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Rx-TO-OTC SWITCH TRANSITION MARKETING THROUGH PHARMACISTS ONLY SHOULD BE PART OF LEGISLATION, APhA AGREES; PROVISION WOULD SATISFY P-A, ASSN. SAYS

Executive Summary

Rx-to-OTC switch legislation establishing a five-year transition period during which FDA designated switch products could be sold only by pharmacists should be introduced at both the federal and state level, the American Pharmaceutical Assn. (APhA) agreed May 10 at its annual meeting in Montreal. The transition period during which pharmacists would control dispensing of such "suitable legend drug products" designated for eventual nonRx status, would "help the proprietary industry" with a "safe and effective transition," APhA's Academy of Pharmacy Practice President Dennis Smith said during debate. Bremerton pharmacy-operator Smith is president of the Washington State Pharmaceutical Assn. Seeking to dispel the view indicated by some delegates that the APhA issue is "another rehash of the third-category-of-drugs issue," Smith told the House of Delegates that the assn.'s policy -- approved almost unanimously -- will "satisfy the Proprietary Assn. concerns." The APhA-sought legislation, under the policy, would authorize FDA to "establish a category of drug products and a process to facilitate the transition of suitable legend drug products to nonRx status." To facilitate the transition, APhA's policy proposes three requirements: (1) dispensing of the "suitable" products by pharmacists; (2) keeping the products "in this transitional category until FDA determines, within a specified time period (e.g., five years), that the drug product can be moved into nonRx status;" and (3) studies "during this time period . . . to assess the appropriateness of such drug products for nonRx use." APhA Endorses Strategic Planning Effort For The '80's To Involve Other Natl. And State Assns. Smith, in opening the debate, viewed the policy as "an excellent opportunity for practicing pharmacists and professional pharmacy to get directly involved in an active way with some legislation involving Rx-to-OTC switch." He added: "In the short-term, we see the deregulation attitude of the current administration. We see a lot of opportunity for Rx-to-OTC switch. We see for the pharmacist a vital role, as an advocate of the consumer. And we see the pharmacist a vital role in helping the proprietary industry have a safe and effective transition from Rx-to-OTC switch." APhA's delegates also directed the assn.'s board to "begin immediately to undertake a strategic planning effort involving the input and participation of other natl. and state assns." The resolution adds that the assn. should develop "a strategic plan for the remainder of the 1980s," and present a progress report for discussion by delegates at their 1985 annual meeting next February in San Antonio. The "strategic-planning" motion, presented by Californi Pharmacists Assn. President Clark Gustafson, of Bakersfield, reflects the proposal for an all-pharmacy, natl. strategic planning conference voiced last September in a speech by the California assn.'s Exec VP Robert Johnson at the University of Texas. The California assn.'s resolution in Montreal was cosponsored by the delegations from Texas, Indiana, Iowa, Kentucky, Nevada and Nebraska. The Nebraska Pharmacists Assn. is a new APhA affiliate.
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