Walking Pharmacists Through The Drug Supply Chain Security Act (DSCSA)

Stay updated with all things DSCSA:

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We can all agree that compliance is:

Aggravating

Costly

Hard Work

But whether we like it or not, the Drug Supply Chain Security Act (DSCSA) is quickly approaching.

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We understand...that nobody understands!

Our most recent survey data shows that 95% of Independent Pharmacists DO NOT understand the DSCSA.

Luckily, you've come to the right place.

Keep scrolling for relevant DSCSA compliance information and answer to questions you may have about the upcoming DSCSA requirements.

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So, what is the DSCSA?

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.

On 11/27/2023, all trading partners (Manufacturers, Wholesalers, and Dispensers (including Pharmacies) will need to begin using an “Enhanced Drug Distribution Security System.”

What should I already be doing today?

Good question! To start, you should have ALREADY:

1. Confirmed your Authorized Trading Partners (ATP) are licensed appropriately

Not sure who qualifies as an ATP?

Wholesalers

Manufacturers

2. Received the 3Ts, before or at the time of, product delivery from your ATPs.

What are the 3Ts?

• Transaction History (TH)

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)

provides detailed information about the specific product (unit level), the transaction, the seller, and the purchaser of the product.

• Transaction Information (TI)

a statement provided by the seller that they did not knowingly provide any false information or sell a suspect or illegitimate product.

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.

3. Responded to FDA and other regulators upon receipt of a request.

How do I  prepare for the Enhanced Drug Dristribution Security Rules that go into effect on 11/27/23? 

1. Start receiving the 2Ts (TI and TS) in an electronic interoperable format.

2. Transaction information must include the product identifier.

Product Identifier: standardized numeric identifier, NDC, and unit level serial number.

Standardized Numeric Identifier: set of numbers or characters used to uniquely identify each package

3. Make sure all products received by an ATP has the product identifier.

There is a lot to keep track of, but we can send reminders so your pharmacy doesn’t skip a beat!

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Good so far? Next, let's talk about Verification

Verification

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.

Does your Pharmacy ensure that products received from a trading partner are legitimate?

If you have ANY doubts:

Quarantine the product

Begin an investigation

Notify trading partners

How will verification 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 manufacturer. If the product identifier does not match, the manufacturer will alert the Pharmacy of a discrepancy. At this point, the Pharmacy would work with trading partners to investigate the product.

You may be thinking,

"Won't my wholesaler take care of all this for me?"

NO WAY!

While the wholesaler must provide you with the TS and TI, they cannot:

Conduct product verification for you.

Quarantine products for you.

Create your SOPs and Training.

Work with other vendors you purchase from.

Respond on your behalf to data requests from the FDA, Boards of Pharmacy, PBMs, or other Authorized Trading Partners (ATPs).

Determine if your ATPs are licensed.

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. We’ll continue to update this page as we move closer to the November 2023 start date. Keep reading for our best solution to these requirements.

We can also send updates and reminders right to you!

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So…what’s next?

Well, here are your options:

1. Try to do it yourself

Not the most efficient or convenient approach, but hey, knock yourself out. 

2. Take your chances without compliance

Only pick this option if you plan on closing your pharmacy.

3. Use the best DSCSA compliance program on the market

PRS and Advasur have partnered to provide the most comprehensive DSCSA compliance program at an affordable price! (Hint: THIS IS THE BEST OPTION)

  • 40 years of pharmacy compliance experience.
  • Thousands of Independent Pharmacies across the U.S. rely on PRS for Regulatory Compliance/Credentialing coverage.
  • Built by Pharmacists for Pharmacists
  • A complete turn-key outsourced solution so you can focus your attention on the important part of your job, your patients.

What will PRS and Advasur do for you?

Provide the standard operating procedures (SOPs) for Community Pharmacies.

Provide helpdesk services for software, SOPs, and audit guidance.

Automatically obtains your electronic transaction data from your ATPs.

Provide alerts when there are issues (missing data, suspect data, and more).

Allow you to document investigations of suspect products.

Provide you with the ability to complete and send forms that notify the FDA of illegitimate products.

Don't try to go through this alone. We have you covered.

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