109th Annual NABP Meeting--Compounding/Manufacturing Debate: When Is a Duck Not A Duck?

May 18-21, 2013
Saturday, May 18, 2013
9 am - 7 pm
Registration/Information Desk Open
2 - 4 pm
Pre-Meeting CPE
The Compounding/Manufacturing Debate: When Is a Duck Not a Duck? ACPE #205-000-13-001-L03-P
(0.2 CEUs – 2 contact hours)
5 - 6 pm
Annual Meeting and District Meeting Orientation
7 - 10 pm
President’s Welcome Reception
Sponsored by Express Scripts Honoring NABP President Michael A. Burleson, RPh Dinner will be served
Dress: business casual
Sunday, May 19, 2013

Institute of Medicine Cites VAWD and VIPPS in Recommended Actions for Fighting Substandard Drugs in the US and Globally

Substandard and falsified medications have led
to thousands of cases of illness, injury, and death around the world, includ- ing the recent cases in the United States involving the distribution of a contaminated compounded inject- able drug to pain clinics and hospitals in 19 states, and the distribution of
fake cancer medication to numerous clinics around the country. Regulators tackling the problem – both in the US and abroad – face challenges including the complexity of the global pharmaceutical distribution chain and varied standards, regulations, and enforcement efforts.
continue to read here  

Iowa Compounding Inspection Program Progresses With Member Support

Iowa Inspection Program Ongoing

In late 2012, the Iowa Board of Pharmacy partnered with other states
and NABP to conduct inspections of all nonresident pharmacies includ- ing those believed to be delivering compounded drugs into the state. Ongo- ing surveys are focused on inspecting all nonresident pharmacies shipping into the state of Iowa for the purpose of facilitating licensure and to confirm that all pharmacies provid- ing product and services
to patients in Iowa, in particular those entities engaging in sterile or other drug compounding, are doing so in a safe and legal manner.

Under the contract
with the Iowa Board, since mid-December, NABP surveyors have completed inspections of 100 pharmacies in nine states. Inspections are ongoing across the nation and as such are not consigned to any one state. On average, NABP surveyors complete 15 to 20 inspections a week, with reports submitted directly to the Iowa Board.

NABP works in part- nership with the boards
of pharmacy in each state, and in several states board inspectors have accompa- nied NABP surveyors on inspections.
Aggregate data reports with relevant survey findings, along with Surveyor Scoring Reports are disseminated to the Iowa Board of Pharmacy on a weekly basis. Initial results of the inspections include a wide range of observations on the entities inspected
to date. For example, when visiting some sites, surveyors discovered that the facilities ceased compounding activity in late 2012. In a few instances, the address of the company was no longer valid, and it must
be determined whether
the entity moved, or is no longer in operation, and whether they notified the home or nonresident states in which they hold licenses. Some facilities had voluntarily surrendered their Iowa license prior
to the date of inspection but their products are still being used in Iowa, and some indicated they main- tained Iowa licensure only as part of the company’s contingency planning,
and were not distributing or dispensing drugs into the state. In those cases an inspection is done because distribution to Iowa can occur at any time. Other initial observations for the Iowa Board include documentation that some pharmacies are distributing sterile or other compounded drugs for office use, and some are using central fill processing for sterile and non-sterile compounded drugs.

Additional information about the Iowa inspection program results will be presented at the NABP 109th Annual Meeting, May 18-21, 2013, in St Louis, MO, and will also be included in future issues of the NABP Newsletter..

Quoted from the National Board of Pharmacy May 2013 Newsletter 

Texas State Board of Pharmacy Meeting Scheduled for May 7, 2013; Task Force on Compounding of Sterile Preparations Is In Agenda

To view complete agenda click here

Interesting Discussion At March 2013 Utah State Board of Pharmacy Meeting Regarding Compounding

Mr. Steinagel met with the Board and reviewed the Division’s response to recommendations made by the Compounding Task Force.

The task force recommends that the Division enforce  an inspection moratorium on compounding pharmacies. The Division is uncomfortable with this idea. The Division cannot cease issuing citations and disciplining compounding pharmacies.

The task force recommends that DOPL investigators and inspectors go through training on federal laws that regulate the pharmacy profession. The Division supports this idea and is willing to provide additional training for investigators. Five investigators will go through intensive NABP training in May that was scheduled before the task force met to discuss recommendations.
The task force encourages inspectors to educate licensees when they investigate them and follow-up on inspections. The Division supports this idea.
The task force recommends updating of the compounding self-inspection report. The Division agrees with this idea and will consult with Board members and others in the field as necessary as updates to the report are made. The Division will make updates to the report and submit a revised self- inspection report to the Board for review at the May meeting.
The task force recommends creation of self- inspection reports for Class B and C pharmacies. The Division is working on this.
The task force recommends that the Pharmacy Practice Act be revised. The Division is happy to provide input to Board members, legislators, and associations as they propose amendments to the Act. The Board will be discussing possible amendments to the Act during future Board meetings.
The task force recommends that standards regarding transferring compounds within the same institutional setting be clarified and that language in regard to manufacturing vs. traditional vs. non-traditional compounding be clarified. The Division is willing to work with the Board on these items.

The task force recommends that DOPL send a letter to compounding pharmacies. A letter was sent last year and the Division is willing to consider sending a second one this year.

The task force recommends that network-network- network become compliant with USP standards. This is something the Division agrees that the industry can work on.
Mr. Steinagel advised the Board that DOPL is interested in inviting NABP to come to Utah to make training available to representatives of pharmacies in Utah that engage in compounding. This training is three or four days and is very intensive. Mr. Steinagel advised the Board that it would require legislation to amend the laws upon which the inspection report is based.
The Board expressed concern regarding sending sterilized compounding out of state. Mr. Steinagel noted that currently pharmacies are self reporting to DOPL and encouraged the Board to consider the following options: (1) Creation of licensure for compounding pharmacy; (2) Require pharmacies to declare whether they do sterile compounding; (3) During renewal, have the pharmacy representative affirm whether they are engaging in sterile compounding. The Board will discuss this at a future meeting.

Quoted from Utah Board of Pharmacy March 3, 2013 minutes 

State Inspector Recommends to Vermont Board of Pharmecy that it Make USP 797 Standard for All Compounding Pharmacies to Follow

Compounding Pharmacy Rules – Inspector Vincent spoke to the Board about the issues he sees when inspecting. He feels our Rules do not adequately address sterile compounding and suggested the Board consider making USP 797 the standard for all compounding pharmacies to follow. Ms. Eaton suggested making a small committee, possibly two Board members with counsel and Mr. Klein, to discuss the adoption of USP 797 and refining the institutional pharmacy regulations.

Source found at http://vtprofessionals.org/opr1/pharmacists/minutes_agenda/Pharmacy_Minutes_2013_0327.

We're dedicated to patients' health: Another view by David Miller

David G. Miller6:29 p.m. EDT April 28, 2013

  Source quoted from USAToday

Let state boards enforce national standards

STORY HIGHLIGHTS

• NECC was essentially manufacturing drugs, not compounding.
• We're studying the bill released by several senators Friday.
• We're concerned that some provisions could reduce patient and physician access to customized medications.

When the tragic news of the deaths and sickness associated with products made at the New England Compounding Center came out last fall, the nation's attention appropriately focused on what went terribly wrong — and what steps to take to keep anything like it from ever happening again.

OUR VIEW: Time to fix 'broken' system

Pharmacists were more concerned than anyone because our profession is dedicated to one thing: the health of the patients we serve by compounding drugs upon request from authorized prescribers, such as doctors. NECC was essentially manufacturing drugs, not compounding.

The difficult matter that the public, the industry, policymakers and Congress are wrestling with is what regulations, laws or jurisdictions must be changed to make sure no NECCs happen again.

The International Academy of Compounding Pharmacists, representing 3,000 pharmacists nationwide, is studying the bill released by several senators Friday. We applaud the steps the Senate is taking to ensure that compounded medications are as safe as they can be.

But we believe aspects of the draft will need further discussion and refinement, and we intend to work with the committee on these. We plan to offer suggestions on improving standards to raise the quality of compounded medications.

Our group is also concerned that some provisions could reduce patient and physician access to customized medications, the very essential services that compounding pharmacists provide. We support nationwide standards enforced by each state's board of pharmacy, the entities that have traditionally regulated compounding pharmacies.

We also want to eliminate loopholes and don't believe that any group of pharmacies should be exempted from regulatory change, as this bill would do.

The states are responsible for licensing and oversight of medical providers, including compounding pharmacies, and the FDA is and should be responsible for pharmaceutical manufacturers. The terminology and some definitions in the proposed category of "compounding manufacturers" create confusion and blur authority of regulators. Our group will recommend improvements to make the proposed categories clearer.

Our members look forward to finding the right steps to ensure the safety of patients everywhere — steps that won't prevent compounding pharmacists from continuing to serve the public's vital health needs.

David G. Miller is CEO of the International Academy of Compounding Pharmacists.

Drug Traceability Drafts Reflect Progress, Supply Chain Stakeholders Say

(Daily News - 04-26-2013)
CHICAGO -- The majority of supply chain stakeholders believe all sectors of industry should be subject to federal standards under a drug traceability system, according to a survey by the Pew Charitable Trusts that emerges as members of Congress prepared to debate the development of a drug track and trace system, including potential exemptions and considerations for small pharmacies.
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Meningitis spreads to finger-pointing

Apr. 27, 2013 10:19 PM    Livingston County is all but the epicenter of the meningitis cases that have grown out of the scandal originating at a large-scale — and woefully unregulated — compounding pharmacy in Massachusetts.  continue reading here

The Chronicle of the Horse Has Interesting Discussion On-going Regarding Vets Liability or Compounded Medications

To read and follow this discussion click here