Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Bulk and active ingredients in compounding must be certified by which standards?

1. ISO or FDA

2. USP or NF

3. OSHA or EPA

4. CDC or WHO

The correct answer is: USP or NF

The correct choice, which refers to the certification standards for bulk and active ingredients in compounding, is based on the requirements set forth by the United States Pharmacopeia (USP) and the National Formulary (NF). USP sets the standards for the quality, purity, strength, and consistency of medicines, and it plays a crucial role in ensuring that compounded medications are made with ingredients that meet specific standards. USP standards are recognized in pharmacy practice as the authoritative source for drug quality, and compliance with these standards is essential for ensuring safe and effective compounded medications. The NF complements the USP by providing additional information on drug components and their formulations. Other options relate to different areas. ISO (International Organization for Standardization) and FDA (Food and Drug Administration) are significant in terms of overall drug manufacturing and safety regulations, but they do not specifically pertain to compounding standards. OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) focus on workplace safety and environmental impacts, respectively, and are not concerned with the purity and quality of pharmaceutical ingredients. Similarly, CDC (Centers for Disease Control and Prevention) and WHO (World Health Organization) focus on public health agendas rather than specific components of pharmaceutical compounding. Thus,