S. 882 would amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration.
Detailed Summary
Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration; and (2) provide for risk-based inspections.
Includes in the definition of "drug" a precursor ingredient.
Requires the Secretary of Health and Human Services to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.
Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.
Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met.
Sets forth provisions governing importation of a drug and its components.
Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.
Establishes actions manufacturers must take regarding any defective drug.
Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy and personal knowledge of information submitted.
Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.
Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities.
Provides for an evaluation of the system to review medical devices for clearance and premarket approval.
Sets forth enforcement provisions.
Status of the Legislation
Latest Major Action: 4/23/2009: Referred to Senate committee. Status: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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