What is the legal framework for drug safety?

In Maryland, the legal framework for drug safety is centered around the Maryland Drug, Device and Cosmetic Act (MDDCA), which is enforced by the Maryland Department of Health. This law is meant to ensure the safety, efficacy, and quality of drugs, devices, and cosmetics used by the public. It requires that drugs, devices, and cosmetics are labeled accurately and that manufacturers and distributors follow the manufacturing regulations set by the Department of Health. In order to ensure safety in the manufacture and distribution of drugs, the MDDCA requires that a manufacturing facility be registered and that the manufacturer comply with the Current Good Manufacturing Practices (CGMPs). This includes ensuring that proper personnel, methods, and equipment are used for manufacturing, and that all records of production are documented, stored, and maintained. The MDDCA also requires that drugs, devices, and cosmetics be tested for safety before they are released onto the market. This is done through clinical trials that are conducted by the manufacturer and reviewed by the US Food and Drug Administration (FDA). The FDA also issues recalls of any drugs, devices, or cosmetics that are found to be dangerous or ineffective. Finally, the MDDCA requires that the public be properly informed of the risks and benefits associated with any drugs, devices, or cosmetics on the market. This includes labeling all products with all relevant information so that consumers can make informed decisions about what they are using. Additionally, any advertising for a drug, device, or cosmetic must be truthful and not misleading.

Related FAQs

What are the legal issues related to medical ethics?
What are the legal issues related to assisted reproductive technologies?
How does health insurance work?
Are there legal requirements for reimbursement of health care services?
What are the legal issues surrounding end-of-life care?
Are there legal requirements for providing health care services to uninsured individuals?
What are the legal rights of patients?
What are the legal issues related to health care?
How do I comply with health care laws and regulations?
What are the legal requirements for accreditation of health care facilities?

What is the legal framework for drug safety?

Related FAQs

Related Blog Posts