Lesson 01 of 14

DSCSA November 2026: Is It Still Your Deadline?

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Count your full-time pharmacists and technicians, projected to November 27, 2026, and write down your deadline.FDA letter, Aug 6, 2026 · Lesson 04
Tell your wholesaler and other trading partners which deadline applies to you.FDA letter, Aug 6, 2026 (recommendation) · Lesson 05
Buy from and sell to authorized trading partners only, and check their licenses or registrations.§582(d)(3); §581(2) · Lesson 06
Accept product only with its transaction information (TI) and transaction statement (TS).§582(d)(1)(A)(i) · Lesson 06
Keep TI and TS for at least 6 years. If a third party stores them, keep a copy of the written agreement.§582(d)(1)(A)(iii), (B) · Lesson 07
Transact only product that carries a product identifier (2D code: NDC, serial, lot, expiration).§582(d)(2); §581(14) · Lesson 06
When selling to another pharmacy, send TI and TS, unless the sale fills a specific patient's prescription.§582(d)(1)(A)(ii); §581(19) · Lesson 09
Keep a written suspect-product procedure, and train everyone who receives deliveries on FDA's red flags.§582(d)(4); FDA guidance, Jun 2021 · Lesson 08
Quarantine suspect product, investigate with your trading partners, and keep records for 6 years.§582(d)(4)(A) · Lesson 08
If a product is illegitimate, notify FDA (Form FDA 3911) and the immediate trading partners who may have received it, within 24 hours.§582(d)(4)(B)(ii) · Lesson 08
Answer FDA or state requests for TI and TS within 2 business days.§582(d)(1)(D) · Lesson 09

Exchange transaction information and statements in a secure, interoperable, electronic way.§582(g)(1)(A) · exempt until Nov 27, 2027
Receive transaction information that includes the product identifier of each package.§582(g)(1)(B) · exempt until Nov 27, 2027
Have systems and processes to verify product at the package level.§582(g)(1)(C) · exempt until Nov 27, 2027
Have systems to promptly answer FDA or state requests with TI and TS.§582(g)(1)(D) · exempt until Nov 27, 2027
Have systems to help gather transaction information back to the manufacturer when asked.§582(g)(1)(E) · exempt until Nov 27, 2027
Verify the product identifier of suspect packages (3 packages or 10%, whichever is greater).§582(d)(4)(A)(ii)(II) · exempt until Nov 27, 2027

Connect RX by Maltexi connects your pharmacy to your trading partners for electronic DSCSA data.