Compounding Regulations

Compounding regulations are rules that govern the preparation of customized medications by pharmacists outside of standard manufacturing processes. They ensure that compounded drugs are made safely, accurately, and consistently, meeting quality standards. These regulations address cleanliness, proper labeling, ingredient sourcing, and documentation to protect patient safety. They also specify when compounding is appropriate—mainly for individualized therapy or when commercial options are unavailable—while preventing unapproved or fraudulent products from reaching consumers. Overall, compounding regulations aim to balance personalized care with public health safety standards.