H.R. 6584: Verifying Authority and Legality In Drug Compounding Act of 2012
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H.R. 6584: Verifying Authority and Legality In Drug Compounding Act of 2012
112th Congress · introduced 2012-11-02 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2012-11-02 · official record
- Who proposed it: Rep. Markey, Edward J. [D-MA-7] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
Verifying Authority and Legality In Drug Compounding Act of 2012
Plain summary
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is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.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.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
Official text
Verifying Authority and Legality In Drug Compounding Act of 2012
Source: Congressional Research Service summary (Introduced in House)
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The strongest published arguments
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Alternatives
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Markey, Edward J. [D-MA-7] · 8 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Steve Cohen (D-TN), Stephen F. Lynch (D-MA), James P. McGovern (D-MA)
Sponsor's campaign money: Rep. Markey, Edward J. [D-MA-7] reported raising $6.0 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (3)
- Appropriation
- Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
- Authorization
- A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
- Rulemaking
- The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in House)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112hr6584.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/hr>
Record fed-us-cong112-hr6584 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112