A new threat to compounded drugs (including bioidentical estriol for women and compounded time-release thyroid) has emerged. Action Alert!
The US Pharmacopeial Convention (USP) has released an overreaching draft proposal that may inadvertently crush many small compounding pharmacies—unless we take action. USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines (including compounded drugs), food ingredients, and dietary supplements. Since USP is considered an authoritative standard-setting body, it is very likely that these USP standards, like earlier ones, will be adopted into law.
The USP is creating new standards with “General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings.” Its stated intention is to protect healthcare workers from exposure to hazardous drugs (HDs). But many of the drugs in question are not hazardous at all. In addition, many compounding pharmacies—especially small traditional pharmacies—will be unable to implement the new standards and as a result could be forced out of business.
Here are just some of the problems with the new USP standards:
- They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, while an important goal, is already covered elsewhere under current law. On the federal level there are EPA and OSHA laws that ensure worker safety, and there are state laws as well. There is simply no need for these additional standards—they will lead only to duplication, confusion, and overregulation.
- There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.
- The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, not to mention all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol is also on the list! These drugs are dispensed by pharmacists, administered by nurses or medication aides, or are self-administered by patients every day.
- The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. However, NIOSH’s own list states in multiple place that there is uncertainty about the contents of their list. They even state that “no attempt has been made to perform drug risk assessments or propose exposure limits.” NIOSH acknowledges that there is little evidence that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.
- Many small pharmacies and healthcare facilities will be unable to comply with the requirements. The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases.Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost several hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.
- The impact will be far-reaching. While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributers, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer. Once again, regulators are not showing any common sense.
The USP predates the Food Drug and Cosmetic Act (FD&C) and has influenced the development of all drug, compounding, and supplement standards in the US. However, there is a great deal of crossover between the USP and the FDA. For example, FDA staff acts as liaisons to various USP standards committees, and they can ask USP to develop or modify standards. Moreover, FDA can comment on proposed USP standards. In return, USP staff have participated in FDA advisory committees.
That’s why we feel the timing of this revision is suspicious. It comes on the heels of the FDA’s draconian implementation of the new compounding law, which also threatens to force compounders out of business, leaving drugs only available from large pharmaceutical companies producing their one-size-fits-all (and often flawed) products. There has been no inciting incident, no official call to address HDs, as a letter to USP from the International Academy of Compounding Pharmacists makes clear—in short, there is simply no logical reason why USP should suddenly want to create these new standards.
Already some insurance companies are no longer covering certain compounded medications, restricting your access to them. If the USP formally adopts this draft proposal, it will likely only be a matter of time before these new standards are incorporated into federal or state law, just as previous USP standards have been—and that may mean the end of most important compounded drugs altogether.
These new USP standards could easily be the final nail in the coffin for small, traditional compounding pharmacies:
- As we’ve reported in earlier articles, the new compounding law allows traditional compounding pharmacies to ship no more than 5% of their products out of state, while the newly created category of compounder, massive “outsourcing facilities” (which are likely owned by Big Pharma) do not have the 5% restriction. Small pharmacies are crippled right from the start. Note also how nonsensical a small percentage limitation like this is. How can pharmacies know how much 5% really is until the end of the year? By then they have violated the rule!
- These massive outsourcing facilities may have the financial resources to build the new negative-pressure rooms required by the new USP standards—something that could further impoverish small, traditional pharmacies.
- If the traditional compounding pharmacies are forced to shut down, important medications like bioidentical estriol and time-released thyroid will almost certainly disappear with them: big outsourcing facilities are allowed to compound only those medications that appear on the FDA’s yet-to-be-released “allowed” list. As regular Pulsereaders will know, the FDA has attempted repeatedly to eliminate estriol, so it’s extremely likely it won’t be on the list.
We can’t stress strongly enough the importance of the small, traditional compounding pharmacies. Without them, natural health advocates will simply lose all access to some of the most important medications they rely upon.
Action Alert! The USP is accepting public comments until May 31, 2015. Tell the USP that General Chapter <800> should not be considered a mandate for healthcare facilities and compounding pharmacies, but instead should be listed in the “recommendations” section of the USP standards. Even more importantly, ask the USP to revise their standards to account for the concerns we raised above. Please send your message to USP today!