AANP is seeking members to serve on a brand new working group with an immediate charge – helping the association develop comments on proposed FDA regulations on compounded drugs used by NDs. The timeframe is short as one set of comments is due Feb. 3 and two other sets are due March 4. A high priority for AANP is to retain the ability for NDs to offer safely compounded medications for office use, i.e., to be able to provide them to patients without an individual prescription.
The FDA has a broad mandate to regulate based on a sweeping overhaul of compounding pharmacies enacted into law recently. The law was one of a handful of genuinely bipartisan measures Congress passed in 2013, responding to concerns about sterile compounded medications in light of the 2012 meningitis tragedy that killed and sickened scores of people.
This will be a true “working” group so volunteers will be expected to put in time and effort to help develop AANP’s comments. It will be composed of NDs although we plan to factor in input from compounding pharmacy suppliers. (AANP has been exchanging information and insight for many months with the national association of compounding pharmacists, IACP.)
If you’re an ND with a strong interest in the future of compounded drugs, your participation is needed! Please contact Mike Jawer, Director of Government and Public Affairs, immediately – either by email
or at 202-237-8150.