Search

Recombinant DNA technology and other aspects of biotechnology are a far newer area of pharmaceutical research and development than areas related to small molecule pharmaceuticals, and the methods employed in all areas of the drug development process, from drug discovery to the manufacturing protocols, equipment, control parameters and testing methodologies required by the FDA are substantially different than those used with small molecule drugs. Beginning with the elucidation of the structure of DNA, advances in molecular biology techniques have led to dramatic progress in medical research, disease diagnosis and drug development and have introduced a new vocabulary to the pharmaceutical industry.

Biologics represent an increasingly important segment of the pharmaceutical market, and were 25% of the worldwide total prescription and OTC sales in 2017. EvaluatePharma predicts that by 2024, 9 of the top 15 pharmaceuticals by sales in the United States, and 10 worldwide will be monoclonal antibodies or fusion proteins. Many of these products have patents that have already or soon will expire. Due to the complex nature of biologics, they are typically expensive to produce, and until recently, the United States had no defined process for approving biosimilar equivalents of biotechnology-derived drugs.

In August 2009, the American Association of Colleges of Pharmacy (AACP) Council of Sections established a Task Force to assess the current status of compounding education at its member institutions and to provide recommendations for future direction. The Task Force conducted a survey in late June 2010 of faculty members enrolled in the AACP Pharmaceutics and Pharmacy Practice sections to gain qualitative information of the current state of compounding education. The survey results were then organized around eight curricular topics for which the Task Force members provided interpretations and recommendations. A final report was sent to the AACP Council of Sections on February 15, 2011. This publication provides the information contained in that final report to the professional community.