PA Board of Pharmacy Discussed Compounding at Meeting Yesterday, January 15, 2013

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. 

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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PA lacks patient protection against sterile compounding errors Read more: http://www.philly.com/philly/blogs/healthcare/PA-lacks-patient-protection-against-sterile-compounding-errors

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.


Read more: http://www.philly.com/philly/blogs/healthcare/PA-lacks-patient-protection-against-sterile-compounding-errors.html#ixzz2AKoHHTg3
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Pennsylvania's Brochure on Compounding With Questions To Ask

To view click here.  This brochure contains a good set of questions that pharmacists, doctors, veterinarians and consumer should ask:


Questions you should ask about suppliers…
Is the supplier FDA registered/inspected?
Is the supplier reputable?
Is the supplier licensed with applicable state
and/or federal authorities?
Do the supplier's substances meet USP–NF standards?
If USP–NF grade substances are not available, is there a Certificate of Analysis?

Pennsylannia Proposal Regarding Compounding Practices

State Board of Pharmacy -Compounding Practices- 49 Pa. Code Chapter 27 (16A-5419) This proposal can be found here.

Fall 2012, as Proposed

This proposed rulemaking would establish standards for the compounding of drugs by pharmacists. Statutory Authority: Section 6(k)(9) of the Pharmacy Act, 63 P. S. § 390-6(k)(9) grants the authority to promulgate rules and regulations to effectuate the purposes of the act. Section 2 of the Pharmacy Act, 63 P. S. § 390-2(11) defines the practice of pharmacy to include the compounding of drugs.

Melanie Zimmerman (717) 783-7156

Pharmacists Included as "Health Care Providers" Under Pennsylvania Health Care Records Law

This article appears in the Pennsylvania Pharmacists Association news:

Diana Yap, APhA - April 10, 2012 - Pennsylvania appeals court opinion declares pharmacists are ‘health care providers’ under the law, citing state Pharmacy Practice Act and state board of pharmacy regulations. Calling pharmacists “health care providers” for the purposes of the Pennsylvania Medical Records Act (MRA), the Superior Court of Pennsylvania on March 23 issued an opinion important to pharmacy in the case of Landay v Rite Aid. The ruling reversed a lower court decision holding that the state’s MRA didn’t apply to pharmacies because a pharmacy customer was not a “patient.” “We find the fact that the court concluded that a pharmacist is a health care provider and that the recipient of prescription medication is a patient very interesting and promising, especially in light of the fact that certain government entities and others sometimes like to argue that pharmacists are not providers,” Patricia A. Epple, CAE, CEO of the Pennsylvania Pharmacists Association, told pharmacist.com. Read more: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/CM/ContentDisplay.cfm&ContentID=28264 

Compounding Rules Proposed in Pennsylvania

Pennsylvania has proposed rules that would establish standards for compound of drugs.  See here. Compounding Practices— 49 Pa. Code Chapter 27 (16A-5419)

This proposed rulemaking would establish standards for the compounding of drugs by pharmacists. Statutory Authority: Section 6(k)(9) of the Pharmacy Act, 63 P. S. § 390-6(k)(9) grants the authority to promulgate rules and regulations to effectuate the purposes of the act. Section 2 of the Pharmacy Act, 63 P. S. § 390-2(11) defines the practice of pharmacy to include the compounding of drugs.