Verifying Authority and Legality In Drug Compounding Act of 2012

Bill: 112-hr-6584
Sponsor: Rep. Markey, Edward J. [D-MA-7]
Introduced: 2012-11-02 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Administrative remedies
Consumer affairs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Food and Drug Administration (FDA)
Government information and archives
Health information and medical records
Licensing and registrations
Manufacturing
Prescription drugs
Retail and wholesale trades
State and local government operations

Summary:
action_date: 2012-11-02
text: 
Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs.
 
Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug.
 
Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.
 
Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers.
 
Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state. 
 
Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition.
 
Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act.
 
Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety.
 
Sets forth a required label statement for any drug compounded pursuant to this Act. 
 
 Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.


Legislative actions:
action_date: 2012-11-02
text: Referred to the Subcommittee on Health.
action_date: 2012-11-02
text: Referred to the House Committee on Energy and Commerce.
action_date: 2012-11-02
text: Introduced in House
action_date: 2012-11-02
text: Introduced in House