Pharmacy Boards Propose Accreditation Program To Ensure Safe Rx Imports
This article was originally published in The Pink Sheet Daily
Executive Summary
National Association of Boards of Pharmacy says its Verified Internet Pharmacy Practice Sites program can be revised and implemented to ensure that foreign pharmacies are dispensing drugs in accordance with U.S. federal and state laws. The VIPPS program is already in place in Canada.
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The National Association of Boards of Pharmacy proposes using its Verified Internet Pharmacy Practice Sites accreditation program to facilitate safe drug importation. "The VIPPS program can be implemented to ensure that foreign pharmacies and wholesale distributors are dispensing and distributing medications, respectively, in accordance with state and federal laws," NABP Exec Director Carmen Catizone said in written testimony before a Senate Health Committee hearing on drug importation safety Feb. 16. If drug importation legislation is signed into law, NABP would be able to "define an International VIPPS Patient Care Pharmacy agreement to certify VIPPS-accredited pharmacies outside of the U.S.," Catizone's testimony states. The group also would amend the VIPPS criteria. The program currently requires that pharmacies comply with the licensing and inspection requirements of their state and that of each state to which they dispense pharmaceuticals. The new criteria would "require pharmacies dispensing medications across the border and seeking VIPPS accreditation to document and provide evidence on an on-going basis that the drug products being distributed were FDA approved and obtained from FDA-registered facilities," Catizone said in his written testimony. "The international pharmacy seeking VIPPS accreditation would also have to document and demonstrate compliance with the laws and the patient care standards of all jurisdictions in which the patient and the pharmacy resides," his testimony states. NABP also would work with U.S. and foreign pharmacy authorities to develop mutual enforcement agreements requiring licensure and registration in the countries where they are located and where the patient resides. "The mutual enforcement agreements would also require continued monitoring of the distribution and dispensing of medications in order to ensure that the pharmacy maintains its compliance with all applicable laws/regulations," Catizone's testimony states. The program would charge slightly higher fees compared to the domestic VIPPS program due to the additional costs of international travel for inspections. To receive a domestic VIPPS seal, an independent community-based pharmacy must pay a $5,375 application fee and an annual participation fee of $2,000 ($4,375 during an inspection year). NABP is in a unique position to set up and run such a program because it currently accredits Canadian internet pharmacies. In November 2003, NABP and Canadian pharmacy regulators expanded the VIPPS program to include "legitimate, legal and safe pharmacies duly registered in the various provinces" of Canada, Catizone's testimony states. Canadian pharmacies that currently export drugs to the U.S. do not quality for VIPPs certification because they are violating state and federal laws, he noted. NABP also proposes that use of its Verified-Accredited Wholesale Distributors program on an international basis would help ensure the safety of imported drugs. - John Rancourt |