Five Questions You Should Be Asking Your Compounding Pharmacy

 Mark Boesen has worked on both sides of the legal and compound pharmacy equation, representing clinics and pharmacists in the regulatory realm as a lawyer after spending decades as a compound pharmacist. This week he talks about the relationship between practitioners and compound pharmacies, a relationships that’s vital to the success of peptide therapy movement.

Below that, see our first Enforcement Update, a new feature for Peptides Business Wire.

Let’s dive in.

I get a version of the same phone call every few weeks. A clinic owner, or a telehealth medical director, calling after something has already gone sideways. A shipment got held up. An investigator showed up and asked for records. A patient had a reaction and now everyone wants to know what was actually in the vial.

Somewhere in the first ten minutes I ask who compounded the product and what they know about that pharmacy. The answer is almost always a version of "they came recommended," or "their pricing was good."

That is the whole problem in one sentence.

I was a pharmacist before I was a lawyer, so I have been on both ends of this conversation. Here are the five questions I would want answered before sending a prescription anywhere. None of them are difficult. What matters is asking them early, in writing, while you still have some leverage and before anyone is under investigation.

Ask it first. You would be surprised how many people never do.

A 503A pharmacy fills patient-specific prescriptions. A 503B outsourcing facility registers with FDA, follows what is called Good Manufacturing Practices, and can ship office stock with no patient name attached to the vial. If you are keeping product in a clinic refrigerator to use on whoever comes in Thursday afternoon, and your pharmacy is a 503A, that hasn’t been permitted under federal law since 2013.  Get the pharmacy’s permit and read it.

Drugs that are manufactured as a raw ingredient in powder form are called bulk substances.  Bulk substances have to come from an FDA-registered establishment with a certificate of analysis (COA). That part is easy. The harder question is whether the substance can be compounded at all.  Is the ingredient monographed and published by USP, is it a component of an approved drug, or on FDA's approved bulks list. A fair amount of what is selling in the peptide space is none of the above.

So ask for the supplier. Ask for the COA. Ask what they are relying on to say the substance qualifies.

"Pharmaceutical grade" is not a legal category. Nobody at FDA uses that phrase. It comes from suppliers’ websites. And if the container that arrived at the pharmacy said research use only, or not for human consumption, you have your answer and you can stop asking questions.

Different question from the last one, and it catches people.  Look at molecules longer than 40 amino acids and you are looking at a biologic rather than a drug. Biologics are not allowed to be compounded under 503A or 503B, full stop. Separately, a pharmacy or physician cannot compound what is “essentially a copy” of a commercially available drug outside some narrow exceptions, and the room that opened up around certain GLP-1s existed because of a shortage. Shortage resolves, room closes. That came as an unpleasant surprise to people who had built a business inside it.

For a sterile injectable: sterility, endotoxin, potency, container closure integrity. Ask for the release panel and actually read it.

Then ask about the beyond-use date, which is where I usually find the soft spot. Under USP 797, with no product-specific stability data, default dating is short, shorter than 90 days. So when I see 90 or 180 days on a peptide vial, I want the study and the lab that ran it. If there is no study, that date is somebody’s guess printed in an official-looking font.

History first. Board discipline, FDA observations, warning letters, recalls, and nonresident licensure in every state where your patients live.

Something that sounds like a read flag but is not: a pharmacy that has been inspected, received and responded to observations, and can walk you through what it fixed is often a safer partner than one with a clean file and no track record. Nobody gets sharper without getting looked at.

Then comes money matters, which is the part people would rather skip. Things to look out for are per-prescription payments, marketing fees that scale with volume, but also any revenue split between the prescriber and the pharmacy. That is Anti-Kickback Statute and Eliminating Kickbacks in Recovery Act of 2018 (EKRA) territory. EKRA and state-prohibited kickbacks are what catches people off guard, because it reaches into cash-pay arrangements where the federal AKS does not. Cash-pay is not a safe harbor and never was.

Send the questions in an email. Keep the answers in a folder. It sounds bureaucratic because it is, and it is still the cheapest insurance available to you.

When an investigator eventually asks why you believed the product you put into a patient was lawfully compounded, the answer that helps you is the one you can hand over on paper. The answer that does not help you is "they came recommended."

In thirty-some years of being a pharmacist I have never had a good pharmacy object to being asked. The ones that object have just saved you a great deal of trouble.

Mark Boesen, Pharm.D., J.D., is a partner of Boesen & Snow Law in Scottsdale, Arizona, where he represents pharmacies and healthcare companies in regulatory, FDA, and compliance matters. This article is general information, not legal advice, and does not create an attorney-client relationship.

 Enforcement Update

Compiled and sponsored by Boesen & Snow Law

·       Striker Pharmacy, LLC, Texas. Eli Lilly and Company filed a civil complaint on August 12, 2026, alleging the compounding pharmacy unlawfully sells illegal retatrutide to medical spas and providers. Case No. 4:26-cv-06563 (S.D. Tex.). Complaint filed; no response on the docket yet.

·       Matthew J. Kawa and Jennifer L. Stechkober (Paradigm Peptides), Indiana. The U.S. Attorney's Office for the Northern District of Indiana announced sentencing on July 30, 2026, after both defendants pleaded guilty to introducing unapproved new drugs into interstate commerce with intent to defraud, following sales of peptides (including BPC-157), SARMs, and HCG through Paradigm Peptides. Kawa received 70 months and Stechkober 16 months, both plus one year of supervised release, with $78,317.52 in restitution and a $5 million money judgment against Kawa. No. N.D. Ind. (USAO press release). Sentencing entered; case concluded.

 ·       Aesthetic Envy Cosmetic Centers LLC, California. Eli Lilly and Company filed a civil complaint on August 12, 2026, alleging the med spa openly advertised its "Triple G" retatrutide product on its website and social media. Case No. 2:26-at-01347 (E.D. Cal.). Complaint filed; no response on the docket yet.

 ·       Texas Peptides Inc., Texas. Eli Lilly and Company filed a civil complaint on August 12, 2026, alleging the seller labeled its retatrutide product research-use-only while marketing it in ways Lilly alleges were directed at human use. Case No. 5:26-cv-05146 (W.D. Tex.). Complaint filed; no response on the docket yet.

 ·       Legendary Peptides, LLC, Texas. Eli Lilly and Company filed a civil complaint on August 12, 2026, with the same research-use-only mislabeling allegation. Case No. 1:26-cv-00347 (E.D. Tex.). Complaint filed; no response on the docket yet.