← American Pharmacists Association (APhA)
FDANonrulemakingFDA-2019-N-5711

Importation of Prescription Drugs

RIN
—
Last modified
Nov 24, 2020
Comment window
closed 2332d ago
American Pharmacists Association (APhA) filings
1

Activity

American Pharmacists Association (APhA) filed 1 comment on this docket between Mar 9, 2020 and Mar 9, 2020. 63 other organizations filed here. The comment window closed 2332d ago.

What American Pharmacists Association (APhA) filed (1)

Mar 9, 2020· Comment from American Pharmacists Association (APhA)· FDA-2019-N-5711-1178

Dear Sir/Madam: The American Pharmacists Association (APhA) appreciates the opportunity to submit comments in response to the Food and Drug Administration's (FDA) proposed rule, "Importation of Prescription Drugs" (Proposed Rule). 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, specialty 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 and the effort FDA took to attempt to address patient safety concerns, APhA is concerned the Proposed Rule will seriously jeopardize patient safety. In addition, the Proposed Rule undermines the ongoing implementation of the Drug Supply Chain Security Act (DSCSA) and the protections it affords to our nation's drug supply. It also creates significant workflow challenges that will disrupt patient care and pharmacist-delivered patient care services. Finally, required onerous program operational and systematic measures will add to drug costs and not result in significant cost savings to consumers. See, attached .PDF for full comments. APhA supports, agrees with, and incorporates by reference the comments submitted by the Pharmaceutical Distribution Security Alliance (PDSA), particularly the concerns related to DSCSA. Accordingly, many of the concerns raised in the PDSA are not repeated in this letter. Additionally, APhA notes that we also submitted comments to this docket jointly with seven major national pharmacy organizations raising significant patient safety and cost concerns, and we incorporate those comments by reference as well. 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.

View on regulations.gov →

Abstract

No abstract recorded.

View on regulations.gov →

Co-filers (63)

See everyone who commented →