NABP e-News July 12, 2007

Death in Canada Confirmed to be Result of Counterfeit Drugs Purchased via Internet
Canada's first confirmed death from counterfeit drugs purchased over the Internet reinforces long-stated concerns of the Canadian Pharmacists Association (CPhA), the association states in a July 6, 2007 press release. A British Columbia Coroner's report concludes that pills bought from a fake online pharmacy are to blame for the March death of a Vancouver Island woman. These drugs were later determined to be contaminated with extremely high quantities of metal. CPhA is calling on Canadian pharmacists to be especially vigilant and discuss these issues with patients when necessary. Since 1999, NABP, through its Verified Internet Pharmacy Practice Sites™ (VIPPS®) program, has warned of the dangers of purchasing potentially counterfeit drugs from illegitimate online pharmacies.

NABP Awards DMEPOS Accreditation to Prescription Solutions
NABP recently announced that Prescription Solutions received accreditation for both its Carlsbad, CA, and Overland Park, KS, facilities through the Association's durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. Pharmacies accredited through the NABP DMEPOS program are in compliance with requirements of the Centers for Medicare and Medicaid Services (CMS) and doing their part to ensure that Medicare beneficiaries receive the appropriate products, services, and patient care associated with DMEPOS products. In addition to its DMEPOS accreditation, Prescription Solutions has been accredited by the NABP Verified Internet Pharmacy Practice Sites™ (VIPPS®) program since April 2005.

FDA Establishes Good Manufacturing Practices for Dietary Supplements
Food and Drug Administration (FDA) recently issued a final rule requiring current good manufacturing practices (CGMP) for dietary supplements. The rule is intended to ensure that dietary supplements are produced in a quality manner, free of contaminants and impurities, and accurately labeled. The regulations establish the CGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and finished products, as well as requirements for record keeping and handling consumer product complaints. Manufacturers are also required to evaluate the identity, purity, strength, and composition of their dietary supplements. If the dietary supplements contain contaminants or lack the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded. FDA also issued an interim final rule that would allow manufacturers to request an exemption to the CGMP requirement for 100% identity testing of specific dietary ingredients used in the processing of dietary supplements. The final CGMP and interim final rule are effective as of August 24, 2007, with a three-year phase-in for small businesses.

FDA Seeks Input on Removing Essential-Use Designations from Ozone-Depleting Substances
Food and Drug Administration (FDA) will hold a public meeting to solicit comments on a proposed amendment to FDA’s regulation on ozone-depleting substances (ODS) in self-pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. In the Federal Register of June 11, 2007 (72 FR 32030), FDA proposed removing the essential-use designations of MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. If the essential-use designations are removed, these drug products could not be marketed after the effective date of the final rule, proposed for December 31, 2009. The public meeting will be held on August 2, 2007, at FDA headquarters in Rockville, MD. Comments for consideration at the meeting, requests to speak at the meeting, and registration to attend the meeting are due by July 25. FDA is accepting written or electronic comments on the proposed rule, “Use of Ozone-Depleting Substances; Removal of Essential-Use Designations” (docket no. 2006N-0454), until August 10.

CMS Proposal Would Eliminate e-Prescribing Exemption for Computer-Generated Faxes
In a push to accelerate adoption of e-prescribing, Centers for Medicare and Medicaid Services (CMS) on June 29, 2007 issued a proposed rule that includes a provision to eliminate the exemption for computer-generated faxes from e-prescribing standards. Through a final rule published in November 2005, CMS adopted e-prescribing standards for use by physicians and suppliers in connection with prescriptions under Medicare Part D, effective January 1, 2006. The standards include a SCRIPT standard for communications between physicians and pharmacies regarding prescription information. The rule exempted entities transmitting prescriptions via computer-generated faxes (ie, faxes generated by a prescriber’s computer and sent to a dispenser’s fax machine) from using the SCRIPT standard. Without this exemption, entities using e-prescribing software that generates faxes would either have been required to comply with the SCRIPT standard or revert to paper prescribing. CMS proposes to eliminate the exemption to encourage e-prescribers and dispensers to move as quickly as possible to using the SCRIPT standard. The proposed rule recommends an effective date on or after January 1, 2008. CMS is accepting comments on the proposed rule via its Web site at http://www.cms.hhs.gov/eRulemaking until August 31, 2007.

Miami DME Supplier Convicted on Charges of Medicare Fraud
The owner of a Miami health care company has been convicted on charges of defrauding the Medicare program of millions of dollars, the Department of Justice (DOJ) announced in a June 28 news release. After a three-day trial in Miami, the federal jury found Gisela Valladares, owner of PRN Home Health Care, Inc, guilty on five counts – conspiracy to defraud the United States Department of Health and Human Services and submit false claims and receive kickbacks, conspiracy to commit health care fraud, and three counts of receiving kickbacks. Two Miami pharmacy owners, Alfonso Rodriguez and Henry Gonzalez, billed the Medicare program for over $20 million based on the referral of false prescriptions for compounded aerosol medications provided by Valladares and other co-conspirator durable medical equipment (DME) suppliers. The full news release is available on the DOJ Web site at http://www.usdoj.gov/criminal/pr/press_releases/2007/06/06-28-07gvalladares-convict.pdf.

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 146 as of July 10, 2007. A full listing of VAWD facilities is available in the VAWD section of the NABP Web site at http://www.nabp.net.

  • Drogueria Central, Inc distributes prescription products to pharmacies, hospitals, and other wholesalers in the 20 states where it holds licenses. The company received accreditation for its Monroe, OH facility.
  • Integrated Commercialization Solutions, dba ICS, ships prescription products nationwide as directed by the manufacturers-owners of the products. The company received accreditation for its Brook, KY facility.
  • PharmPak, Inc is a wholesale and repackaging facility servicing customers – primarily physicians – in the 34 states where it holds licenses. The company received accreditation for its San Rafael, CA facility.
  • RxC Acquisition Company, dba RxCrossroads Third Party Logistics Division, provides distribution services to other distributors, hospitals, pharmacies, and doctors throughout the United States and to South America. The company received accreditation for its Louisville, KY facility.
  • Theracom, Inc distributes injectable medications used in the treatment of cystic fibrosis, cancer types, enzyme replacement, and rheumatoid arthritis to physicians, clinics, and hospitals in 41 states. The company received accreditation for its Rockville, MD facility.

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