Read a compounding offer carefully

To compound a drug is to prepare or alter it for a need. A compound is not an approved finished drug. FDA does not check how safe or well made it is, or how it works, before sale. That was still FDA’s position on November 3, 2026.

FDA on compounding FDA on compounded product information

The 503A route is tied to a named patient with a valid prescription. A licensed pharmacist or physician makes the drug under set conditions. This part of the federal law was checked November 3, 2026.

FDA on compounding

The 503B route is different. An outsourcing facility is a site that makes batches of sterile drugs and elects to register with FDA. It need not have a prescription for each named patient. That registration gives no product approval, as checked November 3, 2026. A sterile preparation has no living germs in it.

FDA on outsourcing facilities

HHS published a draft on October 30, 2026 saying it does not intend to take action against certain compounding that meets its conditions. It describes government plans, without changing the law or approving the medicines. For this policy, the responsible agency is the Department of Health and Human Services (HHS). The scope concerns drugs made for a named patient’s prescription.

HHS draft policy and appendices The published draft-policy notice

The draft covers BPC-157 and semax, among others. It also names KPV alongside MOTS-c. Epitalon and TB-500 complete that group. HHS’s stated intention applies only when all ten conditions in the draft are met. Appendix B limits the exact ingredient form and how the medicine enters the body. Ask the prescriber and pharmacy to show where your proposed ingredient and way of giving it match those limits. Its scope is state-licensed pharmacies and physicians working through 503A.

HHS draft policy and appendices

It covers single-ingredient drugs, leaving blends and 503B facilities out. This draft describes HHS’s intentions; it creates no legal right to compounding and gives no medicine FDA approval. As of November 3, 2026, the named peptides had not been added to the official 503A bulks list of raw drug ingredients. FDA’s reviews from July 2026 found no applicable published drug-ingredient standard for these peptides. Nor did FDA identify an approved drug containing any of them. Those are the other ways a raw ingredient can qualify under 503A. A prescription alone therefore does not establish that these ingredients meet the law; the HHS draft is a separate statement about intended government action.

HHS draft policy and appendices The published draft-policy notice

HHS reports that FDA’s Pharmacy Compounding Advisory Committee backed those peptides in July 2026. That official account records advice. It does not put them on the bulks list; the record was checked November 3, 2026.

HHS draft policy and appendices FDA on bulk ingredients

FDA marks its page as current on April 22, 2026. In the table of withdrawn requests, the entries are ingredient requests that their backers took back. Those backers had asked for the ingredients to be considered for compounding. Its safety concerns remain beside those entries. A withdrawn request confers no clearance or approval. The table gives no date for each withdrawal.

FDA’s ingredient concerns

Florida’s rule calls for strict adherence to the federal compounding law. The state rule was checked November 3, 2026. The HHS draft does not change that state rule.

Florida’s compounding rule

A nonresident sterile compounding permit is needed to send sterile compounds to Florida from either an out-of-state pharmacy or a registered outsourcing facility. The permit and inspection rules were checked November 3, 2026.

Florida’s sterile-compounding permit statute