NABP e-News November 28, 2007

DEA Publishes Rule on Issuing Multiple Prescriptions for Controlled Substances
Drug Enforcement Administration (DEA) published in the Federal Register on November 19, 2007, a final rule titled “Issuance of Multiple Prescriptions for Schedule II Controlled Substances.” Effective December 19, 2007, the rule amends DEA regulations to allow practitioners to provide an individual patient with multiple prescriptions for a specific Schedule II controlled substance, written on the same date, to be filled sequentially. The change will allow patients to receive over time up to a 90-day supply of the prescribed controlled substance. The Controlled Substances Act does not permit the refilling of Schedule II controlled substances; a new prescription must be issued for each quantity of the substance. More information is available in the Federal Register (Docket No. DEA-287).

Beijing Drug Administration Officials Visit NABP to Discuss Pharmacy Regulation
A Beijing Drug Administration delegation met with NABP executives and senior management on November 19, 2007, at NABP headquarters in Mount Prospect, IL to discuss how pharmacy is regulated in the United States. Topics included supervision, management, and regulation of retail pharmacies; regular inspection, confiscation, and discipline to control counterfeit medications; and laws and regulations on medication production, brand advertising, and other manufacturer issues.

Groups Convene Public Workshop to Address Adolescent OTC Drug Product Use
Food and Drug Administration (FDA), National Institutes of Health (NIH), and Consumer Healthcare Product Association (CHPA) will convene a public workshop entitled “Adolescent Over-the-Counter (OTC) Drug Product Use” December 6-7, 2007. The purpose of the workshop is to gain an understanding of current use of OTC drug products by adolescents, including adolescent decision making skills (compared with adult skills) and other factors influencing adolescent OTC drug product use. Information gathered at the workshop and from submitted comments will be used to identify when it would be most appropriate for consumer studies on OTC drugs to enroll adolescents, and to define the type of consumer research and study designs needed to support OTC drug product approval in the adolescent population. More information is available in the Federal Register. Comments will be accepted through January 31, 2008.

CMS Proposes e-Prescribing Standards
Centers for Medicare and Medicaid Services (CMS) published a notice in the Federal Register on November 16, 2007, proposing the adoption of final uniform standards for an electronic prescription drug program, as required by section 1860D-4(e)(4)(D) of the Social Security Act. It also proposes the adoption of a standard identifier for providers and dispensers for use in e-prescribing transactions under sections 1860D-4(e)(3) and 1860D-4 (e)(4)(C)(ii), and section 1102 of the Act. More information is available in the Federal Register (Docket No. CMS–0016–P). Comments will be accepted through January 15, 2008.

NABP Awards DMEPOS Accreditation to Medicine Shoppe Pharmacies
NABP recently accredited seven Medicine Shoppe International, Inc pharmacies through the NABP durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. The DMEPOS program ensures that pharmacies supplying DMEPOS products meet the Centers for Medicare and Medicaid Services’ (CMS) quality and accreditation standards. Medicine Shoppe International, a subsidiary of Cardinal Health Inc, has nearly 1,000 domestic pharmacies operating under the Medicine Shoppe® and Medicap Pharmacy® trade names and more than 400 franchised pharmacies in six other countries. A complete list of pharmacies accredited through the NABP DMEPOS program is available under Accreditation on the NABP Web site.

  • Harrisburg Pharmacy Services, Inc, dba Medicap Pharmacy #8372, Harrisburg, NC
  • Medicap Pharmacy #8334, York, SC
  • Medicine Shoppe #0188, Kansas City, KS
  • Medicine Shoppe #0483, Munhall, PA
  • Medicine Shoppe #1101, Springboro, OH
  • Medicine Shoppe #1114, Greensburg, PA
  • Medicine Shoppe #1788, Deer Park, WA

Four Additional Facilities Awarded VAWD Accreditation
NABP recently accredited four new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 219 as of November 23, 2007. A full listing of VAWD facilities is available under Accreditation on the NABP Web site.

  • Healix Infusion Therapy is a 75-site network of pharmacies and affiliated physicians. The distribution center provides intravenous immune globulin (IVIG) solutions for its network affiliates. The company received accreditation for its Sugar Land, TX facility.
  • Jace Pharmaceuticals, Inc distributes biological prescription drug products such as IVIG solutions, lyophilized products, and injectables to its customers in the hospital, pharmacy, and home infusion markets. The company received accreditation for its Paramus, NJ facility.
  • MMS – A Medical Supply Company provides non-prescription drug products, such as test kits for blood and urine, to physicians and laboratories through its nine distribution centers. The company received accreditation for its Carmel, IN facility.
  • Vedco, Inc provides a full line of veterinary products to veterinary clinicians through a network of 26 distributor locations nationwide. The company received accreditation for its St Joseph, MO facility.

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