Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

I took a quick look and the DEA has adjusted the quotas for 2019-2020-2021, this year remains TBD. Here is what I see...

Medication Shortages

Issue:

DEA received many comments expressing general concerns that the proposed decreases to the production quotas of certain controlled substances may result in shortages of drug products containing those controlled substances.

DEA Response:

DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet the estimated legitimate medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. DEA sets APQs in a manner to provide for all legitimate medical purposes.

A company can ask for an adjustment to their quota and it can be granted AFTER reviewing the logic presented by a company. So, Elite could ask for an increase and could get it if their logic is justified upon review. If this is the case, it should be a question for the next CC in November and here is why...

Issue:

DEA received comments from three DEA-registered manufacturers regarding 13 different schedule I and II controlled substances, requesting that the proposed APQ for 5-MEO-DMT, d-amphetamine (for conversion), dexmethylphenidate (for sale), DMT, lisdexamfetamine, methadone, methadone intermediate, methylphenidate (for sale), noroxymorphone (for conversion), phenylacetone, psilocybin, psilocin, and remifentanil be established to sufficient levels to allow for manufacturers to meet medical and scientific needs.