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 an Approved Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 13286-13288 [2018-06169]
Download as PDF
<![CDATA[
13286
Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Commissioner of Food and Drugs’
authority provided in section
1003(d)(2)(c) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(c)).
Protecting the nation’s food and
agriculture supply against intentional
contamination and other emerging
threats is an important responsibility
shared by Federal, State, local, tribal,
and territorial governments as well as
private sector partners. On January 4,
2011, the President signed FSMA.
FSMA focuses on ensuring the safety of
the U.S. food supply by shifting the
efforts of Federal regulators from
response to prevention, and recognizes
the importance of strengthening existing
collaboration among all stakeholders to
achieve common public health and
security goals. FSMA identifies some
key priorities for working with partners
in areas such as reliance on Federal,
State, and local agencies for inspections;
improving foodborne illness
surveillance; and leveraging and
enhancing State and local food safety
and defense capacities. Section 108 of
FSMA (NAFDS) requires HHS and the
USDA, in coordination with the DHS, to
work together with State, local,
territorial, and tribal governments-to
monitor and measure progress in food
defense.
In 2015, the initial NAFDS Report to
Congress detailed the specific Federal
response to food and agriculture defense
goals, objectives, key initiatives, and
activities that HHS, USDA, DHS, and
other stakeholders planned to
accomplish to meet the objectives
outlined in FSMA. The NAFDS charts a
direction for how the Federal Agencies,
in cooperation with State, local,
territorial, and tribal governments and
private sector partners, protect the
nation’s food supply against intentional
contamination. Not later than 4 years
after the initial NAFDS Report to
Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2017, etc.),
HHS, USDA, and DHS are required to
revise and submit an updated report to
the relevant committees of Congress.
HHS/FDA is primarily responsible for
obtaining the information from Federal
and State, local, territorial, and tribal
partners to complete the NAFDS Report
to Congress. An interagency working
group will conduct the survey and
collect and update the NAFDS as
directed by FSMA, including
developing metrics and measuring
progress for the evaluation process.
The proposed survey of Federal and
State partners will be used to determine
what food defense activities, if any,
Federal and/or State Agencies have
completed (or are planning) from 2015
to 2019. Planning for the local,
territorial, and tribal information
collections will commence after the
collection and reporting of Federal and
State Agency level data.
This survey will be repeated
approximately every 2 to 4 years, as
described in section 108 of FSMA,
NAFDS, for the purpose of monitoring
progress in food and agricultural
defense by government agencies.
A purposive sampling strategy will be
employed, such that the government
agencies participating in food and
agricultural defense cooperative
agreements with FDA (22 State
Agencies) and USDA (27 State
Agencies) will be asked to respond to
the voluntary survey. Food defense
leaders responsible for conducting food
defense activities during a food
emergency for their jurisdiction will be
identified and will receive an emailed
invitation to complete the survey
online; they will be provided with a
web link to the survey. The survey will
be conducted electronically on the
FDA.gov web portal, and results will be
analyzed by the interagency working
group.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
State Survey ............................................................
1 There
49
Total annual
responses
1
49
Average burden per
response
0.33 (20 minutes) ......
Total hours
16.17
are no capital costs or operating and maintenance costs associated with this collection of information.
The total burden for this collection of
information, therefore, is 16.17 hours.
The FDA Office of Partnerships
reviewed the questionnaire and
provided the amount of time to
complete the survey. The total burden is
based on our previous experiences
conducting surveys.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06135 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Food and Drug Administration
DATES:
[Docket No. FDA–2016–D–1267]
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 an Approved Drug Product Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
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:
VerDate Sep<11>2014
20:30 Mar 27, 2018
Jkt 244001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by April 27,
2018.
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 an Approved Drug
Product Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
ADDRESSES:
E:\FR\FM\28MRN1.SGM
28MRN1
Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
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:
I. Background
Guidance for Industry on Compounded
Drug Products That Are Essentially
Copies of a Commercially Available
Drug Product Under Section 503B of the
Federal Food, Drug, and Cosmetic Act
daltland on DSKBBV9HB2PROD with NOTICES
OMB Control Number 0910–NEW
This information collection supports
the above captioned Agency guidance.
Section 503B of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
353b) describes conditions that must be
met in order for compounded drugs to
receive exemptions from certain
sections of the FD&C Act, including
section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use); section 505
(21 U.S.C. 355) (concerning the approval
of human drug products under new
drug applications (NDAs) or abbreviated
new drug applications (ANDAs)) and
section 582 (21 U.S.C. 360eee–1)
(concerning drug supply chain security
requirements). One of the conditions
that must be met for a compounded
drug product to qualify for the
exemptions under section 503B of the
FD&C Act is that ‘‘the drug is not
essentially a copy of one or more
approved drugs’’ (section 503B(a)(5)).
According to section 503B(d)(2) of the
FD&C Act, a compounded drug is
essentially a copy of an approved drug
when it (1) is identical or nearly
identical to an approved drug that is not
on FDA’s drug shortage list at the time
the drug is compounded, distributed,
and dispensed; or to a non-prescription
drug product marketed without an
approved application, or (2) contains
the same bulk drug substance as an
approved drug or a non-prescription
drug product marketed without an
approved application, unless there is a
change that produces a clinical
difference for an individual patient as
determined by the prescribing
practitioner between the compounded
drug and the approved drug (see section
503B(d)(2)(A) and (B)).
Under the policy proposed in the
draft guidance, if an outsourcing facility
intends to rely on a prescriber
VerDate Sep<11>2014
20:30 Mar 27, 2018
Jkt 244001
determination made under section
503B(d)(2)(B) to establish that a
compounded drug is not essentially a
copy of an approved drug, the
outsourcing facility should ensure that
the determination is documented on the
prescription or order (which may be a
patient-specific prescription or a nonpatient specific order) for the
compounded drug.
If a prescription or order does not
make clear that the determination
required by section 503B(d)(2)(B) has
been made, the outsourcing facility may
contact the prescriber or health care
facility, and if the prescriber or health
care facility contact confirms it, make a
notation on the prescription or order
that the prescriber has determined that
the compounded product contains a
change that produces a clinical
difference for patient(s). The date of the
conversation with the health care
facility contact or prescriber, and the
name of the individual providing the
determination, should be included on
the prescription or order.
In addition, if the outsourcing facility
compounded a drug that is identical or
nearly identical to an approved drug
product that appeared on FDA’s drug
shortage list, the outsourcing facility
should maintain documentation (e.g., a
notation on the order for the
compounded drug) regarding the status
of the drug on FDA’s drug shortage list
at the time of compounding,
distribution, and dispensing.
An outsourcing facility should also
maintain records of prescriptions or
orders including notations that a
prescriber has determined that the
compounded drug has a change that
produces a clinical difference for an
individual patient. Because the time,
effort, and financial resources necessary
to comply with this collection of
information would be incurred by
licensed pharmacists and licensed
physicians in the normal course of their
activities, it is excluded from the
definition of ‘‘burden’’ under 5 CFR
1320.3(b)(2).
II. Paperwork Reduction Act of 1995
In the Federal Register of July 11,
2016 (81 FR 44879), we published a
notice of availability for the draft
guidance, including an analysis of
estimated burden under the PRA, and
invited public comment of the proposed
information collection. Several
comments were received and are
discussed below.
III. Comments
Issue One: Several commenters said it
would be unnecessarily burdensome for
prescribers to document the clinical
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
13287
need for a compounded drug, and that
a pharmacist, nurse, or other clinician
choosing to source compounded drugs
from an outsourcing facility should be
able to assess the clinical need for the
compounded drug.
FDA Response to Issue One: Under
section 503B(d)(2), if a drug is not
identical or nearly identical to an
approved drug or a covered over-thecounter monograph (OTC) drug, and a
component of the compounded drug is
a bulk drug substance that is a
component of an approved drug or a
covered OTC drug, then the drug is
essentially a copy and may not be
compounded under section 503B unless
there is a change that produces for an
individual patient a clinical difference,
as determined by the prescribing
practitioner, between the compounded
drug and the comparable approved
drug. If a prescription or order already
documents the determination of clinical
difference, there is no additional
documentation burden for the
compounder. If a prescription or order
does not make clear that the
determination of clinical difference
required by the statute has been made,
the compounder may contact the
prescriber, and if the prescriber
confirms it, make a notation on the
prescription or order that the
compounded product contains a change
that makes a clinical difference for the
patient. The date of the conversation
with the health care facility or
prescriber, and the name of the
individual providing the determination,
should be included on the prescription
or order. 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 or orders for compounded
drug products is part of the usual course
of the practice of compounding and
selling drugs.
FDA also notes that for non-patient
specific orders, the guidance states that
an outsourcing facility may obtain a
statement from the prescribing
practitioner or a person able to make a
representation for the health care
practitioner. For example, a pharmacy
manager could order a compounded
drug and document on the order that the
compounded drug will only be
administered to patients for whom the
prescriber determines that this
formulation will produce a clinical
difference.
Issue Two: At least two commenters
raised concerns that documentation of
the prescriber determination of clinical
E:\FR\FM\28MRN1.SGM
28MRN1
13288
Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
difference could lead to liability
concerns (e.g., for a pharmacy manager
who makes representations to an
outsourcing facility about how a drug
will be used) and scope of practice
concerns (if a doctor concludes he or
she should not be bound by the
representations).
FDA Response to Issue Two: For
certain drugs, one of the conditions to
qualify for exemptions under section
503B is that there is a change that
produces for an individual patient a
clinical difference, as determined by the
prescribing practitioner, between the
compounded drug and the comparable
approved drug. If a pharmacy manager
does not wish to document on the order
that such a drug will only be
administered after an appropriate
prescriber determination, the manager
could ask the prescriber to provide
documentation. If a prescriber, or
person able to make a representation for
a prescriber, refuses to confirm that a
compounded drug produces a clinical
difference for a patient, the
compounded drug may be considered
‘‘essentially a copy’’ of the
commercially-available product. The
outsourcing facility may decide in this
scenario to not compound the drug.
Issue Three: At least one commenter
recommended that the guidance
requires practitioners to provide
additional details regarding the patient
population in need of a compounded
drug as part of the prescriber
determination of clinical difference, and
that both a hospital and practitioner
should produce statements of clinical
difference.
FDA Response to Issue Three: FDA’s
draft guidance states that when an
outsourcing facility intends to rely on a
prescriber determination to establish
that a compounded drug is not
essentially a copy of an approved drug,
the outsourcing facility should ensure
that the determination is documented
on the prescription or order for the
compounded drug. This means the
determination is referenced in the
statute at section 503B(d)(2), which FDA
cannot change through guidance. FDA
cannot give exhaustive guidance
regarding what such documentation
may contain, but we did provide
appropriate examples. Under the
guidance, both a prescribing practitioner
and a person able to make a
representation for the practitioner, such
as, potentially, a hospital pharmacy
manager, would be able to produce a
statement of clinical difference.
Issue Four: At least one commenter
asked about the acceptability of specific
means of applying a determination
statement to a product order.
FDA Response to Issue Four: FDA
does not believe a particular format is
needed for a prescriber determination of
clinical difference, provided that the
determination clearly identifies the
relevant change made to the
compounded product and the clinical
difference that the change will produce
for patient(s), as determined by the
prescriber.
As none of the comments suggested
that we revise our estimated burden for
the information collection, we have
retained our original estimate as
follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Type of reporting recommendations in guidance
Number of
respondents
Consultation between the outsourcing facility and
prescriber or health care facility, and the notation
on the prescription or order documenting the prescriber’s determination of clinical difference.
Checking FDA’s drug shortage list and documenting
on the prescription that the drug is in shortage.
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
40
100
4,000
0.05 (3 minutes) .....
200
30
100
3,000
0.03 (2 minutes) .....
100
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that annually a total of
approximately 40 outsourcing facilities
(‘‘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
clinical difference for an individual
patient as compared to the comparable
approved drug and that outsourcing
facilities will document this
determination on approximately 4,000
prescriptions or orders for compounded
drugs (‘‘total annual disclosures’’ in
table 1, line 1). We estimate that the
consultation between the outsourcing
facility and the prescriber or health care
facility contact adding a notation to
each prescription or order that does not
already document this determination
will take approximately 3 minutes per
prescription or order.
We estimate that a total of
approximately 30 outsourcing facilities
VerDate Sep<11>2014
20:30 Mar 27, 2018
Jkt 244001
(‘‘number of respondents’’ in table 1,
line 2) will document this information
on approximately 3,000 prescriptions or
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 or order.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06169 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6397]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling;
Calorie Labeling of Articles of Food in
Vending Machines and Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
Frm 00067
Fmt 4703
Sfmt 4703
E:\FR\FM\28MRN1.SGM
28MRN1
]]>Agencies
[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13286-13288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-1267]
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 an Approved
Drug Product Under Section 503B 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 April
27, 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 an Approved Drug Product Under Section 503B of
the Federal Food, Drug, and Cosmetic Act.'' Also include the FDA docket
number found in brackets in the heading of this document.
[[Page 13287]]
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.
I. Background
Guidance for Industry on Compounded Drug Products That Are Essentially
Copies of a Commercially Available Drug Product Under Section 503B of
the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-NEW
This information collection supports the above captioned Agency
guidance. Section 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353b) describes conditions that must be met in
order for compounded drugs to receive exemptions from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use);
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)) and section 582 (21 U.S.C. 360eee-1) (concerning
drug supply chain security requirements). One of the conditions that
must be met for a compounded drug product to qualify for the exemptions
under section 503B of the FD&C Act is that ``the drug is not
essentially a copy of one or more approved drugs'' (section
503B(a)(5)).
According to section 503B(d)(2) of the FD&C Act, a compounded drug
is essentially a copy of an approved drug when it (1) is identical or
nearly identical to an approved drug that is not on FDA's drug shortage
list at the time the drug is compounded, distributed, and dispensed; or
to a non-prescription drug product marketed without an approved
application, or (2) contains the same bulk drug substance as an
approved drug or a non-prescription drug product marketed without an
approved application, unless there is a change that produces a clinical
difference for an individual patient as determined by the prescribing
practitioner between the compounded drug and the approved drug (see
section 503B(d)(2)(A) and (B)).
Under the policy proposed in the draft guidance, if an outsourcing
facility intends to rely on a prescriber determination made under
section 503B(d)(2)(B) to establish that a compounded drug is not
essentially a copy of an approved drug, the outsourcing facility should
ensure that the determination is documented on the prescription or
order (which may be a patient-specific prescription or a non-patient
specific order) for the compounded drug.
If a prescription or order does not make clear that the
determination required by section 503B(d)(2)(B) has been made, the
outsourcing facility may contact the prescriber or health care
facility, and if the prescriber or health care facility contact
confirms it, make a notation on the prescription or order that the
prescriber has determined that the compounded product contains a change
that produces a clinical difference for patient(s). The date of the
conversation with the health care facility contact or prescriber, and
the name of the individual providing the determination, should be
included on the prescription or order.
In addition, if the outsourcing facility compounded a drug that is
identical or nearly identical to an approved drug product that appeared
on FDA's drug shortage list, the outsourcing facility should maintain
documentation (e.g., a notation on the order for the compounded drug)
regarding the status of the drug on FDA's drug shortage list at the
time of compounding, distribution, and dispensing.
An outsourcing facility should also maintain records of
prescriptions or orders including notations that a prescriber has
determined that the compounded drug has a change that produces a
clinical difference for an individual patient. Because the time,
effort, and financial resources necessary to comply with this
collection of information would be incurred by licensed pharmacists and
licensed physicians in the normal course of their activities, it is
excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2).
II. Paperwork Reduction Act of 1995
In the Federal Register of July 11, 2016 (81 FR 44879), we
published a notice of availability for the draft guidance, including an
analysis of estimated burden under the PRA, and invited public comment
of the proposed information collection. Several comments were received
and are discussed below.
III. Comments
Issue One: Several commenters said it would be unnecessarily
burdensome for prescribers to document the clinical need for a
compounded drug, and that a pharmacist, nurse, or other clinician
choosing to source compounded drugs from an outsourcing facility should
be able to assess the clinical need for the compounded drug.
FDA Response to Issue One: Under section 503B(d)(2), if a drug is
not identical or nearly identical to an approved drug or a covered
over-the-counter monograph (OTC) drug, and a component of the
compounded drug is a bulk drug substance that is a component of an
approved drug or a covered OTC drug, then the drug is essentially a
copy and may not be compounded under section 503B unless there is a
change that produces for an individual patient a clinical difference,
as determined by the prescribing practitioner, between the compounded
drug and the comparable approved drug. If a prescription or order
already documents the determination of clinical difference, there is no
additional documentation burden for the compounder. If a prescription
or order does not make clear that the determination of clinical
difference required by the statute has been made, the compounder may
contact the prescriber, and if the prescriber confirms it, make a
notation on the prescription or order that the compounded product
contains a change that makes a clinical difference for the patient. The
date of the conversation with the health care facility or prescriber,
and the name of the individual providing the determination, should be
included on the prescription or order. 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 or orders for compounded drug products is part of the
usual course of the practice of compounding and selling drugs.
FDA also notes that for non-patient specific orders, the guidance
states that an outsourcing facility may obtain a statement from the
prescribing practitioner or a person able to make a representation for
the health care practitioner. For example, a pharmacy manager could
order a compounded drug and document on the order that the compounded
drug will only be administered to patients for whom the prescriber
determines that this formulation will produce a clinical difference.
Issue Two: At least two commenters raised concerns that
documentation of the prescriber determination of clinical
[[Page 13288]]
difference could lead to liability concerns (e.g., for a pharmacy
manager who makes representations to an outsourcing facility about how
a drug will be used) and scope of practice concerns (if a doctor
concludes he or she should not be bound by the representations).
FDA Response to Issue Two: For certain drugs, one of the conditions
to qualify for exemptions under section 503B is that there is a change
that produces for an individual patient a clinical difference, as
determined by the prescribing practitioner, between the compounded drug
and the comparable approved drug. If a pharmacy manager does not wish
to document on the order that such a drug will only be administered
after an appropriate prescriber determination, the manager could ask
the prescriber to provide documentation. If a prescriber, or person
able to make a representation for a prescriber, refuses to confirm that
a compounded drug produces a clinical difference for a patient, the
compounded drug may be considered ``essentially a copy'' of the
commercially-available product. The outsourcing facility may decide in
this scenario to not compound the drug.
Issue Three: At least one commenter recommended that the guidance
requires practitioners to provide additional details regarding the
patient population in need of a compounded drug as part of the
prescriber determination of clinical difference, and that both a
hospital and practitioner should produce statements of clinical
difference.
FDA Response to Issue Three: FDA's draft guidance states that when
an outsourcing facility intends to rely on a prescriber determination
to establish that a compounded drug is not essentially a copy of an
approved drug, the outsourcing facility should ensure that the
determination is documented on the prescription or order for the
compounded drug. This means the determination is referenced in the
statute at section 503B(d)(2), which FDA cannot change through
guidance. FDA cannot give exhaustive guidance regarding what such
documentation may contain, but we did provide appropriate examples.
Under the guidance, both a prescribing practitioner and a person able
to make a representation for the practitioner, such as, potentially, a
hospital pharmacy manager, would be able to produce a statement of
clinical difference.
Issue Four: At least one commenter asked about the acceptability of
specific means of applying a determination statement to a product
order.
FDA Response to Issue Four: FDA does not believe a particular
format is needed for a prescriber determination of clinical difference,
provided that the determination clearly identifies the relevant change
made to the compounded product and the clinical difference that the
change will produce for patient(s), as determined by the prescriber.
As none of the comments suggested that we revise our estimated
burden for the information collection, we have retained our original
estimate as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting recommendations in guidance Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation between the outsourcing facility 40 100 4,000 0.05 (3 minutes)......................... 200
and prescriber or health care facility, and
the notation on the prescription or order
documenting the prescriber's determination
of clinical difference.
Checking FDA's drug shortage list and 30 100 3,000 0.03 (2 minutes)......................... 100
documenting on the prescription that the
drug is in shortage.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate that annually a total of approximately 40 outsourcing
facilities (``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 clinical
difference for an individual patient as compared to the comparable
approved drug and that outsourcing facilities will document this
determination on approximately 4,000 prescriptions or orders for
compounded drugs (``total annual disclosures'' in table 1, line 1). We
estimate that the consultation between the outsourcing facility and the
prescriber or health care facility contact adding a notation to each
prescription or order that does not already document this determination
will take approximately 3 minutes per prescription or order.
We estimate that a total of approximately 30 outsourcing facilities
(``number of respondents'' in table 1, line 2) will document this
information on approximately 3,000 prescriptions or 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 or
order.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06169 Filed 3-27-18; 8:45 am]
BILLING CODE 4164-01-P
