31 Questions to Ask a Compounding Pharmacy Before You Sign

Before you start: what you are testing for

A pharmacy sales call is not designed to answer these questions, and a pharmacy that is uncomfortable with them is giving you the most valuable answer in the process. So set the frame early: you are going to ask for documents rather than assurances, and you are going to ask the same questions of every candidate so the answers are comparable.

Two things are worth knowing before the first call. Most of the regulatory history you care about is already public, in FDA's warning letter database and in state pharmacy board records, so several of these questions are really testing whether a partner volunteers what you can already find. And across all eleven public sites we read, exactly one of the eleven published a price of any kind, so assume your number will come from a call and force identical units out of every candidate.

One more framing that saves time. Ask for the answers in writing, in one document, before the second call. A partner who can assemble a release SOP, a lab name, a testing cadence, a licensure roster and five years of inspection history in a few days is demonstrating the quality system you are trying to evaluate. The assembly time is itself the answer.

The one question, if you only get one: if a batch fails potency testing after it ships, who tells my patients, in whose name, and on what timeline? A real quality system answers with a procedure, a role and a number of hours.

Which pharmacy am I actually buying from

Start here because half the later answers depend on it. A 503A pharmacy compounds against patient-specific prescriptions; a registered 503B outsourcing facility may compound without one but does not get the manufacturing-practice exemption a 503A pharmacy does. Some partners hold both and will fill your program from one of them, and which one changes what may legally be made for you.

The subcontracting question matters more than its length suggests. LegitScript's own application asks a pharmacy to disclose the name, address and license number of any facility it contracts with to compound products it dispenses, which tells you the arrangement is common enough to be a standard disclosure item. If your fills are made somewhere you have not evaluated, you have done diligence on the wrong company.

• 1. Are you a 503A pharmacy, a registered 503B outsourcing facility, or both, and which one will fill my program's prescriptions?
• 2. Is any part of my volume compounded by a facility other than this one? If so, give me that facility's name, address and license number.
• 3. Are you the dispensing pharmacy of record for every fill, or is any of it routed to another pharmacy?
• 4. Who is the pharmacist-in-charge for each state I ship into, and where a state requires that person to hold its own license, do they?

What you can legally make for me

This is the group most often answered with confidence and least often answered with a document. Both compounding chassis are restricted from making copies of commercially available drugs, and the tests differ. Under 503A, a compounded drug is essentially a copy when the active ingredient, an easily substitutable strength, and the route of administration match, unless the prescriber documents a change producing a significant difference for that specific patient. FDA's guidance is explicit that a lower price does not qualify as such a difference.

Under 503B the test is both different and stricter: a compounded drug matching an approved drug on active ingredients, route, dosage form, strength and excipients is identical or nearly identical, and FDA states that this cannot be excused by a prescriber's determination of a clinical difference for an individual patient. That applies to the identical-or-nearly-identical branch, and not to 503B generally: section 503B(d)(2)(B) covers a product that is not identical or nearly identical but uses a bulk drug substance that is a component of an approved drug, where a prescriber's clinical-difference determination does count. Ask which branch a partner is relying on, because the answers are not interchangeable.

For GLP-1 programs the ground has moved and is still moving. Semaglutide's shortage was resolved in February 2025 and tirzepatide's in December 2024, and the enforcement-discretion windows behind them closed through spring 2025, so the ordinary copy restrictions apply in full. Separately, FDA proposed in April 2026 to exclude semaglutide, tirzepatide and liraglutide from the 503B bulk drug substances list on a finding of no clinical need. As of September 8, 2026 that proposal was still pending with no final rule, which is exactly why the question below asks what happens if it is finalized rather than whether it will be.

• 5. For each product I plan to sell, what is the specific legal basis on which you compound it? I want it in writing, not on a call.
• 6. Which of my products would meet FDA's test for being essentially a copy of a commercially available drug, and what documented patient-specific difference supports each one?
• 7. Neither semaglutide nor tirzepatide is in shortage and the enforcement-discretion windows closed in 2025. What is your current basis for compounding either, if you do?
• 8. FDA has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. If that is finalized, what happens to my supply and on what notice?
• 9. Who re-verifies the legal basis for each product, on what cadence, and how will I be told when it changes?

Quality, and the release rule

This is the group that separates partners, and every question in it corresponds to something a regulator documented in this category in 2025 or 2026.

A state board decision from 2025 records sterile preparations shipped to patients before bacterial endotoxin testing results returned; when the results arrived they exceeded limits by two to three times or more, and there was no patient notification and no recall. The same matter records end-product testing data for several lots that falsely represented the lots had met testing requirements. The corrective procedure the pharmacy adopted afterwards is the first question below, almost word for word: no GLP-1 or testosterone-containing sterile preparation is released until passing sterility and endotoxin results are received and approved. Ask for that SOP by name.

Federal warning letters in the same period name specific out-of-specification results on GLP-1 products, including semaglutide released at roughly 80 percent of labeled potency and tirzepatide lots in the 86 to 89 percent range. Underpotent product does not present as a safety event to your patient; it presents as your program not working, and it churns quietly.

The storage question is the cheapest check on the list and it has caught real problems: compounded GLP-1 preparations labeled to be stored frozen while the approved products' own labeling says not to freeze and not to use if frozen. If your partner's storage instructions contradict the reference product's, the answer you need is stability data, not reassurance.

• 10. Do you release any sterile preparation before passing sterility and endotoxin results are received and approved? Show me the standard operating procedure that says so.
• 11. Which independent laboratory tests your batches for sterility and potency, and how frequently is a batch tested?
• 12. What is your out-of-specification procedure: who is notified, within how long, and does it include the patient?
• 13. Has a batch failed potency or sterility testing in the past 24 months? What happened to product that had already shipped, and were patients notified?
• 14. What stability data supports the storage instructions on my product's label, particularly anywhere they differ from the reference product's labeling?
• 15. Have you had a product recall or a reported adverse patient outcome in the past year? Describe the incident and the corrective action.
• 16. Which rooms and buildings is compounding for my products performed in, and has each been inspected and approved by your board?

Licensure, shipping and turnaround

Every partner in this category claims broad coverage, and a claim is not a roster. Ask for license numbers and expiration dates, because that is what a certifier asks for and what a state board can check. The reason to insist is that states use materially different mechanisms: Florida requires a non-resident pharmacy registration to ship a dispensed drug into the state, Ohio licenses the same activity as a non-resident terminal distributor and requires an Ohio-licensed responsible person for a pharmacy shipping compounded drugs in, and California can issue an immediate cease-and-desist against sterile compounding on a reasonable belief of an immediate threat, before a full hearing.

That last one is why the licensure questions and the standing questions belong to the same conversation. A single board can remove your largest state within days while the rest of your map keeps selling, so both your diligence and your continuity plan have to be per state rather than national.

• 17. Send the state-by-state list of resident and non-resident licenses with numbers and expiration dates, warranted current as of today.
• 18. Which of my launch states are you not licensed in right now, and what is the realistic timeline for each?
• 19. How do you handle cold chain: what packaging, validated to what excursion threshold, and who pays for the remake when a shipment fails?
• 20. What is your prescription-to-shipment turnaround as a number, and what happens when you miss it?
• 21. What share of your prescription volume ships out of state, and has that changed materially in the last year?

Regulatory standing and disclosure

Most of this group is already public, and asking anyway is the point. You are testing whether a partner volunteers what you could find yourself, because that is the same disposition that decides whether they will call you at 9pm about a failed lot.

Two anchors make the answers checkable. LegitScript defines disciplinary action broadly for its own applicants, explicitly including warning letters, consent agreements and any similar regulatory communication, so a partner treating a warning letter as not really discipline is using a narrower definition than its certifier does. And Ohio requires non-resident pharmacies to report FDA warning letters, injunctions and decrees to the board within 72 hours, which means for any partner shipping into Ohio there is a state record of exactly the thing you are asking about.

The certification question is not optional if you intend to advertise. LegitScript's affiliates and partners standard states that partner pharmacies responsible for fulfilling prescription medication to patients are generally required to be certified or accredited by another recognized body, with limited exceptions at its sole discretion. Worth holding in proportion, though: certification is an application-and-disclosure review rather than an independent audit of every asserted fact. It is strong evidence a partner submitted to scrutiny and disclosed. It is not a substitute for reading the primary records.

• 22. List every FDA inspection, Form 483 and warning letter in the past five years, with the closeout status of each.
• 23. List every state board action, consent agreement, cease-and-desist order or civil penalty in the past five years.
• 24. Have you ever ceased production of a product line at FDA's request or by agreement? Which, when, and what changed before you resumed?
• 25. Are you LegitScript certified or accredited by another recognized body, and will you maintain it for the whole term?
• 26. Will you notify me of a warning letter, board action, recall or adverse outcome within a defined number of days? I want that clock in the agreement.

Money, minimums and leaving

Almost none of this is published. On 2026-09-08 we read the public sites of all eleven compounding pharmacies in our directory: one of the eleven publishes a price of any kind, one of the eleven addresses minimums, and zero publish cold-chain specifications. That is not a reason to skip these questions, it is the reason they have to be structured, because the numbers will come from a call and calls are not comparable unless you force identical units.

Make every candidate answer in identical units at identical volumes. Quotes in different units are not comparable, and a quote that moves when you restate the same volume back to them has told you something useful about how the number was arrived at. Then read the exit terms before the launch terms, on the same principle that applies to every other vendor: you learn the most about a partner by negotiating the ending.

• 27. What is my all-in cost per fill at 100, 500 and 2,000 fills a month, in the same units, including shipping and cold chain?
• 28. What are the minimums, and what happens to my pricing if I miss them?
• 29. Which costs are fixed in the agreement and which are quoted per order or subject to change?
• 30. If we part ways, what do I receive, in what format, on what timeline, and what happens to patients who are mid-titration?
• 31. Who owns the formulation, and who owns the patient's fill history?

How to read the answers

Score the answers on specificity, not on enthusiasm. In this category the correlation between a confident answer and a true one is weak, and the correlation between a documented answer and a true one is strong. Three patterns are worth naming.

Precision where precision is cheap. A licensure roster, a lab name, a testing cadence and a turnaround number are all facts a competent pharmacy has at hand. Vagueness on any of them is not modesty, it is either disorganization or reluctance, and both are your problem later.

The gap between the sales answer and the document. Ask for the SOP, the roster and the inspection history in writing, and compare them against what you were told. Where the deck and the document disagree, the document is the version that will exist when something goes wrong.

What they tell you before you ask. The single best signal across every one of these conversations is a partner who raises a problem you had not found yet. The public record in this category is largely made of firms whose disclosure, at the moment it mattered, was nothing.

Print one copy per candidate and write the answers beside the questions. The comparison that matters is not who scores higher overall, it is where two pharmacies answer the same question differently, because that difference is usually the real difference between them.