The objective of this chapter is to protect personnel and the environment when handling HDs. This includes but is not limited to receipt, storage, mixing, preparing, compounding, dispensing, administering, disposing, and otherwise altering, counting, crushing, or pouring HDs, and includes both sterile and nonsterile products and preparations. The standards in this chapter apply to all personnel who compound HDs preparations and all places where HDs are prepared (e.g., pharmacies, hospitals and other healthcare institutions, patient treatment clinics, physicians’ practice facilities, veterinarians’ offices) and other locations and facilities in which HDs are stored, transported, and administered. Persons who compound HDs include but are not limited to pharmacists, nurses, pharmacy technicians, physicians, physician assistants, veterinarians, and veterinary technicians.
An entity compounding HDs shall have a comprehensive approach to prevent worker
89 and environmental exposure. The entity’s safety and health program shall include but is not limited to:
• Engineering controls (including primary, secondary, and supplemental)
• Competent personnel
• Robust work practices
• Availability of appropriate Personnel Protection Equipment (PPE), such as gloves tested to the American Society for Testing and Materials (ASTM) standard for permeability, gowns made of material tested for HD permeability or with evidence of reduced permeability, and eye and respiratory protection
• Policies for the use of PPE and employee compliance with PPE use and policies
• Medical surveillance program
• Policies for HD waste segregation and disposal
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