[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR441.25]

[Page 258]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 441_SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 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) 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 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, to a drug product that meets the 
conditions of paragraph (a) of this section.

[46 FR 48554, Oct. 1, 1981]