“The stepped-up oversight was hastened by a new law that bolstered FDA authority. But compounders say the get-tough approach is a double-edged sword. Hospitals, doctors and patients may eventually have more confidence in compounded’ medicines, but in the meantime costs and red tape have increased. And a new batch of proposed guidelines issued by the FDA last week has set off another round of anguish.
The FDA maintains the guidelines are “critical to protecting public health.” But Scott Karolchyk of QmedRx, a compounder based in Maitland, Florida, argues “the FDA is trying to punish success. If these [guidelines] go into effect, a lot of pharmacies face onerous restrictions. And limiting good compounding pharmacies only hurts patients and their access to medications.””
Read the full article: via Compound Pharmacies Complain FDA is Compounding Their Problems – Pharmalot – WSJ.
You might also be interested in: FDA issues new draft documents related to compounding of human drugs
Go to DREprof.com: The Designated Representative and Exemptee Training Website
- CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. – Available around-the-clock 24 x 7 – Available for iPad
- FL Certified Designated Representative (CDR) online exam prep course by SkillsPlus Intl Inc. – Lots of practice exams – Practice makes perfect! – Available around-the-clock 24 x 7
- The Designated Representative Institute
- CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc. – Enhanced for iPad
- The Exemptee Institute