The Drug Supply Chain Security Act (DSCSA) has been with us for almost nine years as part of the FDA’s Plan to protect the U.S. drug supply chain. The culmination of the Drug Supply Chain Security Act will reach its final implementation goal in November 2023. On 11/27/2023, all trading partners (Manufacturers, Wholesalers, and Dispensers (including Pharmacies) will need to begin using an “Enhanced Drug Distribution Security System.” However, before we talk about that, let’s talk about what you need to be doing today. While this blog covers many aspects of the current and future DSCSA requirements, it is essential to understand that some items were left out to keep this blog short and sweet. If you have any questions, please do not hesitate to call us at 1-800-338-3688.
The definitions below are provided directly from the Drug Supply Chain Security Act.
Who is Asking for Compliance?
As with any regulations or standards we talk about, we are constantly asked why it is required and who will be asking for you to provide evidence of compliance. Why is easy, compliance is required by Federal Law. The who has multiple answers; the following entities are asking about your compliance:
- State Boards of Pharmacy
- Accreditation Organizations
Authorized Trading Partners
How often do you receive a fax or email from a “so-called” drug wholesaler offering an expensive medication at a significantly reduced cost? Before you even consider this opportunity, you need to verify that the wholesaler is legitimate in your state, ensuring they are licensed and that the products you will be receiving are legitimate. You must verify that all trading partners you receive medication from (or send to) are legitimate operators. This can be accomplished via the links below:
- Check the registration of manufacturers and re-packagers.
- Check the licensing of wholesale distributors and third-party logistics providers.
- Check the licensing of pharmacies through the respective state authority.
If you cannot verify the trading partner, it might not be a good idea to do business with them.
- Trading partner – means:
- a manufacturer, re-packager, wholesale distributor, or dispenser from whom a manufacturer, re-packager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, re-packager, wholesale distributor, or dispenser transfers direct ownership of a product; or
- a third-party logistics provider from whom a manufacturer, re-packager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, re-packager, wholesale distributor, or dispenser transfers direct possession of a product.
One of the first requirements to hit Pharmacies as part of the DSCSA was the requirement to begin receiving the Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) before or at the time of the receipt of the medication from an authorized trading partner (manufacturer or wholesaler).
- Transaction History (TH) – means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.
- Transaction Statement (TS) – means a statement, in paper or electronic form, that the entity transferring ownership in a transaction—
- is authorized as required under the Drug Supply Chain Security Act;
- received the product from a person that is authorized as required under the Drug Supply Chain Security Act;
- received transaction information and a transaction statement from the prior owner of the product, as required under section 582;
- did not knowingly ship a suspect or illegitimate product;
- had systems and processes in place to comply with verification requirements under section 582;
- did not knowingly provide false transaction information; and
- did not knowingly alter the transaction history.
- Transaction Information (TI) – means:
- the proprietary or established name or names of the product;
- the strength and dosage form of the product;
- the National Drug Code number of the product;
- the container size;
- the number of containers;
- the lot number of the product;
- the date of the transaction;
- the date of the shipment, if more than 24 hours after;
- the date of the transaction;
- the business name and address of the person from whom ownership is being transferred; and
- the business name and address of the person to whom ownership is being transferred.
You may receive the 3Ts in paper or electronic form at this time and must save them for no less than six years. If you are using a contractor to maintain this information, you must have a written agreement and understand that you are still required to provide this information within 48 hours of request by an authorized entity.
Verification and Investigation
The next step is the verification of products. All Pharmacies should ensure that products they receive from a trading partner are legitimate. This means carefully reviewing the packaging and the contents to determine that the product is legitimate. If you have doubts, quarantine the product, begin an investigation, and notify the trading partners (wholesalers and manufacturer). If the product is illegitimate, the FDA must also be notified.
You may also receive requests from trading partners and the FDA. In these situations, you need to quarantine any relevant products and assist the trading partner as necessary with any documentation and materials requested.
- Verification or verify – means determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the re-packager.
The FDA has released some guidance to help identify suspect and illegitimate products in the Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry.
The next requirement concerns what is on the manufacturer’s bottle, which will become even more critical in November 2023. Until recently, a typical manufacturer bottle had at least three pieces of information, the NDC, lot number, and expiration date. You would use this information, specifically the NDC and Expiration date, to verify that you received the correct product from your wholesaler (or other trading partners). If you look at the bottles you are receiving now, you will see a new item, the standardized numerical identifier, consisting of NDC and a serial number. The standardized numerical identifier identifies the actual bottle you have in your hand.
The standardized numerical identifier, lot number, and expiration date are collectively referred to as the product identifier. This product identifier must be in a human and machine-readable (2d barcode) format. This machine-readable format will allow you to quickly scan for verification of receipt (more on that in the next section ).
- Product identifier – means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.
- Standardized numerical identifier – means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.
Enhanced Drug Distribution Security System and other Changes in 11/27/2023
On 11/27/2023, we will see all trading partners (including pharmacies) required to use an Enhanced Drug Distribution Security System, which includes a giant mega interoperable database. This database will allow the supply chain (and the FDA) to locate a product down to the unit level anywhere in the supply chain. In the end, the database should be able to help prevent illegitimate products from entering the supply chain and streamline communications, including recall notices, within the supply chain.
The System will be interoperable and allow the trading partners to identify unit-level transactions. To accomplish this, the seller must provide the TI (including the product identifier) and the TS to the database. Then upon receipt, the purchaser will need to verify that the product received matches the information provided on the TI and TS. Gone will be the days of a simple verification of the NDC or even just the name and strength of the product.
How will this occur? The simplest way to accomplish this will be through barcode scanning technologies that will easily allow pharmacies to scan the receipt of the product and then communicate with the database. If the product identifier does not match, the System will alert the Pharmacy of a discrepancy. At this point, the Pharmacy would work with trading partners to investigate the product.
This process must be duplicated in reverse when you return products to wholesalers. You will provide the TI (including product identifier) and TS to the wholesaler, and the wholesaler will verify that the information is correct when receiving the product at their warehouse.
Supply Chain Alerts
The System will also be able to send out alerts throughout the supply chain. The FDA and Trading partners could initiate these alerts through the system to notify the constituents of the supply chain of suspect products or a medication recall.
Clarity Through the Muck
While the big picture of what will be happening is known, the details on the day-to-day operations are still a little fuzzy on the exact methodology independent Pharmacies (and every other Pharmacy) will use or should use. PRS is actively working with a partner (briefly discussed below) with a mission to provide a clear DSCSA Compliance solution for Pharmacies of all sizes and levels.
In the next few weeks, PRS will be providing additional information on a Program that will bring your Pharmacy into full compliance with the 11/27/2023 requirements. The solution will give you access to the DSCSA database and allow you to quickly and easily:
- Conduct the verification of receipt of the correct unit level package
- Communicate with trading partners when you have a suspect product
- Receive alerts when you receive an incorrect, suspect, or illegitimate product
- Provide the necessary information when you want to return products
- Respond to FDA and trading partners
- Notify the FDA
- And more
We will be releasing a series of short blogs over the next few months to better educate Pharmacies on the existing and upcoming DSCSA requirements.
How can PRS help today?
For your compliance needs today, PRS offers the DRUGSUPPLYTrack Program. The DRUGSUPPYTrack Program provides policies, procedures, forms, and employee training to ensure you comply with today’s DSCSA requirements. If you have any questions, don’t hesitate to contact us at 1-800-338-3688.