What Is a 503A Compounding Pharmacy?
Section 503A of the Federal Food, Drug, and Cosmetic Act sets the conditions under which a licensed pharmacist may compound a medication for an individual patient. A pharmacy that compounds under those conditions is commonly called a 503A pharmacy. ProCompounding Pharmacy is a 503A compounding pharmacy in Johnson City, Tennessee.
What Section 503A Actually Says
Manufactured drug products must meet three federal requirements: FDA new-drug approval, current good manufacturing practice (cGMP) regulations, and labeling that carries adequate directions for use. Section 503A exempts a compounded preparation from those three requirements — but only when a specific set of conditions is met.
If any of those conditions is not met, the exemption does not apply and the preparation is treated as an unapproved new drug. The exemption is not a form of approval. It is a narrow allowance for patient-specific compounding.
Section 503A was added to the Federal Food, Drug, and Cosmetic Act by the FDA Modernization Act of 1997 and amended by the Drug Quality and Security Act of 2013, which also created the separate 503B outsourcing facility category.
The Conditions a 503A Pharmacy Works Under
Compounded by a licensed professional
The preparation is compounded by a licensed pharmacist or a licensed physician.
A valid, patient-specific prescription
The preparation is made pursuant to a valid prescription written for an individual, identified patient.
Eligible bulk drug substances
A bulk drug substance must comply with a USP or NF monograph, be a component of an FDA-approved drug, or appear on the FDA's 503A bulk drug substances list.
No withdrawn or removed ingredients
Ingredients must not appear on the FDA's list of drugs withdrawn or removed from the market because they were found unsafe or ineffective.
Not essentially a copy
The preparation must not be essentially a copy of a commercially available drug product.
Not a demonstrable difficulties drug
The drug must not appear on the FDA's list of preparations that present demonstrable difficulties for compounding.
503A and 503B Are Not the Same Thing
503A pharmacy
- Compounds against patient-specific prescriptions
- Licensed and regulated by state boards of pharmacy
- Not required to register with the FDA as an outsourcing facility
503B outsourcing facility
- Registers with the FDA as an outsourcing facility
- Compounds under current good manufacturing practice (cGMP) regulations
- May produce office-stock quantities without patient-specific prescriptions
- Subject to FDA inspection
ProCompounding is a 503A pharmacy. We compound only against a patient-specific prescription.
What 503A Does Not Mean
It does not mean a preparation is FDA-approved
Compounded preparations are not reviewed or approved by the FDA for safety or efficacy. Section 503A describes an exemption, not an approval.
It does not make the pharmacy a manufacturer
A 503A pharmacy does not manufacture, sell, or commercially distribute drug products. It prepares medications for individual patients against prescriptions.
It does not permit copying a commercial product
A 503A pharmacy may not compound a preparation that is essentially a copy of a commercially available drug product simply because a patient would prefer it.
It does not mean anything can be compounded
Not every substance a prescriber asks for is eligible. Bulk drug substances must meet the conditions in Section 503A. "Not a controlled substance" is not the same as "eligible to be compounded."
How to Check a Compounding Pharmacy
503A is a legal category, not an accreditation. Any pharmacy compounding for individual patients operates under Section 503A, so the label alone tells you little. A patient or prescriber can verify a pharmacy independently.
You can verify a compounding pharmacy license with the relevant state board, look at whether the pharmacy holds PCAB accreditation, and review its licensure and compliance information.
Frequently Asked Questions
Is ProCompounding a 503A pharmacy?
Yes. ProCompounding Pharmacy is a 503A compounding pharmacy in Johnson City, Tennessee. We compound only against a valid, patient-specific prescription. We are PCAB accredited and licensed in all 50 states and the District of Columbia.
Are compounded preparations FDA-approved?
No. Compounded preparations are not reviewed or approved by the FDA for safety or efficacy. When a product is described as FDA-approved, that refers to a commercially manufactured product that went through the FDA's new-drug approval process, not to anything compounded for an individual patient.
What is the difference between a 503A pharmacy and a 503B outsourcing facility?
A 503A pharmacy compounds against patient-specific prescriptions and is licensed and regulated by state boards of pharmacy; it is not required to register with the FDA as an outsourcing facility. A 503B outsourcing facility registers with the FDA, compounds under current good manufacturing practice regulations, may produce office-stock quantities without patient-specific prescriptions, and is subject to FDA inspection.
Can a 503A pharmacy compound any medication a prescriber asks for?
No. Each bulk drug substance used must comply with a USP or NF monograph, be a component of an FDA-approved drug, or appear on the FDA's 503A bulk drug substances list. Ingredients withdrawn or removed from the market for safety or effectiveness reasons cannot be used, and a 503A pharmacy may not compound a preparation that is essentially a copy of a commercially available drug product. A substance that is not a controlled substance is not automatically eligible to be compounded.
Who regulates a 503A pharmacy?
State boards of pharmacy in every state where the pharmacy is licensed regulate its practice, and the FDA retains authority over the conditions set out in Section 503A. Compounding practice standards come from USP <795> for non-sterile preparations and USP <800> for handling hazardous drugs.
Prescribers can read how we work with practices on our prescriber page. If you already have a prescription at another pharmacy, you can request a prescription transfer.
FDA disclaimer: Compounded preparations are not FDA approved. The FDA does not evaluate compounded preparations for safety, effectiveness, or quality. References to FDA approval on this page refer solely to commercially manufactured products. ProCompounding Pharmacy is a 503A compounding pharmacy regulated by state boards of pharmacy and prepares medications only against a valid prescription for an individual patient.