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
Monday, March 31, 2014
Second Question of the Day March 31, 2014 With the line now drawn in the sand and the heat on the state boards of pharmacy, what is the first thing state boards of pharmacy need to do? How about educating the inspectors? Wouldn't it be great if the NABP hired a person just to train and educate all the state inspectors on what to look for at compounding pharmacies? Even though each state has their on set of unique rules and regulations there are key things to inspect at look for at all traditional compounding pharmacies If the inspectors aren't trained on the specifics they won't know what to look for.
TimAllenMDJD: Understanding medication compounding issues
TimAllenMDJD: Understanding medication compounding issues: AORN J. 2014 Apr;99(4):466-79. doi: 10.1016/j.aorn.2013.07.021. Understanding medication compounding issues. Hicks RW . Abstract ...
The Pink Sheet Reports State inspectors left early when accompanying the FDA during inspections of Compounding Pharmacies
FDA Compounder Inspections: States Taking Early Leave / State inspectors did not accompany FDA for the full duration of facility inspections and now the agency is turning over the findings to them. / “The Pink Sheet” March 31 2014 12:02 AM
The Pink Sheet Reports that the FDA is REfining Post-inspection Hand-off to States--for traditional compounders it is up to state boards of pharmacy to ensure correctness--just as groups representing compounders requested!
Compounding: FDA Refining Post-Inspection Hand-off To States / When the agency finds a traditional compounder during an inspection, it asks state boards of pharmacy to ensure corrections are made. / “The Pink Sheet” March 31 2014 12:02 AM
FDA Issues Guidance on Fees for Human Drug Compounding Outsourcing Facilities
[PDF]
3 hours ago - Compounding Outsourcing. Facilities Under Sections 503B and. 744K of the FD&C Act. DRAFT GUIDANCE. This guidance document is being distributed for ...
Fees for Human Drug Compounding Outsourcing Facilities
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