Included in this newsletter
Drug Supply Chain Security Act (DSCSA) or Track and Trace
Several companies have started a mass marketing campaign regarding the DSCSA rules that go into effect on November 23rd. A couple of key components of the DSCSA system still need to be completed. You don't need any additional software other than your pharmacy software. Our policy and procedure for the Drug Supply Chain Security (Track and Trace) is current for today and will be updated with any new requirements as necessary.
The pharmacy industry expects this rule to be delayed because the Food and Drug Administration (FDA) has already delayed the implementation of drug manufacturers and wholesalers.
Liberty Software will include the DSCSA requirements within its program. Using the perpetual inventory when receiving drugs will meet the "acceptance" requirement. PioneerRx Software is working on its software to be ready by November. ComputerRx has not responded to our requests at this time.
The biggest change is that the pharmacy must receive the T3 documentation for the drug. Under the DSCSA, the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements include Transaction History (TH), the Transaction Information (TI), and the Transaction Statement (TS). This can be completed through the drug wholesaler's computer or pharmacy software. Pharmacy to pharmacy transfers with the same wholesaler remains the same; however, if there are two different wholesalers, the sending pharmacy must provide the receiving pharmacy with the T3 report,
which is nothing more than an excel spreadsheet. The receiving pharmacy must show they accepted the drug from the wholesaler and, if the pharmacy is scanning their drugs into their pharmacy software, this requirement will be met.
At this time there have been no details provided regarding how the wholesalers and returns companies will handle unused, expired, or contaminated drugs.
APhA Offering a Virtual Medication Therapy Management (MTM)
Certificate Program
In conjunction with Marshall B Ketchum University, APhA is offering a virtual MTM Certificate Program on February 26, 2023, from 8:00 AM to 5:00 PM.
- CE Course Syllabus
- MTM Registration (APhA membership is required)
Non-Sterile Compounding Compliance Program
The policies and procedures for the Non-Sterile Compounding program are about 75% complete. Jeff just returned from a USP conference on preparing for November 1, 2023 and the final items will be completed soon. ACHC accreditation standards are also being incorporated and will we seek ACHC approval of our policies and procedures.
We are also looking for anyone who would like to be a peer reviewer. If you are interested, please
get in touch with your Project Manager.
The complaint alleges that this unlawful conduct resulted in at least hundreds of thousands of violations of the Controlled Substances Act (CSA). The Justice Department seeks civil penalties and injunctive relief. Read more: Click Here
eLearning Training Center Module
The eLearning Center is now live and ready to use. The first training is in February for HIPAA Compliance. You can start entering your employees as "Users" if they have not been added already. Multiple users cannot use the same email address (i.e., training@rjhedges.com) and you cannot enter an invalid email address. Additional required training will be added in the next several months.
You may continue to use the old method of training videos, training logs, and training certificates.
Upcoming Conferences
Maybe our paths will cross at one of these upcoming events- Diversify Rx, Feb 16 – 17, Orlando, FL
- NCPA Ownership Workshop April 1-2, Charlotte, NC
