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Choosing a Compounding Partner: A Diligence Guide for Membership Practices
Many concierge practices now prescribe compounded hormones, weight-loss drugs or peptides, and some want a formulary or a shelf of office stock. Federal law sorts compounders into two lanes with different rules, the GLP-1 shortage that opened a large market has ended, and peptide policy is in motion. This brief lays out what the statute and FDA guidance require, where things stand in October 2026, and a checklist for vetting a pharmacy before your name goes anywhere near its product.
New in October 2026. Federal status checked October 22, 2026. Peptide policy is changing week to week; check the dated sources before relying on Part 3. A companion to Brief No. 11 (GLP-1 marketing) and Brief No. 31 (longevity medicine).
Start here: the questions this brief answers
Tap a question for the short answer, then jump to the evidence.
A compounding pharmacy under section 503A of the federal drug law makes drugs for an identified patient on a valid prescription; it is not a source of office stock. An outsourcing facility registered with FDA under section 503B can supply non-patient-specific product for office use, and the law bars anyone but that facility from reselling it. The semaglutide and tirzepatide shortages are over (resolved February 21, 2025 and October 2, 2024), so routine copies of those drugs are off the table; a 503A version now needs a documented, patient-specific clinical difference, and FDA has proposed keeping both drugs off the 503B bulks list. No peptide had been added to the 503A bulks list as of mid-October 2026, though an interim access policy is under White House review and a further advisory committee review is expected by the end of February 2027. Before choosing a partner, verify licensure in every state you prescribe into, ask for certificates of analysis and testing data, keep the pharmacy’s name on the label, tell patients compounded drugs are not FDA-approved, and do not build the practice on one regulatory window. This is educational material, not legal advice.
Can a concierge practice keep compounded drugs on the shelf?
Only from the right source. FDA says practices can obtain non-patient-specific compounded drugs for office use from registered 503B outsourcing facilities. A 503A pharmacy distributes only on a patient-specific prescription.
Go to the full answer ↓Can we still prescribe compounded semaglutide or tirzepatide?
The shortages ended in 2024 and 2025. A 503A pharmacy may compound a version only when the prescriber documents a significant difference for the individual patient, or in very small volumes. Price alone does not count, and adding vitamin B12 may not change the analysis.
Go to the full answer ↓Are peptides such as BPC-157 now allowed?
Not on the federal list. As of mid-October 2026 no peptide had been added to the 503A bulks list. An advisory committee vote in July was advisory only, and an interim access policy was sent to the White House for review in October. Check current status before prescribing.
Go to the full answer ↓What should patients be told?
That compounded drugs are not FDA-approved and FDA does not review them for safety, effectiveness or quality before they are marketed. Avoid any suggestion that a compound is the same as a branded drug.
Go to the full answer ↓Can the membership include a compounding formulary?
Possibly, but buying patient-specific compounds and reselling them at a markup raises federal and state problems. Outsourcing facility product may not be resold by anyone else. Have counsel review the structure first.
Go to the full answer ↓What should we ask a pharmacy before signing?
Licensure in each state, certificates of analysis, potency, sterility and stability support for extended dating, labeling, adverse event handling, and how it decides a preparation may lawfully be compounded. Part 5 has a checklist.
Go to the full answer ↓Two kinds of compounder, doing two different jobs
Federal law exempts compounded drugs from the new drug approval process only when they come through one of two lanes. Section 503A covers a licensed pharmacist or physician compounding for “an identified individual patient based on the receipt of a valid prescription order.”1 Policy and Law Section 503B covers outsourcing facilities that register with FDA and “may or may not obtain prescriptions for identified individual patients.”2 Policy and Law
The difference decides what a membership practice can do. A practice that wants a compounded testosterone cream for one patient is dealing with a 503A pharmacy. A practice that wants a box of a compounded injectable on hand for in-office use needs a 503B facility. FDA says it plainly: hospitals, clinics and practitioners “can obtain non-patient-specific compounded drug products from” registered outsourcing facilities, while 503A pharmacies distribute only on a valid patient-specific prescription.3
| Question | Section 503A pharmacy | Section 503B outsourcing facility | Evidence type |
|---|---|---|---|
| Who compounds, under whose oversight | A licensed pharmacist in a state-licensed pharmacy, or a licensed physician; state boards of pharmacy are the main regulator1 | A facility registered with FDA, compounding by or under the direct supervision of a licensed pharmacist; FDA inspects on a risk-based schedule2 | Policy and Law |
| Prescription needed? | Yes, for an identified patient. Limited anticipatory compounding is allowed, capped in FDA policy at a 30-day supply based on past prescriptions3 | Not always. Products not dispensed on a patient prescription carry an “Office Use Only” label2 | Policy and Law |
| Office stock | No. Distribution only on a patient-specific prescription3 | Yes, for administration in a health care setting3, | Policy and Law |
| Resale by the practice | Governed by state dispensing law; ask counsel | The statute bars sale or transfer by anyone other than the facility that compounded it. Administering it or dispensing on a valid prescription is not barred2 | Policy and Law |
| Copies of approved drugs | Not “regularly or in inordinate amounts”1 | Not “essentially a copy of one or more approved drugs,” unless the drug is on FDA’s shortage list2 | Policy and Law |
| Bulk ingredients | Must meet a USP monograph, be a component of an approved drug, or be on the 503A bulks list; each bulk substance comes with a valid certificate of analysis1 | Must be on the 503B bulks list (clinical need) or the drug must be on the shortage list2 | Policy and Law |
| Shipping across state lines | Without an FDA memorandum of understanding with the home state, out-of-state distribution is capped at 5 percent of prescriptions1 | Reports its products to FDA twice a year and submits adverse event reports2 | Policy and Law |
State licensure comes first
Federal status is only half the picture. Each state where a patient receives the drug can require its own license or permit from the pharmacy that ships it. Florida, for one, requires a nonresident pharmacy or outsourcing facility to hold a nonresident sterile compounding permit before shipping compounded sterile products into the state, backed by a recent inspection report and written policies that follow USP chapter <797>.4 Policy and Law Other states set their own terms. A partner that is properly licensed at home but not in your members’ states is a problem you inherit.
FDA publishes its list of registered outsourcing facilities with each one’s last inspection date, whether a Form 483 was issued and any recall. FDA notes that a 483 is not a final agency finding and that the table leaves out state board actions.5 It is a starting point for diligence, not a seal of approval.
A compounding pharmacist presenting at the Concierge Medicine Forum in October drew the same line for concierge physicians: 503B outsourcing facilities for office stock, 503A for patient-specific prescriptions. The presenter also urged practices to confirm a pharmacy is licensed in every state it ships to. CMT checked both points against the statute and FDA guidance above.
The GLP-1 shortage is over, and so is the easy path
From 2022 into 2025, shortages of the branded drugs let compounders make semaglutide and tirzepatide at scale, because a drug on FDA’s shortage list is not treated as commercially available. Those shortages ended, and FDA’s grace periods ran out in the spring of 2025.
FDA determines the tirzepatide shortage is resolved, and reaffirms the decision on December 19, 2024.6 Policy and Law
FDA determines the semaglutide shortage is resolved.6 Policy and Law
Tirzepatide: FDA says its enforcement discretion period for 503A compounders has ended after a March 5 court ruling; for 503B facilities it ran to March 19, 2025.6 Policy and Law
Semaglutide: the 503A period ends after an April 24 court ruling; the 503B period runs to May 22, 2025.6 Policy and Law
FDA sends warning letters to 30 telehealth companies over compounded GLP-1 marketing that implied sameness with approved drugs or sold compounds under the company’s own brand without saying who compounded them.7 Policy and Law
FDA reminds compounders that adding an ingredient such as vitamin B12 may still leave a product essentially a copy, when the semaglutide and B12 amounts are within 10% of commercial strengths and the route is the same.6 Policy and Law
FDA proposes not to place semaglutide, tirzepatide or liraglutide on the 503B bulks list, finding no clinical need; supply problems, cost and convenience do not count. A June 26 notice extends the comment period.8 Policy and Law
What “essentially a copy” means for a 503A prescription
FDA’s 2018 guidance treats a compounded drug as a copy when it has the same active ingredient as a marketed drug in the same, similar or easily substitutable strength, by the same route. A drug that is discontinued or listed as currently in shortage is not considered commercially available.9,
“Regularly or in inordinate amounts” is defined in the same guidance. As an enforcement policy, FDA does not intend to act against a compounder that fills four or fewer prescriptions of an essentially-a-copy product in a calendar month.9,
A law firm reading of the May 2026 notice puts the practical result this way: with both drugs off the shortage list, 503A compounding may rest only on documented individual need, such as an allergy to an inactive ingredient, and patient preference or savings are not enough.11
Counts of reports cannot tell anyone how often harm occurs or whether a product caused it; that is CMT’s caution, not FDA’s wording. FDA’s page also describes dosing errors with compounded injectable semaglutide, some leading to hospitalization, and says the salt forms some compounders have sold, such as semaglutide sodium and semaglutide acetate, are different active ingredients from the approved drugs, with no lawful basis it knows of for compounding them.12 Policy and Law
The CMF presenter’s advice not to build a practice on one regulatory window looks sound against this timeline. A weight program that depended on shortage-era compounding lost its footing within months. A program built on clinical follow-up, with the drug sourced lawfully and documented patient by patient, survives a change in supply. Brief No. 11 covers how to market GLP-1 care without overpromising.
Peptides: read the date on every claim
Most peptides marketed to longevity and wellness practices have no USP monograph and are not components of approved drugs. For a 503A pharmacy to use one as a bulk ingredient, it has to be on FDA’s 503A bulks list.1,
FDA’s Pharmacy Compounding Advisory Committee considered seven peptides for the 503A bulks list: BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax and Epitalon.16 Policy and Law FDA scientists found insufficient evidence of benefit or safety for any of them.17 The committee voted to recommend six, rejecting emideltide; BPC-157, KPV and TB-500 each passed 8 to 6 with one abstention.15
Writing in Health Affairs Forefront, researchers noted that the supporting votes came from members with ties to peptide businesses or clinics and that no conflict waivers were posted. The committee’s recommendations are advisory.17 Practice Insight
HHS sent an “interim access policy” on compounding certain peptides to the White House Office of Management and Budget. Its text was not public. People familiar with it told the AP it would let pharmacies temporarily compound some popular peptides under enforcement discretion.15,
As of an October 16, 2026 law firm review, no peptide had been added to the 503A bulks list, and FDA had issued no proposed or final rule.15 Enforcement discretion, if granted, would not change the statute, would not make any peptide FDA-approved, and could be withdrawn without rulemaking; it also would not bind state boards.15 CMT could not open an FDA page confirming the April 2026 Category 2 change or the February 2027 timing, so those rest on the law firm sources cited. Anything after October 16, 2026 is not reflected here. Check FDA’s compounding pages and your state board before prescribing.
Research-grade products are a separate matter. FDA’s GLP-1 page describes warning letters to companies selling semaglutide, tirzepatide, retatrutide and similar drugs labeled “for research purposes” or “not for human consumption” while marketing them for human use.12 Policy and Law The CMF presenter urged attendees not to treat research-grade peptides as equivalent to regulated compounded products. Nothing in the 2026 actions changes that. Brief No. 31 sets out how CMT weighs evidence for longevity interventions; this brief does not assess whether any peptide works.
Quality data, honest labels and plain consent
USP’s revised compounding chapters, <795> for nonsterile and <797> for sterile preparations, took effect November 1, 2023, with a more risk-based approach to beyond-use dates.19 Practice Insight USP says it “has no role in enforcement”; state boards decide how and when the chapters apply.20 Kentucky, for example, began enforcing the 2022 revisions on January 1, 2026.21 Policy and Law
Under <797>, the longest beyond-use dates belong to Category 3 sterile preparations, which undergo sterility testing (plus endotoxin testing when applicable) and meet stricter requirements for staff, garb, cleaning, environmental monitoring and stability evidence.20 When a pharmacy offers a long shelf life on an injectable, ask which category it is using and for the testing behind it.
Certificates and test results
Federal law requires a valid certificate of analysis for each bulk drug substance a 503A pharmacy uses.1 Policy and Law
Ask to see them, along with the pharmacy’s potency, sterility and endotoxin results and the stability data that support any extended beyond-use date. A partner that cannot produce them on request is telling you something.
Keep the pharmacy’s name on the label
In March 2026 FDA cited telehealth firms for advertising compounded drugs under their own name or trademark without saying who made them, which suggested the firm was the compounder.7 Policy and Law
A white-labeled vial with the practice’s logo is a marketing choice. The dispensing pharmacy still belongs on it, and outsourcing facility labels must carry the facility’s name and contact details.2
Consent that says what the drug is
FDA says compounded drugs “are not FDA approved,” and that the agency “does not review compounded drugs for safety, effectiveness or quality before they are marketed.”12 Policy and Law
Consent language should say so in plain words, explain why a compounded product was chosen for this patient, and match the reason written on the prescription.
Marketing without comparisons
FDA’s March 2026 letters targeted claims implying a compound is the same as an approved drug.7 Policy and Law According to a law firm summary, a September 2026 warning letter also questioned GLP-1 products with added B12 or niacinamide and preselected prescription options on telehealth platforms.15
Practice websites that put a compound beside a brand name and a price invite the same reading.
Formularies and markups
Outsourcing facility product “will not be sold or transferred by an entity other than the outsourcing facility,” though administering it in a health care setting is allowed.2 Policy and Law
CMT reading: a membership that buys patient-specific 503A prescriptions and resells them at a markup raises state dispensing, pharmacy and fee-arrangement questions. The CMF presenter warned against it. Counsel should review any formulary design before launch.
Adverse event handling
Outsourcing facilities must submit adverse event reports to FDA.2 Policy and Law
Ask a 503A partner how it receives, tracks and reports problems, who at the practice tells it, and how a recall would reach your patients.
Vetting a compounding partner: the checklist
Check what you have confirmed in writing, not what you have been told. The meter shows how much of the diligence is done. It is a planning aid, not a legal or compliance determination; state rules vary and change.
Before you sign with a compounding pharmacy
Licensure and registration
Quality
Prescribing and documentation
Labels, consent and marketing
Business model
67% of respondents named finding a doctor they like and trust as their top reason for searching (n=1,044). Level-Uppers, 29% of the segmentation sample, are happy with their current doctor and are “reaching for more before anything breaks.”22 Industry Research
CMT reading: Members who come for optimization and prevention will ask about compounded therapies, and what they are trusting is your judgment. Diligence on the pharmacy protects that trust.
CMT Patient Study: people searching for a concierge or membership physician through CMT, January 2013 to December 2024. Self-selected, not nationally representative and not peer-reviewed; DPC patients excluded. CMT original
Know the two lanes
503A for patient-specific prescriptions, 503B for office stock. Most compliance problems start with mixing them up.
Paper the partnership
Licenses, certificates, test data and an adverse event process, collected before the first order and rechecked each year.
Tell patients the truth
Compounded means not FDA-approved. Say so, say why, and leave brand names out of the pitch.
How this brief was built
CMT started from the statute itself (sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, read in current amended form), then read FDA’s guidance on the prescription requirement and its two 2018 guidances on “essentially a copy,” FDA’s GLP-1 statements and press announcements, the May 2026 Federal Register notice on the 503B bulks list, FDA’s bulks list and advisory committee pages, a USP FAQ, one state statute (Florida) and one state board document (Kentucky). Where FDA had not posted outcomes, such as the July 2026 advisory committee votes and the October 2026 interim peptide policy, CMT relied on dated law firm alerts, a Health Affairs Forefront commentary and an Associated Press report, and says so in the text. All sources were opened October 21 and 22, 2026.
The topic grew out of a compounding pharmacy session at the Concierge Medicine Forum in October 2026. The presenter’s points were used as a list of questions to check, never as evidence; every rule stated here comes from a cited source. This brief applies to concierge practices; it contains no direct primary care data, and the federal compounding rules discussed apply regardless of payment model. CMT did not review clinical evidence for any compounded hormone, weight-loss drug or peptide and makes no treatment recommendation. Because this is a legal and regulatory topic, CMT recommends review by a healthcare attorney and a pharmacist familiar with your states before relying on any part of it.
How to read the evidence types
Every key finding is labeled by evidence type. Labels describe the type of evidence, not its value. Each type answers different questions. Funding is disclosed on every source.
Randomized trials and systematic reviews.Best for cause and effect.
Large observational studies and government data.Best for trends at scale.
Surveys, smaller studies and expert consensus.Best for real-world experience.
Company-sponsored or company-reported data that is not peer-reviewed.Best for early signals and operating data.
Statutes, regulation and official guidance.Best for what is required.
What we don't know
- Whether FDA will finalize its proposal to keep semaglutide, tirzepatide and liraglutide off the 503B bulks list, and when. CMT found no final determination as of October 22, 2026.
- What the peptide interim access policy will say, which substances it will cover, and whether it will be issued at all. Its text was not public when CMT checked.
- How many concierge practices prescribe or stock compounded drugs. CMT found no published data for membership practices.
- How state boards will treat peptide compounding if federal enforcement discretion is granted. Law firm commentary notes that a federal policy would not bind state boards.
- Comparative quality and safety data for compounded versus FDA-approved versions of specific drugs. Adverse event reports to FDA cannot establish rates or cause.
How to cite this brief
External review: this brief has not yet been reviewed by an outside expert. When review is complete, the reviewer is credited by name above with any conflicts of interest, and the version number is updated. Reviewers check accuracy and fairness; CMT is responsible for the final content.
Corrections policy: when an error is identified, CMT corrects it in the open and updates the version number above. Send corrections to the editor through conciergemedicinetoday.net.
Related CMT Research Briefs
References
- 21 U.S.C. section 353a (Federal Food, Drug, and Cosmetic Act section 503A): Pharmacy compounding, as amended. United States Code, via Cornell Law School Legal Information Institute. Accessed October 2026. www.law.cornell.eduFunding: not applicable (federal statute; text published by Cornell Law School’s Legal Information Institute)
- 21 U.S.C. section 353b (Federal Food, Drug, and Cosmetic Act section 503B): Outsourcing facilities. United States Code, via Cornell Law School Legal Information Institute. Accessed October 2026. www.law.cornell.eduFunding: not applicable (federal statute; text published by Cornell Law School’s Legal Information Institute)
- U.S. Food and Drug Administration. Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. December 2016. Copy hosted on the HHS guidance portal. www.hhs.govFunding: federal (U.S. Food and Drug Administration publication)
- Florida Statutes, section 465.0158: Nonresident sterile compounding permit. The Florida Senate, 2026 Florida Statutes. m.flsenate.govFunding: state government publication (Florida)
- U.S. Food and Drug Administration. Registered outsourcing facilities (table updated as of September 30, 2026; content current as of October 13, 2026). www.fda.govFunding: federal (U.S. Food and Drug Administration publication)
- U.S. Food and Drug Administration. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (statement with dated updates through April 1, 2026; content current as of April 1, 2026). www.fda.govFunding: federal (U.S. Food and Drug Administration publication)
- U.S. Food and Drug Administration. FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s (press announcement). March 3, 2026. www.fda.govFunding: federal (U.S. Food and Drug Administration publication)
- Food and Drug Administration. List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act (notice of proposed determination: semaglutide, tirzepatide and liraglutide). Federal Register 91 FR 23431, May 1, 2026. Docket FDA-2018-N-3240. www.federalregister.govFunding: federal (U.S. Food and Drug Administration publication)
- U.S. Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. January 2018. www.fda.govFunding: federal (U.S. Food and Drug Administration publication)
- U.S. Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry. January 2018. Copy hosted on the HHS guidance portal. www.hhs.govFunding: federal (U.S. Food and Drug Administration publication)
- Ravitz GC, Esfahani S, Johnson T, Joseph AM, Sherer JD. FDA moves to shut the door on large-scale compounding of GLP-1 drugs. Orrick, Herrington & Sutcliffe client insight (law firm commentary). May 1, 2026. www.orrick.comFunding: not stated (law firm commentary)
- U.S. Food and Drug Administration. FDA’s concerns with unapproved GLP-1 drugs used for weight loss. Content current as of October 1, 2026. fda.govFunding: federal (U.S. Food and Drug Administration publication)
- U.S. Food and Drug Administration. Bulk drug substances used in compounding under section 503A of the FD&C Act (503A bulks list and interim policy categories). Accessed October 2026. fda.govFunding: federal (U.S. Food and Drug Administration publication)
- Ravitz GC, Esfahani S, Johnson T, Sherer JD, Joseph AM. FDA announces removal of 12 peptides from Category 2 and schedules PCAC meetings. Orrick, Herrington & Sutcliffe client insight (law firm commentary). April 16, 2026. www.orrick.comFunding: not stated (law firm commentary)
- Crossan SS, Watkins S. Peptides at a crossroads: what wellness providers need to know about HHS and FDA actions. Holland & Knight alert (law firm commentary). October 16, 2026. www.hklaw.comFunding: not stated (law firm commentary)
- U.S. Food and Drug Administration. July 23 to 24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda, substances under consideration for the 503A bulks list, docket FDA-2025-N-6895). Content current as of August 6, 2026. www.fda.govFunding: federal (U.S. Food and Drug Administration publication)
- Fu M, Ross JS, Nguyen NAH, Ramachandran R. FDA advisory committee’s vote may open a drug-compounding back door for unapproved peptides. Health Affairs Forefront. August 4, 2026. www.healthaffairs.orgFunding: not stated for this article (Health Affairs Forefront commentary; an editor’s note says the broader Forefront topic series is produced with support from the Commonwealth Fund)
- Perrone M. Trump administration advances plan for peptide drugs favored by RFK Jr. Associated Press, October 15, 2026 (republished by News4JAX). www.news4jax.comFunding: not stated (news report)
- American Veterinary Medical Association. USP revised compounding standards go into effect. AVMA@Work news. Undated; accessed October 2026. atwork.avma.orgFunding: not stated (news report published by the American Veterinary Medical Association)
- United States Pharmacopeia. Frequently asked questions: <797> Pharmaceutical Compounding, Sterile Preparations. Updated December 11, 2023. Copy hosted by the Utah Department of Commerce. commerce.utah.govFunding: not stated (published by the United States Pharmacopeia)
- Kentucky Board of Pharmacy. USP <795> and <797> updates (2022 revisions adopted in 201 KAR 2:076; board enforcement from January 1, 2026). Accessed October 2026. pharmacy.ky.govFunding: state government publication (Kentucky)
- Concierge Medicine Today. Your Patients Aren't One Audience. They're Four (CMT Patient Study). Patient inquiries to CMT, January 2013 to December 2024; self-selected respondents searching for a concierge or membership physician; DPC patients excluded; not peer-reviewed or nationally representative. Accessed October 2026. conciergemedicinetoday.netFunding: Concierge Medicine Today (self-conducted; no outside funder) CMT original
Educational and informational only. This CMT Research Brief does not constitute medical, legal, tax, financial, accounting or other professional advice, and it does not create a professional relationship of any kind. Statements about laws, regulations, tax rules and payer policies are general, may not reflect the rules in your state, and can change after publication. Consult a qualified attorney, accountant, tax adviser, compliance professional or licensed clinician before acting on anything here.
Independence. Concierge Medicine Today is an independent publication. It does not accept payment for favorable coverage, and it does not favor one practice model over another. Company names and products are mentioned for context only and are not endorsements. Funding is disclosed for every source in the reference list.
Accuracy. CMT verifies figures against their original or best available sources at the time of publication. Where a figure is an estimate, an inference or a company-reported number, the brief says so. This content is not without possible error or omission.
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