NABP e-News December 12, 2007

Manufacturers Agree to Restrict Distribution of Methadone
As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. Manufacturers will discontinue supplying this formulation to any facility not meeting these criteria. The 5 mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. The 40 mg methadone formulation is indicated for the treatment of opioid addiction; it is not FDA-approved for use in the management of pain. This measure comes in response to the reported increase in methadone-related adverse events. A report on methadone-associated mortality will be forthcoming in the January issue of the NABP Newsletter.

USP Publishes Final Revised Standards for Compounding Sterile Preparations
US Pharmacopeia published final revisions to chapter 797 Pharmaceutical Compounding -- Sterile Preparations on December 3, 2007. These revisions tighten standards and conditions for sterile compounding over the previous version of chapter 797 to help improve patient safety. The revisions will become official on June 1, 2008, and will be included in USP 32–NF 27 and in the second edition of the Pharmacists’ Pharmacopeia, which will be published in March 2008. The revised standards have been published online to give the compounding community time to implement changes before the effective date. USP is offering educational Web-based seminars and workshops to familiarize practitioners with the revised provisions. More information and the revised chapter are available on the USP Web site at www.usp.org/USPNF/pf/generalChapter797.html.

DEA Proposes New Single-Sheet Order Form for Controlled Substances
The Drug Enforcement Administration (DEA) is proposing to implement a new format for order forms (DEA Form 222) for DEA registrants to use when ordering Schedule I and/or II controlled substances. The present format utilizes a three-part, carbon-copy form. The proposed format will use a single-sheet form. The new form includes enhanced security features and is designed to be easier for DEA registrants to use. DEA will accept comments on the proposed rule (Docket No. DEA-303P) through January 28, 2008 via e-mail at dea.diversion.policy@usdoj.gov or via electronic comment form at www.regulations.gov. More information is available in the Federal Register.

Washington Board Adopts Rule for Reporting Suspicious PSE Transactions
The Washington State Board of Pharmacy has adopted a rule to further deter the purchase of pseudoephedrine (PSE) products for use in the illegal manufacture of methamphetamine. Effective December 10, 2007, the rule establishes criteria under which pharmaceutical manufacturers and wholesalers should report to the Board any suspicious transactions involving the sale, transfer, or finishing of products containing PSE, ephedrine, or phenylpropanolamine to retailers. The rule defines a “suspicious transaction” as one that would lead a “reasonable person” to believe the substance will likely be used to illegally manufacture a controlled substance, that involves cash payment of more than $200, that meets Drug Enforcement Administration criteria for suspicious orders, and that includes regulated product exceeding 10% of nonprescription drugs contained in the order. The rule is posted on the Board’s Web site.

NABP Staff Discuss Pharmacy Technician Regulations at ASHP Midyear Meeting
NABP staff presented an educational program on the regulation of pharmacy technicians at the 42nd Midyear Clinical Meeting and Exhibition of the American Society of Health-System Pharmacists (ASHP) December 2-6 in Las Vegas, NV. The program, “Pharmacy Technician Regulation: An Evolution in Progress,” highlighted the mission and role of NABP and the boards of pharmacy in technician regulation, the prevalence of technician regulation among the states, and the NABP examination validation procedure and its relationship to the Pharmacy Technician Certification Board examination. NABP has long been an advocate for standardized, formal training and competency assessment as prerequisites for the registration or licensing of pharmacy technicians by the state boards of pharmacy. Currently, 39 states license/register or certify pharmacy technicians, and 29 states have mandatory training requirements.

Five Additional Facilities Awarded VAWD Accreditation
NABP recently accredited five new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 224 as of December 7, 2007. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Factor Health Management, LLC provides Hemophilic Factor Product for the bleeding disorder community and is licensed in 36 states. The company received accreditation for its Boca Raton, FL facility.
  • Prasco, LLC is a global pharmaceutical company specializing in providing generic prescription medications sold under the Prasco private label. The company received accreditation for its Mason, OH facility.
  • Priority Air Express, LLC, dba Priority Solutions International, is a third-party logistics provider distributing pharmaceutical samples, trade products, and printed materials to health care providers and pharmaceutical sales representatives on behalf of its manufacturer clients. The company received accreditation for its Swedesboro, NJ facility.
  • Seacoast Medical, LLC, dba Seacoast Medical, is a full service distributor of vaccines, injectables and other pharmaceutical products and serves customers in all states. The company received accreditation for its Omaha, NE facility.
  • Wyeth Pharmaceuticals Division of Wyeth distributes prescription drug products, including controlled substances, manufactured by Wyeth Laboratories or with Wyeth as a named distributor. The company received accreditation for its Sparks, NV facility.

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