View Information Collection Request (ICR) Package

OMB Control No: 0910-0800	ICR Reference No: 202512-0910-009
Status: Historical Inactive	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
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 03/23/2026
	Date Received in OIRA: 01/30/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	6 Months From Approved	05/31/2026
Responses	17,191	0	17,191
Time Burden (Hours)	8,944	0	8,944
Cost Burden (Dollars)	0	0	0

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.

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

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

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

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:

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

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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