To advance FFF Enterprises' ongoing commitment to supply chain and patient safety – resulting in over 27 counterfeit-free years – FFF has partnered with TraceLink, Inc. to meet the complex requirements of the U.S. Drug Supply Chain Security Act (DSCSA). Under this law, all records must be kept on file for six years.
As of Jan. 1, 2015, the tracing and verification requirements have gone into effect for manufacturers, repackagers and wholesale distributors. This includes the exchange of specified transaction data called the
Three T's — Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS).
As an FFF customer, there are four ways we will help you to meet these requirements:
- Packing Slips
- Modifications have been made to our packing slips that will include additional information - click here to view sample
- To sign-up and receive the email shipping notification, call Wow! Customer Care (800) 843-7477 or send an email WOWCustomerService@FFFenterprises.com.
- TraceLink Life Sciences Cloud service provides a cloud-based application platform to view all products the dispenser purchased from FFF Enterprises.
- This option applies to large facility hospitals with EDI capability. To request for this option, send an email to PropertyTrackServices@fffenterprises.com. Allow 4-6 weeks to complete this request.
*Please allow some time for these items to be processed and activated.
TraceLink Life Sciences Cloud service provides a cloud-based application platform to easily track, trace and access transaction history of all FFF Enterprises products we distribute. To learn about Tracelink Life Sciences Cloud services and how it benefits you, click here.
For this option, complete the TraceLink Request Form. The information provided will be verified by TraceLink as well as to help connect your FFF transactions. The following process will be completed before your TraceLink access is activated:
- Complete the TraceLink Request Form.
- TraceLink will verify your information and a Partner Activation Email will be sent to you upon successful set up of your organization in Tracelink database in 5-10 business days. Please forward this confirmation to FFF, including your FFF Account Number, via email to email@example.com.
- Once FFF receives your TraceLink’s Partner Activation Email, your request will be completed within 72 business hours of receipt and then you will have access to view your shipping transactions through your TraceLink web portal.
This form is required to be completed by the person who will manage and be the administrator to your TraceLink access. If there is more than one person who will be responsible for managing your TraceLink access, forward this link https://www.surveymonkey.com/s/tracelinkportal-dispensers. Each person is required to have their own TraceLink login account.
Here’s the list of required questions. To begin, click here to complete the TraceLink Request Form.
- Your first and last name.
- Which of your partners (supplier/customer) sent you a letter that triggered you to complete this form?
- Enter FFF Enterprises as the answer
- Please provide an Email Address for a person to be set up as a Company Administrator.
- NOTE: Enter your company email address and not a personal email address such as Gmail, Hotmail, MSN, etc.
- In order to be sure that you are associated to the correct organization, what is the name and location of your organization?
Once TraceLink and FFF confirms your request and the verification process is complete, you will have TraceLink access. In the interim, please take advantage of TraceLink’s resource and join the TraceLink University. This network provides educational and training information, everything from DSCSA compliance to Product Track services. Also, join the Product Track Partner Webinar to view a brief demonstration of TraceLink’s platform.
Drug Quality and Security Act (DQSA)
Effective Jan. 1, 2015, Title II of the Drug Quality and Security Act (DQSA) of the DSCSA established a 10-year timeline to achieve an interoperable track-and-trace system for prescription drugs, as well as strengthen licensure requirements for wholesale distributors, third-party logistics providers and establishes nationwide drug serial numbers.
Manufacturers and repackagers will be required to capture the transaction history and movement of a pharmaceutical product through the supply chain by placing a unique product identifier on drug packages such as a bar code that can be read electronically.
The DSCSA was signed into law on Nov. 27, 2013, to protect U.S. patients from ineffective, counterfeit, low-quality and unsafe drugs entering the market that pose serious public health safety concerns.
For more information visit www.gpo.gov/fdsys/pkg/BILLS-113hr3204enr/pdf/BILLS-113hr3204enr.pdf.
FDA Guidance Compliance Regulatory Information
December 2014 - DSCSA Implementation: Product Tracing Requirements
July 2015 - FDA Extends Enforcement Date to November 1, 2015
For any questions regarding any information listed above, contact Wow! Customer Care (800) 843-7477 or send an email to WOWCustomerService@FFFenterprises.com.