USP Guidelines for related to microbiology

Question

Accepted Answer

The usp microbiology expert committee consider such as metters as tha route of administration the form of tha product and tha source material.

Accepted Answer

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.

Requirements & Process to be Deemed “Approved for Inclusion” in the USP

In order for a drug or biological to be deemed "approved for inclusion" in the USP, below are the requirements and process to follow:

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.

USP Guidelines for related to microbiology

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