85296 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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: 

Sarah Venti, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs.’’ The DSCSA (title II 

of Pub. L. 113–54) was signed into law 

on November 27, 2013. Section 202 of 

the DSCSA added section 582 to the 

FD&C Act (21 U.S.C. 360eee–1), which 

established the requirement that trading 

partners have systems in place to enable 

them to comply with certain verification 

obligations. This guidance provides 

recommendations for robust verification 

systems for the determination, 

quarantine, and investigation of suspect 

products, as well as the quarantine, 

notification, and disposition of 

illegitimate products. This guidance 

also addresses the manner in which 

FDA recommends that trading partners 

submit cleared product notifications 

(i.e., notifications that a suspect product 

is not an illegitimate product), the 

statutory requirements for responding to 

requests for verification, and the 

statutory requirements for processing 

saleable returns. 

FDA initially published the draft 

guidance ‘‘Verification Systems Under 

the Drug Supply Chain Security Act for 

Certain Prescription Drugs’’ on October 

25, 2018 (83 FR 53880). Comments were 

received on the initial draft guidance 

and the Agency made revisions to the 

draft. This guidance finalizes the 

revised draft guidance entitled 

‘‘Verification Systems Under the Drug 

Supply Chain Security Act for Certain 

Prescription Drugs,’’ issued on March 

10, 2022 (87 FR 13738). FDA considered 

comments received on the revised draft 

guidance in finalizing this guidance. 

Changes from the revised draft to the 

final guidance include: (1) clarifying 

that dispensers need not provide 

transaction information for saleable 

return product; (2) clarifying that 

‘‘verification’’ as defined in section 581 

of the FD&C Act (21 U.S.C. 360eee) 

involves confirming that the product 

identifier affixed or imprinted upon a 

package or homogeneous case 

corresponds to the Standardized 

Numerical Identifier or lot number and 

expiration date assigned to the product 

by the manufacturer or repackager by 

more closely mirroring the statutory 

language; (3) further clarifying when the 

discussion is about the verification 

systems requirements in section 582 of 

the FD&C Act and when it is about the 

requirement to verify the product 

identifier; (4) clarifying FDA’s 

understanding about the statutory 

requirement that manufacturers and 

repackagers respond to requests for 

verification within 24 hours or within 

other such reasonable time as 

determined by the Secretary of Health 

and Human Services; (5) clarifying that 

when a trading partner does not receive 

a timely response to a verification 

request, the product that is the subject 

of the request need not automatically be 

classified as suspect; and (6) clarifying 

that certain system attributes are 

suggested as best practices even though 

they are not specifically required under 

the DSCSA. In addition, editorial 

changes were made to improve clarity. 

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 ‘‘Verification 

Systems Under the Drug Supply Chain 

Security Act for Certain Prescription 

Drugs.’’ 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. Paperwork Reduction Act 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information pertaining to 

implementation of the Drug Supply 

Chain Security Act are approved in 

OMB control no. 0910–0806. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26846 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

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 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 draft 

guidance for industry entitled ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under section 503A of 

the Federal Food, Drug, and Cosmetic 

Act’’ (draft guidance or 2023 503A 

Interim Policy Draft Guidance) to 

describe FDA’s interim policy regarding 

the use of bulk drug substances by 

human drug compounders that are not 

registered with FDA as outsourcing 

facilities while FDA develops the list of 

bulk drug substances that can be used 

in compounding under the applicable 

section of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). This draft 

guidance, when finalized, will replace 

the guidance for industry entitled, 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances under section 

503A of the Federal Food, Drug, and 

Cosmetic Act’’ issued in January 2017 

(2017 503A Interim Policy Guidance). 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 8, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85297 

ADDRESSES: You may submit comments 

on any guidance 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.’’ 

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.’’ 

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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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 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: 

Mariestela Buhay, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 5199, Silver 

Spring, MD 20993–0002, 301–796–7313. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under section 

503A of the Federal Food, Drug, and 

Cosmetic Act.’’ This draft guidance, 

when finalized, will replace the 2017 

503A Interim Policy Guidance, available 

at https://www.fda.gov/media/94398/ 

download. Section 503A of the FD&C 

Act (21 U.S.C. 353a) 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: (1) section 505 (21 U.S.C. 355) 

(concerning the approval of drugs under 

new drug applications or abbreviated 

new drug applications); (2) section 

502(f)(1) (21 U.S.C. 352(f)(1)) 

(concerning the labeling of drugs with 

adequate directions for use); and (3) 

section 501(a)(2)(B) (21 U.S.C. 

351(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 chapters on pharmacy 

compounding; (2) if such a monograph 

does not exist, are drug substances that 

are components of drugs approved by 

the Secretary of the Department of 

Health and Human Services (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 of the 

FD&C Act (the 503A bulks list). (See 

section 503A(b)(1)(A)(i) of the FD&C 

Act.) 

This draft guidance, when finalized, 

will revise FDA’s current interim policy 

with respect to categorization of certain 

substances nominated for inclusion on 

the 503A bulks list. The guidance, when 

finalized, will end the categorization of 

bulk drug substances into Categories 1, 

2, or 3 for those bulk drug substances 

nominated on or after the date of 

publication of the final guidance. 

The 2017 503A Interim Policy 

Guidance describes the conditions 

under which FDA does not intend to 

take action against a State-licensed 

pharmacy, Federal facility, or physician 

for compounding drug products using 

certain bulk drug substances that are not 

eligible for use in compounding under 


ddrumheller on DSK120RN23PROD with NOTICES1
85298 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

1FDA recognizes that some compounders and 

other stakeholders may currently be in the process 

of compiling a nomination for the 503A bulks list 

for submission to the Agency. FDA intends to 

categorize nominations of bulk drug substances 

received prior to the date in which FDA announces 

the availability of the final guidance. FDA believes 

that this will provide a sufficient amount of time 

in which to submit nominations that are currently 

in progress. 

section 503A because they are not the 

subject of an applicable USP or NF 

monograph, components of FDAapproved drug products, or on the 503A 

bulks list. One of those conditions is 

that the bulk drug substance appears in 

Category 1. If the 2023 503A Interim 

Policy Draft Guidance is finalized in its 

current form, a substance nominated on 

or after the date of publication of that 

final guidance would not be categorized 

and would not be within the scope of 

the policy for substances that appear in 

Category 1.1 However, FDA would 

consider the substance for inclusion on 

the 503A bulks list in accordance with 

the process and criteria established in 

the FD&C Act and FDA regulations (see 

section 503A(b)(1)(A) of the FD&C Act 

and 21 CFR 216.23(c)). Substances that 

already appear in Category 1 (including 

substances nominated with adequate 

supporting information prior to the date 

of publication of the final guidance) 

may continue to be eligible for the 

policy that applies to Category 1 

substances, as described in the final 

guidance, until FDA promulgates a final 

rule determining whether they will be 

placed on the 503A bulks list in 

accordance with section 

503A(b)(1)(A)(i)(III) of the FD&C Act or 

unless the Agency removes the 

substances from Category 1 based on, for 

example, information about safety risks. 

FDA encourages interested parties to 

focus their comments on the limited 

revisions to the interim policy included, 

for public comment, in the 2023 503A 

Interim Policy Draft Guidance. 

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 ‘‘Interim Policy on Compounding 

Using Bulk Drug Substances Under 

Section 503A 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. 

II. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26886 Filed 12–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: The Alliance 

for Innovation on Maternal Health 

Biannual Survey, OMB No. 0915– 

xxxx—New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 5, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

The Alliance for Innovation on Maternal 

Health Biannual Survey, OMB No. 

0915–xxxx—New. 

Abstract: The Alliance for Innovation 

on Maternal Health (AIM) program is 

administered by HRSA and authorized 

by 42 U.S.C. 254c–21 (Public Health 

Service Act, title III section 330O), as 

added by the Consolidated 

Appropriations Act, 2022 (Pub. L. 117– 

103). 

The AIM program supports the 

identification, development, 

implementation, and dissemination of 

maternal (patient) safety bundles to 

promote safe care for every U.S. birth 

and assist with addressing the complex 

problem of high maternal mortality and 

severe maternal morbidity rates within 

the U.S. The mission of AIM is to 

support best practices that make birth 

safer, improve the quality of maternal 

health care and outcomes, and save 

lives. Maternal patient safety bundles 

address topics commonly associated 

with health complications or risks 

related to prenatal, labor and delivery, 

and postpartum care. 

The AIM program consists of two 

components: The AIM Capacity program 

and the AIM Technical Assistance (TA) 

Center. The AIM Capacity awards began 

in fiscal year 2023 and directly fund 28 

States and jurisdictions (including U.S. 

Territories and the District of Columbia) 

to implement AIM maternal patient 

safety bundles. The second component, 

the AIM TA Center, is funded through 

a cooperative agreement to provide TA 

to all 50 States, the District of Columbia, 

jurisdictions, U.S. Territories, Tribal 

communities, and birthing facilities 

who participate in the AIM program. 

The TA Center builds data capacity for 

participating entities to track progress 

on bundle implementation and support 

improvement of data collection. 

The funding amount for the AIM 

program was increased in fiscal year 

2023, which allowed HRSA to directly 

fund States and Territories to support 

AIM bundle implementation. 

Previously, HRSA supported AIM 

through one cooperative agreement to 

develop maternal patient safety bundles, 

provide TA on bundle implementation, 

and enroll States and Territories in the 

program. The shift to directly fund 

States and jurisdictions for the work 

makes the collection of information 

about the reach of the program, 

participation by birthing facilities, and 

TA needs necessary. The AIM Biannual 

Survey will be administered to AIM 

State Teams (the State-or jurisdictionlevel entity leading AIM 

implementation) twice a year in all 

States and jurisdictions enrolled in 


ddrumheller on DSK120RN23PROD with NOTICES1