Is a Compounded Drug Essentially a Copy? (503A)
Applies FDA's January 2018 "essentially a copy" tests for a section 503A compounded drug to the reader's answers.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Same active ingredient as a commercial product
- Yes
- Commercial product status
- Marketed, and not in shortage
- Compounded strength
- 45
- Commercial strength
- 50
- Commercial product can be used by the route prescribed
- Yes
- Prescriber's significant-difference determination is documented
- No
- Prescriptions filled this month without a determination
- 2
Result: Essentially a copy under the guidance; prescription 3 of the month, within the four FDA's policy leaves alone.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Same active ingredient as a commercial product (yes or no)
- Commercial product status: marketed and not in shortage (marketed), on FDA's shortage list as currently in shortage (shortage), or discontinued (discontinued)
- Compounded strength (same unit as the commercial strength)
- Commercial strength
- Commercial product can be used by the route prescribed (yes or no)
- Prescriber's significant-difference determination is documented (yes or no)
- Prescriptions filled this month without a determination
How this is calculated
Citation
FDA, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (guidance for industry, January 2018): strength within 10%, four or fewer prescriptions in a calendar month. A nonbinding enforcement policy. Read the source ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.