NABP e-News November 15, 2007

NABP Testifies at FDA Meeting on Proposed Behind-the-Counter Class of Drugs
NABP testified at the Food and Drug Administration (FDA) meeting November 14, 2007, stating its support for the proposed creation of a behind-the-counter (BTC) class of drugs. The meeting was held to solicit input on the public health benefits of certain medications being available BTC without a prescription but only after intervention by a pharmacist. A long-time advocate of this measure, NABP passed a resolution in 1993 advocating a third class of drugs that would be dispensed without a prescription only by licensed health care professionals authorized to prescribe and/or dispense prescription drugs. Continuing its support of this concept, NABP passed a resolution in 1995 stating that medications being converted from prescription-only to over-the-counter status that pose serious risks and require patient education for effective use should be placed in a special class requiring sale only by licensed health care professionals after counseling the patients on proper use. FDA is accepting comments electronically until November 28 at www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm (Docket No. 2007N-0356). More information is available in the Federal Register.

Illinois, Wisconsin Legislatures Adopt Legislation to Protect Drug Distribution Systems
Illinois State Bill (SB) 509 was approved by Governor Rod Blagojevich on October 29, 2007. The bill, in part, increases licensing requirements for wholesale drug distributors and also establishes pedigree requirements for prescription drugs that leave the normal distribution channel. Wisconsin SB 40, the Budget Bill, was approved by Governor Jim Doyle on October 26. The bill contains provisions that increase the licensing requirements for wholesale drug distributors, require pedigrees for prescription drugs that leave the normal distribution channel, and recognize inspections of wholesale distributors conducted by NABP.

FDA Study Suggests Consumers Buy Meds Online to Sidestep Rx Rules
Food and Drug Administration (FDA) recently announced the results of a year-long investigation, which suggest that consumers are buying drugs online to avoid the need for a prescription from their physicians. The investigation, comprising surveys conducted from September 2006 to August 2007 in international mail and courier facilities across the country, found 88% of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. More than half (53%) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the US to be generally less expensive than comparable drugs in Canada or Western Europe. Other products included dietary supplements, foreign products with “illegible or incomprehensible” labeling, and medications not available in the US. FDA warns that products from unregulated Internet drug sellers may contain the wrong ingredients or toxic substances. Earlier this year, FDA learned that 24 apparently related Web sites operating outside the US may be involved in the distribution of counterfeit prescription drugs.

NABP Awards VIPPS Accreditation to Rx Direct
NABP recently accredited RxDirect, Inc through its Verified Internet Pharmacy Practice Sites™ (VIPPS®) program. To be VIPPS-accredited, a pharmacy must comply with the licensing and inspection requirements of its state and of each state to which it dispenses medications. In addition, it must meet VIPPS criteria, which address such issues as the patient’s right to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists. Based in Texarkana, TX, RxDirect is a full-service mail-order and online pharmacy that provides prescription and over-the-counter medications to employees of its contract groups. Approximately 30% of the business is composed of Internet pharmacy service. RxDirect is a division of the pharmacy benefits management company US Scripts, Fresno, CA. More information about VIPPS is available under Accreditation on the NABP Web site.

NABP Awards DMEPOS Accreditation to BioScrip Chain, 19 Independent Pharmacies
BioScrip, Inc has received accreditation for its licensed pharmacies and mail-order facility through the NABP durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. NABP also recently awarded DMEPOS accreditation to 19 independent pharmacies. The DMEPOS program ensures that pharmacies supplying DMEPOS products meet the Centers for Medicare and Medicaid Services’ (CMS) quality and accreditation standards. Those pharmacies that are accredited through the program are doing their part to ensure that Medicare beneficiaries receive the appropriate products, services, and patient care associated with DMEPOS. The full news release on the accreditation of BioScrip is posted under News/Press, and a full listing of DMEPOS-accredited pharmacies is available under Accreditation on the NABP Web site.

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 216 as of November 9, 2007. A full listing of VAWD facilities is available under Accreditation on the NABP Web site.

  • Atlantic Biologicals Corporation is a small distribution facility, licensed in 20 states, that serves as an authorized distributor of record for a number of recognized pharmaceutical manufacturers. Its customer base consists of hospitals, medical centers, and physicians’ offices. The company received accreditation for its Goodletsville, TN facility.
  • Cedardale Distributors, LLC distributes generic prescription drugs, including Schedule III-IV controlled substances, to independent pharmacies, small chain pharmacies, hospitals, and long-term care facilities in the 48 states where it is licensed. The company received accreditation for its, Carlstadt, NJ facility.
  • Corporate Mailings, Inc, dba Corporate Communications Group/PharmaWay, distributes over-the-counter and prescription product samples, trade products, and printed materials directly to health care providers and pharmaceutical sales representatives on behalf of its manufacturer clients. The company received accreditation for its Fairfield, NJ facility.
  • Mallinckrodt, Inc manufactures and distributes pharmaceutical products used in nuclear medicine. It provides a full line of contrast media, delivery systems, radiopharmaceuticals, and urology imaging systems for the diagnosis and treatment of disease to hospitals and clinics nationwide. The company received accreditation for its Maryland Heights, MO facility.
  • Reliance Wholesale, Inc is a national distributor of specialty, non-controlled prescription products, such as injectables, vaccines, IGIV, plasma protein factor, anti-hemophilic factors, hyper immunes, and other biological products. Its customer base consists primarily of hospitals. The company received accreditation for its Cordova, TN facility.

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