At its core, a compounding pharmacy exists to create unique and personalized medications tailored to a client’s physical health needs. For instance: did you know that metformin can be applied topically in a cream form to avoid gastrointestinal distress, which can occur when using the oral pill form? Or, that amlexanox, a mouth paste previously utilized for aphthous ulcers, can now be formulated into capsule form to help calm mast cell activation disorder, improve metabolic dysfunction and sometimes help improve asthma and allergies. Whether it’s selecting an old drug for a new purpose, cleaning up the formula filler in a common day medication or simply changing a pill capsule’s structure to a plant-based coating, compounding medications present versatility for both patients and its providers.
However, when it comes to vetting a compounding pharmacy – there are key questions a provider (and consumer) should consider before utilizing their products:
1. Are they a sterile or non-sterile compounding pharmacy? And, I know what you’re thinking – but, no, this does not fully reflect their overall level of cleanliness in a “clean vs. dirty” way as it may sound! But yes… sterile vs. non-sterile does refer to differing “aseptic” levels of technique, facility environments guidelines and production testing with continued monitoring.
2. Where and from whom does the compounding pharmacy supply their ingredients? How does the compounding pharmacy vet their supply vendors and does the pharmacy have set SOP’s (standard operating procedures) for analyzing their vendors’ qualifications? Also, what form of testing (in house vs. third party etc) does a compounding pharmacy employ before contracting with a supplier and/or manufacturer?
To answer these, let’s delve in.
Sterile vs. Non-Sterile: There are a few distinct differences between these compounding pharmacy categories. First, sterile vs. non-sterile differs in the products they compound and the dosages they offer. Sterile compounding’s goal is to prevent ANY microbial contamination because their products can go directly into the bloodstream, eyes or lungs. Sterile compounding pharmacies most habitually produce intravenous formularies (IVs), eye drops and injections. Non-sterile compounding pharmacies more commonly make products delivered in the form of creams, patches, gels, oral capsules, ointments, suppositories etc. As such, their goal is to maintain quality, accuracy and cleanliness. An easy way to think about the delineation between sterile and non-sterile is: If a medication needs to bypass your body’s usual defenses, then it generally needs to be sterile in its production. However, if a medication is applied onto your skin or ingested via your mouth, it usually does not need high-grade sterility. Second, a sterile compounding pharmacy needs a designated “cleanroom” and immaculate, aseptic techniques. It is more restrictive in its rules of conduct (being governed by US Pharmacopeia 797 guidelines) and presumably more expensive to upkeep. A non-sterile compounding pharmacy needs to have “a clean designated compounding area”. This means, while still “clean”, it is differently governed (regulated by US Pharmacopeia 795 rules). The sterile vs. non-sterile facilities rules of conduct and orderliness vary by their production room design, gowning protocols and air quality monitoring rules – and also each have separate rules for documenting and validating their products’ sterility, potency, and stability. Third, sterile pharmacies are registered as a 503B facility, which (yes – I had to Google it too) means they may function not only as a manufacturing company but also as an outsourcing facility. This allows sterile compounding pharmacies to craft and then sell medications directly to hospitals, doctors’ offices etc. Generally speaking, sterile compounding facilities handle large-scale volume (nationally even), repeatable static doses and run multiple shifts of production. As such, sterile compounding pharmacies answer to the Federal Drug Administration (FDA). Non-sterile compounding pharmacies, by contrast, are registered as a 503A facility, which is designed for prescription by prescription production. Non-sterile compounding pharmacies are limited on how much product they make in advance and focus on customized, small-batching for individual needs
(ie. a bioidentical testosterone hormone replacement therapy cream). Non-sterile compounding pharmacies answer to governing State Boards for where the pharmacy is licensed to dispense.
Ingredient Sourcing: There’s a chain of command to understand when it comes to compounding medication manufacturing. Compounding pharmacies are responsible for vetting their raw ingredient vendors, aka the “suppliers”. Common day examples of suppliers may be ‘Medisca’ or ‘Professional Compounding Center of America’ (aka PCCA). However, the suppliers are responsible for vetting the manufacturer of the raw ingredients the suppliers receive. Chemical manufacturers are usually located abroad (ie. China or India) and these manufacturers often do not follow the same quality standard rules as the United States. So, suppliers should be continually vetting their manufacturers to ensure that they are not only FDA registered but also FDA inspected. Many manufacturers can be FDA registered but not pass inspections.
To contextualize this: In late 2025, there became a national shortage of the repurposed oral capsule drug called Amlexanox in the United States. This was due to the manufacturer stopping its ingredient production abruptly and completely. So, compounding pharmacies’ suppliers were tasked to find a new manufacturer while compounding pharmacies were left without the ability to produce oral capsular Amlexanox immediately. Unfortunately, many manufacturers did not pass the test when suppliers were attempting to qualify them as new manufacturers for Amlexanox. And ultimately, it took multiple months for this effective drug to become restocked.
Dr. Bryana’s admonishment thus, when talking to her about this subject of compounding pharmacy ingredient sourcing, is to not blindly trust that compounding pharmacies are doing their due diligence. She recommends asking compounding pharmacies of interest if they have SOPs for vetting their supplier and/or manufacturer qualifications and to describe these SOPs for validity. Common questions within this category may include:
1. How does the compounding pharmacy reassess their manufacturer or supplier entities? And how often: annually, biannually?
2. Does the compounding pharmacy require that an API (active pharmaceutical ingredient) manufacturer be both FDA registered and inspected, in order to purchase from them?
3. What testing does a compounding pharmacy employ (whether in house or third party), to ensure their raw ingredients received from their suppliers are of proper quality, potency and dosage forms before compounding with it?
Finally, Dr. Bryana’s additional pearls, caveats and rules when it comes to vetting any sterile or non-sterile compounding pharmacy entailed the following:
1. Research Purposes Only: Avoid compounding pharmacies with any chemical ingredients listed for “for research purposes only”. This is a big NO NO.
2. Inspections & Warnings: She recommended any provider visit the following site: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters – to view whether the pharmacy in question has incurred any past FDA warning letters issued during their facility and production inspections. If they have received a warning in the past, then ask: did the pharmacy implement correction moving forward or not? If they ignored FDA guidance, this is a red flag.
3. GLP-1’s: This was an interesting take. Dr. Bryana suggested inquiring where a compounding pharmacy lands with their offering (or not) of GLP-1s. If GLP-1 production is a significant source of the pharmacy’s revenue, then she recommends some caution. Pharmaceutical manufacturers are en vogue, presently, suing compounding pharmacies manufacturing their own GLP-1 formularies. Financially speaking, should GLP-1 revenue be a chief revenue source sustaining the compounding pharmacy, then its stability of its business may be tenuous for your clinic, upcoming. Overall, it’s not a hard stop to use that compounding pharmacy’s products, but one should take note.