(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.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
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
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