Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act, 2792-2794 [2018-00917]
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
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In the Federal Register of July 11,
2016 (81 FR 44881), FDA issued a notice
announcing the availability of the draft
version of this guidance. The comment
period on the draft guidance ended on
October 11, 2016. FDA received
approximately 88 comments on the draft
guidance. In response to received
comments or on its own initiative, FDA
made several changes. For example, in
response to requests in comments for
direction on records retention, FDA
added a recommendation that
compounders maintain the records
described in the guidance for a period
of at least 3 years. In addition, to
address questions raised in comments,
FDA clarified that the policies in this
guidance apply to a compounded drug
product without regard to the source(s)
of the active pharmaceutical ingredient
(API) in that product, for example, the
policies would apply regardless of
whether the compounder used an API
that was purchased as an isolate, or if
the compounder modified a finished
drug product containing an API.
FDA received comments on the draft
guidance from hospital organizations
regarding the potential implications of
the proposed policies in the draft
guidance for the preparation of
compounded drugs used in in-patient
settings. The final guidance notes that
FDA is considering the applicability of
the policies described in this guidance
to hospitals and health systems. We
recognize that this issue is of interest to
many stakeholders and will convey our
further thinking on the applicability of
these policies to hospitals and health
systems publicly with an opportunity
for comment.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
This guidance represents the current
thinking of FDA on ‘‘Compounded Drug
Products That Are Essentially Copies of
a Commercially Available Drug Product
Under Section 503A of the Federal
Food, Drug, and Cosmetic Act.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance contains collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act (PRA) of 1995 (44 U.S.C. 3501–
3520). Under the PRA, Federal Agencies
must obtain approval from OMB for
each collection of information they
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Jkt 244001
conduct or sponsor. ‘‘Collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3 and includes
Agency requests or requirements that
members of the public submit reports,
keep records, or provide information to
a third party. Section 3506(c)(2)(A) of
the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information before submitting the
collection to OMB for approval. To
comply with this requirement, in the
Federal Register of July 11, 2016, we
gave interested persons 60 days to
comment on the information collection
provisions in the draft guidance (81 FR
44881).
The information collection provisions
in this guidance have been submitted to
OMB for review as required by section
3507(d) of the PRA. These provisions
are not in effect until they display a
currently valid OMB control number.
FDA will publish a notice in the Federal
Register announcing OMB’s decision
regarding the information collection
provisions in this guidance.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00915 Filed 1–18–18; 8:45 am]
BILLING CODE 4164–01–P
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by February
20, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Guidance for Industry on
Compounded Drug Products that are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Guidance for Industry on Compounded
Drug Products That Are Essentially
Copies of a Commercially Available
Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act
OMB Control Number 0910—NEW
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1309]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Compounded Drug
Products That Are Essentially Copies
of a Commercially Available Drug
Product Under Section 503A of the
Federal Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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This information collection supports
the above captioned Agency guidance
document. In the Federal Register of
July 11, 2016 (81 FR 44881), FDA
announced the availability of a draft
guidance for industry entitled
‘‘Guidance for Industry on Compounded
Drug Products That Are Essentially
Copies of a Commercially Available
Drug Product Under Section 503A of the
Federal Food, Drug, and Cosmetic Act,’’
and included an analysis of the
associated information collection.
Section 503A of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353a) describes conditions that
must be met in order for compounded
drugs to receive exemptions from
certain sections of the FD&C Act,
including section 501(a)(2)(B) (21 U.S.C.
351(a)(2)(B)) (concerning current good
manufacturing practice for drugs);
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
approval of human drug products under
new drug applications or abbreviated
new drug applications).
One condition of section 503A is that
a compounder ‘‘does not compound
regularly or in inordinate amounts (as
defined by the Secretary) any drug
products that are essentially copies of a
commercially available drug product’’
(section 503A(b)(1)(D)). However, for
the purposes of this section, ‘‘essentially
a copy of a commercially available drug
product’’ does not include a drug
product ‘‘in which there is a change,
made for an identified individual
patient, which produces for that patient
a significant difference, as determined
by the prescribing practitioner, between
the compounded drug and the
comparable commercially available drug
product’’ (section 503A(b)(2)).
The draft guidance states that if a
compounder intends to rely on such a
determination to establish that a
compounded drug is not essentially a
copy of a commercially available drug
product, the compounder should ensure
that the determination is documented
on a prescription. If a prescription does
not make clear that the prescriber made
the determination required by section
503A(b)(2), or a compounded drug is
substituted for the commercially
available product at the pharmacy, the
compounder may contact the prescriber
and if the prescriber confirms it, make
a notation on the prescription that the
compounded product contains a change
that makes a significant difference for
the patient. The notations should be as
specific as those described in this
document, and the date of the
conversation with the prescriber should
be included on the prescription.
In addition, if the drug was
compounded because the approved
product was not commercially available
because it was on the FDA drug shortage
list, the prescription or a notation on the
prescription should note that it was on
the drug shortage list and the date the
list was checked.
Finally, compounders under section
503A should maintain records of the
frequency in which they have
compounded drug products that are
essentially copies of commercially
available drug products and the number
of prescriptions that they have filled for
compounded drug products that are
essentially copies of commercially
available drug products to document
that such compounding has not been
done ‘‘regularly’’ or in ‘‘inordinate
amounts.’’
FDA received 88 comments on the
draft guidance, several of which raised
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Jkt 244001
issues pertaining to the information
collection provisions in the draft
guidance. The issues raised are
addressed below.
Issue One: One commenter proposed
that any compounded drug with the
same Active Pharmaceutical Ingredient
(API) as a commercially available drug
product should be considered to be
‘‘essentially a copy’’ of the
commercially available drug product.
FDA Response to Issue One: FDA has
not made this proposed change. A
compounded drug with the same API as
a commercially available drug product
may be very different from that
commercially available drug product.
For example, it may have a different
route of administration and a
substantially different strength. In such
cases, a prescriber determination is not
needed because the compounded drug
would not be considered to be
‘‘essentially a copy’’ of the
commercially available drug product,
even if it had the same API.
Issue Two: Several individuals
submitted comments requesting the
collection of additional information
than what was proposed in the draft
guidance.
• One commenter requested that the
medical record maintained by the
prescriber should include additional
scientific rationale for prescribing the
compounded product.
• Another commenter requested
documentation to justify the use of a
bulk drug substance to compound a
product that could have been made
starting with FDA-approved products.
FDA Response to Issue Two:
Regarding the first comment, this
recommendation regarding what
information a prescriber should
maintain is outside the scope of this
guidance. Regarding the second
comment, the proposal is beyond the
scope of the current guidance and we
express no opinion on the proposed
analysis and documentation.
Issue Three: Several individuals
submitted comments regarding
collection of the prescriber
determination in the hospital setting.
• Some commenters noted the
prescriber determination is not
necessary in the hospital setting because
pharmacists often determine when a
compounded drug is needed for a
patient and not the prescriber. For
example, one commenter noted that
hospitals may have standing policies
that specify use of compounded drugs
in certain scenarios.
• Other commenters suggested use of
a template or ‘‘blanket’’ prescriber
determination statement when certain
PO 00000
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2793
drugs are needed for a patient
population on a consistent basis.
• Another commenter noted that
State scope of practice acts or hospital
policy may prohibit pharmacists from
writing in the patient chart or altering
the electronic health record.
FDA Response to Issue Three: FDA is
considering the applicability of the
policies described in this guidance to
hospitals and health systems and
intends to address these issues in
separate guidance.
Issue Four: Several individuals
commented that it would be
burdensome to document the prescriber
determination, as well as to call a
prescriber to document a prescriber
determination when such determination
is not evident on the original
prescription. Individuals felt a
prescriber determination should not be
necessary in certain cases, such as when
a prescription indicates a compounded
drug.
FDA Response to Issue Four: Section
503A(b)(2) provides that a compounded
drug is not essentially a copy of a
commercially available drug product if
there is a change, made for an identified
individual patient, which produces for
that patient a significant difference, as
determined by the prescribing
practitioner, between the compounded
drug and the comparable commercially
available drug. If a prescription already
documents the prescriber’s
determination of significant difference,
there is no additional documentation
burden for the compounder. However, if
a prescription does not make clear that
the prescriber made the determination
required by section 503A(d)(2), or a
compounded drug is substituted for the
commercially available product at the
pharmacy, the compounder may contact
the prescriber, and if the prescriber
confirms it, make a notation on the
prescription that the compounded
product contains a change that makes a
significant difference for the patient.
FDA estimates this contact will take 3
minutes and should not present
significant burden. Maintaining
prescription records that may include
such notations should not present any
additional burden, as FDA understands
that maintaining records of
prescriptions for compounded drug
products is part of the usual course of
the practice of compounding and selling
drugs and is required by States’
pharmacy laws and other State laws
governing recordkeeping by health care
professionals and health care facilities.
Finally, FDA notes that calling a
prescriber to document a prescriber
determination of significant difference
is not a requirement. For example, the
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Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices
compounder has the option of not filling
a prescription with a compounded drug
if a prescriber determination is not
provided.
Issue Five: One commenter stated that
requiring a notation on the prescription
that a compounded drug was on the
drug shortage list when compounded,
and the date the list was checked,
would be overly burdensome.
FDA Response to Issue Five: FDA
does not believe this presents a
significant burden, as a compounder
that wants to rely on a drug shortage to
establish that a compounded drug is not
essentially a copy of a commercially
available drug would need to check
FDA’s shortage website. Noting the date
the list was checked is not onerous, and
is necessary for FDA to verify
compliance during inspections. FDA
estimates this activity would take 2
minutes.
Issue Six: One commenter requested
clarity on how long records should be
maintained; what specific information
should be maintained; and when such
records should be presented to FDA.
FDA Response to Issue Six: FDA has
revised the guidance to include a
recommended duration of 3 years for
maintaining records. The guidance
describes the records that can be
retained to demonstrate compliance.
FDA may request to review such records
during establishment inspections.
FDA estimates the burden of this
collection of information as follows:
We estimate that annually a total of
approximately 6,888 compounders
(‘‘number of respondents’’ in table 1,
line 1) will consult a prescriber to
determine whether he or she has made
a determination that the compounded
drug has a change that produces a
significant difference for a patient as
compared to the comparable
commercially available drug, and that
the compounders will document this
determination on approximately
172,200 prescription orders for
compounded drugs (‘‘total annual
disclosures’’ in table 1, line 1). We
estimate that the consultation between
the compounder and the prescriber and
adding a notation to each prescription
that does not already document this
determination will take approximately 3
minutes per prescription order.
In addition, we estimate that a total of
approximately 6,888 compounders
(‘‘number of respondents’’ in table 1,
line 2) will document this information
on approximately 344,400 prescription
orders for compounded drugs (‘‘total
annual disclosures’’ in table 1, line 2).
We estimate that checking FDA’s drug
shortage list and documenting this
information will take approximately 2
minutes per prescription order.
We estimate that a total of
approximately 3,444 compounders
(‘‘number of recordkeepers’’ in table 2)
will keep approximately 165,312
records (‘‘total annual records’’). We
estimate that maintaining the records
will take approximately 2 minutes per
record.
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Type of reporting
Total annual
disclosures
Average burden per
disclosure
Total hours
Consultation between the compounder and prescriber and the notation on the prescription documenting the prescriber’s determination of significant difference.
Checking FDA’s drug shortage list and documenting on the prescription that the drug is in
shortage.
6,888
50
344,400
0.05 (3 minutes) .......
17,220
6,888
50
344,400
0.03 (2 minutes) .......
10,332
Total ...................................................................
........................
........................
........................
...................................
27,552
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of recordkeeping
Records of frequency and number of prescriptions
filled for compounded drugs that are essentially a
copy.
1 There
3,444
Total annual
records
48
165,312
Average burden per
recordkeeping
0.03 (2 minutes) .......
Total hours
4,959
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00917 Filed 1–18–18; 8:45 am]
BILLING CODE 4164–01–P
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
Notice; establishment of a
public docket; request for comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2018–N–0055]
Gastrointestinal Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Gastrointestinal Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
HHS.
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19JAN1
]]>Agencies
[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2792-2794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1309]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Compounded Drug Products That Are Essentially Copies of a
Commercially Available Drug Product Under Section 503A of the Federal
Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 20, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910--NEW and
title ``Guidance for Industry on Compounded Drug Products that are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503A of
the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910--NEW
This information collection supports the above captioned Agency
guidance document. In the Federal Register of July 11, 2016 (81 FR
44881), FDA announced the availability of a draft guidance for industry
entitled ``Guidance for Industry on Compounded Drug Products That Are
Essentially Copies of a Commercially Available Drug Product Under
Section 503A of the Federal Food, Drug, and Cosmetic Act,'' and
included an analysis of the associated information collection.
Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 353a) describes conditions that must be met in order for
compounded drugs to receive exemptions from certain sections of the
FD&C Act, including section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing practice for drugs); section
502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with
[[Page 2793]]
adequate directions for use) and section 505 (21 U.S.C. 355)
(concerning the approval of human drug products under new drug
applications or abbreviated new drug applications).
One condition of section 503A is that a compounder ``does not
compound regularly or in inordinate amounts (as defined by the
Secretary) any drug products that are essentially copies of a
commercially available drug product'' (section 503A(b)(1)(D)). However,
for the purposes of this section, ``essentially a copy of a
commercially available drug product'' does not include a drug product
``in which there is a change, made for an identified individual
patient, which produces for that patient a significant difference, as
determined by the prescribing practitioner, between the compounded drug
and the comparable commercially available drug product'' (section
503A(b)(2)).
The draft guidance states that if a compounder intends to rely on
such a determination to establish that a compounded drug is not
essentially a copy of a commercially available drug product, the
compounder should ensure that the determination is documented on a
prescription. If a prescription does not make clear that the prescriber
made the determination required by section 503A(b)(2), or a compounded
drug is substituted for the commercially available product at the
pharmacy, the compounder may contact the prescriber and if the
prescriber confirms it, make a notation on the prescription that the
compounded product contains a change that makes a significant
difference for the patient. The notations should be as specific as
those described in this document, and the date of the conversation with
the prescriber should be included on the prescription.
In addition, if the drug was compounded because the approved
product was not commercially available because it was on the FDA drug
shortage list, the prescription or a notation on the prescription
should note that it was on the drug shortage list and the date the list
was checked.
Finally, compounders under section 503A should maintain records of
the frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products to document that such compounding has not been done
``regularly'' or in ``inordinate amounts.''
FDA received 88 comments on the draft guidance, several of which
raised issues pertaining to the information collection provisions in
the draft guidance. The issues raised are addressed below.
Issue One: One commenter proposed that any compounded drug with the
same Active Pharmaceutical Ingredient (API) as a commercially available
drug product should be considered to be ``essentially a copy'' of the
commercially available drug product.
FDA Response to Issue One: FDA has not made this proposed change. A
compounded drug with the same API as a commercially available drug
product may be very different from that commercially available drug
product. For example, it may have a different route of administration
and a substantially different strength. In such cases, a prescriber
determination is not needed because the compounded drug would not be
considered to be ``essentially a copy'' of the commercially available
drug product, even if it had the same API.
Issue Two: Several individuals submitted comments requesting the
collection of additional information than what was proposed in the
draft guidance.
One commenter requested that the medical record maintained
by the prescriber should include additional scientific rationale for
prescribing the compounded product.
Another commenter requested documentation to justify the
use of a bulk drug substance to compound a product that could have been
made starting with FDA-approved products.
FDA Response to Issue Two: Regarding the first comment, this
recommendation regarding what information a prescriber should maintain
is outside the scope of this guidance. Regarding the second comment,
the proposal is beyond the scope of the current guidance and we express
no opinion on the proposed analysis and documentation.
Issue Three: Several individuals submitted comments regarding
collection of the prescriber determination in the hospital setting.
Some commenters noted the prescriber determination is not
necessary in the hospital setting because pharmacists often determine
when a compounded drug is needed for a patient and not the prescriber.
For example, one commenter noted that hospitals may have standing
policies that specify use of compounded drugs in certain scenarios.
Other commenters suggested use of a template or
``blanket'' prescriber determination statement when certain drugs are
needed for a patient population on a consistent basis.
Another commenter noted that State scope of practice acts
or hospital policy may prohibit pharmacists from writing in the patient
chart or altering the electronic health record.
FDA Response to Issue Three: FDA is considering the applicability
of the policies described in this guidance to hospitals and health
systems and intends to address these issues in separate guidance.
Issue Four: Several individuals commented that it would be
burdensome to document the prescriber determination, as well as to call
a prescriber to document a prescriber determination when such
determination is not evident on the original prescription. Individuals
felt a prescriber determination should not be necessary in certain
cases, such as when a prescription indicates a compounded drug.
FDA Response to Issue Four: Section 503A(b)(2) provides that a
compounded drug is not essentially a copy of a commercially available
drug product if there is a change, made for an identified individual
patient, which produces for that patient a significant difference, as
determined by the prescribing practitioner, between the compounded drug
and the comparable commercially available drug. If a prescription
already documents the prescriber's determination of significant
difference, there is no additional documentation burden for the
compounder. However, if a prescription does not make clear that the
prescriber made the determination required by section 503A(d)(2), or a
compounded drug is substituted for the commercially available product
at the pharmacy, the compounder may contact the prescriber, and if the
prescriber confirms it, make a notation on the prescription that the
compounded product contains a change that makes a significant
difference for the patient. FDA estimates this contact will take 3
minutes and should not present significant burden. Maintaining
prescription records that may include such notations should not present
any additional burden, as FDA understands that maintaining records of
prescriptions for compounded drug products is part of the usual course
of the practice of compounding and selling drugs and is required by
States' pharmacy laws and other State laws governing recordkeeping by
health care professionals and health care facilities. Finally, FDA
notes that calling a prescriber to document a prescriber determination
of significant difference is not a requirement. For example, the
[[Page 2794]]
compounder has the option of not filling a prescription with a
compounded drug if a prescriber determination is not provided.
Issue Five: One commenter stated that requiring a notation on the
prescription that a compounded drug was on the drug shortage list when
compounded, and the date the list was checked, would be overly
burdensome.
FDA Response to Issue Five: FDA does not believe this presents a
significant burden, as a compounder that wants to rely on a drug
shortage to establish that a compounded drug is not essentially a copy
of a commercially available drug would need to check FDA's shortage
website. Noting the date the list was checked is not onerous, and is
necessary for FDA to verify compliance during inspections. FDA
estimates this activity would take 2 minutes.
Issue Six: One commenter requested clarity on how long records
should be maintained; what specific information should be maintained;
and when such records should be presented to FDA.
FDA Response to Issue Six: FDA has revised the guidance to include
a recommended duration of 3 years for maintaining records. The guidance
describes the records that can be retained to demonstrate compliance.
FDA may request to review such records during establishment
inspections.
FDA estimates the burden of this collection of information as
follows:
We estimate that annually a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 1) will consult
a prescriber to determine whether he or she has made a determination
that the compounded drug has a change that produces a significant
difference for a patient as compared to the comparable commercially
available drug, and that the compounders will document this
determination on approximately 172,200 prescription orders for
compounded drugs (``total annual disclosures'' in table 1, line 1). We
estimate that the consultation between the compounder and the
prescriber and adding a notation to each prescription that does not
already document this determination will take approximately 3 minutes
per prescription order.
In addition, we estimate that a total of approximately 6,888
compounders (``number of respondents'' in table 1, line 2) will
document this information on approximately 344,400 prescription orders
for compounded drugs (``total annual disclosures'' in table 1, line 2).
We estimate that checking FDA's drug shortage list and documenting this
information will take approximately 2 minutes per prescription order.
We estimate that a total of approximately 3,444 compounders
(``number of recordkeepers'' in table 2) will keep approximately
165,312 records (``total annual records''). We estimate that
maintaining the records will take approximately 2 minutes per record.
Table 1--Estimated Annual Third Party Disclosure Burden \1\
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Number of
Type of reporting Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
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Consultation between the compounder and 6,888 50 344,400 0.05 (3 minutes).......................... 17,220
prescriber and the notation on the
prescription documenting the prescriber's
determination of significant difference.
Checking FDA's drug shortage list and 6,888 50 344,400 0.03 (2 minutes).......................... 10,332
documenting on the prescription that the
drug is in shortage.
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Total................................... .............. .............. .............. .......................................... 27,552
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Type of recordkeeping Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records of frequency and number of 3,444 48 165,312 0.03 (2 minutes).......................... 4,959
prescriptions filled for compounded drugs
that are essentially a copy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00917 Filed 1-18-18; 8:45 am]
BILLING CODE 4164-01-P
