In a considerable win for patients who need compounded medications, the International Academy of Compounding Pharmacists (IACP), working with the DQSA Coalition, is very pleased to announce that the President has signed the Congressional Omnibus bill into law, H.R. 244, which provides funding through September 30, 2017, and includes language that addresses the Memorandum of Understanding, office-use, and pharmacy inspections.
Marie Antoinette’s quote is a great reminder that at times, new uses can be found with old things, such is the case with the drug Naltrexone. First synthesized as a competitive opioid antagonist in 1963, for many years research on Naltrexone remained dormant until
Researchers reported the first evidence that a new class of drugs known to dramatically lower cholesterol may also reduce risk of heart attacks, strokes and other serious consequences of cardiovascular disease. The drugs represent the most important new class of cholesterol-lowering medications since the first statin was approved in 1987.
BioDelivery Sciences International Inc recently announced that the U.S. Food and Drug Administration had approved its opioid treatment for chronic pain. Belbuca is an opioid film patch and aims to treat patients with chronic pain who need round-the-clock treatment and for whom current alternatives do not suffice. Belbuca has the advantages of lower possibility for abuse and less chance of causing constipation. Physicians will be able to prescribe the medication for 6 months at a time rather than by the month.
The FDA is proposing regulations that would allow massive drug companies to eliminate your access to compounded bioidentical hormones. YOUR ACTION IS NEEDED! Recently, the FDA released a list of nominations to its “Demonstrably Difficult to Compound” (DDC) list. This list derives from section 503A of the Food, Drug, and Cosmetic Act. It is supposed to identify drugs that cannot safely be compounded because of their complexity. The agency is threatening to take away the ability of compounding pharmacies to provide estriol, progesterone and testosterone to their patients, despite the fact that they have been safely providing these prescriptions for over 30 years.
During the last several years, dozens of patients have been infected by improperly sterilized endoscopes, known as duodenoscopes. The FDA has cited the manufacturers of these devices for violations ranging from not properly evaluating cleaning, sterilization and testing procedures to failure to report infections and other problems. Despite the fact that 13 patients have died from these infections, the agency has decided to leave the devices on the market because of their value in life-saving procedures.