H.R. 3019: S.A.F.E. Compounded Drugs Act of 2013

113th Congress · introduced 2013-08-02 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2013-08-02 · official record
Who proposed it: Rep. DeLauro, Rosa L. [D-CT-3] · 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.

What does this mean?

Official title

S.A.F.E. Compounded Drugs Act of 2013

Plain summary

Supporting Access to Formulated and Effective Compounded Drugs Act of 2013 or S.A.F.E. Compounded Drugs Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs. Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Prohibits such pharmacies from compounding: (1) any drug product appearing on a list of active ingredients and dosage forms that the Secretary of Health and Human Services (HHS) determines should not be compounded, or (2) in violation of promulgated minimum standards for the safe production of compounded drug products. Establishes notification requirements before a patient is prescribed, dispensed, or administered a compounded drug, which must include providing the patient a document concerning the availability, safety, and production of such drugs. Requires a drug product compounded under the FFDCA to be clearly labeled as a “non-FDA approved compounded drug product.” Authorizes the Secretary of Health and Human Services (HHS) to establish different labeling requirements for compounded drugs. Requires the Secretary to establish a process for pharmacies to register as compounding pharmacies. Exempts pharmacies that employ fewer than 20 full-time employees and perform traditional compounding of drug products for use in a single state. Requires the Secretary to: (1) establish a database of information on compounding pharmacies licensed in more than one state for oversight purposes, (2) establish minimum standards for the safe production of compounded drugs as well as for which drugs must meet those standards, and (3) conduct regional training for state agencies that regulate compounding pharmacies. Directs the Secretary to establish advisory committees on labeling of compounded drugs and on the database under this Act. Requires the Secretary to convene an Advisory Committee on Pharmacy Compounding as appropriate to consider issues related to the safety and availability of compounded drugs. Directs the Comptroller General (GAO) to review: (1) the extent to which federal health care programs ensure that compounded drug products they pay for are compounded in FFDCA-compliant facilities, (2) whether the reimbursement rates for such products under these federal programs are appropriate, and (3) whether these programs encourage the use of compounded drug products in place of otherwise available lawfully marketed drug products. Prescribes criminal penalties for violations of prohibitions concerning compounded drug products that are committed: (1) knowingly and intentionally to defraud or mislead, or (2) with conscious or reckless disregard of a risk of death or serious bodily injury.

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

S.A.F.E. Compounded Drugs 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. DeLauro, Rosa L. [D-CT-3] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Sponsor's campaign money: Rep. DeLauro, Rosa L. [D-CT-3] reported raising $1.6 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)

Appropriation: Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
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-113hr3019.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/113/hr>

Record fed-us-cong113-hr3019 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113