FDA Revamps Rules to Stop Infections from Body Part Swaps
Published Date: 5/5/2025
Notice
Summary
The FDA is updating its safety advice for people and companies that handle human cells and tissues used in medical treatments. They’re pulling back old rules about stopping infections like sepsis and tuberculosis and sharing new draft versions to get feedback. This means safer products and a chance for industry to weigh in before final rules are set.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Safer human cell and tissue products
The FDA is updating safety advice for people who receive or handle human cells and tissues used in medical treatments by withdrawing prior final guidances and issuing new draft guidances addressing transmission of sepsis and Mycobacterium tuberculosis. The change is intended to reduce the risk that these infections are passed through human cells, tissues, and cellular and tissue‑based products.
Industry can comment on new draft guidances
The FDA withdrew two final guidances titled "Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue‑Based Products (HCT/Ps)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue‑Based Products (HCT/Ps)" and reissued them as draft guidances so people and companies that handle HCT/Ps can provide feedback before final rules are set.
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.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20730, Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
The FDA fixed a previous announcement about pulling approval for 16 generic drug applications. Three drugs from Navinta LLC—ribavirin solution, fosaprepitant powder, and nicardipine capsules—won't lose approval because Navinta asked to keep them active. This means those three drugs stay on the market, while the other 13 still had their approvals withdrawn as planned back in July 2026.
Previous / Next Documents
Previous: 2025-07751, Norfolk Southern Railway Company-Trackage Rights Exemption-CSX Transportation, Inc.
Norfolk Southern Railway (NSR) got special permission to use CSX Transportation’s tracks for about 95 miles to reroute trains while a tunnel in Baltimore is being fixed. Now, NSR and CSX have agreed to end this temporary track-sharing deal once the project is done, and the Surface Transportation Board is approving that plan. This means NSR won’t need extra approvals later, keeping things smooth and simple for everyone involved.
Next: 2025-07754, Foreign-Trade Zone (FTZ) 102, Notification of Proposed Production Activity; Tight Line Composites LLC; (Carbon Fiber Profiles for Wind Turbine Spar Caps); Earth City, Missouri
Tight Line Composites in Earth City, Missouri, wants to make carbon fiber parts for wind turbines inside a special Foreign-Trade Zone (FTZ 102). This lets them use certain imported materials with lower or no import taxes, saving money and speeding up production. Public comments are open until June 16, 2025, before the government gives the final thumbs-up.