What are 21 CFR parts 200s primarily concerned with?

21 CFR parts 200 primarily focus on the regulations concerning labeling, Good Manufacturing Practices (GMPs), and controlled substances. These parts encompass various rules that ensure drug products are properly labeled to provide consumers and healthcare providers with necessary information. Furthermore, they establish standards for manufacturers to follow during the production process to maintain quality and safety, which is the essence of GMPs.

Additionally, controlled substances are covered under these regulations, where specific controls are necessary to prevent misuse and ensure proper distribution among registered entities. This regulatory framework is essential for ensuring that the products approved for sale in the market meet safety and efficacy standards.

In contrast, the other options focus on different aspects of regulatory compliance. For example, options concerning biologics regulations, cosmetic regulations, and the registration of medical device manufacturers pertain to specific categories regulated under 21 CFR but are not the primary focus of parts 200. Each of these areas has its own distinctive regulations that address the unique requirements and safety concerns applicable to their respective sectors.