 483.1. For 
example, basic resident rights and obligations are outlined along with 
certain basic responsibilities of the facility. Some of these 
responsibilities include facility organization such as requiring a 
medical director (42 CFR 483.5(b)(2)(iii)) and maintaining a quality 
assessment and assurance committee consisting of a physician, the 
director of nursing services and three others. 42 CFR 483.75(o). The 
facility must operate and provide services in compliance with all 
applicable Federal, State and local laws and professional standards. 42 
CFR 483.75(b).
    Other HHS requirements for LTCFs establish a level of care. For 
example, the facility must perform periodic assessments of a resident's 
needs (42 CFR 483.20(b), (c)) and must establish and follow nursing 
services standards. 42 CFR 483.30. Among requirements for physician 
care are:
     The facility must have physician orders for the resident's 
immediate care at the time each resident is admitted. 42 CFR 483.20(a).
     Each resident must remain under the care of a physician 
and there must be physician supervision when their attending physician 
is unavailable. 42 CFR 483.40(a).
     The facility must provide or arrange for the provision of 
physician services 24 hours a day, in case of an emergency. 42 CFR 
483.40(d).
     The facility must provide or obtain laboratory services 
only when ordered by the attending physician. 42 CFR 483.75(j)(2)(i).
     A physician may not delegate a task when the regulations 
specify that the physician must perform it personally, or when the 
delegation is prohibited under State law or by the facility's own 
policies. 42 CFR 483.40(e)(2).
    A few of the requirements with respect to medications are that:
     The facility must employ or obtain the services of a 
licensed pharmacist to establish a system of records of receipt and 
disposition of all controlled drugs and, among other responsibilities, 
to review the drug regimen of each resident at least monthly. 42 CFR 
483.60(b), (c).
     The facility must establish minimal requirements for 
quality of care, including that a resident's drug regimen must be free 
from unnecessary drugs as defined in 42 CFR 483.25(l).
     The facility must also provide separately locked, 
permanently affixed compartments for storage of controlled drugs listed 
in Schedule II and other drugs subject to abuse unless the facility 
uses single unit package drug distribution systems in which the 
quantity stored is minimal and a missing dose can be readily detected. 
42 CFR 483.60(e)(2).
     Among the standards required for the provision of hospice-
related inpatient care in a participating Medicare/Medicaid facility is 
the hospice's responsibility to provide ``drugs necessary for the 
palliation of pain and symptoms associated with the terminal illness 
and related conditions.'' 42 CFR 418.112(c)(6).
    As an element of certification and enforcement, HHS utilizes 
different

[[Page 37469]]

``surveys'' of a given facility. These various surveys gather periodic, 
resident-centered information about the quality of service furnished in 
a facility to determine compliance with the requirements for 
participation in Medicare and Medicaid. 42 CFR 488.301.

Solicitation of Information

    Within the foregoing statutory framework, DEA is hereby seeking 
input from interested members of the public regarding the types of 
lawful controlled substance dispensing practices currently taking place 
in the LTCF setting or which might take place if appropriate amendments 
to the DEA regulations were issued that comported with the CSA. Along 
similar lines, DEA is seeking comment on the types of controlled 
substance licensing authorities that States currently provide to LTCFs, 
or which States might be willing to provide in the future. To 
facilitate the gathering of relevant information, DEA has specific 
questions that appear below. These questions are separated into general 
issues. Commenters are encouraged to reference the question number 
enumerated below in their response.

A. Definitions

    The terminology used to describe and classify facilities that DEA 
considers to be LTCFs varies between agencies and from State to State.
    1. The definitions of facilities for Medicare reimbursement 
purposes are different in many respects from the terms used in DEA 
regulations. The DEA regulations define a LTCF as ``a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients.'' How do State 
regulators/licensing authorities define facilities that DEA would 
consider LTCFs?
    2. Are all LTCFs Medicare/Medicaid facilities? If not, what 
differentiates a facility that is not a Medicare/Medicaid facility from 
one that is?
    3. What does the term ``prescription'' mean as used in a LTCF?
    4. What does the term ``chart order'' mean as used in a LTCF?
    5. What does the term ``standing order'' mean as used in a LTCF?

B. Scope

    6. For how many residents does your LTCF provide care? Of those, 
what percentage require controlled substance medications?
    7. Approximately what percentage of those residents requiring 
controlled substance medications receive such medications on a daily 
basis? Further, of those who receive controlled substances on a daily 
basis, what percentage receive Schedule II controlled substances?
    8. When a person comes to a LTCF, does the person bring their own 
already-dispensed medications?
    9. What, if any, State requirements impact a person's ability to 
bring medication into a LTCF?
    10. If a person arrives at the facility without any medication 
information, how does the facility obtain any needed medications?
    11. If a person is moving from an acute care facility to a LTCF, 
what factors impact the acute care practitioner's ability and 
willingness to provide written prescriptions to the person?
    12. If a person arrives at a facility without medication and 
without prescriptions, what steps does the facility take to assess the 
person's medication needs?
    13. What are the current practices for obtaining controlled 
substance prescriptions for residents at a LTCF? How do these practices 
differ between Schedule II controlled substances and Schedule III-V 
controlled substances? How do these practices differ between an 
emergency situation and a non-emergency situation?
    14. What types of emergency situations arise at a LTCF that would 
necessitate the use of controlled substances?
    15. What are the standard operating procedures to address 
emergencies? What are the procedures in a LTCF for obtaining controlled 
substance medications for residents in an emergency situation? Is the 
process different for Schedule II as opposed to Schedule III-V 
controlled substances?
    16. Has your facility experienced delays in obtaining controlled 
substance medications for residents? If so, why have these delays 
occurred? At what steps in the prescribing process have these delays 
occurred? Please specify whether the delay was with a Schedule II 
controlled substance or with a substance in Schedule III through V.
    17. Have any residents at your facility experienced problems caused 
by delays in obtaining prescriptions for controlled substances? If so, 
what was the reason for the delay? How often have such problems 
occurred? Did the delays occur with Schedule II controlled substances 
or with substances in Schedule III through V?
    18. Does your facility send residents to the hospital to receive 
controlled substance medications because they were unable to receive 
the medications at your facility in a timely manner? If so, how many 
times did this occur in the last 12 months?

C. Communication

    19. How often are practitioners contacted by LTCFs regarding 
requests for changes in residents' medications generally? How often 
does this occur for controlled substance prescriptions specifically?
    20. How does communication currently occur among the practitioner, 
the LTCF and the pharmacy, e.g. phone, fax, other? Do you expect the 
new DEA regulations providing the option of electronic prescriptions 
will be used by practitioners and pharmacies in your LTCF setting? If 
so, do you anticipate that the use of electronic prescriptions will 
alleviate delays you may have experienced in providing controlled 
substances to residents?
    21. Does the LTCF or practitioner communicate other information to 
the pharmacy, such as changes in the resident's practitioner or the 
change in status of a resident?
    22. Would practitioners have any interest in designating certain 
persons at LTCFs as their agents solely for the purpose of 
communicating controlled substance prescription information to the 
pharmacy, understanding that the agent would be working under the 
prescriber's DEA registration and that the prescriber would be 
responsible for the agent's actions, which must be consistent with the 
CSA?

D. Pharmacy Service

    23. Would your LTCF be amenable to having a pharmacy on site as an 
integral element of the LTCF? If so, would you seek to have the 
pharmacy operate under a registration granted to the LTCF or operate 
independently at the LTCF under its own pharmacy registration?
    24. Does your State allow pharmacies to install and operate 
automated dispensing systems at LTCFs? If not, is your State 
considering allowing them to do so?

E. Chart Orders

    Additional information about the current use of chart orders for 
other than controlled substances would be helpful.
    25. In current practice, when must a practitioner acknowledge a 
chart order by signing it? Do State laws/regulations, HHS regulations, 
or other standards (e.g. Joint Commission) define the time period 
within which the practitioner must sign the chart order for any care 
setting (hospital, clinic, or LTCF)?
    26. Currently, are chart orders (in hospitals or in LTCFs for non-
controlled substances) required to have an

[[Page 37470]]

``expiration'' date, at which time they must be either reauthorized or 
closed? LTCFs differ from hospitals in that residents in LTCFs by 
definition stay for a longer period. Because of this, should chart 
orders in LTCFs ``expire'' at some time after issuance? If so, what 
time period would be appropriate?
    27. If certain persons at the LTCF were designated to act as agents 
of individual practitioners (to the extent authorized by the CSA) to 
communicate controlled substance information from the individual 
practitioner to the pharmacy, how would this change current practices 
at your facility for obtaining controlled substance medications for 
residents? What safeguards should be required?

F. State Regulatory Authorities

    28. What authority does your State currently give LTCFs for 
handling and managing controlled substances? Which agency is 
responsible for such authority?
    29. What controlled substance activities, if any, are authorized, 
e.g. prescribing, administering, or dispensing? In what schedules? How 
many LTCFs apply for any such authorization and how many receive such 
authorization?
    30. What State requirements are there pertaining to the storage of 
controlled substances at LTCFs?
    31. Is your State considering giving/increasing LTCFs' authority to 
handle/dispense controlled substances? If so, is your State considering 
creating a new type of registration just for LTCFs or would your State 
consider allowing LTCFs to register as institutional practitioners like 
hospitals?
    32. What changes in State pharmacy and LTCF laws/regulations would 
be necessary for pharmacies to operate in LTCFs under a registration 
granted to the LTCF or to operate independently at the LTCF under its 
own pharmacy registration?
    33. Do State laws or regulations specify or limit access to 
emergency kits or to controlled substances in LTCFs?
    34. Do State inspectors check the records and stock of emergency 
kits? If so, how often?

G. Certification/Accreditation

    To be eligible for Medicare or Medicaid reimbursement, nursing 
facilities and skilled nursing facilities must be inspected by State 
officials for compliance with HHS requirements. HHS regulations, for 
instance, impose staffing requirements and requirements regarding the 
safekeeping of drugs.
    35. How often do State regulators inspect LTCFs? What is the legal 
requirement in your State for frequency of inspection, and what is the 
actual timing?
    36. Has your LTCF sought accreditation by the Joint Commission or 
other non-governmental accrediting organization? What do LTCFs see as 
the advantages and disadvantages of seeking such accreditation?

H. Staff

    37. Does the Medical Director of your facility also serve as 
Medical Director for other locations or facilities? If so, for how 
many?
    38. Is the Medical Director of your facility also an attending 
physician?
    39. Is your Medical Director registered with DEA as a practitioner?
    40. If your LTCF is a Medicare or Medicaid approved facility, what 
barriers, if any, has your facility faced in assuring the provision of 
physician services 24 hours a day in case of an emergency?
    41. As a LTCF, does your facility have a physician on site during 
regular business hours?
    42. How does your facility communicate with a resident's 
practitioner?
    43. How frequently is a physician on site at your facility? Do most 
physicians treat multiple residents at a single facility?
    44. Does your facility have a registered nurse on duty for more 
than 8 hours a day, 7 days a week? Less?
    45. When a registered nurse is not on duty at your facility, how 
are procedures relating to medications different?
    46. What are the State education and continuing education 
requirements for licensed nurses other than registered nurses (LPNs, 
etc)? Does the State require a criminal background check prior to 
licensing?
    47. What role do nurses' aides have in helping residents get their 
medications?
    48. What are the State education and continuing education 
requirements for nurses' aides? Does your State license nurses' aides?
    49. What personnel/job descriptions have access to emergency kits 
in your facility?
    50. What personnel/job descriptions have access to controlled 
substance storage in your facility? Are temporary employees or 
volunteers given access?
    51. What personnel/job descriptions have authority to contact the 
pharmacy to relay a noncontrolled substance prescription/drug order for 
a resident?

I. Emergency Kits

    52. Does your facility have an emergency kit that contains 
controlled substances? If so, what controlled substances does your 
emergency kit contain?
    53. If your facility has an emergency kit that contains controlled 
substances, how are those controlled substances procured and dispensed?
    54. What are the current controlled substance inventory protocols 
for any emergency kit and/or automated dispensing system at your LTCF?
    55. What records document receipt and dispensing of controlled 
substances to and from this kit?
    56. How often in the last two years have controlled substances been 
lost or stolen from an emergency kit at your facility?
    Please submit written comments no later than August 30, 2010 using 
the address information provided at the beginning of this document.

    Dated: June 24, 2010
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 2010-15757 Filed 6-28-10; 8:45 am]
BILLING CODE 4410-09-P