---
kind: "section"
citation: "42 C.F.R. § 410.29"
title: "42"
number: "410.29"
heading: "Limitations on drugs and biologicals."
url: "https://uscodex.org/cfr/42/410.29"
---

# §410.29. Limitations on drugs and biologicals.


Medicare part B does not pay for the following:

- (a) Except as provided in [§ 410.28(a)](/cfr/42/410.28.md?p=a) for outpatient diagnostic services and [§ 410.63(b)](/cfr/42/410.63.md?p=b) for blood clotting factors, and except for EPO, any drug or biological which is usually self-administered by the patient.
- (b) **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, that there is a compelling justification of the drug product's medical need. ([21 CFR 310.6](/cfr/21/310.6.md) contains an explanation of the efficacy review program.)
- (c) 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 (b)](#b) of this section.

## Notes

### Amendments

[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 FR 43709, Sept. 4, 1991; 80 FR 70602, Nov. 13, 2015]

### Authority

Authority: 42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

### Source

Source: 51 FR 41339, Nov. 14, 1986, unless otherwise noted.

### Amendments

[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 FR 43709, Sept. 4, 1991; 80 FR 70602, Nov. 13, 2015]