Pharmaceutical Repackaging

This contract augments the prime vendor Pharmaceuticals and Biologicals contract (505ENT-M15-PHARMBIOLG-01) for State of Wisconsin Agencies by providing contracted suppliers that can accept all qualified (unopened, undamaged, oral/sterile, eligible to be repackaged per FDA or manufacturer requirements) products for the purpose of repackaging from Facilities or Wholesaler. Upon receipt of the products, Vendor will repackage the products from the bulk size or other presentations into unit dose packaging formats with bar codes or as defined by the ordering facility.
This contract has been made available by utilizing a contract bid and negotiated by the Minnesota Multi-State Contracting Alliance for Pharmacy (MMCAP) with direct input from the State of Wisconsin.

MMCAP is a free, voluntary, governmental group purchasing organization operated and managed by the State of Minnesota. The State of Wisconsin is a member of MMCAP along with 46 other states who represent over a billion

dollars in purchasing power. For more information on recent MMCAP updates, log-in to 
MMCAP website using your log-in ID and password 
here, click on “Member News”, then click on “MMCAP News”.
To use this contract, you must have a MMCAP member number. To obtain an MMCAP member number, you must fill out MMCAP's application and submit it to the contract manager (John Burnett) as an email attachment to: John.Burnett@wisconsin.gov. After your application is approved, MMCAP will assign your MMCAP ID number to you. If you already have an existing MMCAP number you do not need to fill out the application.

The most up-to-date MMCAP application is located at the following link: 
https://www.infuse-mn.gov/about/membershipapp/index.jsp. 

If you have any questions, please feel free to contact John Burnett at (608) 261-6359. 
Drug Supply Chain Security Act (DSCSA) 

On Nov. 27, 2013, the Drug Quality and Security Act (DQSA) was established. Title II of the Act – Drug Supply Chain Security Act (DSCSA) – establishes a national system for tracing prescription drugs through the supply chain, setting national standards to protect against suspect and illegitimate products. This act replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and raises licensure standards across the U.S. Notable in this law is the pre-emption of state activity, whereby the states cannot alter the standards established by the act, but states can continue to regulate wholesaler and third-party logistics (3PLs) in areas that are not covered by and not directly related to the licensing standards specified in the law. 

TI/TH/TS are new acronyms associated with DSCSA, referring to: Transaction Information, Transaction History and Transaction Statement. DSCSA provides in law, the requirements for the tracing of products through the pharmaceutical distribution supply chain as transacted by what the law refers to as “trading partners,” meaning manufacturers, 3PLs, repackagers, wholesale distributors and dispensers. 

The implementation timeline above starts with the enactment of the law, through all the steps in reaching unit level traceability by Nov. 27, 2023. Initially, the Advance Ship Notification (ASN), which is to contain TI, TH, and TS on the products covered by the law can be provided in paper or electronic format. However, by no later than Nov. 27, 2017, the format is required to be electronic. Each time there is a change in ownership, or a transaction occurs between trading partners, product tracing requirements are triggered. 

For more information concerning DSCSA, please visit: MMCAP 

1) On the left side of the screen: click on “Drug Supply Chain Security Act” (located under "MMCAP News")

2) Read the updates and resources provided by MMCAP and the FDA and become familiar with the law