The topic on the agenda to be discussed was "Center for Medicare and Medicaid Services - Reimbursement for Compounded Medications." If any readers were present, please update us on the discussion at the meeting.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Showing posts with label Pennsylvania State Board of Pharmacy. Show all posts
Showing posts with label Pennsylvania State Board of Pharmacy. Show all posts
Wednesday, January 16, 2013
Thursday, December 27, 2012
PA lacks patient protection against sterile compounding errors
Filed Under: Michael Cohen
POSTED: Thursday, October 25, 2012, 10:38
AM
By Michael R. Cohen, R.Ph. Pennsylvania is one of only 5 states in the US that lacks regulations for compounding pharmacies to follow when preparing and dispensing sterile medications. The state also has no regulations to protect patients when sterile products are prepared by out of state pharmacies and shipped here.
In the wake of 24 deaths and over 300 people who’ve been harmed from contaminated steroids made by a Massachusetts compounding pharmacy, questions have been raised about the lack of regulatory oversight of such pharmacies by state and federal officials.
The pharmacy in the current case, New England Compounding Center (NECC), is being investigated for crossing the line into full-scale manufacturing by taking bulk orders for injectable medications without proof of an individual prescription as required in state regulations, then shipping large batches of drugs nationwide. Such compounding requires registration with FDA as a manufacturer, which was not the case with NECC. Thus oversight was up to the Massachusetts Board of Registration in Pharmacy.
While it’s difficult to understand how the transition to full-scale manufacturing could have been overlooked by authorities, the pharmacy has been accused of misleading state regulators who licensed NECC as a pharmacy.
For sterile compounding, Massachusetts regulations spell out requirements for pharmacies to follow standards set forth by the US Pharmacopeia in Chapter <797>, entitled Pharmaceutical Compounding: Sterile Preparations. The chapter describes a network of systems and processes “to prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations.” The standard has the force of law in states that include mention of it in their regulations, as Massachusetts does.
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Tuesday, September 18, 2012
Pennsylvania State Board of Pharmacy Meeting Today to Discuss Compounding Issue
Pennsylvania's Board of Pharmacy Agenda for today, September 18, 2012, indicates that the following will be discussed:
Ther-Rx Corporation – Compounding of hydroxyprogesterone caproate
injection ..
To view the entire agenda click here
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