Pharmacy Standards: Who May Mix a Medicine, and From What?

A Pharmacy Serving One Patient or a Facility Supplying Clinics

Everyday Denver Scene

Your doctor mentions two custom options—one mixed for a single patient order and another made in larger batches.

Federal law splits custom mixing into two parts of the Food, Drug, and Cosmetic Act: Section 503A and Section 503B. Section 503A applies when a pharmacy prepares medicine to fill an individual patient’s prescription. The state pharmacy board oversees it. USP means United States Pharmacopeia, a medicine standards group: Chapter 795 covers preparations that do not need to be germ-free, and Chapter 797 covers those that do.

Section 503B covers facilities that make batches of sterile medicines, often for clinics. They register with the FDA and must follow the factory quality rules called current Good Manufacturing Practice. Registration does not mean the FDA approved their products. FDA inspects registered 503B facilities on a schedule based on risk. For a batch facility (503B), raw drug ingredients must qualify under its federal ingredient list, the 503B Bulks List, or the FDA’s current shortage list. The first identifies ingredients allowed for this use; the second identifies drugs in national shortage. Ask which rule applies to the exact medicine offered. On May 1, 2026, the FDA proposed keeping semaglutide, tirzepatide, and liraglutide off the 503B Bulks List.

Why Taking Back a Request Does Not Make a Drug Lawful

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You read a clinic blog claiming that because BPC and CJC left a review list, pharmacies can now mix them freely.

Under Section 503A, a pharmacy may mix a bulk powder only if it passes one of three federal tests. First, the raw ingredient must meet a relevant official quality standard, called a monograph, in the United States Pharmacopeia (USP) or National Formulary (NF). When no such standard exists, the next test is whether an FDA-approved medicine contains that ingredient. If neither applies, it must be on the final 503A Bulks List, the federal list of allowed ingredients. Only 6 substances sit on the final 503A Bulks List at 21 CFR 216.23, and zero peptides are on that list. The FDA also used temporary review groups. Category 1 meant enough information was supplied and the FDA generally would not act while reviewing, under stated conditions; it was not legal approval. Category 2 meant serious safety concerns. Category 3 meant too little information to judge, without the Category 1 policy of holding off action. FDA’s revised policy leaves requests submitted on or after January 7, 2025 outside its temporary review groups.

The FDA page carries an April 22, 2026 content date and places GHRP-2, GHRP-6, ipamorelin acetate, and kisspeptin-10 in Category 2. The first three entries are under 503B; kisspeptin-10 is under 503A. BPC-157, TB-500, CJC-1295, AOD-9604, and Melanotan II are listed among withdrawn requests on FDA’s safety page, with content dated April 22, 2026. The nominators took back those requests; FDA still lists its safety concerns. On that April 22, 2026 page, DSIP, epitalon, KPV, selank, semax, and MOTS-c also appear as withdrawn requests. Moving from Category 2 to the withdrawn table is not FDA clearance. Withdrawing a request does not satisfy Section 503A’s ingredient tests. None of the withdrawn peptides is on the final 503A list. For BPC-157 and TB-500, FDA’s July 2026 papers also rule out the other two routes. Neither has a relevant monograph or is an ingredient in an approved drug.

On July 23 and July 24, 2026, an FDA committee reviewed BPC-157, KPV, TB-500, MOTS-c, emideltide, epitalon, and semax. FDA staff argued against adding those seven peptides. On September 26, 2026, this guide’s source check found no FDA record of the committee’s votes. A committee vote is advice; changing the list needs FDA rulemaking. GHK-Cu has different entries by route. On FDA’s May 14, 2026 list, non-injectable GHK-Cu is in Category 1, its conditional policy of holding off enforcement. Injectable GHK-Cu remains on the withdrawn-request table. The injectable entry’s withdrawal does not grant permission to compound it. The same federal ingredient tests still apply.

How Colorado Aligns State Pharmacy Rules With Federal Law

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Someone claims that Colorado passed a state compounding bill that lets local pharmacies skip federal peptide limits.

On June 2, 2026, Colorado signed House Bill 26-1262, stating that pharmacies and 503B plants must meet both federal and state laws. House Bill 26-1262 does not allow any peptide or custom mix barred by federal law. The Colorado Board of Pharmacy scheduled an October 1, 2026 hearing about aligning its mixing rules with FDA guidance. The sources used here were checked before that hearing and do not report its outcome. This guide cannot say that the hearing changed the rules; the state law still requires compliance with federal law.