West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

True or false? Both manufacturing and compounding require CGMP.

1. False; manufacturing does, compounding does not unless it is an outsourcing facility

2. False; compounding requires CGMP, manufacturing does not

3. True; both require CGMP

4. True; both are exempt from CGMP

The correct answer is: False; manufacturing does, compounding does not unless it is an outsourcing facility

The correct answer indicates that manufacturing requires current Good Manufacturing Practice (CGMP) while compounding does not require CGMP unless it is performed by an outsourcing facility. In pharmaceutical regulations, manufacturing involves the production of drugs on a larger scale and is subject to stringent regulatory requirements, including CGMP. This is essential to ensure the quality, safety, and efficacy of medications produced for widespread distribution. Compounding, on the other hand, usually pertains to the preparation of customized medications for individual patients, typically done in smaller quantities. Standard compounding does not fall under CGMP requirements. However, if a compounding pharmacy is designated as an outsourcing facility, it must adhere to CGMP guidelines since it is involved in bulk compounding intended for distribution. Understanding this distinction is crucial for pharmacists as it helps them comply with regulations while ensuring patient safety. The other options present variations that do not accurately reflect the relationship between CGMP and the two practices.