83 FR 22083 - Facility Definition 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 83, Issue 92 (May 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 92 (May 11, 2018)
| Page Range | 22083-22085 | |
| FR Document | 2018-10046 |
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)] [Notices] [Pages 22083-22085] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10046] ----------------------------------------------------------------------- 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; Guidance for Industry; 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 final 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 guidance to provide the Agency's current thinking on these questions and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B. DATES: The announcement of the guidance is published in the Federal Register on May 11, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal. https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 [[Page 22084]] identifies you in the body of your comments, that information will be posted on https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 301-796-3110. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B (21 U.S.C. 353b), added to the Federal Food, Drug, and Cosmetic Act (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) (21 U.S.C. 352(f)(1)) (concerning labeling requirements); Section 505 (21 U.S.C. 355) (concerning drug approval requirements); and Section 582 (21 U.S.C. 360eee-1) (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 (21 U.S.C. 351(a)(2)(B)), outsourcing facilities are subject to current good manufacturing practice 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 guidance to provide its current thinking on these questions and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B. In the Federal Register of April 18, 2016 (81 FR 22611), FDA issued a notice announcing the availability of the draft version of this guidance. The comment period on the draft guidance ended on July 18, 2016. FDA received 19 comments on the draft guidance. In response to received comments, FDA made certain changes. In particular, FDA revised the guidance to provide for a compounder seeking to operate under section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an outsourcing facility provided that there is complete segregation between the outsourcing facility and the 503A compounder. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the guidance at either [[Page 22085]] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: May 7, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10046 Filed 5-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22083
product produced from living 660.36(a)(2) and (b), and 660.46(b) are regulation in the event that protocols are
organisms. In cases of certain biological manufacturers of the specific products submitted in the future.
products (e.g., Albumin, Plasma Protein referenced previously in this document. The estimated total annual responses
Fraction, and therapeutic biological The estimated number of respondents are based on FDA’s final actions
products) that are known to have lot-to- for each regulation is based on the completed in FY 2017 for the various
lot consistency, official lot release is not annual number of manufacturers that
submission requirements of samples
normally required. However, submitted samples and protocols for
and protocols for the licensed biological
submissions of samples and protocols of biological products including
these products may still be required for submissions for lot release, surveillance, products. The average burden per
surveillance, licensing, and export licensing, or export. Based on response is based on information
purposes, or in the event that FDA information obtained from FDA’s provided by industry. The burden
obtains information that the database system, approximately 79 estimates provided by industry ranged
manufacturing process may not result in manufacturers submitted samples and from 1 to 5.5 hours. Under § 610.2, the
consistent quality of the product. protocols in fiscal year (FY) 2017, under hours per response are based on the
The following burden estimate is for the regulations cited previously in this average of these estimates and rounded
the protocols required to be submitted document. FDA estimates that to 3 hours. Under the remaining
with each sample. The collection of approximately 75 manufacturers regulations, the average burden per
samples is not a collection of submitted protocols under § 610.2 and response is based on the higher end of
information under 5 CFR 1320.3(h)(2). two manufacturers submitted protocols the estimate (rounded to 5 or 6 hours)
Respondents to the collection of under the regulation (§ 660.6) for the since more information is generally
information under § 610.2 are other specific product. FDA received no required to be submitted in the other
manufacturers of licensed biological submissions under §§ 660.36 or 660.46, protocols than under § 610.2. FDA
products. Respondents to the collection however FDA is using the estimate of estimates the burden of this information
of information under §§ 660.6(b), one protocol submission under each collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section/activity responses per burden per Total hours
respondents responses
respondent response
610.2—Requests for Samples and Protocols; Official Re-
lease ................................................................................. 75 86.267 6,470 3 19,410
660.6(b)—Protocols ............................................................. 2 3.5 7 5 35
660.36(a)(2) and (b)—Samples and Protocols .................... 1 1 1 6 6
660.46(b)—Protocols ........................................................... 1 1 1 5 5
Total .............................................................................. 79 ........................ 6,479 ........................ 19,456
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the ACTION: Notice of availability. DATES: The announcement of the
information collection reflects an guidance is published in the Federal
overall increase of 764 hours and a SUMMARY: The Food and Drug Register on May 11, 2018.
corresponding increase of 262 Administration (FDA or Agency) is ADDRESSES: You may submit either
responses. We attribute this adjustment announcing the availability of a final electronic or written comments on
to an increase in the number of guidance for industry entitled ‘‘Facility Agency guidances at any time as
submissions we received over the last Definition Under Section 503B of the follows:
few years. Federal Food, Drug, and Cosmetic Act.’’ Electronic Submissions
Dated: May 7, 2018. Section 503B defines an outsourcing
facility, in part, as ‘‘a facility at one Submit electronic comments in the
Leslie Kux,
following way:
Associate Commissioner for Policy. geographic location or address.’’ FDA
• Federal eRulemaking Portal.
[FR Doc. 2018–10052 Filed 5–10–18; 8:45 am] has received questions from outsourcing https://www.regulations.gov. Follow the
BILLING CODE 4164–01–P facilities and other stakeholders about instructions for submitting comments.
the meaning of this term, such as Comments submitted electronically,
whether multiple suites used for including attachments, to https://
DEPARTMENT OF HEALTH AND compounding human drugs at a single www.regulations.gov will be posted to
HUMAN SERVICES street address constitute one or multiple the docket unchanged. Because your
facilities, or whether a single location comment will be made public, you are
Food and Drug Administration where human drugs are compounded solely responsible for ensuring that your
can be subdivided into separate comment does not include any
[Docket No. FDA–2016–D–0238] operations compounding under confidential information that you or a
sradovich on DSK3GMQ082PROD with NOTICES
different standards. FDA is issuing this third party may not wish to be posted,
Facility Definition Under Section 503B
guidance to provide the Agency’s such as medical information, your or
of the Federal Food, Drug, and
current thinking on these questions and anyone else’s Social Security number, or
Cosmetic Act; Guidance for Industry;
related issues regarding how to ensure confidential business information, such
Availability
that the compounding of drugs in an as a manufacturing process. Please note
AGENCY: Food and Drug Administration, outsourcing facility occurs only in that if you include your name, contact
HHS. accordance with section 503B. information, or other information that
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![Federal Register / Vol. 83, No. 92 / Friday, May 11, 2018 / Notices 22085
https://www.fda.gov/Drugs/Guidance The DSCSA Pilot Project Program level tracing and verification that take
ComplianceRegulatoryInformation/ effect in 2023. Such pilot projects will
OMB Control Number 0910—NEW
Guidances/default.htm or https:// be more useful than pilot projects
www.regulations.gov. FDA will be establishing the Drug dedicated to lot-level tracing. If there are
Supply Chain Security Act (DSCSA) adequate pilot project submissions, FDA
Dated: May 7, 2018.
(Title II of Pub. L. 113–54) Pilot Project may establish more than one pilot
Leslie Kux, Program to implement section 582(j) of project to accomplish the goals of the
Associate Commissioner for Policy. the Federal Food, Drug, and Cosmetic DSCSA Pilot Project Program.
[FR Doc. 2018–10046 Filed 5–10–18; 8:45 am] Act (FD&C Act) (21 U.S.C. 360eee–1). Because there is an information
BILLING CODE 4164–01–P This program will assist FDA in collection under the PRA associated
developing an interoperable, electronic with the DSCSA Pilot Project Program,
system to identify and trace certain this Federal Register notice is being
DEPARTMENT OF HEALTH AND prescription drugs as the drugs are issued as part of the process for OMB
HUMAN SERVICES distributed in the United States by the approval to collect this information.
year 2023. The Pilot Project Program After OMB approval of this information
Food and Drug Administration goals include assessing the ability of collection, FDA will accept applications
supply chain members to: (1) Satisfy the to participate in the program and will
[Docket No. FDA–2016–N–0407] requirements of section 582 of the FD&C select qualified applications. FDA will
Agency Information Collection Act; (2) identify, manage, and prevent announce OMB’s approval in the
Activities; Submission for Office of the distribution of suspect and Federal Register, the date that
Management and Budget Review; illegitimate products as defined in applications may be submitted, and
section 581(21) and (8) of the FD&C Act application submission procedures.
Comment Request; Pilot Project
(21 U.S.C. 360eee(21) and (8)), In the Federal Register of July 20,
Program Under the Drug Supply Chain
respectively; and (3) demonstrate the 2017 (82 FR 33497), FDA published a
Security Act
electronic, interoperable exchange of 60-day notice requesting public
AGENCY: Food and Drug Administration, product tracing information across the comment on the proposed collection of
HHS. pharmaceutical distribution supply information. A summary of the
ACTION: Notice. chain, in addition to identifying the comments and FDA’s responses are as
system attributes needed to implement follows.
SUMMARY: The Food and Drug the requirements of section 582 of the (Comment 1) Several comments raised
Administration (FDA, Agency, or we) is FD&C Act, particularly the requirement concerns with the proposed timelines
announcing that a proposed collection to utilize a product identifier for related to initiation of pilot projects,
of information has been submitted to the product tracing purposes. FDA plans to duration of pilot projects, and final
Office of Management and Budget coordinate with stakeholders that reflect reports. One comment expressed
(OMB) for review and clearance under the diversity of the pharmaceutical concern that 4 months (after receiving a
the Paperwork Reduction Act of 1995 distribution supply chain, including letter of acceptance from FDA) may not
(PRA). large and small entities from all be enough time for a potential
industry sectors. participant to be ready to initiate their
DATES: Fax written comments on the Title: The DSCSA Pilot Project pilot project. Another comment
collection of information by June 11, Program. suggested that the proposed duration of
2018. Description of Respondents: pilot projects (no more than 6 months)
ADDRESSES: To ensure that comments on Respondents of this collection of should be longer and FDA should give
the information collection are received, information are participants from the the participant(s) more flexibility to
OMB recommends that written pharmaceutical distribution supply conduct the pilot project. In addition,
comments be faxed to the Office of chain (authorized manufacturers, another comment expressed concern
Information and Regulatory Affairs, repackagers, wholesale distributors, and with the proposed requirement that
OMB, Attn: FDA Desk Officer, Fax: 202– dispensers) and other stakeholders. final reports be completed within 30
395–7285, or emailed to oira_ Background Information: FDA will be days, because that may not be enough
submission@omb.eop.gov. All seeking pilot project participants from time to complete a final report.
comments should be identified with the the pharmaceutical distribution supply (Response 1) The proposed timelines
OMB control number 0910–NEW and chain (authorized manufacturers, were intended to enable completion of
title ‘‘Pilot Project Program Under the repackagers, wholesale distributors, and FDA’s Pilot Project Program within 1
Drug Supply Chain Security Act.’’ Also dispensers) and other stakeholders. FDA year of the start date. FDA would like
include the FDA docket number found expects that participants will propose to complete the program in a timely
in brackets in the heading of this the design and execution of their pilot manner so that the information learned
document. project in their submission to FDA; can be shared and utilized by supply
however, FDA also intends to meet with chain participants as they prepare and
FOR FURTHER INFORMATION CONTACT:
all pilot project participants to ensure implement remaining DSCSA
Domini Bean, Office of Operations, that lessons learned from the pilot requirements that take effect between
Food and Drug Administration, Three project(s) will inform FDA’s 2018 and 2023. To optimize the
White Flint North, 10A–12M, 11601 development of the electronic, program, FDA expects pilot project
Landsdown St., North Bethesda, MD interoperable system that will take effect participants to be ready to initiate their
sradovich on DSK3GMQ082PROD with NOTICES
20852, 301–796–5733, PRAStaff@ in 2023. FDA encourages supply chain pilot project within 4 months after
fda.hhs.gov. members to focus their proposed pilot receiving a letter of acceptance from
SUPPLEMENTARY INFORMATION: In project(s) on the DSCSA requirements FDA. This will help ensure that
compliance with 44 U.S.C. 3507, FDA related to the interoperable, electronic participants have worked out funding,
has submitted the following proposed tracing of products at the package level. resources, planning, and other issues in
collection of information to OMB for Specifically, the pilot project(s) should advance of initiation of the pilot project.
review and clearance: focus on the requirements for package- FDA provided flexibility in the program
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Document Created: 2018-11-02 09:49:29
Document Modified: 2018-11-02 09:49:29
| 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 | The announcement of the guidance is published in the Federal Register on May 11, 2018. | |
| Contact | Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 301-796-3110. | |
| FR Citation | 83 FR 22083 |
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