NIOSH has requested public comments on three draft documents: (1) the 2020 List of Hazardous Drugs; (2) Procedures for Developing the NIOSH List (“the List”) of Hazardous Drugs; and (3) Managing Hazardous Drug Exposures For Health Care Settings available here.
NIOSH is proposing to regroup the drugs by hazards. Table 1 includes only those drugs that meet the NIOSH definition of a hazardous drug and are classified by the National Toxicology Program (NTP) as “known to be a human carcinogen,” or classified by the International Agency For Research on Cancer (IARC) as “carcinogenic” or “probably carcinogenic.” Table 2 includes those drugs that meet the NIOSH definition of a hazardous drug but are not drugs that are classified by the NTP as “known to be a human carcinogen,” or classified by the IARC as “carcinogenic” or “probably carcinogenic.” Table 3 would be removed, and the drugs formerly in that table placed into Table 1 or 2, accordingly. In the draft, many hormonal agents have been moved to Table 2. Thirteen agents are proposed for addition to the List. Comments have been submitted on several the agents such as botulinum toxin, estrogens, gonadotropins, progestins, azole antifungals, and darbepoetin.
Additions to the List present wide-reaching implications for pharmacies that compound since USP 800 incorporates the List by reference. Additionally, USP 800 requires the use of PPE by institutional personnel when handling drugs on the List. This may delay care or undermine patient safety.
Presence on the list may create a variety of obstacles and compliance issues for both prescribers and pharmacies. Moreover, institutions such as hospitals can be significantly affected as inclusions on the list create an additional burden. As described above compounding practices are also affected by the NIOSH list.
How Frier Levitt Can Help
The 60 day comment period ends June 30th, 2020. NIOSH has indicated it will respond to any party that has provided comments for consideration. Frier Levitt can assist your organization in preparing substantive comments and participating in the process to delete substances from the list. Contact us to speak with an attorney.
