I recently acquired a copy of a press announcement from the International Academy of Compounding Pharmacists
announcing changes to (clarifications of) the Drug Quality and Security Act Title I (Compounding Quality Act). Specifically they announced (direct quote):
- Draft a new memorandum of understanding that does not include "dispensing" within the MOU. Congress expressed concern that the FDA draft MOU includes both "dispensing" and "distribution" of compounded medications. Congress made clear in the language that FDA does not possess this authority and specifically stated, "Congress only allowed the FDA to regulate distribution" under the MOU and "Congress did not intend to include dispensing of compounded drugs over state lines within the scope of the MOU."
- Release new guidance to allow 503A pharmacists to compound for "office-use" for prescribers, hospitals and other health systems. Congress expressed concern that patient access is decreasing to compounded medications, due to FDA's implementation actions of prohibiting all office-use compounding even where "this practice is authorized in the vast majority of states and was intended to be allowable under DQSA."
- Cease inspecting state-licensed 503A pharmacies under current Good Manufacturing Practices (cGMPs). Congress instructed FDA to inspect 503A pharmacies under USP standards or other applicably pharmacy inspection standards adopted by state law or regulation. Congress also stated that it "reminds the FDA that compounding pharmacies are not drug manufacturers, but rather, are state licensed and regulated health care providers that are inspected by state boards of pharmacy pursuant to state laws and regulations." Congress further stated, "compounding pharmacies are more appropriately inspected using USP standards or other pharmacy inspection standards adopted by state law or regulation in the state in which a pharmacy is licensed."
It is worthwhile looking at what was changed and what this may or may not imply:Clarification regarding what can be regulated as interstate commerce.
It appears that FDA may not regulate dispensing of prescriptions across state lines. This appears to mean that FDA can regulate the distribution of non-patient-specific product in interstate commerce, but cannot regulate prescription-filling. This would appear to remove FDA jurisdiction over the filling of medications for individual patients pursuant to a prescription by an authorized prescriber even when such filling crosses state lines. This is not permission to manufacture under the guise of compounding.Enable compounding "for office use"
. It appears that "for office" use includes compounding for hospitals and health-systems.This becomes interesting from a variety of fronts. To the extent that a hospital can outsource compounding to a 503a compounding pharmacy, this means that items can come in the back door of a hospital pharmacy without a bar code (or an NDC, for that matter), and without pedigree documentation (items compounded under 503a and 503b are exempted from the requirements of the Drug Supply Chain Security Act - thank you David Aguero for this information).The FDA cannot inspect 503a facilities against current good manufacturing practices (cGMP - 21CFR 210-211).
If it is going to inspect a 503a compounding pharmacy (this would include most hospital pharmacies), it must use applicable state law. It appears that, to the extent that any state adopts USP <797> explicitly, or mimics it in their state law, the FDA is free to interpret the chapter or those laws as it sees fit. It seems unlikely that the FDA would simply accept a consultant report or a state inspection report as evidence of such compliance.
At the very least, one might expect the FDA to go back to the appropriate state board of pharmacy and register their findings, which said board would likely be unwilling to ignore.It is interesting to note what has not changed
1) Compounding is perceived as necessary and appropriate to meet the needs of specific patients as prescribed by specific physicians.
2) Compounding a copy of a commercially available federally regulated drug product is prohibited except during drug shortage (as determined by a list maintained and published by HHS)
3) Compounding certain items on an HHS list of too-difficult-to-compound is still prohibited.
4) Compounding facilities operating under 503b are still required to comply with cGMP.
5) Any 503a compounding pharmacy is still required to produce unadulterated drug product under federal law.
This last is really important, as it is the premise upon which the FDA has cited compounding pharmacies and, in a few instances, hospital pharmacies. There are a number of ways that a drug product can be adulterated, one of which is preparation under unsanitary (the FDA actually uses the word "insanitary") conditions, especially for compounded sterile preparations (CSP's). Thus what has changed is the set of rules by which adulteration is judged. If experience is any indicator, it is quite likely that FDA could find insanitary conditions using USP <797> as a yardstick in some of our facilities.
So this seems to raise up a few immediate concerns for our health-system pharmacy practice:
1) We may be seeing more patients coming in the door with prescriptions for compounded items that they have received from a compounding pharmacy.
How are we going to handle those? We may not know how what ingredients were used, how they were prepared, or how they dating was derived. Will we permit them to be used in our facilities?
2) We will be able to outsource sterile (and non-sterile) compounding to 503a compounding pharmacies.
Doing so, however, will be subject to the prohibitions noted above, and should require us to do our due diligence with such compounding pharmacies on a regular basis. This includes having clear visibility into both their facilities and their processes, and understanding and agreeing with
their determination of beyond-use dating. ASHP published guidelines for outsourcing sterile compounding
3) We are not out of the the FDA cross-hairs.
We are simply being judged by different standards. It seems to me that this would be a really good time to shore up our <797> compliance. It is in our best professional interest to demonstrate to the larger healthcare and regulatory communities that we are capable and willing to regulate ourselves. It also means that we need better tools than we currently have to help us maintain that state of self-regulation.
What do you think?
Dennis A. Tribble, Pharm.D., FASHP
Ormond Beach, FL
The opinions expressed herein are my own, and not necessarily those of either my employer nor of ASHP#PharmacyPracticeManagers #InpatientCare #InpatientCarePractitioner