80 FR 65781 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 207 (October 27, 2015)

Page Range		65781-65783
FR Document		2015-27269

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance.

Federal Register, Volume 80 Issue 207 (Tuesday, October 27, 2015)

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65781-65783]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3517]


Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance entitled ``Interim Policy on 
Compounding Using Bulk Drug Substances Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes 
FDA's interim regulatory policy regarding the use of bulk drug 
substances by licensed pharmacists in State-licensed pharmacies or 
Federal facilities and by licensed physicians to compound human drug 
products while FDA develops the list of bulk drug substances that can 
be used in compounding under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). When final, the guidance will reflect the Agency's current 
thinking on the issues addressed by the guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency

[[Page 65782]]

considers your comment on the draft guidance before it begins work on 
the final version of the guidance, submit either electronic or written 
comments on the draft guidance by December 28, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-3517 for ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503A of the Federal Food, Drug, and Cosmetic 
Act; Draft Guidance; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Interim Policy on Compounding Using Bulk Drug Substances Under 
Sections 503A of the Federal Food, Drug, and Cosmetic Act.'' Section 
503A of the FD&C Act describes the conditions that must be satisfied 
for human drug products compounded by a licensed pharmacist in a State-
licensed pharmacy or Federal facility, or by a licensed physician, to 
be exempt from the following three sections of the FD&C Act: Section 
505 (concerning the approval of drugs under new drug applications or 
abbreviated new drug applications); section 502(f)(1) (concerning the 
labeling of drugs with adequate directions for use); and section 
501(a)(2)(B) (concerning current good manufacturing practice 
requirements).
    One of the conditions that must be met for a compounded drug 
product to qualify for these exemptions is that a licensed pharmacist 
or licensed physician compounds the drug product using bulk drug 
substances that: (1) Comply with the standards of an applicable United 
States Pharmacopeia (USP) or National Formulary (NF) monograph, if a 
monograph exists, and the USP chapter on pharmacy compounding; (2) if 
such a monograph does not exist, are drug substances that are 
components of drugs approved by the Secretary; or (3) if such a 
monograph does not exist and the drug substance is not a component of a 
drug approved by the Secretary, appears on a list developed by the 
Secretary through regulations issued by the Secretary under subsection 
(c) of section 503A. (See section 503A(b)(1)(A)(i) of the FD&C Act).
    This guidance describes the conditions under which FDA does not 
intend to take action against a licensed pharmacist or licensed 
physician for compounding a drug product from a bulk drug substance 
that is not the subject of an applicable USP or NF monograph, is not a 
component of an FDA-approved drug, or does not appear on the list of 
bulk drug substances that can be used in compounding under section 
503A(b)(1)(A)(i)(III) of the FD&C Act by a licensed pharmacist or 
licensed physician while FDA is developing the list.
    Elsewhere in this issue of the Federal Register, the Agency is 
making available for public comment a draft guidance entitled ``Interim 
Policy on Compounding Using Bulk Drug Substances Under Section 503B of 
the Federal Food, Drug, and Cosmetic Act,'' which describes conditions 
under

[[Page 65783]]

which FDA does not intend to object to the compounding of a drug 
product from certain bulk drug substances by an outsourcing facility 
while FDA develops the list of bulk drug substances that can be used in 
compounding under section 503B(a)(2)(A)(i) of the FD&C Act.
    The final guidance ``Pharmacy Compounding of Human Drug Products 
Under Section 503A of the FD&C Act,'' (503A Final Guidance) published 
in 2014 (79 FR 37742; July 2, 2014), states, ``Until a bulk drug 
substances list is published in the Federal Register as a final rule, 
human drug products should be compounded using only bulk drug 
substances that are components of drugs approved under section 505 of 
the FD&C Act, or are the subject of USP or NF monographs.'' Because 
this draft interim guidance proposes to change the Agency's policy 
relating to compounding with bulk drug substances while FDA develops a 
list of bulk drug substances that can be used in compounding, FDA is 
adding a footnote to the 503A Final Guidance referencing this draft 
interim guidance. Once this draft interim guidance is finalized, FDA 
intends to remove that footnote from the 503A Final Guidance and cross-
reference the final interim guidance as establishing the policy for 
compounding with bulk drug substances during the development of the 
503A bulks list. The footnote is being added to the 503A Final Guidance 
as a Level 2 change under 21 CFR 10.115 because the final interim 
guidance, rather than the footnote to the 503A Final Guidance, will set 
forth the actual change in policy. Accordingly, comments on the 
proposed change in policy are being solicited as part of this Notice of 
Availability on the draft interim guidance.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27269 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65781

rule entitled ‘‘Implementation of Device Response Act of 2002, the Medical Drug Administration Amendments Act
Registration and Listing Requirements Device User Fee and Modernization Act of 2007.’’
Enacted in the Public Health Security of 2002, and Title II of the Food and FDA estimates the burden of this
and Bioterrorism Preparedness and collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section FDA form No. responses per burden per Total hours
respondents responses
respondent response

807.20(a)(5) 2—Submittal of manufacturer information by ini-
tial importers .......................................................................... 3673 8,594 1 8,594 1.75 15,040
807.20(a)(5) 3—Submittal of manufacturer information by ini-
tial importers .......................................................................... 3673 8,594 3 25,782 0.1 2,578
807.21(a) 3—Creation of electronic system account ................ 3673 3,559 1 3,559 0.5 1,780
807.21(b) 2—Annual request for waiver from electronic reg-
istration & listing .................................................................... ........................ 14 1 14 1 14
807.21(b) 3—Initial request for waiver from electronic registra-
tion & listing ........................................................................... ........................ 4 1 4 1 4
807.22(a) 3—Initial registration & listing .................................... 3673 3,539 1 3,539 0.5 1,770
807.22(b)(1) 3—Annual registration ........................................... 3673 20,355 1 20,355 0.75 15,266
807.22(b)(2) 3—Other updates of registration ........................... 3673 4,176 1 4,176 0.5 2,088
807.22(b)(3) 3—Annual update of listing information ................ 3673 19,875 1 19,875 1 19,875
807.26(e) 3—Labeling & advertisement submitted at FDA re-
quest ...................................................................................... ........................ 71 1 71 1 71
807.34(a) 2—Initial registration & listing when electronic filing
waiver granted ....................................................................... ........................ 14 1 14 1 14
807.34(a) 3—Annual registration & listing when electronic fil-
ing waiver granted ................................................................. ........................ 4 1 4 1 4
807.40(b)(2) 3—Annual update of US agent information .......... 3673 1,615 1 1,615 0.5 808
807.40(b)(3) 3—US agent responses to FDA requests for in-
formation ................................................................................ 3673 1,535 1 1,535 0.25 384
807.41(a) 3—Identification of initial importers by foreign estab-
lishments ................................................................................ 3673 10,329 1 10,329 0.5 5,165
807.41(b) 3—Identification of other parties that facilitate import
by foreign establishments ...................................................... 3673 10,329 1 10,329 0.5 5,165

Total on-time burden .......................................................... ........................ ........................ ........................ ........................ ........................ 15,068
Total recurring burden ....................................................... ........................ ........................ ........................ ........................ ........................ 54,958
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 One-time burden.
3 Recurring burden.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

807.25(d) 2—List of Officers, Directors & Partners ............................................... 23,806 1 23,806 0.25 5,952
807.26 2—Labeling & Advertisements Available for Review ................................ 11,746 4 46,984 0.5 23,492

Total ............................................................................................................... ........................ ........................ ........................ ........................ 29,444
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden.

Dated: October 21, 2015. DEPARTMENT OF HEALTH AND Compounding Using Bulk Drug
Leslie Kux, HUMAN SERVICES Substances Under Section 503A of the
Associate Commissioner for Policy. Federal Food, Drug, and Cosmetic Act.’’
Food and Drug Administration The draft guidance describes FDA’s
[FR Doc. 2015–27199 Filed 10–26–15; 8:45 am]
interim regulatory policy regarding the
BILLING CODE 4164–01–P [Docket No. FDA–2015–D–3517] use of bulk drug substances by licensed
pharmacists in State-licensed
Interim Policy on Compounding Using pharmacies or Federal facilities and by
Bulk Drug Substances Under Section licensed physicians to compound
503A of the Federal Food, Drug, and human drug products while FDA
Cosmetic Act; Draft Guidance; develops the list of bulk drug substances
Availability that can be used in compounding under
AGENCY: Food and Drug Administration, the Federal Food, Drug, and Cosmetic
tkelley on DSK3SPTVN1PROD with NOTICES

HHS. Act (FD&C Act). When final, the
ACTION: Notice of availability. guidance will reflect the Agency’s
current thinking on the issues addressed
SUMMARY: The Food and Drug by the guidance.
Administration (FDA or Agency) is DATES: Although you can comment on
announcing the availability of a draft any guidance at any time (see 21 CFR
guidance entitled ‘‘Interim Policy on 10.115(g)(5)), to ensure that the Agency

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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices 65783

which FDA does not intend to object to DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
the compounding of a drug product HUMAN SERVICES as amended. The grant applications and
from certain bulk drug substances by an the discussions could disclose
outsourcing facility while FDA develops National Institutes of Health confidential trade secrets or commercial
the list of bulk drug substances that can property such as patentable material,
National Heart, Lung, and Blood and personal information concerning
be used in compounding under section
Institute Notice of Closed Meeting individuals associated with the grant
503B(a)(2)(A)(i) of the FD&C Act.
Pursuant to section 10(d) of the applications, the disclosure of which
The final guidance ‘‘Pharmacy would constitute a clearly unwarranted
Compounding of Human Drug Products Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is invasion of personal privacy.
Under Section 503A of the FD&C Act,’’
hereby given of the following meeting. Name of Committee: National Eye Institute
(503A Final Guidance) published in The meeting will be closed to the Special Emphasis Panel; NEI Clinical and
2014 (79 FR 37742; July 2, 2014), states, public in accordance with the Epidemiological Applications: Retina,
‘‘Until a bulk drug substances list is provisions set forth in sections Glaucoma and Neuro-Ophthalmology.
published in the Federal Register as a 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Date: December 10, 2015.
final rule, human drug products should Time: 8:30 a.m. to 4:00 p.m.
as amended. The grant applications and
be compounded using only bulk drug Agenda: To review and evaluate grant
the discussions could disclose applications.
substances that are components of drugs confidential trade secrets or commercial Place: Embassy Suites at the Chevy Chase
approved under section 505 of the FD&C property such as patentable material, Pavilion, 4300 Military Road NW.,
Act, or are the subject of USP or NF and personal information concerning Washington, DC 20015.
monographs.’’ Because this draft interim individuals associated with the grant Contact Person: Brian Hoshaw, Ph.D.,
guidance proposes to change the applications, the disclosure of which Scientific Review Officer, National Eye
would constitute a clearly unwarranted Institute, National Institutes of Health,
Agency’s policy relating to
Division of Extramural Research, 5635
compounding with bulk drug invasion of personal privacy. Fishers Lane, Suite 1300, Rockville, MD
substances while FDA develops a list of Name of Committee: National Heart, Lung, 20892, 301–451–2020, hoshawb@
bulk drug substances that can be used and Blood Institute, Special Emphasis Panel; mail.nih.gov.
in compounding, FDA is adding a T32 Training Program for Institutions that (Catalogue of Federal Domestic Assistance
footnote to the 503A Final Guidance Promote Diversity. Program Nos. 93.867, Vision Research,
Date: November 16, 2015. National Institutes of Health, HHS)
referencing this draft interim guidance. Time: 2:30 p.m. to 3:30 p.m.
Once this draft interim guidance is Agenda: To review and evaluate grant Dated: October 22, 2015.
finalized, FDA intends to remove that applications. Natasha Copeland,
footnote from the 503A Final Guidance Place: National Institutes of Health, 6701 Program Analyst, Office of Federal Advisory
and cross-reference the final interim Rockledge Drive, Room 7189, Bethesda, MD Committee Policy.
guidance as establishing the policy for 20892, (Telephone Conference Call). [FR Doc. 2015–27324 Filed 10–26–15; 8:45 am]
Contact Person: Stephanie L Constant,
compounding with bulk drug Ph.D., Scientific Review Officer, Office of BILLING CODE 4140–01–P
substances during the development of Scientific Review/DERA, National Heart,
the 503A bulks list. The footnote is Lung, and Blood Institute, 6701 Rockledge
being added to the 503A Final Guidance Drive, Room 7189, Bethesda, MD 20892, 301– DEPARTMENT OF HEALTH AND
as a Level 2 change under 21 CFR 443–8784, constantsl@nhlbi.nih.gov. HUMAN SERVICES
10.115 because the final interim (Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for National Institutes of Health
guidance, rather than the footnote to the Sleep Disorders Research; 93.837, Heart and
503A Final Guidance, will set forth the Vascular Diseases Research; 93.838, Lung National Institute of Allergy and
actual change in policy. Accordingly, Diseases Research; 93.839, Blood Diseases Infectious Diseases Notice of Closed
comments on the proposed change in and Resources Research, National Institutes Meeting
policy are being solicited as part of this of Health, HHS)
Pursuant to section 10(d) of the
Notice of Availability on the draft Dated: October 22, 2015.
Federal Advisory Committee Act, as
interim guidance. Michelle Trout, amended (5 U.S.C. App.), notice is
Program Analyst, Office of Federal Advisory hereby given of the following meeting.
II. Electronic Access
Committee Policy. The meeting will be closed to the
Persons with access to the Internet [FR Doc. 2015–27325 Filed 10–26–15; 8:45 am] public in accordance with the
may obtain the guidance at either BILLING CODE 4140–01–P provisions set forth in sections
http://www.fda.gov/Drugs/ 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
GuidanceCompliance as amended. The grant applications and
RegulatoryInformation/Guidances/ DEPARTMENT OF HEALTH AND the discussions could disclose
default.htm or http:// HUMAN SERVICES confidential trade secrets or commercial
www.regulations.gov. property such as patentable material,
National Institutes of Health
and personal information concerning
Dated: October 21, 2015.
National Eye Institute Notice of Closed individuals associated with the grant
Leslie Kux, applications, the disclosure of which
Meeting
Associate Commissioner for Policy. would constitute a clearly unwarranted
tkelley on DSK3SPTVN1PROD with NOTICES

[FR Doc. 2015–27269 Filed 10–26–15; 8:45 am] Pursuant to section 10(d) of the invasion of personal privacy.
Federal Advisory Committee Act, as
BILLING CODE 4164–01–P Name of Committee: National Institute of
amended (5 U.S.C. App.), notice is Allergy and Infectious Diseases Special
hereby given of the following meeting. Emphasis Panel; NIAID Clinical Trial
The meeting will be closed to the Implementation Cooperative Agreement
public in accordance with the (U01).
provisions set forth in sections Date: November 24, 2015.

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Document Created: 2015-12-14 15:36:41
Document Modified: 2015-12-14 15:36:41

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 of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 28, 2015.
Contact		Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 301- 796-3110.
FR Citation		80 FR 65781

80 FR 65781 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 207 (October 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration