Document ID: FDA-2019-D-2011-0001
Agency: fda
Document Type: Rule
Title: Guidance: Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide; Availability
Posted Date: 2019-05-24T04:00Z

[Federal Register Volume 84, Number 101 (Friday, May 24, 2019)]
[Rules and Regulations]
[Pages 24027-24028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10953]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 216

[Docket No. FDA-2019-D-2011]

Section 503A Bulks List Final Rule Questions and Answers; 
Guidance for Industry; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the availability of a guidance for industry entitled 
``Section 503A Bulks List Final Rule Questions and Answers--Small 
Entity Compliance Guide.'' The small entity compliance guide (SECG) is 
intended to help small entities comply with the final rule establishing 
the list of bulk drug substances that can be used in accordance with 
certain compounding provisions of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal 
Register on May 24, 2019.

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 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.''

[[Page 24028]]

    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-2011 for ``Section 503A Bulks List Final Rule Questions and 
Answers; Guidance for Industry; Small Entity Compliance Guide; 
Availability.'' 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.gpo.gov/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 the SECG 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 SECG.

FOR FURTHER INFORMATION CONTACT: Rosilend Lawson, Center for Drug 
Evaluation and Research, Office of Unapproved Drugs and Labeling 
Compliance, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 5197, Silver Spring, MD 20993-0002, 240-402-6223, 
Rosilend.Lawson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of February 19, 2019 (84 FR 4696), we 
issued a final rule establishing the list of bulk drug substances that 
can be used in compounding under section 503A of the FD&C Act (the 
final rule) (21 U.S.C. 353a). The final rule, entitled ``List of Bulk 
Drug Substances That Can Be Used To Compound Drug Products in 
Accordance With Section 503A of the Federal Food, Drug, and Cosmetic 
Act,'' is codified at 21 CFR 216.23 and became effective March 21, 
2019.
    We examined the economic implications of the final rule as required 
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and, because we do 
not have enough information about the effect of the final rule on small 
entities, determined that the final rule will have a significant 
economic impact on a substantial number of small entities. In 
compliance with section 212 of the Small Business Regulatory 
Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-
28), we are making available the SECG to explain the actions that a 
small entity must take to comply with the rule.
    We are issuing the SECG consistent with our good guidance practices 
regulation (21 CFR 10.115). The SECG represents the current thinking of 
FDA on the final rule. 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 SECG at either 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Use the FDA 
website listed in the previous sentence to find the most current 
version of the guidance.

    Dated: May 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10953 Filed 5-23-19; 8:45 am]
 BILLING CODE 4164-01-P