Looks like Congress is pressing forward on efforts to clean up the regulatory gaps implicated in the New England Compounding Center tragedy.
Rita Ayers, CEO of Tower MSA Partners, has been tracking the US Senate’s work on the issue; the latest is Tom Harkin, (D IA) Chair of the HELP Committee sent a letter to the Boards of Pharmacy in all fifty states requesting information on their oversight of compounding pharmacies and their efforts to follow up on the NECC disaster. The letter, which went out in mid-November, requested responses by December 7 of this year.
No word on what Harkin et al heard back, or if the Pharmacy Boards did respond on schedule.
What we do know is this.
- Oversight of compounding pharmacies is quite a bit looser than pharmaceutical manufacturers, and the regulatory compliance process is much less onerous for compounders
- Compounds are supposed to be developed/made up for individual patients or a relatively small number of patients.
- Some compounders look a lot like manufacturers, as they make thousands of doses – just like manufacturers
- Some states have a very light regulatory “touch” while others are pretty tough.
What does this mean for you?
A warning for patients, providers, and pharmacists alike, and evidence that – in some instances – we need more and better regulation, not less.