Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document Name	Status
0800 503A 503B SSA 2026 EXT.docx Supporting Statement A	2026-01-30

IC Document Collections

IC ID	Document Title	Status
256583	Outsourcing Facilities: Registration and reporting of drugs under 503B(b) Other-Statutory Authority	Unchanged
241793	503A; Disclosure Other-Memorandum of Understanding	Unchanged
241792	503A; Recordkeeping Other-Memorandum of Understanding	Unchanged
241791	503A; Reporting Other-Memorandum of Understanding	Unchanged
217572	503B Recordkeeping; AERs Other-Guidance	Unchanged
217571	503B Reporting: AERs Other-Guidance	Unchanged

ICR Details

OMB Control No: 0910-0800	ICR Reference No: 202512-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202210-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/01/2026
Date Submitted to OIRA: 01/30/2026

	Requested	Previously Approved
Expiration Date	6 Months From Approved	01/31/2026
Responses	17,191	17,191
Time Burden (Hours)	8,944	8,944
Cost Burden (Dollars)	0	0

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Abstract: This information collection helps support implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which governs pharmacy compounding and outsourcing facilities. References to statutory reporting, recordkeeping, and disclosures are discussed in specific FDA guidance documents, however we intend the ICR to account for burden that may be attributable to recommended tasks not accounted for elsewhere in our active collection invetory .

Emergency Justfication: Unanticipated staffing adjustments have significantly impacted the timeliness with which FDA is able to publish its requisite documents in the Federal Register. As a result, we are unable to publish our 30-day notice prior to the expiration date of this information collection. We are therefore submitting this ICR in accordance with our understanding of requirements in 5 CFR 1320.13, noting that we believe the collection of information Is needed prior to the expiration of established time periods under the PRA and is essential to the mission of the agency. While an unanticipated event has recently occurred that has disrupted processing of the collection of information, we expect to meet applicable deadlines within a 30-day period. We are therefore requesting an approval date of March 1, 2026, by which time we expect our 30-day notice (attached for OMB reference) will have published and at which time we will subsequently submit an ICR in accordance with 5 CFR 1320.10, as we believe applicable to this ICR.

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Authorizing Statute(s): PL: Pub.L. 116 - 8 503A; 503B Name of Law: FD&C Act: Pharmacy Compounding; Outsourcing Facilities
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52965	11/24/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
503A; Disclosure
503A; Recordkeeping
503A; Reporting
503B Recordkeeping; AERs
503B Reporting: AERs
Outsourcing Facilities: Registration and reporting of drugs under 503B(b)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	17,191	17,191	0	0	0	0
Annual Time Burden (Hours)	8,944	8,944	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,444,738

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/30/2026

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