HR 3089 · 113th Congress 2013–2015, ended

Compounding Clarity Act of 2013

Fact sheet

Latest action · Sep 12, 2013 Referred to the House Committee on Energy and Commerce.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedSep 12, 2013
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

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.

Cosponsors 6

Members who signed on, in the order they did. Signatures ran from Sep 12, 2013 to Sep 20, 2013, with 2 there on the day it was introduced.

SeatCosponsorSigned on
D-CODiana DeGetteOriginalSep 12, 2013
D-TXGene GreenOriginalSep 12, 2013
R-MSGregg HarperSep 16, 2013
R-VAJ. Randy ForbesSep 16, 2013
R-VARobert J. WittmanSep 18, 2013
D-TXRuben HinojosaSep 20, 2013

Actions 2

Everything that happened, newest first.

  1. Sep 12, 2013Introduced in House
  2. Sep 12, 2013Referred to the House Committee on Energy and Commerce.

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

  1. Sep 12, 2013Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.