Ask what is being made
Imagine the proposal uses a short name for a blend. Ask for the full ingredient list and the form of the preparation. Ask what specific need the prescriber is trying to meet and why the proposed preparation fits that need.
The federal route called 503A requires a valid prescription for a named person, along with other conditions. Under 503B, a facility can choose to register with FDA to make batches of sterile medicine, often for clinics and hospitals. The law calls this an outsourcing facility. It can make those batches without a separate prescription for every person who may receive them.
“Sterile” means free of living germs.
Find out which kind of compounder the offer involves. Then read the policy for that route. Keep the full preparation name at hand as you compare the policy with the offer.
What the October draft actually says
A draft published October 30, 2026 sets out an enforcement plan from the U.S. Department of Health and Human Services (HHS).
State-licensed pharmacies and doctors are the draft’s intended compounders. HHS says it plans to leave their compounding without enforcement action when every condition is met. The preparation must be made for an individual patient’s prescription and use a peptide named in the draft.
Six peptide names appear in the draft: MOTS-c, BPC-157, semax, TB-500, KPV and epitalon. Compare those ingredient names with the proposed prescription. Ask the prescriber which, if any, it contains and what evidence supports that use.
The draft applies to one listed peptide at a time; mixtures of peptides, called blends, are outside it. The draft also leaves out 503B facilities, the FDA-registered batch compounders described above. The exact form of the ingredient and the way the medicine is given must match the draft’s Appendix B. Ask the pharmacy to show which entry matches your prescription; the draft does not cover every form or way of giving it.
This is a draft that does not bind the government. It is not FDA approval, and none of those six peptides appears on the official 503A Bulks List.
A bulk drug substance is the raw active ingredient used to make the finished medicine. The 503A Bulks List is part of federal regulations; a statement about when the government plans to enforce those rules does not change that list.
In its October 30, 2026 publication, HHS reports that the committee voted for six of the seven peptides considered at its July 2026 meeting. As of November 3, 2026, FDA’s meeting page still has neither minutes nor a transcript. HHS’s account records support for the same six named above. The vote is advice; changing the official list requires a separate rulemaking process.
For a proposed preparation, ask the prescriber to identify the exact policy, its conditions and the pharmacy involved. A general reference to “the new rules” leaves too much unanswered.
Withdrawn requests are a different record
FDA gives April 22, 2026 as the page’s “current as of” date. The table records requests to consider BPC-157 and other peptides; the groups who made those requests later withdrew them.
The group’s withdrawal gives the ingredient no FDA approval. For the six peptides named above, the October 30, 2026 draft sets out the separate plan to refrain from enforcement if all its conditions are met. FDA still prints its safety concerns next to those ingredients. FDA supplies no date for the withdrawal of any individual request on that page.
Keep that table separate from the later HHS draft. They are different records with different purposes. If an offer points to a screenshot of a list, ask for the source page, its date and the exact entry being discussed.
Georgia adds pharmacy rules
Georgia’s compounding material was checked September 28, 2026.
Georgia’s rule allows a pharmacy to make medicine for a particular person with a prescription. It restricts making a near-copy of a medicine that is commercially available. Its exceptions include a change ordered by the prescriber for an individual patient, or a manufacturer or wholesaler supply problem.
The same rule bars ordinary pharmacies from supplying compounded stock for a doctor’s office to use on unnamed patients. It makes an exception for the registered batch compounders called 503B facilities.
Those state rules do not replace federal ingredient and product restrictions. Ask about both levels, using the full preparation name. A written explanation can then be compared with the actual rule rather than a category label.
For retatrutide and cagrilintide, FDA’s position in the November 3, 2026 check is that federal law does not permit their use in compounding.
Neither retatrutide nor cagrilintide is among the ingredients in the October draft.
When the offer is a copy of a familiar drug
The federal check dated November 3, 2026 records that semaglutide and tirzepatide injections are not on FDA’s shortage list.
Federal law limits making near-copies of medicines already available. Under the exception for an individual prescription, your prescriber has to decide the change creates a “significant difference” for you. A lower bill does not qualify by itself. FDA’s examples include trouble swallowing tablets and an allergy to a medicine’s dye. Ask which change matters for you and why.
Local stock can run out while a drug remains off the national shortage list.
Ask what makes this particular preparation relevant to your care. File the reply with its ingredients, the pharmacy record and the complete quote.
Keep the next question in view.
Separate the costs in the quote