October 23, 2024
Revisiting Florida’s Plan to Import Drugs from Canada
An FDA-Approved Plan with Major Implications Earlier this year, the FDA authorized Florida’s proposal to import select drugs from Canada under section 804 of the FD&C Act. The law allows companies to import prescription drugs in bulk if doing so saves Americans money and doesn’t put the health and safety of Americans at risk. According […]
October 15, 2024
Beware of Counterfeit Ozempic, says FDA
Counterfeiting: A Major Issue with Drastic Consequences On October 2nd, the FDA released an article highlighting the risk of unapproved weight loss drugs, including semgalutide and tirzepatide. These drugs pose a major risk to patients due to their lack of quality assurance. Illegally marketed versions of these drugs have infiltrated pharmaceutical supply chains, most notably, […]
October 10, 2024
DSCSA Exemptions from Section 582 and Other Requirements of the FD&C Act for Certain Trading Partners
Published October 10th, 2024 The FDA announced on October 9th that they are granting eligible pharmaceutical trading partners exemptions from Enhanced Drug Distribution Security (EDDS) requirements of the FD&C Act. Eligible trading partners include those who have initiated systems and processes and successfully completed data connections with immediate trading partners, or those who have initiated […]
October 9, 2024
HDA DSCSA Guidance
Following the recent HDA Traceability Seminar between August 26th-28th, I had the opportunity to lead a conversation amongst dozens of pharmaceutical partners and solution providers; we discussed various important topics related to the DSCSA, from Waiver, Exception, and Exemptions, to Verification Routing Services, and more. Emphasizing the importance of transparency and open conversation, I thought […]
October 9, 2024
7 Things to Know About DSCSA Enhanced Drug Distribution Security Requirements
The DSCSA: A Phased Approach to Implementation Published October 10th, 2024 Over a decade ago, the FDA established the Drug Supply Chain Security Act to help protect consumers from potentially counterfeit, stolen, contaminated, or otherwise harmful prescription drugs as they’re distributed throughout the United States. The legislation focuses on establishing procedures for achieving interoperable, electronic […]
