Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just released a new interim policy for pharmacies that mix medicines using bulk drug ingredients. This update affects outsourcing facilities by setting clearer rules while the FDA finishes a list of approved bulk drugs. Starting January 7, 2025, these changes help keep medicines safe without slowing down production or adding extra costs right now.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 0 costs, 1 mixed.
End of Category 1–3 Nominations Rule
The guidance ends FDA's practice of categorizing bulk drug substances into Categories 1, 2, or 3 for substances nominated for the 503B bulks list on or after the publication date (January 7, 2025). Outsourcing facilities should note that new nominations submitted on or after that date will no longer receive a Category 1, 2, or 3 designation under this policy.
Category 1 Substances Retain Interim Scope
Bulk drug substances that appear in Category 1, including those nominated with adequate supporting information prior to January 7, 2025, may continue to be within the scope of the policy for Category 1 substances until FDA makes a final determination to place them on the 503B bulks list or removes them from Category 1. Facilities using Category 1 substances should follow the guidance until FDA acts on those substances.
Final FDA Interim Guidance Published
The FDA published a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act" on January 7, 2025. The guidance describes FDA's interim regulatory policy for outsourcing facilities that compound using bulk drug substances while FDA develops the 503B bulks list.
Nominations Considered on Rolling Basis
FDA will evaluate bulk drug substances nominated for the 503B bulks list on a rolling basis and will consider such substances for inclusion in accordance with the process and clinical need standard in section 503B(a)(2)(A)(i) of the FD&C Act. Outsourcing facilities may expect nominations to be reviewed continuously rather than in a single batch process.
Guidance Is Nonbinding and Flexible
The guidance represents FDA's current thinking and does not establish any rights for any person; it is not binding on FDA or the public and alternative approaches that satisfy applicable statutes and regulations may be used. Outsourcing facilities may follow other approaches if they meet legal requirements.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-11331 — Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results of the Expedited Fourth Sunset Review of the Antidumping Duty Order
The U.S. Department of Commerce decided to keep the antidumping duties on hand trucks and parts from China because dropping them could lead to unfair low prices again. This means importers from China will still pay extra fees to keep things fair for U.S. businesses. These rules stay in effect starting June 5, 2026, protecting American companies from cheap imports that could hurt them.
2026-11280 — Self-Regulatory Organizations; NYSE American LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend Sections 1003 and 1009 of the NYSE American Company Guide
The NYSE American Exchange wants to change its rules to require companies to keep a certain market value to stay listed. This affects companies listed on the exchange and could lead to some being removed if they don’t meet the new standards. The SEC is reviewing this change and will decide by June 18, 2026, so companies and investors should watch for updates that might impact stock listings and market activity.
2026-11296 — Notice of Determinations and Request for Comments Concerning Actions in Section 301 Investigations of Acts, Policies, and Practices of Various Economies Related to the Failure To Impose and Effectively Enforce a Prohibition on the Importation of Goods Produced With Forced Labor
The U.S. Trade Representative found that many countries aren’t stopping goods made with forced labor from entering the U.S. To fix this, they’re planning to add extra taxes (tariffs) on products from these countries, with rates between 10% and 12.5%. They’re also offering a special deal for some clothing imports and want your thoughts before finalizing these changes by early July 2026.
2026-11327 — Proposed Revisions to the National Handbook of Conservation Practices
The USDA’s Natural Resources Conservation Service is updating some rules in the National Handbook of Conservation Practices to help farmers and landowners protect the environment better. These changes could affect how conservation projects are planned and done, and the public can share their thoughts until July 6, 2026. No big costs are expected, but the updates aim to make conservation easier and more effective.
2026-11276 — Long Island Rail Road's Request To Amend Its Positive Train Control System
The Long Island Rail Road wants to make some changes to its safety system that helps prevent train crashes, called Positive Train Control (PTC). They asked the government for approval on May 21, 2026, and now the public can share their thoughts until June 25, 2026. These updates aim to keep trains safer without causing delays or extra costs for riders.
2026-11282 — Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend It Rules Related to Binary Options
The Cboe Exchange wants to update its rules to let traders buy and sell binary options on more indexes, with flexible settlement times and new position limits. The SEC is taking extra time, until July 19, 2026, to review these changes carefully. This affects traders and could impact how they manage risk and trade binary options on the Exchange.
Previous / Next Documents
Previous: 2024-31544 — Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
The FDA just dropped new rules to help companies that handle human cells and tissues keep tuberculosis (TB) from spreading. These rules tell them how to check donors for TB risks and what extra steps to take until better TB tests are ready. This change starts right away and helps protect everyone who gets these medical products without adding big costs.
Next: 2024-31546 — Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The FDA just released a new interim policy for pharmacies that mix medicines using bulk drug ingredients. This update affects compounders who aren’t big outsourcing facilities and sets clearer rules while the FDA finalizes an official list of allowed bulk drugs. The policy kicks in January 2025 and aims to keep medicine mixing safe without slowing down your prescriptions or adding extra costs.