What does section 503A require?
Section 503A sets conditions. A compounded drug keeps its exemptions only if it meets all of them. The main ones, from the statute and FDA’s summary:
- An identified patient. The drug is compounded for a named individual on a valid prescription order.
- A licensed compounder. A licensed pharmacist in a state-licensed pharmacy or federal facility, or a licensed physician, does the compounding.
- Eligible ingredients. A bulk drug substance must meet one of three tests: it complies with a USP or NF monograph if one exists, it is a component of an FDA-approved drug if no monograph exists, or it appears on FDA’s 503A bulks list.
- Traceable supply. Bulk substances need a valid certificate of analysis and must come from an establishment registered under section 510.
- No routine copies. The pharmacy cannot regularly or in inordinate amounts compound what is essentially a copy of a commercially available drug.
What does a 503A pharmacy get exempted from?
Three things: FDA approval before marketing, current good manufacturing practice (CGMP) requirements, and certain labeling requirements. The rest of the Act still applies, including the rules against false or misleading advertising.
Who regulates a 503A pharmacy?
Per FDA, state boards of pharmacy hold primary responsibility for day-to-day oversight of state-licensed pharmacies that are not registered as outsourcing facilities. FDA can also inspect them, through surveillance and for-cause inspections.
Are drugs from a 503A pharmacy FDA-approved?
No. FDA states that compounded drugs are not FDA-approved, and that it does not verify their safety, effectiveness or quality before they reach the market. A prescriber who writes for one, and a business that sells one, should say so plainly. Our guide on marketing compounded medications covers why that matters.
Can a 503A pharmacy compound before a prescription arrives?
Only in limited quantities. FDA’s guidance calls this anticipatory compounding. The compounder needs a history of valid prescriptions from an established relationship with the patient or prescriber, and can hold no more than a 30-day supply based on prescriptions received over the past year. It can distribute only against a valid patient-specific prescription.
Can a 503A pharmacy ship to other states?
Usually, with licensing. Most states require an out-of-state pharmacy to hold a nonresident license or registration before it ships to patients there. The statute also addresses interstate distribution through agreements between FDA and the states, so confirm the current position with healthcare counsel before you plan your footprint.
What does this mean for a telehealth brand?
A brand that sells compounded care depends on a chain it does not run itself: a prescriber licensed where the patient is, a pharmacy licensed where the drug ships, and a record tying each order to a real prescription. SourceRX runs that chain underneath approved brands. It is not a pharmacy; licensed compounding pharmacies fill the prescriptions.
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General information, not legal or medical advice. Rules vary by state and change over time, so have healthcare counsel review your plans.