Wednesday, February 3, 2016

Reminder of the DQSA's requirement of Report on pharmacy compounding and the adequacy of State and Federal efforts to assure the safety of compounded drugs from the Comptroller General of the United States not later than 36 months after the date of enactment of the DQSA

 (a) <<NOTE: Deadline. Reports.>>  Study.--Not later than 36 months 
after the date of the enactment of this Act, the Comptroller General of 
the United States shall submit to Congress a report on pharmacy 
compounding and the adequacy of State and Federal efforts to assure the 
safety of compounded drugs.

    (b) Contents.--The report required under this section shall 
include--
            (1) a review of pharmacy compounding in each State, and the 
        settings in which such compounding occurs;
            (2) a review of the State laws and policies governing 
        pharmacy compounding, including enforcement of State laws and 
        policies;
            (3) an assessment of the available tools to permit 
        purchasers of compounded drugs to determine the safety and 
        quality of such drugs;
            (4) an evaluation of the effectiveness of the communication 
        among States and between States and the Food and Drug 
        Administration regarding compounding; and
            (5) an evaluation of the Food and Drug Administration's 
        implementation of sections 503A and 503B of the Federal Food, 
        Drug, and Cosmetic Act.

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