Guidance On Quantitative Thresholds
Written-by: Deneen Fumich, RPh
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?”
To receive more articles like this and other industry news, make sure to subscribe to our newsletter by clicking here.
Disclaimer: Pharma Solutions makes every effort to provide accurate information in the content it offers. However, the information provided is “as is” and Pharma Solutions makes no warranties, express or implied, as to the content provided. Pharma Solutions assumes no liability or responsibility for any errors or omissions in the content provided. Laws and regulations that are referenced herein may change over time and as such the content offered is not to be interpreted as advice. Pharma Solutions shall not be liable for any damages whatsoever incurred in connection with the use or performance of this information.