80 FR 48324 - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 155 (August 12, 2015)

Page Range		48324-48325
FR Document		2015-19740

The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.

Federal Register, Volume 80 Issue 155 (Wednesday, August 12, 2015)

[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48324-48325]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19740]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1399]


Guidance for Entities Considering Whether To Register as 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance entitled ``Guidance for Entities 
Considering Whether to Register as Outsourcing Facilities Under Section 
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is 
intended to inform entities that are considering registering as 
outsourcing facilities under section 503B of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), as added by the Drug Quality and 
Security Act (DQSA), of the regulatory implications of registration as 
an outsourcing facility.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Guidance for Entities Considering Whether to Register as 
Outsourcing Facilities Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.'' On November 27, 2013, President Obama signed the 
DQSA (Pub. L. 113-54) into law. The DQSA added a new section 503B to 
the FD&C Act that created a category of entities called ``outsourcing 
facilities.'' Section 503B(d)(4) of the FD&C Act (21 U.S.C. 353b(d)(4)) 
defines an outsourcing facility, in part, as a facility that complies 
with all of the requirements of section 503B, including registering 
with FDA as an outsourcing facility and paying associated fees. If the 
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a 
drug compounded by or under the direct supervision of a licensed 
pharmacist in an outsourcing facility is exempt 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) and 
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)). Drugs compounded in outsourcing facilities are 
not exempt from the requirements of section 501(a)(2)(B) of the FD&C 
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing 
practice for drugs).
    FDA has received questions about whether entities engaged in 
various types of activities (e.g., a facility that is compounding only 
non-sterile drugs or only repackaging biological products) should 
register as an outsourcing facility. Because entities that register as 
outsourcing facilities must pay a registration fee and FDA has 
determined that fees paid pursuant to sections 503B and 744K of the 
FD&C Act will not be refunded, FDA is issuing this guidance to answer 
some of these questions and to provide potential registrants additional 
information about the regulatory impact of registering as an 
outsourcing facility.
    In the Federal Register of February 19, 2015 (80 FR 8871), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. The comment period on the draft guidance ended on May 
20, 2015. FDA received eleven comments on the draft guidance. Some of 
the comments raised issues that were not directly pertinent to the 
topics addressed in this guidance. FDA intends to consider those 
comments as they relate to issues being addressed in other policy 
documents being developed by the Agency.
    In response to received comments or on its own initiative, FDA made 
the following changes as it finalized this guidance: (1) Removed the 
reference to a separate guidance document that explains how outsourcing 
facilities should report the products they compound to FDA because that 
guidance is not directly related to the issue of entities considering 
whether to register as outsourcing facilities; (2) noted that FDA has 
issued separate guidance documents addressing some of the conditions of 
section 503B and that it intends to publish additional guidance 
addressing other conditions; (3) added a reference to FDA's draft 
guidance regarding compounding animal drug products from bulk drug 
substances, which addresses outsourcing facilities engaging in this 
activity; and (4) made grammatical and other minor editorial changes 
for clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on registering as an outsourcing facility 
under section 503B of the FD&C Act. It does not create 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.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division

[[Page 48325]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

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

    Dated: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19740 Filed 8-11-15; 8:45 am]
 BILLING CODE 4164-01-P

48324 Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices

labels × 7.25 hours = 174 hours). In 4th Floor, Silver Spring, MD 20993– that fees paid pursuant to sections 503B
addition, 12 respondents will each 0002. Send one self-addressed adhesive and 744K of the FD&C Act will not be
spend 1 hour reading the guidance label to assist that office in processing refunded, FDA is issuing this guidance
document, for a total of 12 hours. Thus, your requests. See the SUPPLEMENTARY to answer some of these questions and
we estimate the total hour burden of the INFORMATION section for electronic to provide potential registrants
proposed collection of information to be access to the guidance document. additional information about the
186 hours (174 hours + 12 hours = 186 Submit electronic comments on the regulatory impact of registering as an
hours). guidance to http://www.regulations.gov. outsourcing facility.
The guidance also refers to previously Submit written comments to the In the Federal Register of February
approved collections of information Division of Dockets Management (HFA– 19, 2015 (80 FR 8871), FDA issued a
found in our regulations. The 305), Food and Drug Administration, notice announcing the availability of the
collections of information in §§ 101.3, 5630 Fishers Lane, Rm. 1061, Rockville, draft version of this guidance. The
101.4, 101.5, 101.9, 101.22, and 101.105 MD 20852. comment period on the draft guidance
have been approved under OMB control FOR FURTHER INFORMATION CONTACT: Sara ended on May 20, 2015. FDA received
number 0910–0381. Allergen labeling of Rothman, Food and Drug eleven comments on the draft guidance.
these beers under section 403(w)(1) of Administration, 10903 New Hampshire Some of the comments raised issues that
the FD&C Act, which was added by the Ave., Silver Spring, MD 20993, 301– were not directly pertinent to the topics
Food Allergen Labeling and Consumer 796–3110. addressed in this guidance. FDA intends
Protection Act of 2004, has been to consider those comments as they
SUPPLEMENTARY INFORMATION:
approved under OMB control number relate to issues being addressed in other
0910–0792. I. Background policy documents being developed by
the Agency.
Dated: August 6, 2015. FDA is announcing the availability of In response to received comments or
Leslie Kux, a final guidance for industry entitled on its own initiative, FDA made the
Associate Commissioner for Policy. ‘‘Guidance for Entities Considering following changes as it finalized this
[FR Doc. 2015–19741 Filed 8–11–15; 8:45 am] Whether to Register as Outsourcing guidance: (1) Removed the reference to
BILLING CODE 4164–01–P
Facilities Under Section 503B of the a separate guidance document that
Federal Food, Drug, and Cosmetic Act.’’ explains how outsourcing facilities
On November 27, 2013, President should report the products they
DEPARTMENT OF HEALTH AND Obama signed the DQSA (Pub. L. 113– compound to FDA because that
HUMAN SERVICES 54) into law. The DQSA added a new guidance is not directly related to the
section 503B to the FD&C Act that issue of entities considering whether to
Food and Drug Administration created a category of entities called register as outsourcing facilities; (2)
‘‘outsourcing facilities.’’ Section noted that FDA has issued separate
[Docket No. FDA–2014–D–1399]
503B(d)(4) of the FD&C Act (21 U.S.C. guidance documents addressing some of
Guidance for Entities Considering 353b(d)(4)) defines an outsourcing the conditions of section 503B and that
Whether To Register as Outsourcing facility, in part, as a facility that it intends to publish additional
Facilities Under Section 503B of the complies with all of the requirements of guidance addressing other conditions;
Federal Food, Drug, and Cosmetic Act; section 503B, including registering with (3) added a reference to FDA’s draft
Guidance for Industry; Availability FDA as an outsourcing facility and guidance regarding compounding
paying associated fees. If the conditions animal drug products from bulk drug
AGENCY: Food and Drug Administration, outlined in section 503B(a) of the FD&C substances, which addresses
HHS. Act are satisfied, a drug compounded by outsourcing facilities engaging in this
ACTION: Notice. or under the direct supervision of a activity; and (4) made grammatical and
licensed pharmacist in an outsourcing other minor editorial changes for clarity.
SUMMARY: The Food and Drug facility is exempt from certain sections This guidance is being issued
Administration (FDA) is announcing the of the FD&C Act, including section consistent with FDA’s good guidance
availability of a final guidance entitled 502(f)(1) (21 U.S.C. 352(f)(1)) practices regulation (21 CFR 10.115).
‘‘Guidance for Entities Considering (concerning the labeling of drugs with The guidance represents the Agency’s
Whether to Register as Outsourcing adequate directions for use) and section current thinking on registering as an
Facilities Under Section 503B of the 505 (21 U.S.C. 355) (concerning the outsourcing facility under section 503B
Federal Food, Drug, and Cosmetic Act.’’ approval of human drug products under of the FD&C Act. It does not create any
This guidance is intended to inform new drug applications (NDAs) or rights for any person and is not binding
entities that are considering registering abbreviated new drug applications on FDA or the public. You can use an
as outsourcing facilities under section (ANDAs)). Drugs compounded in alternative approach if it satisfies the
503B of the Federal Food, Drug, and outsourcing facilities are not exempt requirements of the applicable statutes
Cosmetic Act (the FD&C Act), as added from the requirements of section and regulations.
by the Drug Quality and Security Act 501(a)(2)(B) of the FD&C Act (21 U.S.C.
(DQSA), of the regulatory implications 351(a)(2)(B)) (concerning current good II. Comments
of registration as an outsourcing facility. manufacturing practice for drugs). Interested persons may submit either
DATES: Submit either electronic or FDA has received questions about electronic comments regarding this
written comments on Agency guidances
mstockstill on DSK4VPTVN1PROD with NOTICES

whether entities engaged in various document to http://www.regulations.gov
at any time. types of activities (e.g., a facility that is or written comments to the Division of
ADDRESSES: Submit written requests for compounding only non-sterile drugs or Dockets Management (see ADDRESSES). It
single copies of this guidance to the only repackaging biological products) is only necessary to send one set of
Division of Drug Information, Center for should register as an outsourcing comments. Identify comments with the
Drug Evaluation and Research, Food facility. Because entities that register as docket number found in brackets in the
and Drug Administration, 10001 New outsourcing facilities must pay a heading of this document. Received
Hampshire Ave., Hillandale Building, registration fee and FDA has determined comments may be seen in the Division

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Federal Register / Vol. 80, No. 155 / Wednesday, August 12, 2015 / Notices 48325

of Dockets Management between 9 a.m. by establishing consistent stakeholder professional associations, as well as
and 4 p.m., Monday through Friday, and representation. scientific and academic experts notify
will be posted to the docket at http:// DATES: FDA is extending the closing FDA of their intent to participate in
www.regulations.gov. date in the notice published June 3, periodic consultation meetings on
2015 (80 FR 31602). Submit notification GDUFA reauthorization. FDA believes
III. Electronic Access
of intent to participate by April 30, that consistent stakeholder
Persons with access to the Internet representation at these meetings will be
2016.
may obtain the document at either important to ensuring progress in these
http://www.fda.gov/Drugs/ ADDRESSES: Submit notification of
discussions. If you wish to participate in
GuidanceComplianceRegulatory intent to participate in monthly this part of the reauthorization process,
Information/Guidances/default.htm or stakeholder meetings by email to please designate one or more
http://www.regulations.gov. GenericDrugPolicy@fda.hhs.gov. representatives from your organization
Dated: August 6, 2015. FOR FURTHER INFORMATION CONTACT: who will commit to attending these
Leslie Kux,
Connie Wisner, Center for Drug meetings and preparing for the
Evaluation and Research, Food and discussions as needed. Stakeholders
Associate Commissioner for Policy.
Drug Administration, 10903 New who identify themselves through this
[FR Doc. 2015–19740 Filed 8–11–15; 8:45 am]
Hampshire Ave., Bldg. 75, Rm. 1718, notice will be included in all
BILLING CODE 4164–01–P Silver Spring, MD 20993–0002, 240– stakeholder discussions while FDA
402–7946, Connie.Wisner@fda.hhs.gov. negotiates with the regulated industry.
SUPPLEMENTARY INFORMATION: Stakeholders who decide to participate
DEPARTMENT OF HEALTH AND
HUMAN SERVICES I. Introduction in these monthly meetings at a later
time may still participate in remaining
Food and Drug Administration FDA is requesting that public
monthly meetings by notifying FDA (see
stakeholders, including patient and
[Docket No. FDA–2012–N–0882] ADDRESSES). These stakeholder
consumer advocacy groups, health care
discussions will satisfy the requirement
professionals, and scientific and
Generic Drug User Fees; Stakeholder in section 744C(d)(3) of the FD&C Act.
academic experts, notify the Agency of
Meetings on Generic Drug User Fee their intent to participate in periodic II. Notification of Intent To Participate
Amendments of 2012 Reauthorization; consultation meetings on the in Periodic Consultation Meetings
Request for Notification of Stakeholder reauthorization of GDUFA. GDUFA
Intent To Participate; Extension of If you intend to participate in
authorizes FDA to collect fees from drug continued periodic stakeholder
Closing Date companies that submit marketing
consultation meetings regarding GDUFA
AGENCY: Food and Drug Administration, applications for certain generic human
reauthorization, please provide
HHS. drug applications, certain drug master
notification by email to
ACTION: Notice; request for notification files, and certain facilities. GDUFA
GenericDrugPolicy@fda.hhs.gov by
of intent to participate; extension of requires that generic drug manufacturers
April 30, 2016. Your email should
closing date. pay user fees to finance critical and
contain complete contact information,
measurable generic drug program
SUMMARY: The Food and Drug including name, title, affiliation,
enhancements. The statutory authority
Administration (FDA) is extending the address, email address, phone number,
for GDUFA expires at the end of
closing date for the document that and notice of any special
September 2017. Without new
appeared in the Federal Register of June accommodations required because of
legislation, FDA will no longer be able
3, 2015. In that document, FDA to collect user fees for future fiscal years disability. Stakeholders will receive
requested that public stakeholders, to fund the human generic drug review confirmation and additional information
including patient and consumer process. Section 744C(d) (21 U.S.C. about the first meeting once FDA
advocacy groups, health care 379j–43(d)) of the FD&C Act requires receives their notification.
professionals, and scientific and that FDA consult with a range of Dated: August 6, 2015.
academic experts, notify FDA of their stakeholders in developing Leslie Kux,
intent to participate in periodic recommendations for the next GDUFA Associate Commissioner for Policy.
consultation meetings on the program, including representatives from [FR Doc. 2015–19768 Filed 8–11–15; 8:45 am]
reauthorization of the Generic Drug User patient and consumer groups, health BILLING CODE 4164–01–P
Fee Amendments of 2012 (GDUFA). The care professionals, and scientific and
statutory authority for GDUFA expires academic experts. FDA initiated this
at the end of September 2017. At that process on June 15, 2015, by holding a DEPARTMENT OF HEALTH AND
time, new legislation will be required public meeting at which stakeholders HUMAN SERVICES
for FDA to continue collecting user fees and other members of the public were
for the generic drug program. The given an opportunity to present their Food and Drug Administration
Federal Food, Drug, and Cosmetic Act views on reauthorization (April 21,
(the FD&C Act) requires that FDA [Docket No. FDA–2015–N–0001]
2015, 80 FR 22204). The FD&C Act
consult with a range of stakeholders in further requires that FDA continue Pediatric Advisory Committee; Notice
developing recommendations for the meeting with these stakeholders at least of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES

next GDUFA program. The FD&C Act once every month during negotiations
also requires that FDA hold continued with the regulated industry to continue AGENCY: Food and Drug Administration,
discussions with patient and consumer discussions of stakeholder views on the HHS.
advocacy groups at least monthly during reauthorization. ACTION: Notice.
FDA’s negotiations with the regulated FDA is issuing this Federal Register
industry. The purpose of the request for notice to request that stakeholder This notice announces a forthcoming
notification is to ensure continuity and representatives from patient and meeting of a public advisory committee
progress in these monthly discussions consumer groups, health care of the Food and Drug Administration

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Document Created: 2016-09-27 22:26:46
Document Modified: 2016-09-27 22:26:46

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		Submit either electronic or written comments on Agency guidances at any time.
Contact		Sara Rothman, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-3110.
FR Citation		80 FR 48324

80 FR 48324 - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 155 (August 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration