Can a pharmacy compound this peptide?

Where each peptide sits on FDA’s compounding lists, what that means for a pharmacy filling a prescription, and FDA’s own words for each, with the page and the date we read it.

7 substances Checked on FDA’s pages Oct 24, 2026

Compounded drugs are not FDA-approved. This page reports FDA’s published lists only; FDA updates them, and its current pages decide. It is not medical advice.

By substance

Open a row for the list it is on, what that means and FDA’s own words. Read on FDA’s pages Oct 24, 2026.

Status on FDA’s lists

7 substances

Sermorelin (sermorelin acetate)Ingredient of an FDA-approved drug

Which list: Not on the 503A category lists. FDA’s 503B list marks sermorelin acetate as a component of an FDA-approved drug (Geref) and places it in 503B category 1.
A 503A pharmacy: Section 503A lets a pharmacy compound from a bulk ingredient that is a component of an FDA-approved drug product when no USP or NF monograph exists. Compounded versions are not FDA-approved.
A 503B outsourcing facility: Listed for evaluation under the 503B interim policy (see the list above).
FDA-approved product: No FDA-approved sermorelin is sold in the US. Geref (sermorelin acetate) is listed as discontinued; FDA determined in 2013 that it was not withdrawn from sale for reasons of safety or effectiveness.
FDA’s words: Sermorelin Acetate**
FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (categories list, PDF) · Updated March 21, 2025 · read Oct 24, 2026
**Designates bulk drug substances that are components of FDA approved drugs
FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (categories list, PDF) · Updated March 21, 2025 · read Oct 24, 2026
The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness.
Federal Register, March 4, 2013 (FDA notice 2013-04827) · read Oct 24, 2026
GEREF · SERMORELIN ACETATE · marketing status: Discontinued (NDA019863, NDA020443)
openFDA Drugs@FDA: sermorelin (data updated 2026-10-23) · read Oct 24, 2026

Sermorelin by prescription: prices

NAD+ (nicotinamide adenine dinucleotide)503A Category 1: under FDA review

Which list: 503A category 1 (bulk drug substances under evaluation), FDA’s list updated May 14, 2026. Beta-NAD is also listed for evaluation under the 503B interim policy.
A 503A pharmacy: FDA says it does not intend to take action against a 503A compounder using a substance listed there, provided the conditions in its guidance are met. Compounded versions are not FDA-approved.
A 503B outsourcing facility: Listed for evaluation under the 503B interim policy, as beta-nicotinamide adenine dinucleotide.
FDA-approved product: No FDA-approved NAD+ drug product.
FDA’s words: Nicotinamide Adenine Dinucleotide (NAD)
FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (categories list, PDF) · Updated May 14, 2026 · read Oct 24, 2026
Beta-Nicotinamide Adenine Dinucleotide
FDA: Bulk Drug Substances Nominated for Use in Compounding Under Section 503B (categories list, PDF) · Updated March 21, 2025 · read Oct 24, 2026
FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met.
FDA: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act · Content current as of 05/14/2026 · read Oct 24, 2026

NAD+ by prescription: prices

TesamorelinFDA-approved as Egrifta, a biologic

Which list: Tesamorelin is the active ingredient of Egrifta, licensed as a biological product (BLA 022505).
A 503A pharmacy: FDA says biological products are not eligible for the 503A compounding exemptions.
A 503B outsourcing facility: FDA says biological products are not eligible for the 503B compounding exemptions.
FDA-approved product: Yes: Egrifta SV and Egrifta WR (tesamorelin), by prescription.
FDA’s words: EGRIFTA · TESAMORELIN ACETATE · application BLA022505 · marketing status: Prescription
openFDA Drugs@FDA: tesamorelin (data updated 2026-10-23) · read Oct 24, 2026
Marketing Category: BLA · Application Number: BLA022505
DailyMed: EGRIFTA WR (tesamorelin) label · read Oct 24, 2026
Biological products are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act.
FDA: Compounding and the FDA: Questions and Answers · Content current as of 09/16/2025 · read Oct 24, 2026

Tesamorelin and Egrifta: prices

PT-141 (bremelanotide)FDA-approved as Vyleesi

Which list: Bremelanotide is the active ingredient of Vyleesi (NDA 210557), an FDA-approved drug.
A 503A pharmacy: Section 503A lets a pharmacy compound from a bulk ingredient that is a component of an FDA-approved drug product when no USP or NF monograph exists. Compounded versions are not FDA-approved.
A 503B outsourcing facility: Not named on the 503B category list we read.
FDA-approved product: Yes: Vyleesi (bremelanotide) injection, by prescription.
FDA’s words: VYLEESI (AUTOINJECTOR) · BREMELANOTIDE ACETATE · EQ 1.75MG BASE/0.3ML · SOLUTION;SUBCUTANEOUS · Prescription
FDA Drugs@FDA: NDA 210557 (Vyleesi) · read Oct 24, 2026

PT-141 by prescription: prices

Ipamorelin (ipamorelin acetate)503B Category 2; off the 503A lists

Which list: 503B category 2 (significant safety risks) since September 29, 2023. Its 503A nomination was withdrawn, so it is on none of the 503A lists.
A 503A pharmacy: Not a USP monograph, not a component of an FDA-approved drug and not on the 503A bulks list or its categories.
A 503B outsourcing facility: FDA has identified significant safety risks and would consider taking action against an outsourcing facility that compounds with it.
FDA-approved product: No FDA-approved ipamorelin product.
FDA’s words: Ipamorelin acetate · 503B · September 29, 2023
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026
Compounded drugs containing Ipamorelin acetate may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation or peptide-related impurities. Ipamorelin acetate also contains unnatural amino acids, which add to the complexity of peptide characterization. A study published in literature identified serious adverse events including death when ipamorelin was administered intravenously for improving gastric motility.
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026
Ipamorelin acetate, which also appears in the table above because it is in category 2 under the 503B interim policy
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026

CJC-1295Nomination withdrawn; FDA notes risks

Which list: Previously in category 2; the nomination was withdrawn. It is not on the 503A or 503B lists or categories.
A 503A pharmacy: Not a USP monograph, not a component of an FDA-approved drug and not on the 503A bulks list or its categories.
A 503B outsourcing facility: Not on the 503B bulks list or its categories.
FDA-approved product: No FDA-approved CJC-1295 product.
FDA’s words: This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026
Compounded drugs containing CJC-1295 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to for peptide-related impurities and API characterization. FDA has identified serious adverse events associated with CJC-1295 including increased heart rate and systemic vasodilatory reaction. Available clinical data are limited.
FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026

BPC-157Not listed; FDA panel voted to add it

Which list

Not on the 503A or 503B lists or categories; its nominations were withdrawn and FDA is evaluating it on its own initiative. FDA advisory committee voted 8–6 on Jul 23, 2026 to recommend adding it to the 503A list; FDA has not acted (checked Oct 24, 2026).

Advisory committee

Vote reported by press; FDA minutes not yet posted. The committee voted 8–6 with one abstention; the vote is non-binding.

ABC News, Jul 23, 2026 · RAPS, Jul 23, 2026

A 503A pharmacy

Not a USP monograph, not a component of an FDA-approved drug and not on the 503A bulks list. An advisory committee vote does not add it to the list; FDA decides.

A 503B outsourcing facility

Not on the 503B bulks list or its categories.

FDA-approved product

No FDA-approved BPC-157 product.

FDA’s words

On July 23, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/ BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/ KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/ TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/ MOTs-C acetate).

FDA: July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee · Content current as of 08/06/2026 · read Oct 24, 2026

The nominations were withdrawn and FDA is evaluating the substances at its discretion.

FDA Briefing Document for BPC-157-Related Bulk Drug Substances, PCAC meeting July 23-24, 2026 (PDF) · read Oct 24, 2026

After considering the information currently available, a balancing of the criteria weighs against BPC-157 (free base) and BPC-157 acetate being placed on that list

FDA Briefing Document for BPC-157-Related Bulk Drug Substances, PCAC meeting July 23-24, 2026 (PDF) · read Oct 24, 2026

This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators.

FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026

Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.

FDA: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks · Content current as of 04/22/2026 · read Oct 24, 2026

What the lists mean

FDA’s rules for pharmacies (503A) and outsourcing facilities (503B), in FDA’s words.

A pharmacy filling a prescription (503A)

State-licensed physicians and pharmacists that compound under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) may only compound drug products using bulk drug substances that:
Comply with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding;
Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist; or
Appear on FDA’s list of bulk drug substances that can be used in compounding (the 503A bulks list) if such a monograph does not exist and the substance is not a component of an FDA-approved drug product.

FDA: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act · Content current as of 05/14/2026 · read Oct 24, 2026

FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met.

FDA: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act · Content current as of 05/14/2026 · read Oct 24, 2026

FDA would consider taking action against a compounder for compounding drug products with this bulk drug substance under its general enforcement policies.

FDA: Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act · Content current as of 05/14/2026 · read Oct 24, 2026

An outsourcing facility (503B)

Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless:
The bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need (the 503B bulks list), or
The drug product compounded from such bulk drug substance appears on FDA’s drug shortage list at the time of compounding, distribution and dispensing.

FDA: Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act · Content current as of 01/07/2025 · read Oct 24, 2026

Approval

Compounded drugs are not FDA-approved.

FDA: Compounding and the FDA: Questions and Answers · Content current as of 09/16/2025 · read Oct 24, 2026

Questions this page answers

Questions

3 answers

Is ipamorelin legal to prescribe in 2026?

FDA’s lists answer a narrower question: whether a pharmacy may compound it. As of Oct 24, 2026, ipamorelin acetate is in category 2 (significant safety risks) of FDA’s 503B interim policy, and its 503A nomination was withdrawn, so it is on none of the 503A lists. There is no FDA-approved ipamorelin product.

Sermorelin vs ipamorelin: which can a pharmacy fill?

FDA’s 503B list marks sermorelin acetate as a component of an FDA-approved drug (Geref, now discontinued), one of the routes section 503A allows a pharmacy to compound from. Ipamorelin is in 503B category 2 and on none of the 503A lists. Compounded drugs are not FDA-approved.

Can a pharmacy compound NAD+?

NAD is in category 1 of FDA’s 503A interim policy (under evaluation), where FDA says it does not intend to take action against a compounder if the conditions in its guidance are met. There is no FDA-approved NAD+ drug, and compounded versions are not FDA-approved.

How we checked

On Oct 24, 2026 we read each status on FDA’s own pages: the 503A and 503B bulk drug substance pages and their category lists, the category 2 safety-risks page, FDA’s compounding questions and answers, its 2020 notice on biological products, the Federal Register, Drugs@FDA, and the July 23–24, 2026 advisory committee meeting page and FDA’s BPC-157 briefing document.
An advisory committee vote FDA has not posted minutes for is cited to the press reports and labeled so.
Every quote is copied word for word and links to its page, with the date the page states it was last updated.
A substance FDA’s pages do not name would read “Not on FDA’s published lists”; none of the seven needed it.
This page carries no partner links and links no research-peptide seller.