1136 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled ‘‘Action 

Levels for Lead in Processed Food 

Intended for Babies and Young 

Children.’’ We are issuing this guidance 

consistent with our good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on this topic. 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. 

In the Federal Register of January 25, 

2023 (88 FR 4749), we made available 

a draft guidance for industry entitled 

‘‘Action Levels for Lead in Food 

Intended for Babies and Young 

Children’’ and gave interested parties an 

opportunity to submit comments by 

March 27, 2023, for us to consider 

before beginning work on the final 

version of the guidance. In the Federal 

Register of April 6, 2023 (88 FR 20525), 

we announced that we were reopening 

the comment period until May 8, 2023, 

to allow interested parties additional 

time to submit comments. We received 

several comments on the draft guidance 

and have modified the final guidance 

where appropriate. Changes to the 

guidance include clarifications to the 

foods that the guidance addresses, 

including the age range of the foods’ 

intended consumers. We added 

information about the method that FDA 

uses to test for lead in food and made 

several editorial changes to improve 

clarity of the guidance. We also 

collected and analyzed additional 

samples from our Toxic Elements 

Program and special FDA surveys to 

inform our exposure and achievability 

assessments. The guidance announced 

in this notice finalizes the draft 

guidance dated January 2023. 

In accordance with § 109.6 (21 CFR 

109.6), this guidance establishes the 

following action levels for lead in 

processed food intended for babies and 

young children less than 2 years old: 10 

parts per billion (ppb) for fruits, 

vegetables (excluding single-ingredient 

root vegetables), mixtures (including 

grain- and meat-based mixtures), 

yogurts, custards/puddings, and singleingredient meats; 20 ppb for singleingredient root vegetables; and 20 ppb 

for dry infant cereals. Consistent with 

§ 109.6(d), these action levels reflect 

levels of lead at which FDA may regard 

the food as adulterated within the 

meaning of section 402(a)(1) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 342(a)(1)). We intend to 

consider these action levels, in addition 

to other factors, when considering 

whether to bring enforcement action in 

a particular case. 

II. Paperwork Reduction Act of 1995 

This 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 guidance at https://

www.fda.gov/FoodGuidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. Use the 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31534 Filed 1–6–25; 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; 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 ‘‘Interim 

Policy on Compounding Using Bulk 

Drug Substances Under Section 503A of 

the Federal Food, Drug, and Cosmetic 

Act.’’ This guidance describes FDA’s 

interim policy concerning compounding 

by human drug product compounders 

that are not outsourcing facilities using 

bulk drug substances 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 guidance finalizes the draft 

guidance of the same title issued in 

December 2023 and replaces the final 

guidance of the same title issued in 

January 2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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.’’ 

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. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1137 

• 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 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: 

Mariestela Buhay, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Silver Spring, 

MD 20993–0002, 301–796–7313, 

Compounding@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act’’ (2024 503A Interim 

Policy Guidance). This guidance 

finalizes the draft guidance entitled 

‘‘Interim Policy on Compounding Using 

Bulk Drug Substances Under Section 

503A of the Federal Food, Drug, and 

Cosmetic Act’’ issued on December 7, 

2023 (88 FR 85296), and replaces the 

guidance of the same title issued in 

January 2017 (2017 503A Interim Policy 

Guidance). 

Section 503A of the FD&C Act (21 

U.S.C. 353a) sets forth 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.) 

FDA is developing the 503A bulks 

list, and this guidance describes FDA’s 

interim policy for licensed pharmacists 

in State-licensed pharmacies and 

Federal facilities and for licensed 

physicians who compound human drug 

products using bulk drug substances 

while the list is being developed. This 

guidance revises the policy described in 

FDA’s 2017 503A Interim Policy 

Guidance with respect to categorization 

of certain substances nominated for 

inclusion on the 503A bulks list. This 

guidance ends 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 this guidance. 

The 2024 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 

section 503A of the FD&C Act because 

they are not the subject of an applicable 

USP or NF monograph, components of 

FDA-approved drug products, or on the 

503A bulks list at § 216.23(a) (21 CFR 

216.23(a)). One of these conditions is 

that the bulk drug substance appears in 

Category 1. As described in the 

guidance, FDA does not intend to 

categorize bulk drug substances 

nominated for inclusion on the 503A 

bulks list on or after the publication 

date of this guidance. However, FDA 

intends to consider such substances 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 § 216.23(c)). FDA is 

evaluating bulk drug substances 

nominated for the 503A bulks list on a 

rolling basis. Substances that appear in 

Category 1 (including substances 

nominated with adequate supporting 

information prior to the date of 

publication of this guidance) may 

continue to be within the scope of the 

policy that applies to Category 1 

substances, as described in this 

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. 

Prior to preparing this guidance, FDA 

considered comments received on the 

draft guidance. Editorial changes were 

made to improve clarity, such as 

updating references to the publication 

date of this guidance. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 


ddrumheller on DSK120RN23PROD with NOTICES1
1138 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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 

This 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 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 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31546 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2978] 

Food and Drug Administration Animal 

Food Ingredient Consultation; 

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 #294 entitled 

‘‘Animal Food Ingredient Consultation 

(AFIC).’’ This guidance describes FDA’s 

interim AFIC process and explains one 

way FDA will work with firms that are 

developing animal food ingredients now 

that the Memorandum of Understanding 

(MOU) with the Association of 

American Feed Control Officials 

(AAFCO) expired on October 1, 2024, 

and while FDA evaluates the animal 

Food Additive Petition and Generally 

Recognized as Safe (GRAS) Notification 

programs. The AFIC process provides an 

additional way for engagement with 

FDA regarding ingredients for which 

firms may otherwise have used the 

AAFCO ingredient definition process. 

AFIC will help FDA identify any 

potential safety concerns associated 

with such ingredients. The AFIC 

process also allows for public awareness 

of and input on such ingredients. In 

addition, this guidance describes FDA’s 

enforcement policy for certain 

ingredients assessed using the AFIC 

process. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–2978 for ‘‘Animal Food 

Ingredient Consultation (AFIC).’’ 

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 guidance to the Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 


ddrumheller on DSK120RN23PROD with NOTICES1