H.R. 3089: Compounding Clarity Act of 2013
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H.R. 3089: Compounding Clarity Act of 2013
113th Congress · introduced 2013-09-12 · Health · Latest: Referred to the House Committee on Energy and Commerce.
federal
Follow this bill, step by step
- Where it came from: introduced 2013-09-12 · official record
- Who proposed it: Rep. Griffith, H. Morgan [R-VA-9] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Referred to the House Committee on Energy and Commerce. 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
Compounding Clarity Act of 2013
Plain summary
Compounding Clarity Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the regulation of compounding drugs. Revises the exemption of compounded drugs from certain new drug, labeling, and biological product requirements. Adds an exemption for drug products compounded by a licensed pharmacist or a licensed physician, pursuant to a non-patient-specific purchase order, which: (1) will be administered by a health care practitioner within a physician's office, a hospital, or another health care setting; and (2) meet other specified criteria. Revises requirements for exempted bulk drug substances. Prohibits the sale of a drug product by an entity other than the pharmacy or physician that compounded it. Directs the Secretary of Health and Human Services (HHS) to develop a system for receiving and reviewing submissions from state boards of pharmacy: (1) describing actions taken against compounding pharmacies, or (2) expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section. Requires the Secretary to review such submissions and determine whether the pharmacy involved may be in violation of one or more compounding requirements. Authorizes the Secretary to inspect a pharmacy's records to determine whether the pharmacy is in violation of one or more FFDCA requirements. Exempts from certain new drug, labeling, and biological product requirements a drug product compounded for human use by a licensed pharmacist in a registered outsourcing facility if specified conditions, including labeling requirements, are met. Establishes annual registration requirements for any outsourcing facility. Requires a facility to report to the Secretary biannually on what drugs are compounded in it and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule. Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list. Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary. Prohibits the intentional falsification of a required prescription, a purchase order, or patient name for a compounded drug. Prohibits the intentional failure of an outsourcing facility to register.
Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.
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A “Yea” vote
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A “Nay” vote
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What does this mean? (plain words)
Official text
Compounding Clarity Act of 2013
Source: Congressional Research Service summary (Introduced in House)
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How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Griffith, H. Morgan [R-VA-9] · 6 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
Diana DeGette (D-CO), Robert J. Wittman (R-VA)
Sponsor's campaign money: Rep. Griffith, H. Morgan [R-VA-9] reported raising $2.2 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 (2)
- Exemption
- A rule that removes certain people, property or activities from a tax or requirement.
- 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-113hr3089.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/113/hr>
Record fed-us-cong113-hr3089 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113