Filed Under: Michael Cohen
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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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.
Continue reading here
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