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.

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.

DSCSA implementation will mean some changes to how payments by credit cards will work. If you currently pay with a credit card, check out this page to see what steps you need to take to ensure a smooth transition with DSCSA.

GENERAL DSCSA INFORMATION

On Friday, August 25, 2023, 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 November 27, 2024. The FDA is providing a one-year “Stabilization Period” from the statutory deadline of November 27, 2023. This Stabilization 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 help 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 serialization implementation and will adapt its processes as needed. Given the FDA announcement of the Stabilization Period, the following is an overview of Masters key dates.

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.

During the Stabilization Period, all DSCSA Transaction Information for in-scope products will continue to be shared in a lot-based format and, as it is made available, in a serial-based format. On November 27, 2024, in addition to the previous requirements for DSCSA Transaction Information, serialized product identifier information for in-scope products must be added to the DSCSA Transaction Information.

  • A new serial number is provisioned by the manufacturer at each salable product unit (e.g., pallet, case, box, each) of packaging to be uniquely identified.
  • Each serial number must be tracked through all transactional events across the supply chain (events can include packing, shipping, receiving, returns, etc.)

Beginning on November 27, 2024, the current Lot-based Transaction History will be sunset and electronic-based approaches will be used among all trading partners to meet the enhanced requirements. Masters will use the 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 1) 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).

In-scope DSCSA product will continue to have NDC numbers. The GTIN includes the NDC.

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 in Section 582 of the Act apply to product as defined by Section 581(13) of 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. This information is available on the item product page of Masters ordering portal.

To distinguish between an FDA-granted exception and a case of missing data, customers should cross reference the indicator in your ordering portal against data provided in your Transaction History to determine if the product is subject to DSCSA.

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 with Masters. We are requesting all customers to have one or more GLNs on file with Masters by June 30, 2024, to allow the parties in the supply chain to mature and test their systems and processes prior to November 27, 2024.

Global Location Numbers (GLNs) are typically created by the customer who has purchased a license to create GLNs from GS1 or under GS1’s Managed GLN program based on submissions by wholesalers or group purchasing organizations.

Each customer should obtain a GLN for:

  • Sold To – represents the party acquiring ownership of the DSCSA in-scope product shipped.
  • Ship To – represents the physical location where the DSCSA in-scope 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.

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 Account Manager.
  3. Masters has begun printing Sold-To and Ship-To GLN’s 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 Account Manager to see if we have the GLN(s) assigned to your account loaded in our system.

If you are unable to locate your GLN:

Masters can assist independent and small businesses with nine or fewer locations (with the exception of government facilities) in getting their GLN(s) as a GS1 US GLN issuing partner. This is at no cost to you.

Customers with more than nine locations will need to visit the my.GS1US.org website to create a GLN(s).

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

If you have more than one Ship To location or if your Sold To location is separate from your Ship To location, you will need a GLN for each distinct location. If your Sold To and Ship To location are the same, you only need one GLN.

A particular location only needs a single GLN to identify itself. The same GLN should be used for all suppliers servicing that location. If the GLN(s) you have are different from the ones Masters has on file, please contact your Masters Account Manager.

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 Account Manager for assistance.

Yes, any change to the physical address of the location requires the allocation of a new GLN. For more information on the rules regarding GLNs, visit the GS1 GLN allocation rules document. Contact your Masters Account Manager with any changes to your GLN and address.

For most ownership, location and name changes, a new GLN will need to be procured. For more information on the rules regarding GLNs, visit the GS1 GLN allocation rules document.

Yes, GLNs are universal. All suppliers and distributors, that have elected to use GLNs as customer identifiers, will use the same GLN for common customers.

Masters has a direct connection with the GS1 US Data Hub system to check for previously assigned GLNs and, where appropriate, 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 in-scope product between locations that share the same Sold To GLN, which indicates common ownership and control. Should a product be returned following such a transfer, Masters will complete an association test to verify that the returned product matches our historical DSCSA record with the correct Sold To GLN and product serial number.

Yes, Masters will still be able to assist in requesting GLNs for customers with nine or less locations under the GS1 Managed GLN program, with the exception of all government facilities. GS1 will create GLN(s) for the customer based on information provided by Masters and Masters will load the GS1 created GLN to the customer account.

GS1 has a search function to help locate the GLN: Search by Party Name | GEPIR (gs1.org) The search is available by company or GLN.

If the health system covered entity owns the contract pharmacy, then the contract pharmacy is a location within the health system. If, on the other hand, the contract pharmacy is separate, it will need to have its own Ship To GLN. In that situation, the Sold To GLN will be the health system covered entity.

The covered entity only needs to have a GLN as the Sold To location. The contract pharmacies have their own Ship To GLNs.

Entities under common ownership frequently use the same Sold To GLN. For a 340B replenishment account, Masters loads the covered entity GLN as the Sold To GLN and the contract pharmacy GLN the Ship To GLN.

For 340B replenishment programs, the purchaser is the covered entity, which generally bears the responsibility for the DSCSA Drug Traceability requirements. The covered entity may enter into an agreement with the contract pharmacy(ies) to share the responsibility for DSCSA compliance.

The ordering process for a customer will remain exactly as it is today. You do not need to enter your GLN. Ordering is done by account number.

An sGLN has a slightly different format from the 13-digit GLN for use in EPCIS files. It has all the similar identifiers as found in the GS1-issued GLN: Sold To, Sold By, Ship To and Ship From. It is different in format because EPCIS is based on the JSON computer language which requires this formatting. The GLN and sGLN both point to the same GS1-issued GLN, but [sGLN] has decimals inthe middle of it and [the GLN] is a straight 13-digit string of integers.

 

There is an option in GS1 Data Hub to request a change of “ownership” of the GLN. When you request a change of ownership in the GS1 Data Hub, the GS1 Data Hub automatically sends this request to the entity that owns that GLN.

Masters is not using Bill To GLNs for DSCSA. The Pharma Distribution team uses Sold To and Ship To GLNs in our reporting. Sold To is used to represent the customer’s legal entity (corporation, LLC, etc.). The Ship To is the physical location receiving the product. The Sold To and Ship To can be the same if the billing and shipping addresses are the same.

To aid in the adoption of GLNs for DSCSA purposes, Masters has purchased a group license from GS1 for the identification of independent and small customers with nine or fewer locations (excluding government facilities). Based on data submitted by Masters and other distributors, GS1 is creating GLNs and posting those GLNs to the GS1 Data Hub tool for these independent and small customers. Masters and other distributors will have visibility to those GLNs. The goal is to eliminate the work necessary for independent and small customers to speed up identification. Customers who meet these criteria do not need to take any action now with respect to GLN.

Customers who have more than nine locations must create their own GLNs. Please visit gs1us.org.

Many health systems, through their group purchasing organizations, have GLNs in the GS1 Data Hub which we will use to identify such customers.

We are completing a review of the GS1 Data Hub to determine customers that do not have a GLN. A plan to gather that information is forthcoming.

Most Large Retail and National Accounts can generate GLNs using their Global Company Prefix (GCP) from GS1. If all your locations do not have individual GLNs, please contact GS1 for assistance in generating the necessary GLNs. We are currently collecting GLN information from all Strategic Account customers. We are reviewing that information to identify customers that do not have a GLN.

Masters is conducting a review to determine which practices still require GLNs and, where possible, will assign GLNs to those practices. At this time, there is no action required of our practices. If Specialty Provider customers and practices in The US Oncology Network need to sign up for their own GLN, their account manager or RSVP/RVP will contact them directly.

SERIALIZED TRANSACTION INFORMATION

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

The FDA will require serialized data for DSCSA in-scope products to be shared effective November 27, 2024. Masters began sharing limited serialized data for DSCSA in-scope products in December 2023, through the same portals from which you receive lot-level data today.

In order to receive any serialized transaction data for DSCSA in-scope products from Masters, you must have a Sold To and Ship To GLN on file with us. The serialized transaction data is tied directly to your GLN. You will continue to receive lot-level transaction data until November 27, 2024. Additionally, if you select to use a third-party DSCSA solution provider as your repository, you must complete the enrollment process by contacting your Sales team member. Important note: Masters is requesting all customers to have their GLNs on file by July 1, 2024.

Limited serialized transaction data for in-scope product will begin to be available to all Masters customers in December 2023. When the information goes live, you will access your serialized data the same way that you access your lot-level data from your designated Masters ordering portal or, if you have contracted with a third-party provider, through their service.

Per DSCSA requirements, Masters will maintain a record of your serialized transaction data for DSCSA in-scope products for six years.

Masters will transmit lot data for DSCSA in-scope products throughout the Stabilization Period, which ends November 27, 2024. Limited serialized data for DSCSA in-scope products became available in December 2023. The availability of a customer’s serialized transaction data for such products will depend on the manufacturer’s ability to provide full EPCIS data and the Masters shipping distribution center’s capability to capture and transmit that serialized data. As of November 27, 2024, only serialized transaction data for DSCSA in-scope product will be gathered and distributed. Masters will maintain lot and serial DSCSA data for six years after the transaction date for such data as required by the DSCSA.

Masters is working with our supplier partners to obtain DSCSA serialized data for all DSCSA in-scope products. We are also implementing DSCSA serial number capture capabilities in our distribution centers, which will enable serial DSCSA data to become available in the Masters portal and to be able to send serial DSCSA EPCIS files to customers who request this service, provided we have that serial information from our suppliers. Masters distribution centers will have this capability by April 2024.

Masters will be aggregating the serial information of the individual DSCSA in-scope products to their totes and including that level of detail in the DSCSA transaction data. It is the dispenser’s decision how to use this information. Recent FDA guidance has suggested that customers should confirm DSCSA transaction data was received.

Masters is making DSCSA transaction data available through our online portal. Masters data repository called ATTP (Advanced Track and Trade for Pharmaceuticals) will store serialization data from Masters and allow searching, downloading, and printing upon requests made through the customer-facing portal, provided that the customer has the required GLN(s). Masters customers may use our portal link to manage their DSCSA transaction data during the six-year DSCSA record retention requirement. Additionally, customers may opt to have the data transmitted daily using an EPCIS file to their in-house or third-party DSCSA repository for storage.

The “Agreement to Maintain DSCSA-Required Transactional Data” is necessary for Masters to manage and retain DSCSA data in the Masters portal for customers. This licensing agreement will appear when you attempt to access the DSCSA data in the portal for the first time and then periodically thereafter to re-verify the license agreement. You must accept the agreement to access
the data. The agreement can also be printed.

When Masters purchases DSCSA in-scope product directly from the manufacturer, we provide a Direct Purchase Statement in lieu of providing the lot number in the DSCSA Transaction Data. Starting November 27, 2024, the Transaction Data must contain the lot number, serial number and expiration date of DSCSA in-scope product. Masters will be incrementally providing this Transaction Data during the Stabilization Period as it tests and matures its systems.

If you will be using a third-party solution provider for your transaction data, you should first contact your Sales representative to complete the enrollment process. Have the following details to share with your representative:

  • Contact Name for Serialization Responsible Party (Name of third-party solution provider)\
  • Contact Email Address
  • Your GLN(s), and Global Corporate Prefix
  • Expected readiness date (the first date the customer & third-party provider want to receive data
    from Masters) or desired date for contact to kick off onboarding

The Sales representative will complete the enrollment process and submit to
serializationIT@mckesson.com. You will receive a notification of progress and
completion of onboarding.

The process takes approximately:

  • 7-10 business days to onboard a customer and start sending EPCIS files through an existing
    solution provider with an established and certified connection.
  • 3-4 weeks to complete onboarding of a new solution provider.

Masters would not have access to the agreement between the customer and the customer’s third-party service provider to manage and store the customer’s DSCSA Transaction Data. Please contact your service provider directly for a copy of the agreement.

EPCIS data for 340B purchases will be provided to the covered entity, not the contract pharmacy. The covered entity can grant access to EPCIS data to their contract pharmacies, but this must be handled by the covered entity and the contract pharmacy.

The ordering process for drop shipments of DSCSA in-scope products will remain the same as it is now. The manufacturers shipping your product will send you the lot-level DSCSA Transaction Data; Masters currently does not provide this data. Our ordering lot-level DSCSA system will indicate a drop shipment occurred but will not have complete DSCSA information as the manufacturer must provide that detail.

To improve the process for serialized DSCSA transaction data, Masters is building functionality to enable it to receive the drop ship serial DSCSA data from the manufacturer and pass it onto the customer. This functionality is in development and depends on the manufacturer sending the DSCSA data to Masters. Even if Masters provides this service, the manufacturer retains the ultimate obligation to send the data.

For drop ship orders of DSCSA in-scope products, Masters owns the product prior to transferring that ownership to the customer. However, since Masters does not possess the product in a drop ship situation, the DSCSA transaction data is created by the shipper. We do expect the shipper to share the data with us which, if received, we will load into our portal or provide to a customer’s third-party DSCSA solution.

RETURNS INFORMATION

Yes, DSCSA creates additional obligations for saleable returns of DSCSA in-scope products. Once the process goes into effect, the process will be as follows, which we will communicate to our customers:

  • As a customer, we will ask you to confirm that the serial number of the item being returned was purchased from Masters.
  • The distributor (Masters) must verify the product identifier of the returned package against the manufacturer’s assigned data.
  • The distributor (Masters) must also associate the returned product with its original DSCSA transaction data at the serial product identifier level from Masters’ initial sale to the customer.
  • Masters will not be able to accept any saleable product returns where Masters cannot verify or associate the product with the original DSCSA transaction data from the initial sale.

IMPORTANT NOTE: A detailed product returns process communication will be shared at a later date.

There are no DSCSA tracking requirements for unsaleable product. Any unsaleable product, whether going to a third-party processor or subject to a recall, is not subject to DSCSA Track and Trace requirements.

The DSCSA requires that a purchaser can only return DSCSA in-scope product to the immediate trading partner from which they purchased the product. Distributors will be expected to associate the serial number of the returned package with the purchaser’s DSCSA transaction information and only accept saleable returns where the serial number matches.

For 340B replenishment programs, only the covered entity and not the contract pharmacy has this return right.

IMPORTANT NOTE: A detailed product returns process communication will be shared at a later date.

NEXT STEPS AND WHAT TO EXPECT

Please use the FDA link to find a full list of actions that should be taken at https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

In summary, Masters recommends the following:

  • Prior to November 27, 2024, 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 DSCSA in-scope products they purchased.
    • 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 in the Summer of 2024, DSCSA transaction data where available will be accessible through the Masters portal or your in-house or third-party system where you requested this information to be transferred.
    • All trading partners must confirm that the serial number of the saleable DSCSA in-scope product they intend to return was purchased from Masters before initiating the return.
    • DSCSA in-scope product returns where Masters is unable to verify or associate the serial number of the product cannot be accepted as a saleable return under the DSCSA.

Your pharmacy should have procedures to identify and investigate suspect and illegitimate product according to the requirements in DSCSA. The DSCSA transaction data may assist you in conducting these investigations. Additional information for dispensers from NACDS, NCPA, HDA and NABP about dispenser requirements is available at www.dscsa.pharmacy.

IMPORTANT NOTE: For some of these processes, Masters will provide a more detailed process communication to enable testing of our systems and processes prior to November 27, 2024.

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

You can find more information about DSCSA on the McKesson website:
https://www.mckesson.com/Pharmaceutical-Distribution/Supply-Chain-Security/

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.

Proud Members

Ready to see the full catalog?

Register today. No contracts, no risk. Why wait?

Masters Pharmaceutical Distributor / Distributors & Pharmaceutical Wholesaler / Wholesalers