It is done... HR 3204 is finally signed into law. It is worthy of a look, if you haven't read it.
Basically the bill amends the federal law regarding the compounding of drugs, and around traceability of drug products in the supply chain.
Focusing on the first part, the bill amends the Food Drug and Cosmetic act to recognize a third level of drug product preparation. Previously, the law recognized pharmacy compounding as one source of drug products and pharmaceutical manufacturers as the other source. Pharmacy compounding was exempted specifically from the provisions of the act that require registration of drug products with the FDA, labeling requirements for manufactured products, and compliance with 21 CFR 211, also known as current good manufacturing practices (cGMP).
The Drug Quality and Security Act (DQSA) inserts a third intermediate and voluntary class of drug product preparation called outsourcing facilities.
The law leaves a number of unanswered questions:
There's more, but you get the idea. Clearly there is still a lot of regulatory work to be done to implement this new law. The FDA will shortly solicit nominations for participation in a Pharmacy Compounding Advisory Board to help sort this all out. We need to be certain that our organization is at the table for that discussion.
- An outsourcing facility exists solely to prepare sterile products (what USP <797> would call compounded sterile preparations [CSP]). What about non-sterile stuff?
- Registration as an outsourcing facility is voluntary. What is the incentive for someone to register as one?
- What power does the FDA have (that it didn't have before) to force someone who engages in interstate commerce as a pharmacy to register as an outsourcing facility or as a manufacturer?
- An outsourcing facility must be operated under the supervision of a registered pharmacist, but need not be a pharmacy. How is that going to work?
- An outsourcing facility may receive prescriptions and compound them but need not be a pharmacy. How is that going to work?
- An outsourcing facility may receive and compound prescriptions for patients but appears to be obliged to follow cGMP. Now one doesn't have to get very far down the road in cGMP to realize that one could not perform this task and perform all the controls stipulated in 21 CFR 211. For example, if an outsourcing facility compounds daily TPNs for a hospital, the TPN doses will need to be prepared, delivered, and administered before the release testing required under 21 CFR 211 could possibly be completed. How is that going to work?
- Between the compliance activities and cGMP, outsourcing facilities seem likely to have to spend more time, effort and money on compliance. Hopefully that will result in better quality of product. How will that affect the price?
I also believe that we need to embrace the notion of good manufacturing practice. Our professional bretheren outside the US have long done so. How that gets translated into steps that permit us to prepare just-in-time doses remains to be seen.
It looks like the fun is just beginning. What do you think?
Dennis A. Tribble, Pharm. D., FASHP
Daytona Beach, FL
The opinions expressed herein are my own, and do not necessarily reflect the opinions of my employer or of ASHP.#Quality #DQSA