---
kind: "section"
citation: "42 C.F.R. § 441.25"
title: "42"
number: "441.25"
heading: "Prohibition on FFP for certain prescribed drugs."
url: "https://uscodex.org/cfr/42/441.25"
---

# §441.25. Prohibition on FFP for certain prescribed drugs.

- (a) FFP is not available in expenditures for the purchase or administration of any drug product that meets all of the following conditions:
  - (1) **The drug product was approved by the Food and Drug Administration (FDA) before October 10, 1962.**
  - (2) **The drug product is available only through prescription.**
  - (3) The drug product is the subject of a notice of opportunity for hearing issued under [section 505(e)](/cfr/42/505.md?p=e) of the Federal Food, Drug, and Cosmetic Act and published in the Federal Register on a proposed order of FDA to withdraw its approval for the drug product because it has determined that the product is less than effective for all its labeled indications.
  - (4) The drug product is presently not subject to a determination by FDA, made under its efficacy review program (see [21 CFR 310.6](/cfr/21/310.6.md) for an explanation of this program), that there is a compelling justification of the drug product's medical need.
- (b) FFP is not available in expenditures for the purchase or administration of any drug product that is identical, related, or similar, as defined in [21 CFR 310.6](/cfr/21/310.6.md), to a drug product that meets the conditions of [paragraph (a)](#a) of this section.

## Notes

### Amendments

[46 FR 48554, Oct. 1, 1981]

### Authority

Authority: 42 U.S.C. 1302.

### Source

Source: 43 FR 45229, Sept. 29, 1978, unless otherwise noted.

### Amendments

[46 FR 48554, Oct. 1, 1981]