Pharmacy and public policy: Evolution of the legal and regulatory framework for generic interchange

The past 40 years have seen a movement in the profession of pharmacy to modify the strictures on professional judgment and professional service to patients emanating from antisubstitution laws, both statutes and regulations, at the state level of government. The shift of responsibility for preparing final dosage forms more and more from the community pharmacist to the pharmaceutical industry led the brand name pharmaceutical manufacturers to form an organization to seek enactment of restrictions on the ability of pharmacists to select the brand of medication to be dispensed. Beginning in 1970, the American Pharmaceutical Association sought to change these laws, and through that decade, coalitions were formed with a variety of groups to effect the modifications. A variety of public policy issues were presented for consideration as part of this movement, with the states adopting a variety of approaches, with all jurisdictions eventually restoring to pharmacists the ability to make professional judgments in the area of drug product selection. This initiative within the profession was a highlight of the past century and may have built the confidence of pharmacists to seek other modifications in public policy related to the legal and regulatory framework within which they practice.