Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
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Food and Drug Administration and Compliance Issues
Saturday, August 30, 2014
FDA Releases Slew of Warnings to Compounding Pharmacies
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
1 comment:
Anonymous
said...
I could not access the entire article, but, if you look at historical warning letters over time, you will see the FDA has used the same enforcement options prior to 1997 FDAMA, and under Section 503A, and under Section 503A in regions where it held with advertising restrictions severed after the SC ruling, and where 503A was not in force post SC ruling, under prior guidance. The new law resolves ambiguity--nothing new with respect to enforcement options?
1 comment:
I could not access the entire article, but, if you look at historical warning letters over time, you will see the FDA has used the same enforcement options prior to 1997 FDAMA, and under Section 503A, and under Section 503A in regions where it held with advertising restrictions severed after the SC ruling, and where 503A was not in force post SC ruling, under prior guidance. The new law resolves ambiguity--nothing new with respect to enforcement options?
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