FDA Wants Comments on Drug Compounding Paperwork Overload
Published Date: 8/31/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and associated fees.
Analyzed Economic Effects
7 provisions identified: 1 benefits, 4 costs, 2 mixed.
Annual Outsourcing Facility Registration
If you operate an outsourcing facility that compounds human drugs and elect to register, you must register annually between October 1 and December 31 and provide your name, place of business, a unique facility identifier, and a point-of-contact email and phone. Registered facilities must submit a drug product report when first registering and then twice each year in June and December for products made in the prior 6-month period.
Annual Establishment Fee & Payment Rule
Facilities are assessed an annual establishment fee and receive an FDA invoice with payment instructions; a facility is not considered registered for a fiscal year until payment is made. Certain facilities may qualify for a small business reduction but must submit a written request for the reduction by April 30 of the preceding fiscal year (for example, by April 30, 2026, to qualify for FY 2027).
Small Business Fee Reduction Process
To request a small business reduction in the annual establishment fee, a facility must submit Form FDA 3908 titled 'Outsourcing Facilities for Human Drug Compounding: Small Business Establishment Fee Reduction Request' in the specified format and email it to OFCFEe[email protected]. FDA will send a notification letter with its decision and recommends keeping that letter.
Estimated Reporting and Recordkeeping Burden
FDA estimates the total annual burden for this collection is 213 responses and 704 hours. Example estimates include 4.5 hours for electronic registration submissions (100 respondents), 25 hours for each small business reduction request (8 respondents), and 0.5 hours to remit annual establishment or reinspection fees (90 and 12 respondents respectively).
Electronic Submission Requirement (SPL)
FDA requires registration and related data to be submitted electronically in Structured Product Labeling (SPL) format unless a waiver is granted. A waiver request may be submitted; FDA estimates no more than one waiver request annually and assumes a waiver request takes about 1 hour to prepare.
Reinspection Fees for Noncompliance
If FDA conducts a reinspection of an outsourcing facility because of noncompliance found during a prior inspection, the facility will incur a reinspection fee and receive an invoice at the email address listed in its registration file. FDA estimates 12 reinspection fee responses annually and assumes 30 minutes per remittance.
Fee Disputes and Appeals Process
Outsourcing facilities can seek internal Agency reconsideration and, if denied, appeal FDA decisions related to fees under the procedures in 21 CFR 10.75. Requests for reconsideration should explain why FDA's decision was in error and may be appealed consistent with Sec. 10.75; contact email for dispute submissions is Division of User Fee Management at [email protected].
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Key Dates
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