USP Guideline on Drugs Approved for Inclusion

Background

Under the Social Security Act (Act), the Medicare program provides reimbursement for certain medical and other health services, including drugs and biologicals which cannot be self-administered and are provided in a physician's offices as part of a physician's professional service. The Act defines the term "drugs and biologicals" to include those drugs and biologicals that are included or approved for inclusion in the United States Pharmacopeia (USP), the National Formulary, or those approved by a hospital's pharmacy and drug therapeutics committee.¹

When the Act was passed in 1965, the USP consisted of monographs for those drugs that were considered to be the "best" therapeutically. Accordingly, drugs were "approved for inclusion" in the USP based on their therapeutic merit. In 1980, however, the USP Convention determined that the USP should attempt to include monographs for all drug entities and drug products marketed in the United States, and subsequently all drugs approved by FDA were deemed to be eligible for inclusion in the USP.

In order to give continuing meaning to the "approved for inclusion" language of the Act, and ensure that patients and physicians will have appropriate access under the Medicare program to newly approved drugs and biologicals, USP has developed a process that allows a drug or biological for which a monograph is under development to be granted "approved for inclusion" status.

In order for a drug or biological to be deemed "approved for inclusion" in the USP, the following requirements must be met:

The manufacturer must submit information, including proposed standards and analytical procedures, sufficient to initiate development of a monograph, following USP's Guideline for Submitting Requests for Revision to the USP-NF and labeling the Request "Approved for Inclusion".
The manufacturer must agree in writing to:
- provide further assistance to USP to allow completion of the monograph and publication in Pharmacopeial Forum (PF) within six (6) months after the date approved for inclusion status has been granted, and
- provide reference standard material not later than the time the monograph is ready for publication in PF sufficient to allow the development of a USP Reference Standard that can be made available by the time the monograph becomes official.

Process

Upon receipt of the Request for Revision and the commitment to assist USP in completing the monograph and to provide reference standard material, USP shall notify the Centers for Medicare and Medicaid Services (CMS) and the manufacturer that the drug or biological has been approved for inclusion.
If the manufacturer fails to honor its commitment to assist USP in completing the monograph and to provide reference standard material, USP may revoke the approved for inclusion status upon written notification to CMS and the manufacturer.

¹42 U.S.C. §§ 1395k, 1395x