Saturday, August 30, 2014

FDA Releases Slew of Warnings to Compounding Pharmacies

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?