Pharmacy Compounding Pharmacy Compounding: FDA Actions

Pharmacy Compounding Pharmacy Compounding: FDA Actions

Meningitis outbreak sparks investigations, lawsuits, fears

Second of two parts

Part 1: National fungal meningitis outbreak hits Michigan the hardest; 259 infected, 14 killed

In September, Milda Mattila became unsteady on her legs. Soon, she was unable to walk.

The 87-year-old South Lyon woman had been infected with fungal meningitis through a tainted steroid shot meant to relieve back pain.

"Why did I have to get this?" she asked her family.

That question fills households and hospital rooms as hundreds of people struggle with the physical, emotional and financial scars left in the wake of the national fungal meningitis outbreak that has killed at least 51 people, including 17 Michigan residents. Nationwide, 730 people have fallen ill, including 259 in Michigan.

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California State Board of Pharmacy LEGISLATION AND REGULATION COMMITTEE April 11, 2012

California State Board of Pharmacy
1625 N. Market Blvd, N219, Sacramento, CA 95834 Phone: (916) 574-7900
Fax: (916) 574-8618
www.pharmacy.ca.gov
NOTICE OF MEETING AND AGENDA

STATE AND CONSUMER SERVICES AGENCY DEPARTMENT OF CONSUMER AFFAIRS GOVERNOR EDMUND G. BROWN JR.

California State Board of Pharmacy LEGISLATION AND REGULATION COMMITTEE April 11, 2012

DATE: April 11, 2013
PLACE: Department of Consumer Affairs Headquarters Building II
1747 North Market Blvd., Room 186 Sacramento, CA 95834

This committee meeting is open to the public and is accessible to the physically disabled. A person who needs a disability‐related accommodation or modification in order to participate in the meeting may make a request by contacting Laura Hendricks at (916) 574‐7918, by emailing laura.hendricks@dca.ca.gov or sending a written request to the Board of Pharmacy, 1625 N. Market Blvd., Suite N‐219, Sacramento, CA 95834. Providing your request at least five business days before the meeting will help to ensure availability of the requested accommodation.
Opportunities are provided to the public to address the committee on each open agenda item. Board members who are not on the committee may attend the meeting as observers. Action may be taken on any item on the agenda.
CONTINUING EDUCATION: Pharmacists and pharmacy technicians who attend the full committee meeting in person may be awarded two hours of Continuing Education (CE) in accordance with the Board’s CE policy. Sign‐in and sign‐out that day is required for the CE credit.

Contact Person: Virginia Herold (916) 574‐7911

Call to Order
A. LEGISLATION REPORT

9:00 a.m.

1.

Board‐Sponsored Legislation for 2013

1. SB 294 (Emmerson) – Compounded Sterile Drug Products
   
2. Board‐Approved Proposals for 2013‐2014
   
3. Board Proposal – Section 4046 “Correctional Pharmacy” Defined
   
4. Omnibus – SB 822, SB 821
   

Agenda

Page 1 of 3
Meeting Materials will be available on the board’s Web site at www.pharmacy.ca.gov by April 9, 2013.

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AMCP, Pharmacy Stakeholders Discuss Compounding Issues at FDA Meeting

The Academy joined other pharmacy stakeholders last month in an invitation-only meeting on pharmacy compounding issues. The Dec. 14 meeting was convened by the Food and Drug Administration (FDA) in the wake of the deadly fungal meningitis outbreak linked the New England Compounding Center’s (NECC) production of tainted drugs.

The pharmacy groups were generally in agreement that the recent actions of NECC constitute illegal manufacturing and not pharmacy compounding. While the participants indicated that distinctions are necessary to delineate traditional compounding from larger-scale activities, no specific recommendations were offered.

The pharmacy groups focused on the need to ensure that pharmacies that compound conform to the standards in USP Chapters 795, non-sterile preparations and 797, sterile preparations. State boards must be given resources and training to understand issues associated with compounding practices. Accreditation of compounding pharmacies should be highly encouraged but not required.

The FDA noted that eliminating the ability to conduct larger-scale compounding activities would disrupt hospitals and cause unnecessary financial implications.

The FDA further indicated that the traditional distinctions between compounding and manufacturing may not be suited for the needs of modern medicine, particularly as personalized medicine will require more customized preparations.

To meet these needs, FDA has offered recommendations for a two-tiered approach giving FDA oversight for large scale compounding and allowing the states to maintain oversight of traditional pharmacy compounding. Some members of Congress and various pharmacy groups reject this approach and prefer oversight be maintained by state boards with a default to FDA only if states fail in their responsibilities. 

This meeting was one of many ongoing meetings between FDA and health care professionals, consumer groups, state boards, hospitals, and other entities affected by compounding.

Other pharmacy stakeholders at the meeting included: American Association of Colleges of Pharmacy; American Pharmacists Association; American Society of Health-System Pharmacists; International Academy of Compounding Pharmacy; Institute of Safe Medication Practices; National Association of Chain Drug Stores; National Community Pharmacists Association; Pharmacy Compounding Accreditation Board; Society of Veterinary Hospital Pharmacists; and, Express Scripts, Inc. Participants from FDA included representatives from the Administrator's office and key pharmacists and others with pharmacy expertise from various sections of the Agency.