What is one reason why compounding pharmacies must follow state regulations laid out in the USP-NF, while mass producers of medications do not have to follow state-specific regulations when they produce drugs?
O The FDA is a federal agency that cannot test every compounded prescription, but since the FDA does test every
mass-produced drug, it can assure the safety of those drugs without the need for separate state regulations.
O Drugs that are prepared in compounding facilities must meet the strong quality-control requirements of the FDA, but
since mass-produced drugs are not tested by the FDA, their production facilities are not regulated as tightly.
O Technicians working in mass-production facilities are highly educated and trained pharmacists, so the quality of their
work is assured, but smaller businesses such as compounding pharmacies cannot hire experts like these.
Since a mass producer of a medication serves so many more patients than a compounding pharmacy, if a mass-
produced medication were contaminated, there would be reports of it from many people and the production facility
would be shut down.