HR 3089 · 113th Congress · Health

Compounding Clarity Act of 2013

Introduced 2013-09-12· Sponsored by Rep. Griffith, H. Morgan [R-VA-9]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the House Committee on Energy and Commerce.(2013-09-12)

Plain Language Summary

[AI summary unavailable — showing source text] 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…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (6)

3 Democrats3 Republicans