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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

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

ICR Details

OMB Control No: 0910-0800	ICR Reference No: 202603-0910-014
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: Regular	Date Submitted to OIRA: 03/27/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	17,191	17,191
Time Burden (Hours)	8,960	8,944
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) - which governs pharmacy compounding and outsourcing facilities. The requirements include reporting, recordkeeping, and disclosures.

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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
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 8495	02/23/2026
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)	8,960	8,944	0	0	16	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: While we have retained our currently approved burden estimates, we have corrected several inadvertent errors. We added more precision to the number of responses per respondent figures in rows 3 and 6; corrected the average burden per response in row 6 (from 0.2 to 0.025 hour (1.5 mins.)); and corrected the total hours calculation in rows 3, 6, and 7. Due to these corrections, we have adjusted our total burden estimate upward by 16 hours (from 8,944 to 8,960) annually.

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Annual Cost to Federal Government: $1,513,211

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: 03/27/2026

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