Resources for the Drug Supply Chain Security Act (DSCSA)

Masters, collaborating with McKesson, has actively tracked the Drug Supply Chain Security Act (DSCSA) since its inception in 2013. We’ve been deeply involved with the FDA, manufacturers, and even our rivals to guarantee our full compliance and smooth implementation across the entire pharmaceutical supply chain, gearing up for the November 27, 2023 deadline.

Our distribution, technology, and customer service teams are diligently preparing for the launch. Furthermore, we’ve joined forces with manufacturers to make sure they’re ready. Below, find an FAQ section for review. As the launch date approaches, we promise to keep you informed about our progress and any industry shifts that will change our product tracing methods. For any queries, please reach out to our customer support.

GENERAL DSCSA INFORMATION

On Friday, Aug. 25, the U.S. Food and Drug Administration (FDA) announced through a compliance policy that it would not take action to enforce the Enhanced Drug Distribution Security requirements of the Drug Supply Chain Security Act (DSCSA), section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act, until Nov. 27, 2024. The FDA is providing a one-year stabilization period (“Stabilization Period”), beyond the legal deadline of Nov. 27, 2023. This period will allow all key players within the supply chain (manufacturers, distributors, dispensers and trading partners) to mature processes and refine operations that are required to comply with these specific package-level tracing requirements. The FDA will continue to enforce the other DSCSA requirements during this Stabilization Period.

The FDA expects all parties to continue progressing toward stabilization and maturing the implemented systems during this Stabilization Period. Masters will continue to roll out enhanced DSCSA capabilities including:

  • Sending enhanced DSCSA transaction information using customer portals and EPCIS (Electronic Product Code Information Services) data files
  • Providing additional educational tools to further prepare dispensers for the full DSCSA implementation

During this Stabilization Period, Masters will continue to provide the lot level DSCSA Transaction Information, Transaction History and Transaction Statements using the existing portals and DSCSA enabled EDI files.

Masters will continue to monitor the FDA’s policy and requirements for DSCSA implementation and will adapt its processes as needed.

The Drug Supply Chain Security Act, signed into law on November 27, 2013, outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. These requirements will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Implementation of these requirements will also improve the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

All DSCSA Transaction Information will change from lot based to serial-based transactions. Currently, DSCSA transactions are traced at the lot level with a transaction history and a transaction statement.

On November 27, 2023, in addition to the previous requirements for DSCSA transaction information, the DSCSA will require that the serialized product identifier information be added to the DSCSA Transaction Information.

  • A new serial number is provisioned by the manufacturer at each level to be uniquely identified.
  • Each serial number must be tracked through all transactional events across the supply chain
    (events= packing, shipping, receiving, returns, etc.)

Beginning on November 27, 2023, the current transaction history will be sunset and electronic-based approaches will be used among all trading partners to meet the enhanced requirements.

Masters will use FDA recommended Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements.

GS1 (Global Standard) standard identifiers will be used for product and party/location identification in the interoperable electronic exchange.

  • Products will be identified by a Global Trade Identification Number (GTIN).
  • Trading partners will be identified by the Global Location Number (GLN).

DSCSA requirements do not apply to nonprescription drugs (over-the-counter drugs) or animal drugs (drugs subject to section 512 of the FD&C Act). Drugs that fall under the DSCSA requirements are defined by the FD&C Act.

Product tracing, product identifier, authorized trading partner, and verification requirements apply to product as defined by this act. Product means “a prescription drug in finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution).”

The section 582 requirements do not apply to:

  • Blood or blood components intended for transfusion
  • Radioactive drugs or biologic products
  • Imaging drugs
  • Certain intravenous (IV) products
  • Medical gases
  • Certain homeopathic drugs
  • Lawfully compounded drugs

There are also exclusions, refer to the definition of transaction noted in section 581(24) of the FD&C Act. This list of applicable DSCSA drugs is dynamic and is subject to change.

ALL ABOUT GLNs

A GLN, or Global Location Number, is a unique identifier that lets businesses know who is involved in transactions and where things are located throughout the supply chain.

Establishing and submitting your GLN number(s) is imperative to continue to conduct business throughout the supply chain. Remember, you MUST have a GLN on file with Masters to order and receive product after November 27, 2023.

Masters is gathering established GLNs for our customers from GS1. If no GLN is found, Masters will provide customer information to GS1 if there are 9 or less locations associated with the customer. GS1 will enumerate GLN(s) for the customer. Masters will load the GS1 created GLN to the customer account.

Global Location Numbers (GLNs) are typically created by the organization that is being identified by subscribing to a license from GS1.

To aid in the adoption of GLNs for DSCSA purposes, Masters, our affiliate company, and other distributors have purchased a group license from GS1 for the identification of independent and small customers.

A cross-functional team is working to collect and enter all customer account data into the GS1 system.

All customers must provide two GLN numbers to designate their status:

  • Sold to – represents the party acquiring ownership of the product shipped.
  • Shipped to – represents the physical location where the products are being delivered.

These numbers may be the same for some customers if their sold-to and ship-to addresses are identical.

If you have not created a GLN or need assistance retrieving a Global Location Number, please visit gs1us.org to get a GLN. Please be advised that a registration fee is involved.

Following are more details about the GLN retrieval process for each customer segment.

Community Pharmacy, Providers and Practitioners
To aid in the adoption of GLNs for DSCSA purposes, Masters and other distributors have purchased a group license from GS1 for the identification of independent and small customers. The goal is to eliminate the work necessary for independent and small customers to speed up identification.

Based on data submitted by Masters and other distributors, GS1 is creating GLNs and posting those GLNs to the GS1 Data Hub tool for independent and small customers

In Data Hub, these assigned GLNs are visible to the distributor who submitted the GLN information for the dispenser and others in the supply chain so they may use the GLN to identify the same customer.

Customers in the Community Pharmacy segment who are small businesses with fewer than nine locations do not need to take any action now.

If your business has more than nine locations, you must create your own GLNs. Please visit gs1us.org .

Health Systems and Clinics
Many health systems implemented the use of GLNs through their GPOs years ago.

Health systems identified with a GLN by their group purchasing organization are currently visible in the GS1 Data Hub, which we use to identify GLNs for customers.

We are completing an audit to determine customers that do not have a GLN. A plan to gather that information is forthcoming.

Large Retail and National Accounts
Most Large Retail and National Accounts can generate GLNs using their Global Company Prefix (GCP) from GS1.

Customers with your own GCP can contact GS1 for assistance in generating your GLNs if you do not already have your locations listed with GLNs.

We are currently collecting GLN information from all Strategic Account partners. We are completing an audit to determine customers that do not have a GLN.

VA
Masters has an internal team coordinating with the VA to assign GLNs for all VA locations.

Specialty Provider Customers & The US Oncology Network
Masters account management supporting Specialty Provider customers and practices in the US Oncology Network are completing an audit to determine which practices have GLNs already assigned, and which do not. We will then work with the Masters DSCSA teams to assign GLNs where missing. At this time, there is no action required of our practices. If Specialty Provider customers and practices in The Network need to sign up for their own GLN, their account manager or RSVP/RVP will contact them directly in the coming weeks.

A GLN is a 13-digit number consisting of a company prefix, a location reference, and a check digit.

You can find your GLN in a few ways:

  1. Visit the my.GS1US.org website to search for your GLN.
  2. Contact your Masters Customer Support Team.
  3. Masters has begun printing Sold-To and Ship-To GLNs on invoices for many pharmacy customers. If we do not have a GLN on file for you, these fields will populate with a series of zeroes. Here is a sample invoice:

Before requesting a GLN , please be sure to confirm that you do not already have a GLN by searching the my.GS1US.org website or by contacting your Masters Customer Support team to see if the GLN(s) have been loaded in our system.

If you are unable to locate your GLN , there are a couple of paths for getting a GLN.

Masters can assist in getting independent and small businesses with up to nine locations a GLN as a GS1 US GLN issuing partner. This is at no cost to you.

Customers larger than nine locations will need to visit the my.GS1US.org website to create a GLN.

GLNs created by GS1 with information from either distributors or GPOs begin with either 1100 or 1200. Additionally some GS1 issued Single Location GLNs also begin with 1100 or 1200.

A single GLN can be used to identify a single party or location or a combination of the two.

A separate, unique GLN is required whenever there is a need to distinguish one entity from another or one location from another. Each customer account has two places where McKesson will use the GLN. One field in the account uses the GLN to designate Sold To and another field designates Ship To. These fields may contain the same GLN in both fields for single location entities.

If the GLN you have is different from what Masters has on file, please confirm that the Ship to and Sold to location for the GLN matches the location that we have on file for you. If you would like Masters to change the GLN we have on file for you, contact your Masters Customer Support team to request for your GLN number to be updated.

If for any reason you desire to secure your GLN at your own expense or maintain it with GS1 yourself, we can deactivate the Masters assigned GLN. Before attempting to secure your own GLNs from GS1, to avoid receiving an error that a GLN already exists, your Masters assigned GLN will need to be deactivated. Please contact your Masters Customer Support team via email:

Yes, any change to the physical address of the location requires the allocation of a new GLN. For more rules and regulations regarding GLNs visit the GS1 GLN allocation rules document. Contact your Masters Customer Support team with any changes to your GLN and address.

If ownership of a trading partner is being changed or is being relocated, a new GLN will need to be procured. Changes to who holds the stock of a corporation do not require the allocation of a new GLN. This runs almost parallel to the rules for when a new DEA number is required. For more rules and regulations regarding GLNs visit the GS1 GLN allocation rules document.

Yes, GLNs are universal. Your GLN will stay the same no matter which distributor or manufacturer you use to purchase product. All suppliers and distributors will use the same GLN for common customers.

Masters has a direct connection with the GS1 US Datahub system to check for previously assigned GLNs and to assign GLNs when one is needed. The process takes just a couple of minutes when we receive a request to assign or correct a GLN.

Yes, you may transfer DSCSA applicable product between locations that share the same Sold To GLN. The fact that the Sold to GLN is the same indicates that these are one entity and intercompany transfers are not subject to DSCSA track and trace requirements. If the product is returned, Masters will be required to complete an association test that will verify that there is a historical DSCSA record containing a combined Sold to GLN and that specific serial number.

Yes, Masters will still be able to request GLNs for customers with 9 or less locations after go-live.

SERIALIZED TRANSACTION INFORMATION

Masters will make your DSCSA transaction data available to you through our customer-facing portals (Connect, Customer Center, Lynx, and Supply Manager Online).

A repository called ATTP will store serialization data from Masters and will allow searching, downloading, and printing upon request. You may use the portal link to manage your DSCSA transaction data for the entire six years of record retention requirement.

In addition, you may opt-in to have the data transmitted daily to your in-house or third-party DSCSA repository to store on your behalf.

Data connections and testing for the ability to receive the daily push is targeted for September 2023.

We will keep you updated when the transaction data capability is live. A link will be housed on a designated DSCSA page within your Masters ordering portal. In addition, detailed instructions will be made available before the rollout to help educate you about how to use the new data feature.

RETURNS INFORMATION

Yes, there are increased requirements, defined in the federal law governing DSCSA, that will be imposed on saleable returns, including:

  • As a customer,we will ask you to match and confirm that the serial number of the item being returned was purchased from Masters.
  • The distributor (Masters) must verify the product identifier of there turned package to the manufacturer’s assigned data beginning on November 27.
  • The distributor (Masters) must also associate there turned product with its original DSCSA transaction data from Masters initial sale to the customer. As of November 27, this association is at the serial product identifier level.

Product returns where Masters cannot verify or associate the product cannot be accepted for saleable return under the DSCSA.
A detailed product returns process communication will be shared at a later date.

NEXT STEPS AND WHAT TO EXPECT

Prior to November 27, 2023, you should make changes, including but not limited to the following:

  • All customers (dispensers, health systems, pharmacies, etc.) should be prepared to respond directly to regulators if asked about tracing information for products they purchased. Masters, unfortunately, cannot respond to regulators on your behalf.
  • All trading partners, including dispensers, are expected to be able to search the repositories where their serial DSCSA transaction information and transaction statements are stored and retrieve the requested information upon request.
    • Beginning this fall, DSCSA transaction data will be accessible through Masters portals or in your in-house or third-party system if you request this information to be transferred. A link to this data will be added to the portals once this feature goes live.
  • All trading partners will need to check the serialization number before making a return to Masters to ensure that they purchased the serial product identifier on the product in question from Masters before initiating the return.
  • Product returns where Masters is unable to verify or associate the product cannot be accepted for saleable return under the DSCSA.
  • Dispensers should evaluate all product within their possession and control for suspect product indications. If suspect product is identified, use of the DSCSA transaction data may be necessary when conducting suspect product investigations.
  • Your pharmacy must have procedures to identify suspect product according to the requirements in DSCSA. If you find that a product is illegitimate after conducting an investigation, according to your Procedures, you will potentially Report and Notify your Trading Partners.
  • Masters is here to support you during this transition by providing guidance and assistance where possible. We are not able to take action for you. Additional information for dispensers from NACDS, NCPA, HDA and NABP about dispenser requirements is available at www.dscsa.pharmacy.

Need More Information or Have Further Questions?

As Masters determines final processes to support DSCSA, we will continually communicate any and all information in order to help you better prepare for the November 27, 2023, effective date.

Masters online ordering platforms will be updated as information is available. For questions regarding DSCSA you can also contact us via email.

Please watch the first episode of our new DSCSA webisode series featuring our Masters and DSCSA industry expert, Scott Mooney, who explains all things GLN!
Video: Episode 1: DSCSA- Preparing for DSCSA – All About GLNs

McKesson is here to support you during this transition by providing guidance and assistance where possible. We are not able to take action for you. Additional information for dispensers from NACDS, NCPA, HDA and NABP about dispenser requirements is available at www.dscsa.pharmacy.

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