Comment on: DEA proposes to reduce the amount of five opioids manufactured in 2020, marijuana quota for research increases by almost a third

DEA proposes to reduce the amount of five opioids manufactured in 2020, marijuana quota for research increases by almost a third

https://admin.dea.gov/press-releases/2019/09/11/dea-proposes-reduce-amount-five-opioids-manufactured-2020-marijuana-quota

“The five opioid substances were subject to special scrutiny following the enactment last year of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which requires DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions. DEA’s estimates of the amount of diversion that took place for each of these five opioid substances and how those estimates were calculated appear in the Notice.

Interested parties may submit public comments on the proposed APQ until 11:59 p.m. on October 10, following the instructions in the Notice. After taking the comments into account, DEA will publish another notice later in the year informing the public of the established APQ. After that, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports, new manufacturers entering the market, new product development, or product recalls.”

We have to act VERY QUICKLY & MAKE THOSE COMMENTS! PLEASE SHARE TO ALL!

WASHINGTON – The U.S. Drug Enforcement Administration is proposing to reduce the amount of five Schedule II opioid controlled substances that can be manufactured in the United States next year compared with 2019, per the Notice of Proposed Rulemaking being published in the Federal Register tomorrow and available for public inspection here today. 

 

DEA proposes to reduce the amount of fentanyl produced by 31 percent, hydrocodone by 19 percent, hydromorphone by 25 percent, oxycodone by nine percent and oxymorphone by 55 percent. Combined with morphine, the proposed quota would be a 53 percent decrease in the amount of allowable production of these opioids since 2016.

 

DEA proposes to increase the amount of marijuana that can be produced for research by almost a third over 2019’s level, from 2,450 kilograms to 3,200 kilograms, which is almost triple what it was in 2018. This will meet the need created by the increase in the amount of approved research involving marijuana. Over the last two years, the total number of individuals registered by DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) has increased by more than 40 percent, from 384 in January 2017 to 542 in January 2019.

 

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” said Acting Administrator Uttam Dhillon. “DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

 

The Proposed Aggregate Production Quotas and Assessment of Annual Needs being published in the Federal Register addresses more than 250 Schedule I and II controlled substances and three List I chemicals, which include ephedrine, pseudoephedrine, and phenylpropanolamine. This reflects the total amount of substances needed to meet the country’s legitimate medical, scientific, research, industrial and export needs for the year and for the maintenance of reserve stocks. DEA endeavors to set production limits at a level required to meet these needs, without resulting in an excessive amount of these potentially harmful substances.

 

In setting the APQ, DEA considers data from many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s internal system for tracking controlled substance transactions; and past quota histories. As a result of new laws and regulations that took effect in 2018, the number of factors that DEA considers in setting the APQ has increased. Information on these factors and how they were assessed appears in the Notice.

 

The five opioid substances were subject to special scrutiny following the enactment last year of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which requires DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions. DEA’s estimates of the amount of diversion that took place for each of these five opioid substances and how those estimates were calculated appear in the Notice.

 

Interested parties may submit public comments on the proposed APQ until 11:59 p.m. on October 10, following the instructions in the Notice. After taking the comments into account, DEA will publish another notice later in the year informing the public of the established APQ. After that, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports, new manufacturers entering the market, new product development, or product recalls. 

https://www.federalregister.gov/documents/2019/09/12/2019-19785/proposed-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment-of

9 Responses

  1. for those having trouble burrowing thru to the comment form (it sure took me a while; you have to actually leave the Fed Reg site to comment), try:
    https://www.regulations.gov/comment?D=DEA-2019-0008-0001

    use: Docket No. DEA-508P

  2. You say to leave a comment. WHERE? There is no link. The link you posted has no link to a comment. I cannot find where to leave a comment. Can you please give a link? I have been talking with friends and family and a number of them want to comment to, but how do we do that with no link?

  3. This can not Stand! The DEA and the CDC have ruined my quality of life. Stop with the opiate hysteria. It’s an illness called addiction, I am betting more people have died from alcohol related deaths then od on prescription meds. Cause as the reports keep coming out it’s almost completely illicit fentyal and please don’t give the excuse that it’s a gateway drug, just like the DEA likes to preach marijuana is a gateway drug. It’s not. Keep your politics out of my doctors office, don’t harass my doctor for keeping his oath to treat my pain. Oh but you already have, cause now they are scared to even write a prescription all though he knows I need it. Just wait till the suicide rates go up from the lack of care for chronic pain patients. Who will be to blame then? Nothing but the people passing these restrictions like they went to med school. The war on drugs is the wrong war. The money the dea has spent on marijuana and prescription Meds could have been used to help mental health and addiction treatment.

  4. The Chronic Pain Community was doing just fine before the gov messed with our medication. we don’t get high or give ot away, we need every pill
    we are prescribed. The CDC falsified their numbers, caused riots, put out a corrected notice later butbit was too late. The DEA didn’t do its job of keeping cartel drugs lacedbw/fentanyl off our street, so the Chronic Pain Patients were blamed. Now you are once again screwing with
    our meds, we are all different, one size does not fit all. Some people need more meds and some need less depending on our diseases. Some meds work for some and not for others. Some like me have tried every drug out there, I prefer what my current medication is because I can
    function and live a normal life.

    My advice, let the DEA handle the Cartels, let the CDC handle bacteria infections, and the FDA should actually try to keep up with other Country’s in passing products.

    Leave all medical decisions to Doctors and
    their patients.

  5. And what the hell is this going to do? I will tell you..People that need pain medication an cant get it because of clowns saying we cant have it,will only make us look to the streets.And dont think the cartels arent laughing at your stupidity! It really is time for a “civil war” against these morons in government

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