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NABP e-News August 25, 2006
FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older, Remains Prescription Only for those 17 and Under
On August 24, the Food and Drug Administration (FDA) announced approval of Plan B, commonly referred to as emergency contraception or the "morning after pill", as an over-the-counter (OTC) option for women aged 18 and older. Prior to yesterday's FDA decision, Plan B like other birth control pills has been available to all women as a prescription drug. Plan B will remain available as a prescription-only product for women age 17 and under. Barr Pharmaceuticals, manufacturer of Plan B, has agreed to initiate a rigorous labeling, packaging, education, distribution, and monitoring program to ensure the OTC/Rx only split is enforced. Plan B will only be available at licensed pharmacies and clinics, not gas stations or convenience stores where health-care professionals are not present. Individuals who want to obtain this drug product will have to show identification proving they are at least 18 years old. For those younger than 18, the drug will still require a prescription. For more information on Plan B and the FDA's action, visit http://www.fda.gov/cder/drug/infopage/planB/default.htm.
NABP's Executive Director Joins Senator Marvin D. Reigsecker at Midwestern Legislative Conference
NABP Executive Director Carmen A. Catizone, MS, RPh, DPh, worked with Senator Marvin D. Reigsecker (R-IN) on the dangers of counterfeit drugs during the 61st Annual Meeting of the Midwestern Legislative Conference (MLC), held at the Chicago Sheraton Hotel and Towers in Chicago, IL, August 20-23, 2006. Speaking in front of MLC's Health and Human Services Committee, Senator Reigsecker discussed the need for more effective regulation of wholesale drug distributors and NABP's Verified-Accredited Wholesale Distributors (VAWD) program. The Senator was also successful in having a resolution introduced that requests the Council of State Governments (CSG) and the National Conference of State Legislatures to address legislation for the licensure and accreditation of wholesale drug distributors. The Midwestern Legislative Conference is hosted annually by the CSG Midwestern Office, a nonpartisan, nonprofit association that provides state leaders in all three branches of government with resources and tools needed to address public policy challenges.
NABP Joins APhA/FWS Collaborative Medication Disposal Effort
In late July, NABP attended a meeting hosted by the American Pharmacists Association (APhA) and US Fish & Wildlife Service (FWS) aimed to assist the two organizations in developing a national consumer marketing campaign addressing medication disposal. The meeting consisted of representation from a cross-section of organizations from within the health care, pharmaceutical, and environmental communities. With a launch date set for the later part of the year, APhA and FWS are currently reviewing the recommendations from the meeting to develop the consumer marketing campaign. During the 102nd NABP Annual Meeting, Resolution 102-2-06, Safe and Environmentally Friendly Medication Destruction Programs, directed NABP to work with the pharmacy, environmental, and regulatory communities to develop guidance for patients in the safe and proper disposal of medication.
NABP Accredits Three New VAWD Facilities
NABP is pleased to announce the addition of three wholesale distributors to the current list of Verified-Accredited Wholesale Distributors (VAWD) Program facilities. Two Henry Schein Inc facilities, one located in Jacksonville, FL, and the other in Indianapolis, IN, were awarded accreditation on July 27, 2006. ParMed Pharmaceuticals, Inc, based in Niagara Falls, NY, received VAWD accreditation on July 28, 2006. This brings the total number of VAWD-accredited facilities to nine. For a list of VAWD-accredited facilities, visit http://www.nabp.net/vawd/vawdlist.asp.
