Which law governs the compounding of sterile products in Colorado?

The compounding of sterile products in Colorado is primarily governed by the Colorado Pharmacy Practice Act. This Act establishes the legal framework within which pharmacists operate and sets forth the standards, responsibilities, and regulatory requirements related to pharmacy practice, including compounding.

It addresses specific aspects such as the necessary training, environment, and procedures for compounding sterile products to ensure patient safety and adherence to sanitary standards. By regulating these practices, the Colorado Pharmacy Practice Act ensures that pharmacists are held to a high standard in the preparation of compounded medications, particularly those that are sterile and may be administered through injections or other means that bypass the normal barriers of the body.

In contrast, while the Federal Food, Drug, and Cosmetic Act provides a broader regulatory background for pharmaceuticals, including safety and efficacy standards, it does not specifically address the compounding processes as closely as the Pharmacy Practice Act does at the state level. Other options, such as the Colorado Controlled Substances Act and the Drug Enforcement Administration Regulations, relate more to the management and regulation of controlled substances rather than specifically focusing on the compounding of sterile products.