Compounding Pharmacy Compliance: What Providers Should Know

An Interview with Strive’s Tyler Chamberlain, Director of Compliance, PharmD

Compliance has a reputation for slowing things down. Tyler Chamberlain sees it differently.

As Strive Pharmacy's Director of Compliance, Chamberlain spends his time navigating state requirements, supporting provider partnerships, evaluating processes, and solving the regulatory puzzles that come with operating in a complex healthcare environment.

In this Q&A, he discusses what providers should ask when evaluating a compounding pharmacy, the warning signs that can appear as organizations scale, the challenges of operating across multiple states, and why stronger compliance and greater access to personalized medicine can coexist.

Rethinking the Role of Compliance in Compounding Pharmacy

Question: How did you first get into pharmacy compliance, and what drew you to this side of the industry?

It started in my previous position, where I was the pharmacist in charge and we were licensed in 38 states. With my name on everything, I wanted to make sure we were following the rules and regulations not only in our home state but in every state we served.

That gave me a lot of practice reading laws, understanding how different states approached pharmacy, and realizing you shouldn’t be afraid to reach out to boards with questions. Most of the time, they’re there to help.

I found that I really enjoyed taking the rules and regulations and figuring out how operations could work within them. It became a puzzle-solving exercise. How do we check the right boxes while still being able to make medicine and serve the public?

Later, when I saw an opportunity to focus specifically on compliance, it caught my attention. Not many people want to dive completely into compliance, but I realized I actually enjoyed it, so I decided to pursue it.

Question: After working inside pharmacy compliance, what do you understand about the industry today that you didn’t understand when you first entered it?

Early on, it’s easy to think, “If this is acceptable in one state, it should probably be acceptable everywhere else.” That isn’t how it works. You have to get into each state’s regulations and understand what that state expects from the pharmacy.

Every state is its own puzzle. You need to be comfortable with how each one expects you to practice and then build those requirements into your operations.

Question: Providers sometimes experience compliance as the department that says “no.” What is compliance actually protecting, and where can strong compliance create more opportunity rather than less?

At Strive, we’ve really tried to make compliance a department people want to come talk to and bring problems to, rather than some dark force that enters the room and simply says "no."

We’d rather present the information and help work through the problem. Sometimes the answer is, “We can’t accept it this way, but if you do it this way, we can, and here’s why.”

At the end of the day, our first priority is protecting patients. We’re also protecting Strive so we can continue serving our community, and we’re helping protect the provider’s practice. I think of it as a trifecta: the patient, the provider, and Strive.

Strong compliance can create opportunity by helping providers understand why certain requirements exist and how to operate within them. Instead of identifying a problem and stopping there, we want to explain why it’s a problem and help work through it.

That creates a much stronger long-term partnership.

How to Evaluate a Compounding Pharmacy's Compliance and Quality Systems

Question: What should a provider or healthcare organization look for when evaluating a compounding pharmacy, and what questions should they be asking that most people don’t think to ask?

One of the first things I would ask about is testing. What testing is the pharmacy doing, and are they willing to share information about it?

I would also ask where they source their APIs and other ingredients. Can they provide certificates of analysis? Are they transparent about ingredient pedigree?

If a pharmacy isn’t willing to show you how it approaches quality assurance, testing, and sourcing, that should give you pause. A pharmacy should be open about its quality assurance procedures because those processes can tell you a lot about how the organization operates.

I would also ask what resources the pharmacy has for making sure it’s practicing correctly in every state it serves.

As I mentioned earlier, each state is its own animal. If a pharmacy can’t demonstrate that it understands the requirements of the states where it operates, that could be a sign of a rough road ahead.

Question: What are the red flags that should make a provider reconsider working with a compounding pharmacy, even if everything looks legitimate on the surface?

A lack of transparency around quality assurance would be one. If a pharmacy is overly protective or vague about its testing procedures, ingredient sourcing, or ingredient pedigree, I would want to understand why.

Another area is the prescription submission process, particularly with controlled substances. The pharmacy should understand the applicable requirements and be able to explain what it needs from the provider.

I’d also pay attention to whether the pharmacy is actually trying to understand your practice and your patient population.

If the entire relationship feels focused on getting prescriptions in and medications out the door, rather than understanding who you serve, why you serve them, and how the partnership should operate, I would consider that a red flag.

You want a pharmacy that can demonstrate strong processes and a reputable track record, because those things help create a partnership that can last.

Compounding Pharmacy Compliance at Scale: What Telehealth Companies and Clinics Should Know

Question: As prescription volume grows, what becomes harder about compliance, and what systems have to mature for a compounding pharmacy to scale responsibly?

One of the biggest challenges is making sure your core standards don’t change as volume increases.

If you’re strict about what’s required on a prescription when you receive 10 prescriptions a day, you should be just as strict when you’re receiving hundreds or thousands.

Every prescription should receive the same level of attention and detail. You don’t want things slipping under the radar simply because the volume increased.

That means scaling your people, but it also means scaling your training. Everyone you bring into a growing organization needs to understand how to do the job, what to look for, and what the potential compliance red flags are.

Growth can't mean lowering the standard.

Question: When a clinic or telehealth organization starts scaling rapidly, what signs tell you that its compliance infrastructure has not kept pace with its growth?

One of the first signs is when prescriptions start arriving without information that was consistently included before.

If we begin seeing missing required information or missing clinical difference statements when they’re needed, and those problems start snowballing as volume grows, that can indicate the organization’s checks and balances haven’t scaled with the business.

Another warning sign is when speed or volume starts taking priority over making sure everything is handled properly.

If the response becomes, “We’ve done this before, just annotate it and move on,” but required information is missing, that creates repeated back-and-forth and slows everyone down anyway.

At that point, the organization may need to refocus on its processes and make sure everyone in the system understands what’s required.

Compounding Pharmacy Compliance Across State Lines: What Multi-State Telehealth Providers Should Know

Question: When providers or virtual-first healthcare companies expand across multiple states, what regulatory complexities tend to surprise them most?

Licensing is one of the biggest areas we see.

Each state can have its own telehealth and professional licensing requirements. Providers need to pay attention not only to where they’re practicing from, but also to the requirements that apply where the patient is located during the interaction.

That surprises some people. They may think, “I’m licensed in my state, and this is where I’m practicing,” without realizing there may also be requirements tied to the patient’s state.

Controlled substances add another layer. Providers may assume their DEA registration is the only requirement, but some states have separate controlled-substance licenses or registrations.

Those are exactly the kinds of details that make multi-state healthcare complicated. Expanding into another state can mean opening an entirely new regulatory puzzle.

Where Telehealth Regulation Hasn’t Kept Pace With Modern Healthcare

Question: Where do you see the biggest mismatch today between how modern healthcare is actually delivered and the regulatory framework governing compounding?

Telehealth is probably the clearest example.

COVID accelerated telehealth dramatically, and healthcare hasn’t looked back. But the rules have been trying to catch up ever since.

I see telehealth as a complicated opportunity. It can help serve patients where they are and improve access for people in areas where healthcare options may be limited.

But when it comes to compounding, the prescribing rules eventually affect the pharmacy. We have to navigate telehealth requirements, licensing requirements, registration requirements, and other state-specific rules because the pharmacy is one of the final checks before a patient receives a medication.

If we want the system to improve, I think we need clearer, more durable telehealth regulations and greater clarity around where the prescriber’s responsibilities end and where the pharmacy’s responsibilities begin.

When you’re operating across multiple states, you’re essentially solving a different puzzle for every state.

The Future of Compounding: Access, Advocacy, and Higher Standards

Question: If “Defy the Odds” means refusing to accept the status quo, what part of the status quo in compounding or healthcare most needs to be challenged?

One of the ideas we talk about at Strive is that one size doesn’t fit all.

One size may fit most, but compounding gives us the ability to address individual patient needs with medications that can be customized for them.

We have technology, compounding experience, and tools that allow us to think beyond the idea that every patient has to fit into the same handful of options.

For me, defying the odds also means standing up to pressures that would unnecessarily shrink the role of compounding. I believe personalized medicine should continue to have a place in healthcare for patients who need those options.

Question: You’ve spent time on Capitol Hill advocating for compounding. What do lawmakers and policymakers most often misunderstand about modern compounding, and what tends to change their perspective once they see how the system actually works?

One of the biggest things we try to do during visits to Capitol Hill is challenge some of the outdated images people may have of compounding.

There can still be this perception that compounding means someone working in a basement, combining powders on a tabletop and hoping everything works.

Modern compounding facilities can look very different from that.

When we talk about our pharmacies, we can show policymakers laboratory environments, automated systems, quality checks, ingredient sourcing procedures, and the investments being made in the facilities themselves.

That tends to change the conversation.

At Strive, we also talk about our quality checks, our testing procedures, our API pedigree process, certificates of analysis, and the steps pharmacists take to review and double-check the work.

A big part of advocacy is showing people what modern compounding actually looks like, rather than allowing an outdated picture of the industry to define the conversation.

Question: Is there an unavoidable tension between expanding access to personalized medicine and raising the compliance bar, or can the industry realistically do both? What has to change to make that possible?

As your reach grows and you affect more patients, your compliance and quality systems should grow with it.

That means investing in testing procedures. It means investing in people and education. It may mean sending employees to classes or conferences so they can bring new practices and ideas back into the organization.

If you aren’t regularly improving or changing processes in your pharmacy, you’re stagnant while the rest of the industry continues to evolve.

The focus should be: How can we continue raising our internal standards as the number of people we serve grows?

Access and higher standards should rise together.

Why Strive: What Providers Should Expect From Their Compounding Pharmacy Partner

Question: When providers ask “Why Strive?”, what are the areas where you believe they simply shouldn’t settle when choosing a compounding pharmacy partner?

Before coming to Strive, I had been in the compounding industry for about 12 years, and I had never seen a pharmacy approach compounding the way Strive does.

What stood out immediately was the investment in laboratory space, quality assurance, technology, people, and infrastructure. I was blown away by how much had been invested in building the organization to operate at its current scale.

But one of the biggest things that defines Strive for me is how we interact with patients and providers.

We’re trying to make the experience as smooth as possible on both sides while still protecting the compliance requirements around licensure and quality assurance, and standing behind every medication that leaves the pharmacy.

Providers shouldn’t have to settle for a pharmacy relationship where they aren’t confident in the processes behind the product their patients are receiving.

For me, testing, quality assurance, infrastructure, and the way a pharmacy supports its providers and patients are areas where you shouldn’t settle.

Raising the Standard for Personalized Medicine

Choosing a compounding pharmacy is about more than the medications it can provide. Providers should also understand the systems behind them: how the pharmacy approaches quality, how transparent it is about its processes, how it navigates regulatory complexity, and whether its standards can hold up as volume grows.

For Chamberlain, that's where compliance becomes part of a stronger pharmacy partnership. It's not simply about identifying what can't be done. It's about building the processes, infrastructure, and communication needed to help providers serve patients responsibly as personalized medicine continues to evolve.

The questions providers ask before choosing a pharmacy partner can reveal a great deal about what that partnership will look like when the stakes, complexity, and prescription volume increase.

Partner With Strive, a Compounding Pharmacy Built on Compliance

A stronger pharmacy partnership starts with the right questions. See how Strive's compliance and quality systems are built to support providers, clinics, and telehealth teams at any scale.

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FAQ: Compounding Pharmacy Compliance for Providers

What is compounding pharmacy compliance?

Compounding pharmacy compliance is the set of federal, state, and quality-standard requirements a pharmacy must follow to prepare personalized medications legally and consistently. It covers everything from ingredient sourcing and testing to prescription documentation, licensing, and recordkeeping.

For providers, compounding pharmacy compliance is about more than paperwork. It's a window into how a pharmacy operates day to day: whether its quality-assurance systems, staff training, and regulatory processes can hold up as prescription volume grows. As Tyler Chamberlain puts it, strong compliance isn't the department that says "no." It's the infrastructure that lets a pharmacy scale personalized medicine responsibly, without cutting corners on the standards that protect patients.

Who regulates compounding pharmacies?

Compounding pharmacies operate under a layered regulatory structure:

• The FDA, through Section 503A, which sets the conditions under which patient-specific compounding is exempt from standard drug-approval requirements.
• USP compounding standards (USP <795> for non-sterile preparations, <797> for sterile preparations, and <800> for hazardous drug handling), which govern facility design, testing, and quality-assurance practices.
• State boards of pharmacy, which license pharmacies and can layer on requirements beyond the federal baseline, from sterile-compounding licensure to beyond-use dating limits.

Because every state approaches pharmacy regulation differently, a pharmacy operating across multiple states is effectively managing a distinct regulatory puzzle in each one. Chamberlain describes this as one of the most misunderstood parts of the industry: what's acceptable in one state isn't automatically acceptable in the next.

What is the difference between 503A and 503B compounding pharmacies?

The difference comes down to how each is regulated and what they're built to do:

• 503A pharmacies compound patient-specific medications pursuant to a valid, individual prescription. They operate under USP compounding standards and state board oversight.
• 503B outsourcing facilities register with the FDA and operate under full current Good Manufacturing Practice (cGMP) requirements, which allow them to compound in larger batches, with or without patient-specific prescriptions, for office use.

Strive currently operates as a 503A pharmacy, licensed in all 50 states and DC, and applies cGMP-minded quality practices voluntarily, even where 503A regulations don't strictly require them. Understanding this distinction matters for providers and telehealth organizations evaluating personalized medicine compliance, since it shapes what documentation, testing, and prescription requirements will apply to their patients.

What compounding pharmacy compliance questions should providers ask?

Knowing how to evaluate a compounding pharmacy starts with asking the right questions before signing on as a partner. Chamberlain recommends providers ask:

• What quality testing do you perform, and can you share documentation?
• Where are your active pharmaceutical ingredients (APIs) and other components sourced, and can you provide Certificates of Analysis?
• What quality-assurance systems are in place, and how are they maintained as volume grows?
• How do you manage licensing and regulatory requirements across the states you serve?
• How are prescription documentation issues communicated back to providers?

A pharmacy that answers these openly is signaling real transparency around compounding pharmacy quality assurance and testing. Compounding pharmacy red flags tend to show up in the opposite pattern: vagueness about sourcing, reluctance to share testing data, or a partnership that feels focused only on moving prescriptions through rather than understanding the patients and practice behind them. Choosing a compounding pharmacy partner comes down to whether these questions get clear, substantiated answers.

What should telehealth companies consider when working with a compounding pharmacy across multiple states?

Multi-state telehealth compliance introduces regulatory complexity that goes beyond where the provider is licensed. Telehealth pharmacy compliance and multi-state prescribing compliance both depend on requirements tied to the patient's location during the visit, not just the provider's home state, along with state-specific telehealth and professional licensing rules.

Controlled substances add another layer: some states require separate controlled-substance registrations beyond a provider's DEA number. And as prescription volume scales, the pharmacy's compounding pharmacy regulatory compliance systems, staff training, and documentation standards need to scale with it. Chamberlain points to missing required information or clinical difference statements as early warning signs that an organization's compliance infrastructure hasn't kept pace with its growth.

Telehealth companies and clinics evaluating a compounding pharmacy partner should look for one that understands this landscape state by state and can demonstrate consistent compounding pharmacy provider support as their footprint expands.

Disclaimer

Compounded medications are specially prepared for identified individual patient needs based on a valid prescription from a prescribing healthcare practitioner and, as such, are not reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. Compounded drugs are intended for patients whose prescriber has determined their medical needs are not met by an available FDA-approved drug. These statements have not been evaluated by the FDA.