Anticipatory Compounding Limit (503A)

Highest 30-day total of units on prescriptions received in the past year for one compounded product.

Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.

Example

Prescriptions received, one per line
2026-01-20, 200 2026-02-10, 300 2026-03-25, 100
As-of date, YYYY-MM-DD
2026-10-11
Units now held for distribution
120

Result: 380 more units may be made under the policy: 120 on hand against a ceiling of 500.

The tool opens with these values already filled in. Replace them with your own.

What you enter

  • Prescriptions received, one per line: date received (YYYY-MM-DD), then the units
  • As-of date, YYYY-MM-DD (blank for today)
  • Units now held for distribution (optional)
How this is calculated

Citation

FDA, Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (guidance for industry, December 2016): hold no more than a 30-day supply, based on a 30-day period in the past year. A nonbinding interim policy. Read the source ↗

A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.

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Built by Clay Good. Source on GitHub.