83 FR 13286 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 60 (March 28, 2018)

Page Range		13286-13288
FR Document		2018-06169

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.

Federal Register, Volume 83 Issue 60 (Wednesday, March 28, 2018)

[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13286-13288]
From the Federal Register Online  [www.thefederalregister.org]
[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

13286 Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices

Commissioner of Food and Drugs’ In 2015, the initial NAFDS Report to completed (or are planning) from 2015
authority provided in section Congress detailed the specific Federal to 2019. Planning for the local,
1003(d)(2)(c) of the Federal Food, Drug, response to food and agriculture defense territorial, and tribal information
and Cosmetic Act (21 U.S.C. goals, objectives, key initiatives, and collections will commence after the
393(d)(2)(c)). activities that HHS, USDA, DHS, and collection and reporting of Federal and
Protecting the nation’s food and other stakeholders planned to State Agency level data.
agriculture supply against intentional accomplish to meet the objectives This survey will be repeated
contamination and other emerging outlined in FSMA. The NAFDS charts a approximately every 2 to 4 years, as
threats is an important responsibility direction for how the Federal Agencies, described in section 108 of FSMA,
shared by Federal, State, local, tribal, in cooperation with State, local, NAFDS, for the purpose of monitoring
and territorial governments as well as territorial, and tribal governments and progress in food and agricultural
private sector partners. On January 4, private sector partners, protect the defense by government agencies.
2011, the President signed FSMA. nation’s food supply against intentional
FSMA focuses on ensuring the safety of contamination. Not later than 4 years A purposive sampling strategy will be
the U.S. food supply by shifting the after the initial NAFDS Report to employed, such that the government
efforts of Federal regulators from Congress (2015), and every 4 years agencies participating in food and
response to prevention, and recognizes thereafter (i.e., 2019, 2023, 2017, etc.), agricultural defense cooperative
the importance of strengthening existing HHS, USDA, and DHS are required to agreements with FDA (22 State
collaboration among all stakeholders to revise and submit an updated report to Agencies) and USDA (27 State
achieve common public health and the relevant committees of Congress. Agencies) will be asked to respond to
security goals. FSMA identifies some HHS/FDA is primarily responsible for the voluntary survey. Food defense
key priorities for working with partners obtaining the information from Federal leaders responsible for conducting food
in areas such as reliance on Federal, and State, local, territorial, and tribal defense activities during a food
State, and local agencies for inspections; partners to complete the NAFDS Report emergency for their jurisdiction will be
improving foodborne illness to Congress. An interagency working identified and will receive an emailed
surveillance; and leveraging and group will conduct the survey and invitation to complete the survey
enhancing State and local food safety collect and update the NAFDS as online; they will be provided with a
and defense capacities. Section 108 of directed by FSMA, including web link to the survey. The survey will
FSMA (NAFDS) requires HHS and the developing metrics and measuring be conducted electronically on the
USDA, in coordination with the DHS, to progress for the evaluation process. FDA.gov web portal, and results will be
work together with State, local, The proposed survey of Federal and analyzed by the interagency working
territorial, and tribal governments-to State partners will be used to determine group.
monitor and measure progress in food what food defense activities, if any, FDA estimates the burden of this
defense. Federal and/or State Agencies have collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

State Survey ............................................................ 49 1 49 0.33 (20 minutes) ...... 16.17
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total burden for this collection of DEPARTMENT OF HEALTH AND (OMB) for review and clearance under
information, therefore, is 16.17 hours. HUMAN SERVICES the Paperwork Reduction Act of 1995.
The FDA Office of Partnerships DATES: Fax written comments on the
Food and Drug Administration
reviewed the questionnaire and collection of information by April 27,
provided the amount of time to [Docket No. FDA–2016–D–1267] 2018.
complete the survey. The total burden is
based on our previous experiences Agency Information Collection ADDRESSES: To ensure that comments on
Activities; Submission for Office of the information collection are received,
conducting surveys.
Management and Budget Review; OMB recommends that written
Dated: March 22, 2018. Comment Request; Guidance for comments be faxed to the Office of
Leslie Kux, Industry on Compounded Drug Information and Regulatory Affairs,
Associate Commissioner for Policy. Products That Are Essentially Copies OMB, Attn: FDA Desk Officer, Fax: 202–
[FR Doc. 2018–06135 Filed 3–27–18; 8:45 am]
of an Approved Drug Product Under 395–7285, or emailed to oira_
Section 503B of the Federal Food, submission@omb.eop.gov. All
BILLING CODE 4164–01–P
Drug, and Cosmetic Act comments should be identified with the
AGENCY: Food and Drug Administration, OMB control number 0910–NEW and
HHS. title ‘‘Guidance for Industry on
daltland on DSKBBV9HB2PROD with NOTICES

ACTION: Notice. Compounded Drug Products That Are
Essentially Copies of an Approved Drug
SUMMARY: The Food and Drug Product Under Section 503B of the
Administration (FDA) is announcing Federal Food, Drug, and Cosmetic Act.’’
that a proposed collection of Also include the FDA docket number
information has been submitted to the found in brackets in the heading of this
Office of Management and Budget document.

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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices 13287

FOR FURTHER INFORMATION CONTACT: determination made under section need for a compounded drug, and that
Domini Bean, Office of Operations, 503B(d)(2)(B) to establish that a a pharmacist, nurse, or other clinician
Food and Drug Administration, Three compounded drug is not essentially a choosing to source compounded drugs
White Flint North, 10A–12M, 11601 copy of an approved drug, the from an outsourcing facility should be
Landsdown St., North Bethesda, MD outsourcing facility should ensure that able to assess the clinical need for the
20852, 301–796–5733, PRAStaff@ the determination is documented on the compounded drug.
fda.hhs.gov. prescription or order (which may be a FDA Response to Issue One: Under
patient-specific prescription or a non- section 503B(d)(2), if a drug is not
SUPPLEMENTARY INFORMATION: In identical or nearly identical to an
patient specific order) for the
compliance with 44 U.S.C. 3507, FDA approved drug or a covered over-the-
compounded drug.
has submitted the following proposed If a prescription or order does not counter monograph (OTC) drug, and a
collection of information to OMB for make clear that the determination component of the compounded drug is
review and clearance. required by section 503B(d)(2)(B) has a bulk drug substance that is a
I. Background been made, the outsourcing facility may component of an approved drug or a
contact the prescriber or health care covered OTC drug, then the drug is
Guidance for Industry on Compounded
facility, and if the prescriber or health essentially a copy and may not be
Drug Products That Are Essentially
care facility contact confirms it, make a compounded under section 503B unless
Copies of a Commercially Available there is a change that produces for an
notation on the prescription or order
Drug Product Under Section 503B of the individual patient a clinical difference,
that the prescriber has determined that
Federal Food, Drug, and Cosmetic Act as determined by the prescribing
the compounded product contains a
OMB Control Number 0910–NEW change that produces a clinical practitioner, between the compounded
difference for patient(s). The date of the drug and the comparable approved
This information collection supports
conversation with the health care drug. If a prescription or order already
the above captioned Agency guidance.
facility contact or prescriber, and the documents the determination of clinical
Section 503B of the Federal Food, Drug,
name of the individual providing the difference, there is no additional
and Cosmetic Act (FD&C Act) (21 U.S.C.
determination, should be included on documentation burden for the
353b) describes conditions that must be
the prescription or order. compounder. If a prescription or order
met in order for compounded drugs to does not make clear that the
In addition, if the outsourcing facility
receive exemptions from certain determination of clinical difference
compounded a drug that is identical or
sections of the FD&C Act, including required by the statute has been made,
nearly identical to an approved drug
section 502(f)(1) (21 U.S.C. 352(f)(1)) the compounder may contact the
product that appeared on FDA’s drug
(concerning the labeling of drugs with prescriber, and if the prescriber
shortage list, the outsourcing facility
adequate directions for use); section 505 confirms it, make a notation on the
should maintain documentation (e.g., a
(21 U.S.C. 355) (concerning the approval prescription or order that the
notation on the order for the
of human drug products under new compounded product contains a change
compounded drug) regarding the status
drug applications (NDAs) or abbreviated that makes a clinical difference for the
of the drug on FDA’s drug shortage list
new drug applications (ANDAs)) and patient. The date of the conversation
at the time of compounding,
section 582 (21 U.S.C. 360eee–1) with the health care facility or
distribution, and dispensing.
(concerning drug supply chain security An outsourcing facility should also prescriber, and the name of the
requirements). One of the conditions maintain records of prescriptions or individual providing the determination,
that must be met for a compounded orders including notations that a should be included on the prescription
drug product to qualify for the prescriber has determined that the or order. FDA estimates this contact will
exemptions under section 503B of the compounded drug has a change that take 3 minutes and should not present
FD&C Act is that ‘‘the drug is not produces a clinical difference for an significant burden. Maintaining
essentially a copy of one or more individual patient. Because the time, prescription records that may include
approved drugs’’ (section 503B(a)(5)). effort, and financial resources necessary such notations should not present any
According to section 503B(d)(2) of the to comply with this collection of additional burden, as FDA understands
FD&C Act, a compounded drug is information would be incurred by that maintaining records of
essentially a copy of an approved drug licensed pharmacists and licensed prescriptions or orders for compounded
when it (1) is identical or nearly physicians in the normal course of their drug products is part of the usual course
identical to an approved drug that is not activities, it is excluded from the of the practice of compounding and
on FDA’s drug shortage list at the time definition of ‘‘burden’’ under 5 CFR selling drugs.
the drug is compounded, distributed, 1320.3(b)(2). FDA also notes that for non-patient
and dispensed; or to a non-prescription specific orders, the guidance states that
drug product marketed without an II. Paperwork Reduction Act of 1995 an outsourcing facility may obtain a
approved application, or (2) contains In the Federal Register of July 11, statement from the prescribing
the same bulk drug substance as an 2016 (81 FR 44879), we published a practitioner or a person able to make a
approved drug or a non-prescription notice of availability for the draft representation for the health care
drug product marketed without an guidance, including an analysis of practitioner. For example, a pharmacy
approved application, unless there is a estimated burden under the PRA, and manager could order a compounded
change that produces a clinical invited public comment of the proposed drug and document on the order that the
difference for an individual patient as information collection. Several compounded drug will only be
daltland on DSKBBV9HB2PROD with NOTICES

determined by the prescribing comments were received and are administered to patients for whom the
practitioner between the compounded discussed below. prescriber determines that this
drug and the approved drug (see section formulation will produce a clinical
503B(d)(2)(A) and (B)). III. Comments difference.
Under the policy proposed in the Issue One: Several commenters said it Issue Two: At least two commenters
draft guidance, if an outsourcing facility would be unnecessarily burdensome for raised concerns that documentation of
intends to rely on a prescriber prescribers to document the clinical the prescriber determination of clinical

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Document Created: 2018-11-01 08:55:18
Document Modified: 2018-11-01 08:55:18

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by April 27, 2018.
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]
FR Citation		83 FR 13286

83 FR 13286 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 60 (March 28, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration