The United States Pharmacopeial Convention (USP) published a new standard on hazardous drugs in healthcare in February of this year, establishing a more than two-year moratorium to allow time for adoption by healthcare facilities.
The standard or “chapter” will become part of healthcare quality standards included in the United States Pharmacopeia-National Formulary (USP-NF), which is available by subscription. The USP posted the following frequently asked questions on the new chapter, including how to order the document, on its website at: http://bit.ly/1PCi6yY.
- What is the purpose of General Chapter 800? The purpose of the chapter is to describe practice and quality standards for handling hazardous drugs in healthcare settings and help promote patient safety, worker safety, and environmental protection. The new general chapter defines processes intended to minimize the exposure to hazardous drugs in healthcare settings.
- Does General Chapter 800 apply to me? The chapter applies to all healthcare personnel who handle hazardous drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians). The chapter also covers all healthcare entities that store, prepare, transport, or administer hazardous drugs (e.g., pharmacies, hospitals, other healthcare institutions, patient treatment clinics, physicians’ practice facilities, and veterinarian offices).
- What is a hazardous drug? A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.
- What is the status of the General Chapter 800 and when will it become official? General Chapter 800 was published on February 1, 2016, in the First Supplement to USP 39–NF 34. The Expert Committee approved a delayed official implementation date of July 1, 2018 to allow entities additional time to implement the standard. With the delayed official date, entities have more than two years to implement this new standard.