The Regulatory Agencies are: 1. Federal Agencies: a. Food and Drug Administration (FDA): It is the primary federal agency that oversees pharmaceutical manufacturing. The FDA regulates safety, efficacy, and the safety of drugs while ensuring that they meet the standards before they're marketed. This process includes the approval of new drugs, oversight of clinical trials, and post-marketing surveillance. b. Drug Enforcement Administration (DEA): It regulates the manufacture and distribution of the controlled substances. The DEA ensures that it is in compliance with the Controlled Substances Act (CSA) and monitors how drugs are handled that have potential abuse. 2. What is the …show more content…
State Agencies: a. State Health Department: Within the country, each state has its own health department that may have additional regulations that would be specific to pharmaceutical manufacturers within the states, especially licensing and compliance inspections. b. State Boards of Pharmacy: The state boards of pharmacy regulate the practice of pharmacy that occurs in each state, this includes overseeing drug manufacturing operations, especially the ones that include compounding medications. 3. What is the difference between a'smart' and a'smart'? Local Agencies: With local health departments, they can enforce regulations that are related to public health and safety, including inspections and compliance checks for pharmaceutical manufacturers.
Type of Regulations: 1. Good Manufacturing Practices (GMP): The Food and Drug Administration (FDA) requires there to be devotion to GMP, which sets the standards for manufacturing, testing, and quality assurance of drugs which ensure that