81_FR_22685 81 FR 22611 - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability

81 FR 22611 - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

Page Range22611-22612
FR Document2016-08878

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.

Federal Register, Volume 81 Issue 74 (Monday, April 18, 2016) 
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22611-22612]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0238]


Facility Definition Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Facility 
Definition Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' Section 503B defines an outsourcing facility, in part, as ``a 
facility at one geographic location or address.'' FDA has received 
questions from outsourcing facilities and other stakeholders about the 
meaning of this term, such as whether multiple suites used for 
compounding human drugs at a single street address constitute one or 
multiple facilities, or whether a single location where human drugs are 
compounded can be subdivided into separate operations compounding under 
different standards. FDA is issuing this draft guidance to answer these 
questions.

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 this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 18, 2016.

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-2016-D-0238 for ``Facility Definition Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act; 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 the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug 
Evaluation

[[Page 22612]]

and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Facility Definition Under Section 503B of the Federal Food, 
Drug, and Cosmetic Act.''
    Section 503B, added to the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) by the Drug Quality and Security Act in 2013, created a 
new category of compounders called outsourcing facilities. Section 503B 
describes the conditions that must be satisfied for human drug products 
compounded by or under the direct supervision of a licensed pharmacist 
in an outsourcing facility to qualify for exemptions from three 
sections of the FD&C Act:
     Section 502(f)(1) (concerning labeling requirements);
     Section 505 (concerning drug approval requirements); and
     Section 582 (concerning Drug Supply Chain Security Act 
requirements).
    Section 503B(d)(4) of the FD&C Act defines an outsourcing facility 
as a facility at one geographic location or address that: (1) Is 
engaged in the compounding of sterile drugs; (2) has elected to 
register as an outsourcing facility; and (3) complies with all of the 
requirements of this section. In addition, an outsourcing facility is 
not required to be a licensed pharmacy, and it may or may not obtain 
prescriptions for identified individual patients. Because drugs 
compounded by outsourcing facilities are not exempt from section 
501(a)(2)(B) of the FD&C Act, outsourcing facilities are subject to 
current good manufacturing practice (CGMP) requirements.
    FDA has received questions from outsourcing facilities and other 
stakeholders about the meaning of the term ``facility at one geographic 
location or address,'' such as whether multiple suites used for 
compounding human drugs at a single street address constitute one or 
multiple facilities, or whether a single location where human drugs are 
compounded can be subdivided into separate operations compounding under 
different standards. FDA is issuing this draft guidance to answer these 
questions.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the meaning of 
the term ``facility at one geographic location or address'' under 
section 503B of the FD&C Act. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Electronic Access

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

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08878 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices 22611 new drug applications (NDAs) or draft guidance to answer these those submitted as ‘‘Confidential abbreviated new drug applications questions. Submissions,’’ publicly viewable at (ANDAs)). DATES: Although you can comment on http://www.regulations.gov or at the The guidance describes how FDA Division of Dockets Management any guidance at any time (see 21 CFR intends to apply section 503A of the between 9 a.m. and 4 p.m., Monday 10.115(g)(5)), to ensure that the Agency FD&C Act to drugs compounded by through Friday. considers your comment on this draft licensed pharmacists or physicians in guidance before it begins work on the • Confidential Submissions—To State-licensed hospital or health system submit a comment with confidential final version of the guidance, submit pharmacies. information that you do not wish to be This draft guidance is being issued either electronic or written comments on the draft guidance by July 18, 2016. made publicly available, submit your consistent with FDA’s good guidance comments only as a written/paper practices regulation (21 CFR 10.115). ADDRESSES: You may submit comments submission. You should submit two The draft guidance, when finalized, will as follows: copies total. One copy will include the represent the current thinking of FDA Electronic Submissions information you claim to be confidential on this topic. It does not establish any with a heading or cover note that states rights for any person and is not binding Submit electronic comments in the following way: ‘‘THIS DOCUMENT CONTAINS on FDA or the public. You can use an CONFIDENTIAL INFORMATION’’. The alternative approach if it satisfies the • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the Agency will review this copy, including requirements of the applicable statutes the claimed confidential information, in and regulations. instructions for submitting comments. Comments submitted electronically, its consideration of comments. The II. Electronic Access including attachments, to http:// second copy, which will have the www.regulations.gov will be posted to claimed confidential information Persons with access to the Internet the docket unchanged. Because your redacted/blacked out, will be available may obtain the draft guidance at either comment will be made public, you are for public viewing and posted on http:// http://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your www.regulations.gov. Submit both ComplianceRegulatoryInformation/ comment does not include any copies to the Division of Dockets Guidances/default.htm or http:// confidential information that you or a Management. If you do not wish your www.regulations.gov. third party may not wish to be posted, name and contact information to be Dated: April 12, 2016. made publicly available, you can such as medical information, your or Leslie Kux, provide this information on the cover anyone else’s Social Security number, or Associate Commissioner for Policy. confidential business information, such sheet and not in the body of your [FR Doc. 2016–08879 Filed 4–15–16; 8:45 am] as a manufacturing process. Please note comments and you must identify this BILLING CODE 4164–01–P that if you include your name, contact information as ‘‘confidential.’’ Any information, or other information that information marked as ‘‘confidential’’ identifies you in the body of your will not be disclosed except in DEPARTMENT OF HEALTH AND accordance with 21 CFR 10.20 and other comments, that information will be HUMAN SERVICES applicable disclosure law. For more posted on http://www.regulations.gov. • If you want to submit a comment information about FDA’s posting of Food and Drug Administration comments to public dockets, see 80 FR with confidential information that you [Docket No. FDA–2016–D–0238] do not wish to be made available to the 56469, September 18, 2015, or access public, submit the comment as a the information at: http://www.fda.gov/ Facility Definition Under Section 503B written/paper submission and in the regulatoryinformation/dockets/ of the Federal Food, Drug, and manner detailed (see ‘‘Written/Paper default.htm. Cosmetic Act; Availability Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to read background documents or the AGENCY: Food and Drug Administration, Written/Paper Submissions electronic and written/paper comments HHS. Submit written/paper submissions as received, go to http:// ACTION: Notice. www.regulations.gov and insert the follows: SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for docket number, found in brackets in the Administration (FDA or Agency) is written/paper submissions): Division of heading of this document, into the announcing the availability of a draft Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts guidance for industry entitled ‘‘Facility and Drug Administration, 5630 Fishers and/or go to the Division of Dockets Definition Under Section 503B of the Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. Federal Food, Drug, and Cosmetic Act.’’ • For written/paper comments 1061, Rockville, MD 20852. Section 503B defines an outsourcing submitted to the Division of Dockets Submit written requests for single facility, in part, as ‘‘a facility at one Management, FDA will post your copies of the draft guidance to the geographic location or address.’’ FDA comment, as well as any attachments, Division of Drug Information, Center for has received questions from outsourcing except for information submitted, Drug Evaluation and Research, Food facilities and other stakeholders about marked and identified, as confidential, and Drug Administration, 10001 New the meaning of this term, such as if submitted as detailed in Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– mstockstill on DSK4VPTVN1PROD with NOTICES whether multiple suites used for ‘‘Instructions.’’ compounding human drugs at a single Instructions: All submissions received 0002. Send one self-addressed adhesive street address constitute one or multiple must include the Docket No. FDA– label to assist that office in processing facilities, or whether a single location 2016–D–0238 for ‘‘Facility Definition your requests. See the SUPPLEMENTARY where human drugs are compounded Under Section 503B of the Federal INFORMATION section for electronic can be subdivided into separate Food, Drug, and Cosmetic Act; access to the draft guidance document. operations compounding under Availability.’’ Received comments will FOR FURTHER INFORMATION CONTACT: Sara different standards. FDA is issuing this be placed in the docket and, except for Rothman, Center for Drug Evaluation VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1

22612 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices and Research, Food and Drug This draft guidance is being issued DATES: The effective date is April 18, Administration, 10903 New Hampshire consistent with FDA’s good guidance 2016. Ave., Bldg. 51, Rm. 5197, Silver Spring, practices regulation (21 CFR 10.115). ADDRESSES: For access to the docket to MD 20993, 301–796–3110. The draft guidance, when finalized, will read background documents, go to SUPPLEMENTARY INFORMATION: represent the current thinking of FDA http://www.regulations.gov and insert on the meaning of the term ‘‘facility at the docket number, found in brackets in I. Background one geographic location or address’’ the heading of this document, into the FDA is announcing the availability of under section 503B of the FD&C Act. It ‘‘Search’’ box and follow the prompts a draft guidance for industry entitled does not establish any rights for any and/or go to the Division of Dockets ‘‘Facility Definition Under Section 503B person and is not binding on FDA or the Management (HFA–305), 5630 Fishers of the Federal Food, Drug, and Cosmetic public. You can use an alternative Lane, Rm. 1061, Rockville, MD 20852. Act.’’ approach if it satisfies the requirements Section 503B, added to the Federal of the applicable statutes and FOR FURTHER INFORMATION CONTACT: Jay Food, Drug, and Cosmetic Act (the regulations. Sitlani, Center for Drug Evaluation and FD&C Act) by the Drug Quality and Research, Food and Drug Security Act in 2013, created a new II. Electronic Access Administration, 10903 New Hampshire category of compounders called Persons with access to the Internet Ave., Bldg. 51, Rm. 6282, Silver Spring, outsourcing facilities. Section 503B may obtain the draft guidance at either MD 20993–0002, 301–796–5202. describes the conditions that must be http://www.fda.gov/Drugs/Guidance SUPPLEMENTARY INFORMATION: satisfied for human drug products ComplianceRegulatoryInformation/ I. Background compounded by or under the direct Guidances/default.htm or http:// supervision of a licensed pharmacist in www.regulations.gov. A. Applications for Niacin ER Tablets an outsourcing facility to qualify for Dated: April 12, 2016. FDA first approved NDA 020381 for exemptions from three sections of the Leslie Kux, Niaspan (niacin extended-release) FD&C Act: Associate Commissioner for Policy. tablets for several indications on July • Section 502(f)(1) (concerning [FR Doc. 2016–08878 Filed 4–15–16; 8:45 am] 28, 1997. On March 26, 2009, FDA labeling requirements); • Section 505 (concerning drug BILLING CODE 4164–01–P approved a revised indication that read approval requirements); and as follows: • Section 582 (concerning Drug • Niaspan in combination with Supply Chain Security Act DEPARTMENT OF HEALTH AND simvastatin or lovastatin is indicated for requirements). HUMAN SERVICES the treatment of primary hyperlipidemia Section 503B(d)(4) of the FD&C Act (heterozygous familial and nonfamilial) defines an outsourcing facility as a Food and Drug Administration and mixed dyslipidemia (Fredrickson facility at one geographic location or Types IIa and IIb) when treatment with address that: (1) Is engaged in the [Docket No. FDA–2016–N–1127] Niaspan, simvastatin, or lovastatin compounding of sterile drugs; (2) has monotherapy is considered inadequate. AbbVie Inc. et al; Withdrawal of In addition, the following Limitation elected to register as an outsourcing Approval of Indications Related to the facility; and (3) complies with all of the of Use was added to the Indications and Coadministration With Statins in Usage section of the labeling: requirements of this section. In Applications for Niacin Extended- addition, an outsourcing facility is not • No incremental benefit of Niaspan Release Tablets and Fenofibric Acid coadministered with simvastatin or required to be a licensed pharmacy, and Delayed-Release Capsules it may or may not obtain prescriptions lovastatin on cardiovascular morbidity for identified individual patients. AGENCY: Food and Drug Administration, and mortality over and above that Because drugs compounded by HHS. demonstrated for niacin, simvastatin, or outsourcing facilities are not exempt ACTION: Notice. lovastatin monotherapy has been from section 501(a)(2)(B) of the FD&C established. Niaspan has not been Act, outsourcing facilities are subject to SUMMARY: The Food and Drug studied in Fredrickson Type I and III current good manufacturing practice Administration (FDA or Agency) is dyslipidemias. (CGMP) requirements. withdrawing approval of the indications This indication was revised between FDA has received questions from related to the coadministration with a March 26, 2009, and April 27, 2015, at outsourcing facilities and other statin for niacin extended-release (ER) which time it was removed from the stakeholders about the meaning of the tablets and fenofibric acid delayed- approved labeling. The Limitation of term ‘‘facility at one geographic location release (DR) capsules. Affected Use currently reads: or address,’’ such as whether multiple applications include one new drug • Addition of Niaspan did not reduce suites used for compounding human application (NDA) and seven cardiovascular morbidity or mortality drugs at a single street address abbreviated new drug applications among patients treated with simvastatin constitute one or multiple facilities, or (ANDAs) for niacin ER tablets, and one in a large, randomized controlled trial whether a single location where human NDA and three ANDAs for fenofibric (AIM–HIGH). drugs are compounded can be acid DR capsules. The holders of these There are seven approved ANDAs that subdivided into separate operations applications have requested that FDA cited Niaspan as the reference listed mstockstill on DSK4VPTVN1PROD with NOTICES compounding under different standards. withdraw approval of the indications drug (RLD) and that are approved for the FDA is issuing this draft guidance to and have waived their opportunities for same indications as Niaspan (see table answer these questions. a hearing. 1). VerDate Sep<11>2014 17:54 Apr 15, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\18APN1.SGM 18APN1


Document Created: 2016-04-16 01:45:43
Document Modified: 2016-04-16 01:45:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAlthough 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 this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 18, 2016.
ContactSara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.
FR Citation81 FR 22611 
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