Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry; Availability

Greetings. The American Pharmacists Association ("APhA") appreciates the opportunity to submit comments in response to the Food and Drug Administration's ("FDA"), "Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug and Cosmetic Act, Draft Guidance for Industry," (hereinafter, "Draft Guidance"). Founded in 1852 as the American Pharmaceutical Association, APhA represents nearly 60,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and the uniformed services. APhA supports efforts to provide Americans access to quality, safe, effective, and affordable prescription drugs. Despite FDA's good intentions, APhA is concerned the Draft Guidance will cause patient and pharmacy confusion, raises concerns with patient care, and will not meaningfully enhance competition. In addition to raising concerns of potential unintended consequences, we seek additional clarity regarding several components of the Draft Guidance. See, attached .PDF for full comments. APhA shares FDA's goal to ensure that patients receive quality, safe, and effective drugs. We look forward to continuing to work with FDA on the implications of drug importation policies on patients and pharmacists and thank you in advance for considering our concerns. If you have any questions, or if we can be of any assistance, please do not hesitate to contact Michael Baxter, Director of Regulatory Affairs, at mbaxter@aphanet.org or by phone at (202) 429-7538.