Pharmacy Groups Submit Comments to FDA Regarding Prescription Drug Importation

NASPA, in collaboration with other national pharmacy groups, submitted comments opposing the FDA’s proposed rule allowing wholesale importation of prescription drugs from Canada.  The joint comment letter from NASPA and other national pharmacy organizations, including the American Pharmacists Association, National Community Pharmacists Association, American Society of Consultant Pharmacists, Academy of Managed Care Pharmacy, ASHP, and […]

FDA Releases New Policies on REMS Programs Used to Block Generic Drug Entry

FDA Commissioner Scott Gottlieb, MD released a statement this week regarding some brand-name drug makers’ use of REMS requirements to block the timely entry of generic drugs to market.   Risk Evaluation and Mitigation Strategy (REMS) requirements are required for drugs with serious risks to ensure that the benefits outweigh the risks.  “On the front end, […]

FDA Restricts the Use of Codeine and Tramadol Medications in Children

The FDA has restricted the use of prescription codeine pain and cough medicines and tramadol pain medicines in children.  Side effects of these medicines in children under 12 include slowed or difficult breathing and death.  The FDA also warns against the use of codeine and tramadol medicines in breastfeeding mothers. They are now requiring the […]

APhA’s Comments on the Importation of Non-FDA Approved Drugs

The American Pharmacists Association (APhA) submitted comments to Congress in March 2017 on the importation of non-FDA approved prescription drugs. APhA stated in the letter that they  “believe proposals to legalize importation of non-FDA approved drugs is in direct conflict with recent efforts by Congress and federal agencies to increase the integrity and security of the […]