[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR441.25]



[Page 272]

 

                         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 

 

                      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]