Compounded Semaglutide and Tirzepatide: Regulations, Salts, and Safety

Written by Dan Cripe, RN, BSN & Marcia Cripe, RN | Last Updated: September 25, 2026

You finally decide you're ready to start a GLP-1 medication. Then the pharmacy tells you what it will cost, your insurance denies it, or you discover that the product your clinician prescribed simply isn't affordable for you.

Later that day, an ad appears on your phone offering semaglutide or tirzepatide for a fraction of the price. There is a medical intake form, a telehealth visit, and a medication shipped directly to your house. The website may even say the product contains the same active ingredient as Ozempic, Wegovy, Mounjaro or Zepbound.

It is completely understandable to wonder: If the medication is compounded by a pharmacy and costs dramatically less, why wouldn't I use it?

During the national GLP-1 shortages, that question became extremely common. Compounded semaglutide and tirzepatide became remarkably easy to find. Telehealth companies advertised them, social media normalized them, and thousands of people received packages containing multidose vials and syringes instead of branded injection pens.

That history is part of what makes the situation so confusing now.

Compounding itself is a legitimate pharmacy practice. But a compounded medication is not an FDA-approved generic version of Ozempic, Wegovy, Mounjaro or Zepbound, and not every product marketed online as “compounded semaglutide” or “compounded tirzepatide” necessarily comes through the same kind of legitimate pharmacy pathway.

The regulatory environment also changed when the national shortages resolved.

So if you're asking whether a compounded GLP-1 is safe, neither of these statements is accurate:

“Compounded medications are dangerous.”

or

“They're exactly the same thing for less money.”

The more useful questions are: Who made the medication? Why was it compounded? What active ingredient was used? Who prescribed it? And does that prescription fit within the current compounding framework?

Those answers tell you considerably more than the word compounded printed on a website.

First: What Does “Compounded” Actually Mean?

Compounding is the practice of preparing a medication to meet an individual patient's medical needs. It is a longstanding part of pharmacy practice, and it existed long before semaglutide and tirzepatide became household names.

A patient might, for example, need a medication in a formulation that is not commercially available or be unable to use an available product because of a particular ingredient. Under appropriate circumstances, a licensed pharmacist may prepare a compounded formulation for that patient while following the federal and state requirements that apply to the pharmacy.

That is very different from a company marketing what looks like a cheaper copy of a commercially available drug to a large national audience. Both products may carry the word compounded, but the circumstances behind them can be very different.

That distinction matters because the central question is not whether compounding itself is legitimate. It is. The question is whether this particular medication was compounded appropriately, by an appropriate pharmacy, for a reason that fits within the rules governing compounding.

When you're trying to evaluate a GLP-1 vial, that is a much more useful place to start than assuming either that all compounded medications are unsafe or that all compounded medications are equivalent to FDA-approved products.

Compounded does not mean generic

This is one of the easiest distinctions to lose when compounded GLP-1s are advertised online.

A generic drug is an FDA-approved medication. Generic manufacturers use an FDA approval pathway and must demonstrate that the product meets the applicable requirements for an approved generic drug.

A compounded medication does not go through FDA premarket approval for safety, effectiveness and quality in the same way an approved brand-name or generic drug does. That difference does not automatically make the compounded medication unsafe, but it does mean it belongs to a different regulatory category.

So when you see a phrase such as “generic Ozempic” used to describe compounded semaglutide, the wording itself is misleading. A compounded semaglutide preparation is not an FDA-approved generic version of Ozempic simply because it contains a semaglutide ingredient.

For you, the practical takeaway is that compounded and generic answer two very different questions. One describes a pharmacy-prepared medication made under compounding rules; the other describes an FDA-approved drug product.

Pharmacy Licensing, Batch Testing, and Sterility Standards: 503A vs. 503B

If you have tried to research a compounded GLP-1 pharmacy on your own, you may have quickly run into two terms that sound more like tax forms than pharmacy regulation: 503A and 503B.

They refer to different sections of the Federal Food, Drug, and Cosmetic Act and describe different models of pharmaceutical compounding. Understanding the distinction can help you figure out who actually prepared your medication and what kind of oversight applies.

Neither designation should be treated as a simple quality score. A 503A pharmacy is not automatically inferior to a 503B facility, and a 503B registration does not mean FDA has approved every medication that facility produces.

The categories serve different purposes, which is why the most useful question is not “Which number is better?” but “Which framework is this compounder operating under, and is it appropriate for what they are doing?”

503A compounding pharmacies

Traditional compounding pharmacies generally operate under Section 503A, where the basic model centers on an individual patient and a prescription.

A licensed prescriber identifies a patient's medical need and writes a prescription. The pharmacy then prepares the medication for that patient while following the federal conditions that apply to 503A compounding as well as applicable state pharmacy law.

503A pharmacies are primarily overseen by state boards of pharmacy, although FDA retains regulatory authority and can take action when federal requirements are violated.

This becomes important when you are trying to verify a pharmacy. A legitimate 503A pharmacy does not have to appear on FDA's list of registered 503B outsourcing facilities, so failing to find a pharmacy on that particular FDA list does not automatically prove that the pharmacy is illegitimate.

Instead, you may need to verify the pharmacy through the state board of pharmacy where it is licensed. That is why knowing the actual name of the dispensing pharmacy matters much more than knowing the name of the telehealth company that connected you to it.

503B outsourcing facilities

A 503B outsourcing facility operates under a different federal framework. These facilities register with FDA and are subject to additional federal requirements, including current good manufacturing practice requirements.

Unlike the traditional patient-specific 503A model, a 503B outsourcing facility can compound certain medications without first receiving an individual prescription for a named patient. That framework can support larger-scale production for healthcare facilities when the applicable requirements are met.

FDA maintains a searchable database of registered outsourcing facilities and publishes information that may include inspection history, regulatory observations and other facility information.

For you, that database can be useful when a telehealth company tells you its medication comes from a “503B facility” or an “FDA-registered outsourcing facility.” Instead of treating the phrase as a quality seal, you can identify the facility and look at the regulatory information associated with it.

Does 503B automatically mean “safe”?

No. A facility's 503B registration tells you something important about the regulatory framework it operates under, but it is not FDA approval of every medication that facility makes.

FDA inspection information can include whether inspectors issued a Form 483 documenting observations, whether recalls occurred and whether additional regulatory action followed. That information exists because registered facilities can still have quality or compliance problems.

The reverse is also important. A properly licensed 503A pharmacy should not automatically be dismissed because it is not registered as a 503B outsourcing facility. The two categories are designed around different compounding models.

When you are evaluating your own medication, the useful goal is not to hunt for one reassuring acronym. It is to identify the actual compounder, verify the appropriate license or registration and understand which regulatory pathway applies to the medication you received.

Salt Forms vs. Active Pharmaceutical Ingredients

This is one of the most important questions to ask when the compounded medication is semaglutide.

Online, you may encounter several terms that sound almost interchangeable:

• semaglutide
• semaglutide base
• semaglutide sodium
• semaglutide acetate

They should not be treated as different ways of saying the same thing.

The semaglutide active ingredient used in FDA-approved products is not semaglutide sodium or semaglutide acetate. Those are salt forms of semaglutide.

FDA has specifically raised concerns about compounded products using semaglutide sodium or semaglutide acetate. The agency has stated that those salt forms are different active ingredients from the ingredient used in FDA-approved semaglutide medications and that it does not have information showing that the salts have the same chemical and pharmacologic properties as the active ingredient in the approved products.

FDA has also stated that it is unaware of a lawful basis for using those salt forms in compounding.

That means the word semaglutide on a marketing page does not necessarily answer the question you think it answers. If you are considering or already receiving compounded semaglutide, you can ask the dispensing pharmacy exactly which active pharmaceutical ingredient it used.

If the answer is semaglutide sodium or semaglutide acetate, that is not simply another name for the same active ingredient used in FDA-approved Ozempic or Wegovy.

What about “semaglutide base”?

You will often see the phrase semaglutide base used specifically to distinguish a compounded product from semaglutide sodium or semaglutide acetate.

That distinction can be useful, but the word base does not answer every other question about the medication. It does not, by itself, establish where the active pharmaceutical ingredient came from, whether it was manufactured under appropriate controls, whether the finished preparation was appropriately tested or whether the compounding itself fits within current law.

This is a good example of why one reassuring phrase should not end your investigation.

If a website says “semaglutide base,” the next question is still who actually compounded and dispensed the medication? Once you know the pharmacy, you can evaluate the pharmacy rather than relying on a marketing description from the company selling the program.

The FDA Drug Shortage List and Statutory Exceptions

The enormous growth of compounded semaglutide and tirzepatide makes much more sense when you understand what happened during the national shortages.

For several years, demand for GLP-1 medications dramatically exceeded supply. Affected drugs appeared on FDA's Drug Shortages List, and that designation did more than tell patients that a medication might be difficult to find.

It also mattered under federal compounding law.

Federal law generally restricts compounders from routinely producing medications that are essentially copies of commercially available FDA-approved drugs. Without those restrictions, compounding could become a parallel manufacturing pathway for copies of approved drugs that had never gone through FDA's drug-approval process.

Shortage status can create an exception to some of those restrictions. When an approved medication appears on FDA's shortage list, certain rules involving essentially copies may not apply in the same way, as long as the compounder continues to satisfy the other requirements that apply under federal law.

That shortage environment helped create the rapid expansion of compounded semaglutide and tirzepatide. When patients could not consistently find branded medication, compounded versions became a major alternative pathway.

For someone who started treatment during that period, the market may have looked almost permanent. But the legal significance of the shortage depended on the shortage actually existing.

Then the shortages changed

As branded supply improved, FDA determined that the tirzepatide shortage had resolved. The semaglutide shortage was later resolved as well.

That changed the compounding landscape because the broad shortage-based justification for producing large volumes of essentially copies was tied to shortage status. It was not intended to create a permanent second market for cheaper copies once the FDA-approved products were considered commercially available again.

In April 2026, FDA again emphasized that 503A compounders generally cannot regularly or in inordinate amounts compound medications that are essentially copies of commercially available approved drugs. Restrictions involving essentially copies also apply to 503B outsourcing facilities under their own framework.

FDA has also increased enforcement activity against businesses marketing compounded GLP-1 medications in ways that make them appear to be interchangeable substitutes for approved products.

This is why the date on a compounded-GLP-1 article matters. Advice that was accurate during the height of the shortages may not accurately describe what a compounder can lawfully do after the shortage ends.

For you, that means a company cannot answer a current regulatory question simply by saying that semaglutide or tirzepatide used to be in shortage.

Is Compounded Tirzepatide Legal During an FDA Shortage?

Potentially, but the shortage itself is only part of the answer.

When an approved medication appears on FDA's Drug Shortages List, certain restrictions involving essentially copies of that drug can be relaxed under the applicable federal compounding provisions. That can create a legitimate pathway for some compounded versions while commercial supply is inadequate.

The rest of federal compounding law still applies. A compounder operating under Section 503A or Section 503B still has to satisfy the requirements that apply to that pathway, and shortage status does not turn an unlicensed peptide seller into a legitimate pharmacy.

Timing matters as well. A medication's presence on the shortage list is not a permanent historical exemption that follows the molecule forever.

For 503B outsourcing facilities using bulk drug substances under a shortage pathway, the relevant drug generally needs to appear on FDA's shortage list at the times required by law. Once shortage conditions change, the legal analysis can change too.

So if a website's entire explanation is “tirzepatide was in shortage, so compounded tirzepatide is legal,” that explanation is incomplete. You still need to know who is doing the compounding, under which pathway and whether the current circumstances fit the law that applies today.

Can GLP-1s still ever be compounded after a shortage?

Yes. The end of a shortage does not eliminate the legitimate practice of compounding.

There may still be circumstances in which an individual patient has a documented clinical need for a compounded medication that is meaningfully different from the commercially available product. That type of patient-specific compounding fits the traditional reason the practice exists.

What changes is the justification for routinely producing large quantities of a near-identical copy of a commercially available medication. Lower price alone is not the same thing as a clinical need for a compounded formulation.

That distinction is important because many consumers entered the compounded-GLP-1 market when shortage-based compounding was highly visible. Once the shortage disappears, the fact that the compounded product is still cheaper does not automatically preserve the same legal basis for making it.

The 2026 Enforcement Shift

If you remember compounded semaglutide and tirzepatide advertisements appearing almost everywhere online, you are not imagining it. The market expanded rapidly during the shortage years, particularly through telehealth companies that could prescribe treatment remotely and arrange for medication to be shipped directly to patients.

FDA's posture became substantially more aggressive in 2026 as the supply situation and regulatory landscape changed.

In February 2026, FDA announced plans to restrict GLP-1 active pharmaceutical ingredients intended for mass-marketed, non-FDA-approved compounded drugs. In March, the agency announced warning letters to 30 telehealth companiesover false or misleading marketing involving compounded GLP-1 products.

Among the concerns FDA identified were claims that could lead consumers to believe compounded drugs were the same as FDA-approved medications and marketing that made it difficult to determine which pharmacy actually compounded the medication.

In April 2026, FDA also proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list after concluding that it had not identified a clinical need supporting their inclusion.

These developments matter because GLP-1 compounding is not a static regulatory topic. An article written during the shortage period can remain online long after the rules and enforcement priorities surrounding the market have changed.

If you are evaluating a compounded GLP-1 now, current information matters more than what a telehealth company was legally doing two years ago.

Certificate of Analysis and Red Flags: How to Verify a Compounded GLP-1 Pharmacy

Once you decide you want to verify a compounded medication, it is easy to get pulled into marketing language that sounds scientific without necessarily answering the questions that matter.

You may see phrases such as:

• “Third-party tested”
• “Pharmaceutical grade”
• “99% pure”
• “Made in an FDA-registered facility”
• “COA available”

Any of those statements may describe something real. None, by itself, establishes that the vial you received was legitimately compounded, appropriately prepared or accurately represented.

The most useful verification process starts with the people and organizations responsible for the finished medication, not with a laboratory graphic on a website.

Start with the pharmacy

Look at the prescription label and identify the pharmacy that actually compounded and dispensed the medication.

Do not assume that the telehealth company whose name appears on your credit-card statement is the pharmacy. The telehealth company may provide the clinical platform while an entirely separate pharmacy prepares and ships the medication.

FDA has documented fraudulent compounded GLP-1 labels in which the named pharmacy either did not exist or was a legitimate pharmacy that had not actually compounded the product being sold under its name.

Once you identify the pharmacy, verify it through the appropriate state board of pharmacy. If the medication came from a 503B outsourcing facility, check FDA's registered outsourcing-facility database as well.

That step gives you something much more valuable than a promise that the medication is “pharmacy grade.” It gives you an identifiable regulated entity that can be tied to the vial you received.

Then ask what is actually in the vial

Once you know who prepared the medication, look at what they prepared.

For compounded semaglutide, ask which form of the active pharmaceutical ingredient was used. Then check the concentration of the finished medication and make sure you understand how that concentration relates to your prescribed dose.

This is where three different measurements often appear at once: milligrams, milliliters and syringe units.

They are not interchangeable.

Your prescribed amount of active medication may be expressed in milligrams. The vial concentration may be expressed in milligrams per milliliter. The syringe may be marked in units that represent a volume.

Those numbers only become useful when you understand how they relate to one another for the specific concentration in your vial.

If you know only that you are supposed to inject “20 units,” you do not yet know the actual milligram dose unless you also know the concentration.

What does a COA tell you?

A Certificate of Analysis, or COA, is documentation describing testing or specifications associated with a substance or batch.

For bulk substances used by 503B outsourcing facilities, federal requirements include having a valid COA and using substances manufactured by an establishment registered with FDA.

That can make the document useful, but it does not make a COA a magic proof-of-safety certificate.

A PDF labeled Certificate of Analysis does not independently demonstrate that the vial in your refrigerator came from the batch described on the document. You need traceability connecting the ingredient, batch, compounder and medication you actually received.

Purity also answers only one part of the quality question. For a sterile injectable medication, relevant considerations include:

• sterility
• potency
• concentration
• identity
• endotoxin control
• appropriate storage
• beyond-use dating
• integrity of the supply chain

A laboratory result showing a high percentage of chemical purity does not tell you whether the finished vial remained sterile, whether its concentration is correct or whether it was stored appropriately after compounding.

That is why a polished COA should support an identifiable pharmacy and traceable product, not replace them.

Red Flags That Deserve Your Attention

One of the clearest warning signs is the ability to purchase an injectable prescription medication without a legitimate prescription or clinical evaluation.

You should also be cautious when a company describes a compounded medication as “FDA approved,” “FDA licensed,” “generic Ozempic,” “exactly the same as Wegovy,” or “exactly the same as Zepbound.” FDA has taken action against misleading marketing of this kind because compounded medications are not FDA-approved copies of those products.

Another major warning sign is a vial labeled “research use only” or “not for human consumption” that is nevertheless being marketed to people who clearly intend to inject it.

Those labels do not create a lawful workaround. A research peptide does not become a legitimate compounded prescription medication because a website also provides instructions for mixing and injecting it.

Transparency matters too. If you cannot determine which licensed pharmacy prepared the medication, who prescribed it or how to contact the pharmacist responsible for it, that uncertainty should not be brushed aside simply because the website looks professional.

Before you inject a medication, you should be able to trace it back to the licensed professionals responsible for prescribing, preparing and dispensing it.

The Dosing Problem People Don't Expect

Compounded injectable GLP-1 medications can introduce a dosing problem that many branded injection devices largely remove: you may have to measure the medication yourself.

Instead of receiving a pen designed to deliver a predetermined amount, you may receive a multidose vial and an insulin syringe. Suddenly, the instructions involve milligrams, milliliters, milligrams per milliliter and syringe units.

Those measurements describe different things.

The milligram amount describes the amount of active medication. The milliliter amount describes liquid volume. A concentration such as milligrams per milliliter tells you how much medication is contained within a particular volume, while the units printed on an insulin syringe are another way of marking volume.

FDA has received reports of compounded semaglutide dosing errors serious enough to require hospitalization, including cases in which patients drew substantially more medication into the syringe than intended.

Different compounded products can also have different concentrations. That means a friend saying “I inject 20 units”does not tell you what dose you should take and does not even tell you how many milligrams that person is receiving unless you know the concentration of their vial.

This is why syringe-unit instructions should always be tied to your specific prescription and concentration.

If you receive a compounded injectable and cannot clearly explain how your prescribed dose in milligrams translates into the volume you are supposed to draw into your syringe, contact the dispensing pharmacy or prescriber before injecting it.

The goal is not for you to become a pharmacist. It is for you to understand your own dose well enough that you are not relying on guesswork.

Shipping and Storage Matter Too

Verifying the pharmacy does not end the safety conversation because sterile injectable medications also have to survive preparation, storage and shipping.

FDA has received complaints involving compounded injectable GLP-1 medications arriving warm or without adequate refrigeration. FDA currently advises consumers not to use injectable GLP-1 medication that arrives warm or with inadequate refrigeration when refrigerated storage is required.

If your medication arrives outside the temperature conditions the pharmacy told you to expect, the right next step is to contact the pharmacy and ask whether the product remains usable. A cold pack that is no longer frozen does not automatically tell you whether a medication experienced an unacceptable temperature excursion, and guessing based on how the package feels is not a reliable substitute for product-specific guidance.

Multidose vials also introduce handling considerations after the first injection. Repeatedly puncturing a vial creates contamination opportunities that do not exist in exactly the same way with a sealed single-use device.

FDA currently recommends discarding multidose compounded GLP-1 vials within 28 days after first use, even when medication remains. A new sterile needle and syringe should be used for every injection.

For you, the practical point is that safety does not begin and end with the active ingredient. How the medication was prepared, stored, shipped and handled after arrival all matter when the final product is something you are injecting into your body.

Compounded GLP-1 vs. “Research Peptide”

These are not two versions of the same thing.

A legitimately compounded prescription medication comes through a healthcare and pharmacy pathway. There is a prescription or other lawful basis under the applicable compounding framework, an identifiable pharmacy or outsourcing facility, a finished medication label and a regulated entity responsible for the preparation.

A peptide vial purchased from a website and labeled “research use only” does not become a compounded prescription medication because you reconstitute it at home.

There may be no legitimate pharmacy involved, no patient-specific prescription, no reliable chain of custody and no regulated professional responsible for the final injectable preparation. A vendor-provided purity report does not change that category.

This distinction becomes especially important with investigational compounds that have generated intense online interest.

FDA states that retatrutide is not an FDA-approved medication and cannot legally be used in compounding under current federal law. So seeing the phrase “compounded retatrutide” should not make the product sound more medically legitimate.

It should prompt the opposite reaction: who is actually making this, and under what lawful pharmacy pathway?

If there is no credible answer, the product should not be confused with a legitimate compounded prescription simply because it arrives in a vial.

So, Are Compounded GLP-1s Safe?

The word compounded does not contain enough information to answer that question by itself.

A patient-specific medication prepared by an appropriately regulated compounding pharmacy for a legitimate clinical need is very different from an injectable peptide bought through an anonymous online seller. Those products should not be placed in the same category simply because neither arrives in a branded Wegovy or Zepbound pen.

At the same time, even a legitimately compounded medication is not equivalent to an FDA-approved product.

FDA-approved drugs undergo FDA review for safety, effectiveness, quality and manufacturing before approval. Compounded drugs do not undergo that same premarket approval process.

FDA's position is therefore that compounded drugs should generally be used when a patient's medical needs cannot be met by an FDA-approved medication.

That statement does not mean compounding has no legitimate role. It means the role of compounding is specific rather than interchangeable with ordinary commercial drug manufacturing.

For you, the safest way to think about the question is not “Are compounded GLP-1s good or bad?” It is “Can I verify the prescription, pharmacy, active ingredient, concentration, legal pathway, storage and instructions for the specific product I have been given?”

That is the level at which the safety question becomes meaningful.

What to Do Before Using a Compounded GLP-1

If you are considering compounded semaglutide or tirzepatide, start with the prescription and work forward through the medication's chain of responsibility.

Identify who prescribed it and whether you received a legitimate clinical evaluation. Then identify the pharmacy that actually compounded and dispensed the medication rather than relying only on the name of the telehealth company.

Verify the pharmacy through the appropriate state board of pharmacy. If the supplying facility is a 503B outsourcing facility, verify its registration and available regulatory information through FDA.

For compounded semaglutide, ask which active pharmaceutical ingredient was used. Check the medication concentration and make sure you understand your dose in milligrams, not only as a number of syringe units.

Know how the medication should be stored, what to do if it arrives outside the expected temperature range and how long the multidose vial should be used after the first puncture.

If a company will not clearly tell you who compounded the medication, what active ingredient was used, how to contact the dispensing pharmacy or how your prescribed dose corresponds to the liquid you are drawing into the syringe, that lack of transparency is useful information in itself.

You do not need to become an expert in compounding law or sterile pharmaceutical manufacturing before filling a prescription. You should, however, be able to answer one basic question before you inject the medication:

Who is responsible for the medication I'm about to put into my body?

If you cannot answer that confidently, resolve that question before using it.

Sources

1. U.S. Food and Drug Administration. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.Updated 2026.
   https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
2. U.S. Food and Drug Administration. Compounding When Drugs Are on FDA's Drug Shortages List.
   https://www.fda.gov/drugs/human-drug-compounding/compounding-when-drugs-are-fdas-drug-shortages-list
3. U.S. Food and Drug Administration. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize. April 1, 2026.
   https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
4. U.S. Food and Drug Administration. FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs.February 6, 2026.
   https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
5. U.S. Food and Drug Administration. FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s. March 3, 2026.
   https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
6. U.S. Food and Drug Administration. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List. April 30, 2026.
   https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
7. U.S. Food and Drug Administration. Registered Outsourcing Facilities. Updated September 8, 2026.
   https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
8. U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act.
   https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503b-fdc-act