ASHP Statement on Senate HELP Committee Draft Compounding Bill

Published Online: Friday, April 26, 2013
Follow Pharmacy_Times:
PRESS RELEASE

April 26, 2013 -- The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released today by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.

"Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, Pharm.D., FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a "compounding manufacturer" that would be overseen by the Food and Drug Administration (FDA)."

The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.

The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.

ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.
Related Articles
Pharmacy operations can be improved by investing in continuing education for pharmacy technicians.
With so many NAPLEX review books on the market, how can you decide which one is best?
Joseph Saseen, PharmD, from the Department of Clinical Pharmacy at the University of Colorado School of Pharmacy, discusses key points for determining blood pressure goals in patients with hypertension.
Joseph Saseen, PharmD, from the Department of Clinical Pharmacy at the University of Colorado School of Pharmacy, discusses which points in the new hypertension guidelines are particularly different from the previous guidelines.
Latest Issues
  • photo
    Pharmacy Times
    photo
    Health-System Edition
    photo
    Directions in Pharmacy
    photo
    OTC Guide
    photo
    Generic Supplements
  • photo
    Pharmacy Careers
    photo
    Specialty Pharmacy Times
    photo
    Generic
$auto_registration$