A 503A compounding pharmacy is a traditional compounding pharmacy that prepares medications for one named patient at a time, on a prescription from that patient's prescriber. A 503B outsourcing facility is a different category created by Congress in 2013: it registers with the FDA, follows current good manufacturing practice, and can make batches of a preparation without a prescription for any individual patient, usually for clinics and hospitals to keep on the shelf. If you handed a prescription to a pharmacy and picked up a compounded cream, capsule, or suspension with your name on the label, it almost certainly came from a 503A pharmacy. Bayview Pharmacy is a 503A pharmacy.
Most of what is written about this online is written for clinic buyers deciding where to source office stock. This article is written for the person holding the prescription. Below: which type fills your prescription, whether you can buy from a 503B directly, what oversight each one answers to, how to check a pharmacy's license yourself, and what "not FDA-approved" actually means in each case. You can browse what a 503A pharmacy prepares in our searchable catalog of compounded medications.
What is a 503A compounding pharmacy?
The name comes from section 503A of the Federal Food, Drug, and Cosmetic Act. That section describes the conditions under which a licensed pharmacist or physician can compound a drug preparation that is exempt from certain federal requirements, including the requirement to be an FDA-approved product and the requirement to be made under manufacturing rules written for mass production.
The central condition is the prescription. A 503A pharmacy compounds in response to a valid prescription for an identified individual patient. That prescription is what makes the preparation lawful, and it is why a 503A pharmacy cannot sell a compounded preparation to a clinic to keep in a drawer for whoever walks in next.
A 503A pharmacy is licensed and inspected by its state board of pharmacy, and by the boards of other states it ships into. It compounds according to the United States Pharmacopeia standards written for pharmacy practice, including USP 795 non-sterile compounding for creams, capsules, suspensions, and troches, and USP 797 for sterile preparations such as injections and eye drops. Bayview compounds sterile preparations in our USP 797 sterile lab.
Section 503A also limits what a pharmacy can start from. Compounding generally uses ingredients that are components of FDA-approved drugs, ingredients that appear in a USP or National Formulary monograph, or bulk substances that appear on an FDA list developed for this purpose. There are also limits on compounding copies of commercially available drugs, and on how much of a pharmacy's dispensing can cross state lines, addressed through an FDA memorandum of understanding with the states. The details of those provisions have shifted over the years, so the practical answer for a patient is simpler than the regulation: a compounding pharmacy is expected to know which substances it may use and which it may not, and a state board inspection is where that gets checked.
What is a 503B outsourcing facility?
The 503B category was created by the Drug Quality and Security Act of 2013, after a national fungal meningitis outbreak traced to contaminated sterile injections from a compounding operation in Massachusetts. Congress built a middle category between a pharmacy and a drug manufacturer.
An outsourcing facility registers directly with the FDA, is subject to FDA inspection, reports what it compounds, and must follow current good manufacturing practice, the same framework used by drug manufacturers. In exchange, it may compound in batches without a patient-specific prescription and sell those batches to healthcare facilities for administration in the office or hospital.
You are most likely to encounter a 503B preparation without ever knowing it: the numbing gel at a dermatology visit, a prefilled syringe drawn up before a procedure, a bag of medication hung in an infusion suite. Those are supplied to the practice, not dispensed to you by name.
What is the difference between 503A and 503B compounding pharmacies?
| Feature | 503A pharmacy | 503B facility |
|---|---|---|
| Serves | Named patients | Clinics and hospitals |
| Prescription | Required | Not required |
| Primary regulator | State boards | FDA |
| Quality standard | USP 795, USP 797 | cGMP |
| Scale | One prescription at a time | Batches held in inventory |
| Customization | Strength, form, flavor, excipients | Fixed catalog items |
| Where encountered | Labeled with your name | Given at a clinic |
| FDA status | Not FDA-approved | Not FDA-approved |
A 503A pharmacy also answers to the boards of the states it ships into, a 503B facility registers with FDA for inspection and may hold state licenses as well, and customization on the 503A side happens only on the prescriber's order. The last row is the one people misread most often.
Which compounding pharmacies are 503A or 503B?
There is no visual tell. Both types can be large, both can be small, and a company can hold both, running a 503A pharmacy and a separately registered 503B facility under one brand. Two ways to find out for a given company:
- The FDA publishes a list of registered outsourcing facilities. If a company is a 503B, it is on that list. If it is not on the list, it is not operating as an outsourcing facility.
- Every 503A pharmacy holds a pharmacy license with its state board of pharmacy. State boards publish license lookup tools, usually a searchable database on the board's website, that show the license number, its status, and any disciplinary history.
A pharmacy that ships to you in another state should also hold a nonresident pharmacy license or registration with your state's board. That is worth checking if you are ordering from out of state, and it is one of the things covered in our guide to finding a compounding pharmacy near you.
Can I buy directly from a 503B outsourcing facility?
Generally no, not as a retail purchase. Outsourcing facilities sell to healthcare facilities for administration to patients there. Some 503B facilities do dispense against patient-specific prescriptions as well, but the common path for an individual is still a 503A pharmacy: your prescriber writes for you, the pharmacy compounds for you, and the label carries your name and the prescriber's directions.
If you are told you can order a compounded medication with no prescription at all, that is the signal to stop. Both 503A and 503B preparations are prescription drugs. A website that will sell you an injectable or a prescription-strength cream with nothing but a credit card is not operating under either section.
What does "not FDA-approved" mean for a compounded preparation?
It means what it says, and it means the same thing for both categories: the specific preparation has not gone through FDA's new drug approval process, so FDA has not reviewed data on that exact formulation and has made no finding about it. This is not a loophole either category is exploiting. It is the structural premise of compounding. A preparation made for one patient cannot be the subject of a multi-year approval program.
What "not FDA-approved" does not mean: that the drug substance is unknown, that no one is inspecting anything, or that the preparation is unregulated. The active ingredients used in compounding are typically the same well-characterized drug substances found in approved products, and a compounding pharmacy is inspected, licensed, and accountable for how it sources, tests, and prepares them. The difference between the categories is which rulebook the inspection follows: USP compounding chapters and state board rules for 503A, cGMP and FDA inspection for 503B.
The practical consequence for a patient is that a compounded preparation does not carry FDA-approved labeling, and your prescriber is the one deciding whether a compounded preparation is appropriate for you, at what strength, and in what form. That decision is theirs, not the pharmacy's.
Can 503A pharmacies compound a drug that is in shortage?
Both sections address drug shortages, and the rules differ between them. A 503A pharmacy is generally restricted from compounding a copy of a commercially available drug, but the analysis changes when the drug appears on FDA's drug shortage list, and the FDA has at times issued temporary guidance during specific shortages. A 503B facility operates under its own shortage-related provisions. Because these lists and guidances change as supply changes, the answer to "can you compound this right now" is a question for the pharmacy on the day you ask, not something to read off a static page.
Compounded versions of drugs that have been in high-profile shortage, including the weight-management injectables, have drawn FDA warnings and litigation, and we do not discuss those products here.
What protections do I have as a patient?
Several, and they are worth knowing:
- Licensure. A pharmacy filling your prescription holds a license you can look up, in your state as well as its own.
- Inspection. State boards inspect compounding pharmacies, and FDA also inspects 503A pharmacies in some circumstances. Findings can be public.
- A named pharmacist. Every pharmacy has a pharmacist in charge who is personally accountable for the pharmacy's practice. At Bayview that is Ryan Dyer, RPh.
- A prescription record. Your preparation is tied to a prescription, a patient profile, and a formulation record. You can call and ask what is in it, what the beyond-use date is, and how it was prepared.
- Adverse event reporting. You and your prescriber can report a problem with a compounded preparation to the pharmacy and to FDA's MedWatch program.
Ask questions. A pharmacy that will not tell you which ingredients it used, where the drug substance came from, or whether it tests its preparations is telling you something.
What Bayview compounds for this
Bayview Pharmacy is a 503A compounding pharmacy in Warwick, Rhode Island, compounding since 2006 on prescriptions written for named patients. That covers non-sterile preparations under USP 795 (capsules, creams, ointments, oral suspensions, troches, suppositories) and sterile preparations in our USP 797 sterile lab, in the strengths and dose forms a prescriber specifies. Preparations such as low dose naltrexone are typical of this work: a strength or form that is not available as a manufactured product, prepared to the order. The full range is in our compounded medications catalog.
Because we are a 503A pharmacy, we cannot supply office stock without patient-specific prescriptions. Prescribers who need bulk office stock are looking for a 503B outsourcing facility.
How to order from a 503A pharmacy
Start with your prescriber. Compounded preparations require a prescription, and the choice of drug, strength, and dose form is a clinical decision your prescriber makes with you. If they agree a compounded preparation is appropriate, they can send the prescription to us electronically, by fax, or by phone, and we can fill and ship it to the states where Bayview is licensed. Details on shipping and licensure are on our FAQ page.
Compounded preparations are usually paid in cash rather than billed to a pharmacy benefit, for reasons we cover in do compounding pharmacies take insurance. Call us with the prescription in hand and we can quote the price before anything is prepared.
Frequently asked questions
Are these compounded preparations FDA-approved?
No. Compounded preparations are not FDA-approved, and FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. They are prepared under USP <797> sterile compounding standards and dispensed only on a valid prescription for an identified individual patient.
Where an FDA-approved commercial product exists, Section 503A restricts compounding a copy of it absent a documented shortage or a documented patient-specific need, such as a dye-free, alcohol-free, or different concentration. Note that need on the prescription.
what is a 503a compounding pharmacy
A 503A compounding pharmacy is a traditional compounding pharmacy operating under section 503A of the Federal Food, Drug, and Cosmetic Act. It prepares medications for one identified patient at a time, in response to a valid prescription from that patient's prescriber. It is licensed and inspected by its state board of pharmacy, and by the boards of other states it ships into, and it compounds according to the USP compounding chapters, including USP 795 for non-sterile preparations and USP 797 for sterile ones.
what is the difference between 503a and 503b compounding pharmacies
The core difference is the prescription. A 503A pharmacy compounds for a named patient on a prescription and answers primarily to state boards of pharmacy under USP compounding standards. A 503B outsourcing facility, a category created by the 2013 Drug Quality and Security Act, registers with the FDA, follows current good manufacturing practice, and may compound batches without patient-specific prescriptions for clinics and hospitals to stock. Preparations from both are not FDA-approved.
can I buy directly from a 503b pharmacy
Generally not as a retail purchase. Outsourcing facilities supply healthcare facilities with preparations to administer on site, so most patients encounter a 503B product at a clinic without knowing it. Some 503B facilities also dispense against patient-specific prescriptions, but the usual route for an individual is a 503A pharmacy. Either way a prescription is required: any site selling compounded prescription drugs without one is not operating under either section.
how do I check if a compounding pharmacy is licensed
Two lookups. State boards of pharmacy publish searchable license databases showing a pharmacy's license number, status, and disciplinary history, both in its home state and in states where it holds a nonresident license to ship. Separately, the FDA publishes a list of registered outsourcing facilities, so a company on that list is operating as a 503B. Checking your own state's board matters most if the pharmacy is shipping to you from out of state.
is bayview pharmacy 503a or 503b
Bayview Pharmacy is a 503A compounding pharmacy, based in Warwick, Rhode Island and compounding since 2006. We prepare medications on prescriptions written for named patients, in the strengths and dose forms the prescriber specifies, and we cannot supply office stock without patient-specific prescriptions. Prescribers who need bulk stock for in-office administration are looking for a 503B outsourcing facility instead.
can 503a pharmacies compound drugs in shortage
Both sections contain shortage-related provisions, and they differ between the two categories. A 503A pharmacy is generally restricted from compounding a copy of a commercially available drug, but that analysis changes when a drug appears on FDA's drug shortage list, and FDA has issued temporary guidance during specific shortages. Because shortage lists and guidance change with supply, ask the pharmacy about a specific drug on the day you need it.
does a 503a pharmacy need a prescription
Yes. The patient-specific prescription is the condition that makes 503A compounding lawful, which is why a 503A pharmacy cannot prepare a compounded medication for a clinic to keep on hand for unnamed patients. The prescription also determines the drug, strength, and dose form, all of which are your prescriber's clinical decisions. The finished preparation carries your name and your prescriber's directions on the label.
What Bayview compounds for this
Important: Compounded medications are prepared to a prescriber's order for an individual patient. They are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. This article is educational and is not a substitute for advice from your prescriber or pharmacist.
This preparation contains a controlled substance. Controlled-substance prescriptions carry refill limits, must be e-prescribed, and can only be shipped to states where Bayview holds the required licensure.
Uses discussed here may be off-label, meaning they are not part of any FDA-approved labeling. Off-label use is a decision for you and your prescriber, based on the available evidence.
Veterinary preparations are compounded to a veterinarian's order for a specific animal and are not FDA-approved animal drugs. Never give a compounded human medication to an animal without veterinary direction.
Compounded prescriptions are paid for directly rather than billed through insurance. Most are HSA/FSA-eligible, and many patients submit the receipt to their plan for possible reimbursement. Pricing depends on the strength, dose form and quantity your prescriber orders. Read more about cost and insurance.
Bayview Pharmacy is an NABP-accredited compounding pharmacy in Warwick, Rhode Island, licensed to fill and ship compounded prescriptions for patients in Rhode Island, Massachusetts, Connecticut, New Jersey, New Hampshire, Florida, New York and Maine. Controlled substances are not shipped to New York addresses. See where we ship and how to get started.
