The FDA and the Arkansas Board of Pharmacy are seeing the same thing in very different lights.
The federal agency wants to impose more control and take liberties never given to it by Congress in hyper regulating something pharmacists have done for CENTURIES: compounded drugs extemporaneously.
Warren Lee, owner of Lee Pharmacy at 4300 Grand Ave in Fort Smith, AR works in his pharmacy last Thursday in Fort Smith. Inspectors for the US Food and Drug Administration and the Arkansas State Board of Pharmacy saw things entirely different from each other as they inspected the Lee Pharmacy in Fort Smith on Feb 19, 2013.
The federal inspectors found seven areas of concern in the pharmacy. State inspectors gave the pharmacy a Class A rating, the highest possible.
The divergence of opinion highlights a debate ongoing in Congress over whether the federal government needs more authority, or just needs to use the authority it already has. It also raises the questions about whose standards are appropriate for so-called “compounding pharmacies.”
We need public safety in drug regulation, but it should be done at the state level as it always has. The federal government through the FDA should only get involved in truly manufacturing situations, not an independent pharmacy compounding items for its patients and based on specific drug orders from licensed prescribers.
ESH says enough of governmental intrusion already!