|Capitol Connections September 28, 2012|
September 28, 2012
Utah Compounders Success
In mid-August, the Utah Board of Pharmacy issued a notice to pharmacists in the state warning against the compounding of estriol without an FDA-issued IND (Investigational New Drug) approval. This followed on the heels of a July 23, 2012 letter from IACP to the Board raising concerns about those regulations -- UT BReg R156-17b-614a(3)(c) and UT BReg R156-17b-614a(3)(d) – which requires that pharmacists compounding with bulk active ingredients may only do so when the ingredient is a component of a Food and Drug Administration (FDA) approved drug. Lacking that status, the pharmacy licensee is required to obtain an Investigational New Drug application (IND) from the FDA and retain it for inspection for a period of five years. Click here to read the article in its entirety and view original IACP correspondence.
Texas Board of Pharmacy Finalizes Regulations
In July, IACP submitted written comments on draft compounding regulations issued by the Texas Board of Pharmacy. As written, the new regulations would have required mandatory recalls of compounded preparations whenever a pharmacist received a report or had reason to believe that an adverse patient effect was due to the dispensed product. Additionally, the regulations included an entirely new provision which would have enabled the state to create a “do not compound” list. Click here to view article in its entirety.
Maine Medicaid Reduces Reimbursement
The state of Maine and its Medicaid program has issued a new set of reimbursement guidelines for community and compounding pharmacies. Due to increasing budgetary pressures, ingredient cost reimbursement has decreased to AWP less 16 percent and a mandatory generic substitution requirement is now in effect. Compounding fees for stock supply and for solutions and lotions for which no weighing is involved have been eliminated.
IACP is providing the entire document on the new reimbursement methodologies for our New England members. Click here to view.
Iowa Board of Pharmacy Proposed Regulations
The Iowa Board of Pharmacy has issued several proposed regulation changes that would amend Chapter 13, "Sterile Compounding Practices," and Chapter 20, "Pharmacy Compounding Practices," Iowa Administrative Code.
The proposed amendments change definitions in both chapters to clarify the terms used and to ensure uniformity of interpretation of like terms contained in both chapters. Click here to view article in its entirety.
Misleading Statements and “Special” DEA Licenses
For the past several weeks, IACP has received numerous reports from members that a pharmacy is distributing marketing materials through its sales representatives that indicate they are involved in a special “pilot” program with the Drug Enforcement Administration (DEA) which enables them – and only them – to compound controlled substances prescriptions for “office-use” dispensing.
IACP Coordinating DEA Efforts with Veterinary Practitioners
IACP is working closely with the American Veterinary Medical Association (AVMA) on an issue that directly relates to IACP’s concerns with the Drug Enforcement Administration’s current interpretation of "constructive transfer." AVMA has formally sent a letter to the Drug Enforcement Administration (DEA) citing practitioner problems with both DEA regulation and existing statutory language in the Controlled Substances Act (CSA).
Congressman Tiberi Takes DEA to Task on Constructive Transfer
On September 19, 2012, Congressman Patrick J. Tiberi (R-OH) sent a letter to Michelle M. Leonhart, Deputy Administrator of the Drug Enforcement Administration (DEA), on the issue of the “constructive transfer” of controlled substances. Click here to view letter.
As reported in previous issues of Capitol Connections...Click here to view article in its entirety.
Requesting NABP e-Profile ID and Birth Date!
Pharmacists and pharmacy technicians are now required to submit their NABP e-Profile ID and birth date to receive credit for any ACPE-accredited CPE session. The new electronic system, CPE Monitor, will now track completed CPE credits online for pharmacists and pharmacy technicians. Please click here to register for your NABP e-Profile ID. You will be asked for your NABP e-Profile ID and birth date when registering for IACP Continuing Education events.
To make sure you receive your IACP Continuing Education Credits, please take a moment to log into the IACP Member Center and update your membership profile with your NABP e-Profile ID and birth date. Click here to view article in its entirety.
Drug Theft Bill Cleared to go to President
H.R. 4223 – the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (also known as the SAFE DOSES Act) – has passed and been agreed upon by both the House and Senate. H.R. 4223, which is currently awaiting the signature of President Barack Obama, creates several criminal penalties for individuals who steal or misappropriate drugs, namely those within the supply chain.
California Pharmacists Association’s (CPhA) Compounders Day: An Educational Event!
The California Pharmacists Association’s (CPhA) annual Compounders Day was held on September 8, 2012, at the Town & Country Resort & Conference Center in San Diego, Calif. Attendees were pleased with the variety and relevance of the programming, beginning with a very hot topic: Anti-Aging and Cosmeceutical Niche, presented by IACP Member Kristen Riddle, PharmD, of US Compounding Pharmacy in Conway, Ark. This was a useful program to assist compounders...Click here to view article in its entirety.
USP’s Upcoming Vet Drug Activities
In November, the United States Pharmacopeia (USP) will be holding two important meetings related to veterinary medicines.
The first is a two-day workshop (November 7-8, 2012) on Solubility Criteria for Vet Products. This workshop, co-sponsored with the American Academy for Veterinary Pharmacology and Therapeutics, is a first step towards a new USP General Chapter on the topic. To register or for more information about this meeting, click here.
The second meeting occurs the day after the workshop (Nov. 9) – the Veterinary Drug Stakeholder Forum—the first of its kind for USP. To register or for more information about this meeting, click here.
IACP Members are encouraged to share this information with colleagues as well as consider attending.
NCPA Debuts Mail Order Pharmacy Problems Video
The National Community Pharmacists Association (NCPA) recently released a new video intended to raise awareness of 1) common problems patients experience with mail order pharmacy and 2) the importance of providing patients with a choice of pharmacy. It can be viewed at www.whorunsmydrugplan.com, as well as on YouTube.
IACP Members, please consider mentioning this NCPA video in any blogging, tweeting, sharing on Facebook, etc. Click here for more information.
Drug Shortages Update
Duke physicians come up with a plan for 'tragic choices' – WRAL-TV Raleigh
Coping with Critical Drug Shortages – Archives of Internal Medicine
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