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H.R. 2939 (112th): Pharmaceutical Stewardship Act of 2011


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.


9/15/2011--Introduced. Pharmaceutical Stewardship Act of 2011 - Establishes the National Pharmaceutical Stewardship Organization as a nonprofit private corporation whose board of directors shall be appointed by the Administrator of the Environmental Protection Agency (EPA). Requires the Organization to begin implementation of a certified national pharmaceutical stewardship program within two years.

Requires each manufacturer and brand owner of a drug marketed in the United States to participate in such program or another certified national pharmaceutical stewardship program.

Establishes requirements for program certification, including requirements to: (1) provide a system to facilitate the collection and disposal of any drug that is a household waste, as defined under the Resource Conservation and Recovery Act, that is delivered to the program by an individual in the United States; and (2) collect and dispose of drugs in a manner that is safe and secure, that results in incineration of the drug in accordance with the hazardous waste incineration requirements under the Solid Waste Disposal Act, that protects patient information, and that is accessible and, in the case of a controlled substance, consistent with the Controlled Substances Act. Prohibits programs from imposing fees on individuals for delivery or disposal of a drug.

Establishes a program certification process, including requiring the Administrator to consult with the Administrator of the Drug Enforcement Agency (DEA) on the adequacy of the proposed program's security measures for collection, transportation, and disposal of drugs, disposal systems, and mechanisms for secure tracking and handling. Authorizes the Administrator to suspend certification of a program if necessary to protect the public from imminent danger.

Requires the Director of National Drug Control Policy to establish a campaign to increase public awareness of how drugs may be lawfully disposed consistent with public safety, public health, and environmental protection.

Requires the Administrator to establish an interagency commission, to be known as the Commission on Drug Disposal and its Public Safety, Public Health, and Environmental Impacts, to develop a strategy to: (1) prevent the entry of drugs into the nation's water supply and environment consistent with current public safety standards, and (2) protect public health and promote public safety by reducing diversion and the risk of abuse and accidental overdose.

Requires the Comptroller General (GAO) to report on drugs and drug byproducts in surface water and groundwater in the United States within a year.