Pharmacist FAQsFrequently Asked Questions for Pharmacists on Compounded Products/Compounding Q: Has the FDA taken action against pharmacies that compound "bio-identical hormone replacement" products? A: Yes. See http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html. ----------------------------------------------------------------------------------- Q: Must a prescription label state the drug's generic name? A: Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone". Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke’s Mouthwash" or "Compounded Cafergot". This rule is intended to meet a health need and is not meant as a punitive measure. Board staff does expect pharmacies to be in compliance within a reasonable time. Some patients have expressed confusion over the rule. A consumer-friendly explanatory FAQ is available here. ----------------------------------------------------------------------------------- Q: Should I compound Itraconazole? A: Pharmacists should note the following important information regarding compounding of itraconazole products from the bulk chemical: Itraconazole bulk powder (brand name - Sporonox) is NOT bioavailable in mammalian species. All of the commercially available Itraconazole products (capsules, oral solution and injectable) are complexed onto a cyclodextran molecule to increase solubility and systemic bioavailability. Unless compounding pharmacists are also utilizing this cyclodextran technology, the Itraconazole products from bulk chemical are not being absorbed and are therapeutically worthless. Dr. Mark Papich, our clinical pharmacologist, has studied the bioavailability of Itraconazole (both FDA-approved and compounded from bulk) in animal patients, and the bulk chemical is simply not bioavailable. We have had MULTIPLE therapeutic failures (and some resulting deaths in dogs suffering from blastomycosis) in the veterinary community from Itraconazole capsules and suspension compounded from the bulk chemical. We had another therapeutic failure today that resulted from the compounding pharmacist offering to compound Itraconazole suspension because the commercially available products are "too expensive". As most of the systemic fungal infections that animals suffer from are life-threatening, we must do everything we can to educate compounding pharmacists to stop compounding with Itraconazole bulk chemical. Thank you for any intervention that you might be able to provide. Gigi Davidson, BSPh, RPh, DICVP phone: 919-513-6575 ----------------------------------------------------------------------------------- Q: What is the FDA's position on the compounding of hydroxyprogesterone caproate injection? A: Many pharmacists are aware that the FDA approved Makena, a hydroxyprogesterone caproate injection, to be marketed by KV Pharmaceuticals. Significant press coverage has focused on KV Pharmaceuticals' decision to price that injection at over $1,500 per dose when compounded versions were available at $10 to $15 per dose. FDA issued a statement on March 30, 2011 stating that it has no intention of "exercising enforcement discretion" when pharmacists compound hydroxyprogesterone caproate injection pursuant to a "valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products." FDA's statement may be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm |
