The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded. It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption. Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.
The reason for the old Rule withdrawal and replacement is that, since the list last published on January 4, 2000, new information has come to the Agency’s attention that requires a revised list be published. The entire 34 page Rule in its prepublication form can be found here.
The FDA is also asking for comment on a more efficient way to make updates to the list. In the past, FDA has received nominations for inclusions to the list or published Proposed Rules identifying which drugs it intends to include on the list and why. This was then brought to a Pharmacy Compounding Advisory Committee for their input. According to FDA, this process is cumbersome and take too much time, and, to assure public safety, the Agency is looking for ways to get this information out to the public and pharmacy compounding community in a more efficient and timely manner.
Some interesting drugs appear on the list of 25 including phenylpropanolamine (PPA) which is implicated in causing hemorrhagic stroke – a product that has been off the market for 14 years. In addition, FDA has added oxycodone hydrochloride extended-release products that do not have abuse deterrent technologies which correlated to the FDA decision not to permit the approval of ANDA for oxycodone ER product that do not incorporate those features into their products. Propoxyphene-containing products also appear on the list due to evidence that showed potential life threatening heart toxicity even at therapeutic doses. Most of the other products on the list FDA has removed for various safety reasons including potential for serious liver toxicity, ischemic colitis, and heart valve damage, to name a few.
For more information or questions on this and other compounding issues please contact Joan Janulis at j.janulis@LachmanConsultants.com.