Guidance On Quantitative Thresholds

| by: Deneen Fumich, RPh  | Article Posted: January 20, 2023 |

As the Pharmaceutical Supply Chain continues to digest the Injunctive Relief requirements for the Big 3 Wholesalers, questions have been posed by industry to both the DEA and State Regulators as to the requirements and expectations of setting Quantitative Thresholds. 

DEA has spoken up and provided a guidance document that clarifies that neither the CSA or DEA regulations establish quantitative thresholds or place limits on the volume of controlled substances that a registrant can order or dispense. 

The following question with answer is available on the Q& A:  “Are DEA-registered manufacturers or distributors required by the CSA or DEA regulations to establish limits (quantitative thresholds) on the amounts of controlled substances, including MOUD, that another DEA registrant can order or dispense?” 

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