The Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) is inviting public comment through Jan. 18, 2013, on a framework for pharmacy compounding. The FDA is soliciting comments on several specific questions related to federal and state roles in the regulation of pharmacy compounding, such as (1) whether the states currently are able to provide oversight of pharmacy compounding and consumer protection; (2) what the federal role should be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution; and (3) whether or not there is a role for the states in enforcing a federal standard for "nontraditional" compounding. Comments are due by January 18, 2013.
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
Showing posts with label FDA Comments. Show all posts
Showing posts with label FDA Comments. Show all posts
Monday, January 7, 2013
Friday, January 4, 2013
Reminder: Public comment's on pharmacy compounding Due to FDA by Jan. 18, 2013
The Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) is inviting public comment through Jan. 18, 2013, on a framework for pharmacy compounding. The FDA is soliciting comments on several specific questions related to federal and state roles in the regulation of pharmacy compounding, such as (1) whether the states currently are able to provide oversight of pharmacy compounding and consumer protection; (2) what the federal role should be in regulating higher risk pharmacy compounding such as compounding high-volumes of drugs for interstate distribution; and (3) whether or not there is a role for the states in enforcing a federal standard for "nontraditional" compounding. Comments are due by January 18, 2013.
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