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H.R. 2186: VALID Compounding Act

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H.R. 2186: VALID Compounding Act

113th Congress · introduced 2013-05-23 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2013-05-23 · official record
  2. Who proposed it: Rep. Markey, Edward J. [D-MA-5] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

VALID Compounding Act

Plain summary

Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs. Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from any person identifying a substance that should be added to or removed from the list. Sets forth requirements for such petitions. Requires the Secretary also to develop and maintain a list of drug products that should not be compounded. Allows a pharmacy to compound drugs which are not for an identified individual patient based on the receipt of a prescription order if the pharmacy registers with the Secretary and agrees to comply with any condition of operation or limitation of activity the Secretary specifies. Sets forth information that must be included in any such registration. Authorizes the compounding of a drug that is a copy of a commercially available drug product if: (1) the drug is on the drug shortage list with notice given to the Secretary by the pharmacy, or (2) the drug product is necessary to protect public health and well-being. Requires the pharmacy to demonstrate to the Secretary that controls will be used that are comparable to elements required for safe use for a drug subject to a risk evaluation and mitigation strategy. Requires the Secretary to establish standards, processes, and procedures for high-risk sterile compounding. Establishes requirements related to inspections, labeling, and adverse event reporting for compounded drugs. Requires the Secretary to assess an annual establishment fee from compounding pharmacies and a reinspection fee for any pharmacy subject to a reinspection in a fiscal year. Sets forth a methodology for setting such fees and requires reduced fees for small businesses (pharmacies with $1 million or less in annual sales). States that the requirements of this Act do not preempt any non-federal requirement that is in addition to, and compatible with, such requirements.

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

VALID Compounding Act

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-5] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Sponsor's campaign money: Rep. Markey, Edward J. [D-MA-5] 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 (2)
Fiscal year
The 12-month period a government uses for its budget. The federal fiscal year runs from October 1 to September 30 and is named for the calendar year in which it ends. Most states use July 1 to June 30.
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

Record fed-us-cong113-hr2186 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113