FDA Issues Guide for Generic Cream Chemistry
Published Date: 3/18/2026
Notice
Summary
The FDA just released new rules to help companies making generic skin creams and gels prove their products work the same as brand-name ones. If you submit these drug applications, you’ll need to show detailed info about your product’s makeup and structure to get approval. This update starts now and aims to speed up safe, affordable generics without extra costs.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16944, Gardenia Blue Interest Group; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Gardenia Blue Interest Group (GBIG or petitioner), c/o Exponent, Inc., proposing that we amend our color additive regulations to expand the safe use of gardenia (genipin) blue in various foods at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue.
Previous / Next Documents
Previous: 2026-05274, Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program-OMB No. 0915-0334-Revision
HRSA is updating the forms and questions for the Countermeasures Injury Compensation Program to make things easier and clearer for people filing claims. This affects anyone who might get injured by certain medical countermeasures, like vaccines or treatments during emergencies. The public can comment on these changes until April 17, 2026, and no new costs are expected.
Next: 2026-05276, Over-the-Counter Monograph Drug Facility Fee Rates for Fiscal Year 2026
Starting October 1, 2025, companies that make or submit requests for over-the-counter (OTC) drug products will pay new facility fees for fiscal year 2026. These fees help the FDA keep OTC drugs safe and effective. If you own or run an OTC drug facility, get ready for these updated charges that last through September 30, 2026.