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67348 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices inspection at the Office of the Secretary SUMMARY: This final order establishes persons were invited to comment on or and on EDIS. the initial 2019 aggregate production object to the proposed aggregate The authority for the Commission’s quotas for controlled substances in production quotas and the proposed determination is contained in section schedules I and II of the Controlled assessment of annual needs on or before 337 of the Tariff Act of 1930, as Substances Act and the assessment of September 19, 2018. amended (19 U.S.C. 1337), and in part annual needs for the list I chemicals Comments Received 210 of the Commission’s Rules of ephedrine, pseudoephedrine, and Practice and Procedure (19 CFR part phenylpropanolamine. The DEA received 48 comments from 210). professional organizations, patients, DATES: Valid December 28, 2018. associations, universities, Senators, By order of the Commission. FOR FURTHER INFORMATION CONTACT: State Attorneys General, a doctor, DEA Issued: December 20, 2018. Kathy L. Federico, Regulatory Drafting registered entities, and non-DEA Lisa Barton, and Policy Support Section (DPW), entities. The comments included Secretary to the Commission. Diversion Control Division, Drug concerns about the quota process, [FR Doc. 2018–28175 Filed 12–27–18; 8:45 am] Enforcement Administration, 8701 shortages, prescriptions, diversion, BILLING CODE 7020–02–P Morrissette Drive, Springfield, VA marihuana, requests for a hearing, 22152, Telephone: (202) 598–6812. requests for increase in specific SUPPLEMENTARY INFORMATION: production quotas, and other comments JUDICIAL CONFERENCE OF THE Legal Authority that are outside the scope of the notice. UNITED STATES Section 306 of the Controlled Quota Process Hearing of the Judicial Conference Substances Act (CSA) (21 U.S.C. 826) There were eight commenters that Advisory Committee on the Federal requires the Attorney General to expressed concerns about the quota Rules of Evidence establish aggregate production quotas process. Some of these commenters for each basic class of controlled requested that the DEA consider AGENCY: The Advisory Committee on substance listed in schedules I and II information from the Department of the Federal Rules of Evidence, Judicial and for the list I chemicals ephedrine, Health and Human Services (HHS) and Conference of the United States. pseudoephedrine, and the Food and Drug Administration ACTION: Notice of cancellation of public phenylpropanolamine. The Attorney (FDA) to determine the aggregate hearing. General has delegated this function to production quota. Other commenters the Administrator of the DEA pursuant stated that the DEA did not consider the SUMMARY: The January 18, 2019 public to 28 CFR 0.100. factors contained in the Controlled hearing in Washington, DC, on proposed Substances Quotas Final Rule published Background amendments to the Evidence Rules has on July 16, 2018, 83 FR 32784, to been canceled. The 2019 aggregate production quotas determine the 2019 aggregate FOR FURTHER INFORMATION CONTACT: and assessment of annual needs production quota. Rebecca A. Womeldorf, Rules represent those quantities of schedule I The DEA has obtained and considered Committee Secretary, Rules Committee and II controlled substances and the list relevant information from the FDA. The Staff, Administrative Office of the I chemicals ephedrine, information the DEA received included United States Courts, Washington, DC pseudoephedrine, and the observed and estimated domestic 20544, telephone (202) 502–1820. phenylpropanolamine that may be usage of 26 schedule II controlled SUPPLEMENTARY INFORMATION: manufactured in the United States in substances, new drug applications and Announcements for this hearing were 2019 to provide for the estimated abbreviated drug application approvals, previously published in 83 FR 39463 medical, scientific, research, and and clinical trials for schedule I and II and 83 FR44305. industrial needs of the United States, for controlled substances. lawful export requirements, and for the Regarding the Final Rule published Dated: December 20, 2018. establishment and maintenance of on July 16, 2018, 83 FR 32784, the DEA Rebecca A. Womeldorf, reserve stocks. These quotas include amended the factors set forth in 21 CFR Rules Committee Secretary. imports of ephedrine, pseudoephedrine, 1303.11 to be considered when setting [FR Doc. 2018–28160 Filed 12–27–18; 8:45 am] and phenylpropanolamine, but do not the aggregate production quotas to BILLING CODE 2210–55–P include imports of controlled include the extent of diversion of the substances for use in industrial controlled substances in each class, and processes. relevant information obtained from the DEPARTMENT OF JUSTICE On August 20, 2018, the DEA HHS, the FDA, the Centers for Disease published a notice titled ‘‘Proposed Control and Prevention (CDC), the Drug Enforcement Administration Aggregate Production Quotas for Centers for Medicare and Medicaid Schedule I and II Controlled Substances Services (CMS), and the states. [Docket No. DEA–488E] and Assessment of Annual Needs for the The DEA has solicited the states and List I Chemicals Ephedrine, federal partners to obtain relevant Established Aggregate Production Pseudoephedrine, and information to be considered when Quotas for Schedule I and II Controlled Phenylpropanolamine for 2019’’ in the setting the aggregate production quota Substances and Assessment of Federal Register. 83 FR 42164. This pursuant to 21 CFR 1303.11 and this Annual Needs for the List I Chemicals notice proposed the 2019 aggregate information will be considered for the Ephedrine, Pseudoephedrine, and production quotas for each basic class of 2019 proposed adjustments to the Phenylpropanolamine for 2019 controlled substance listed in schedules aggregate production quota. The DEA AGENCY: Drug Enforcement I and II and the 2019 assessment of will continue to solicit information from Administration, Department of Justice. annual needs for the list I chemicals the states for the 2020 aggregate ephedrine, pseudoephedrine, and production quotas and the years to ACTION: Final order. phenylpropanolamine. All interested follow. VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 PO 00000 Frm 00138 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67349 However, the DEA is obligated to medical needs of the United States are products entering and exiting the issue individual production and met. market, expected product development, procurement quotas sufficiently in Notably, at the time of the proposed expected exports, inventory data, theft advance of the upcoming year to allow aggregate production quota, 21 U.S.C. and loss data, and company forecasts. manufacturers to prepare for the 826(a) provided that ‘‘production quotas As a result, the final aggregate legitimate needs of the United States. shall be established in terms of production quota for several opioids are The DEA may not issue individual quantities of each basic class of decreased from the proposed initial production and procurement quotas controlled substance and not in terms of 2019 levels. These decreases take into until the aggregate production quotas individual pharmaceutical dosage forms account the combined efforts of the the have been established. As a result of prepared from or containing such a DEA, the FDA, and the CDC enforcing these obligations under the CSA, the controlled substance.’’ On October 24, regulations and issuing guidance DEA was not able to obtain and consider 2018, the President signed into law the documents as well as many states the amended factors set forth in Final SUPPORT for Patients and Communities enacting prescription monitoring Rule, 83 FR 32784, for the purpose of Act of 2018, (Pub. L. 115–271), which database programs to stem the opiate/ issuing the 2019 proposed aggregate now allows but does not require the opioid epidemic. production quota. DEA to grant quotas in terms of dosage Quotas and Prescriptions The DEA has a fluid process for forms if the agency determines that setting quotas which allows the agency doing so will assist in avoiding the Eleven State Attorneys General to make necessary quota adjustments. overproduction, shortages, or diversion submitted a joint comment recognizing The process involves setting the of a controlled substance. DEA will be DEA’s efforts to combat the opioid proposed aggregate production quotas evaluating these issues over time. epidemic and expressed concerns about Furthermore, the DEA and the FDA for a calendar year, and, following the excessive quotas for opioids. These can coordinate efforts to prevent or review of any comments, the issuance of commenters also expressed concerns alleviate drug shortages pursuant to 21 a Final Order to establish the aggregate about overprescribing and referenced U.S.C. 826a(2). For example, the production quota. Later in the process, various studies. The referenced material asserted domestic shortage of injectable the DEA issues a Proposed Adjustment cited in these comments also discuss controlled substances was alleviated to the aggregate production quota, and patients who divert their prescriptions through the FDA and the DEA following the review of any comments, by sharing their prescriptions with collaboration to get specific injectable DEA issues a final order setting the others. controlled substances imported
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    Synthetic Cannabinoids, Forensic & Legal Aspects Marilyn A. Huestis, PhD Chief, Chemistry & Drug Metabolism National Institute on Drug Abuse, National Institutes of Health Council of Forensic Medicine Istanbul, Turkey August 18, 2011 Synthetic Cannabinoid Overview Cannabinoid pharmacology Chemistry of synthetic cannabinoids Metabolism of synthetic cannabinoids Controlled drug administration studies Analytical methods for the identification of synthetic cannabinoids in biological & non-biological matrices Current legal status of synthetic cannabinoids Cannabis Mechanisms of Action THC binds to cannabinoid receptors & modulates endogenous cannabinoid & other neurotransmitter systems CB-1 receptors primarily in central nervous & cardiovascular systems CB-2 receptors primarily in immune system Non-CB1, non-CB2 receptors G-protein receptors discovered & cloned in late 1980’s Endogenous cannabinoids include anandamide, 2-AG, virodhamine, N-arachidonyl dopamine (NADA), oleamide, 2-arachidonyl glyceryl ether (noladin ether) & others High CB1 Receptor Density Hypothalamus Appetite, Hormones & Sexual behavior Neocortex High cognitive function & Sensory data Basal Ganglia integration Motor control & planning Hippocampus Memory & Learning Amygdala Anxiety, Emotion & Fear Cerebellum Brain Stem Motor control & Spinal Cord & coordination Vomiting reflex & Pain sensation Cannabinoid Mechanisms of Action Receptor distribution in brain correlates with areas involved in physiological, psychomotor & cognitive effects High density in caudate
  • Analysis of Oxycodone and Its Metabolites-Noroxycodone, Oxymorphone, and Noroxymorphone in Plasma by LC/MS with an Agilent ZORBAX Stablebond SB -C18 LC Column

    Analysis of Oxycodone and Its Metabolites-Noroxycodone, Oxymorphone, and Noroxymorphone in Plasma by LC/MS with an Agilent ZORBAX Stablebond SB -C18 LC Column

    Analysis of Oxycodone and Its Metabolites-Noroxycodone, Oxymorphone, and Noroxymorphone in Plasma by LC/MS with an Agilent ZORBAX StableBond SB -C18 LC Column Application Note Pharmaceutical Authors Abstract Linda L. Risler Oxycodone and its oxidative metabolites (noroxycodone, oxymorphone, and Fred Hutchinson Cancer Research noroxymorphone) were analyzed by high performance liquid chromatography/mass Center, spectrometry (HPLC/MS), coupled with chromatographic separation by an Agilent Seattle, WA 98109 ZORBAX Rapid Resolution High Throughput (RRHT) StableBond SB-C18 column. The method used an ammonium acetate/acetonitrile gradient with detection by a mass Anne E. Mack spectrometer in electrospray mode with positive polarity. Spiked human plasma Agilent Technologies, Inc. samples underwent solid phase extraction (SPE) prior to LC/MS analysis. This method provided good linearity (R 2 > 0.9900) and reproducibility (< 10% difference between duplicates) for all compounds, while increasing productivity with a fast, efficient analysis and minimal solvent usage. Introduction Experimental Oxycodone was developed in 1916 as an opioid analgesic An Agilent 1100 Series LC/MS was used for this work: medication intended to replace the far too addictive analgesic at the time, heroin. Today, oxycodone is a Schedule II drug in • Agilent G1312A Binary Pump. Mobile phase A: 20 mM the US, which means, while it has proven medical uses, it is ammonium acetate, pH 4.0 and B: acetonitrile. Flow rate still considered highly addictive with the possibility of both was 0.300 mL/min. Hold 5% B for 2.33 minutes, then physical and psychological dependencies. Figure 1 shows increase B from 5% to 20% from 2.33 to 4.33 minutes, stop oxycodone and its metabolic scheme, yielding noroxycodone, time is 6 minutes, and post time is 4 minutes.
  • Drugs of Abuseon September Archived 13-10048 No

    Drugs of Abuseon September Archived 13-10048 No

    U.S. DEPARTMENT OF JUSTICE DRUG ENFORCEMENT ADMINISTRATION WWW.DEA.GOV 9, 2014 on September archived 13-10048 No. v. Stewart, in U.S. cited Drugs of2011 Abuse EDITION A DEA RESOURCE GUIDE V. Narcotics WHAT ARE NARCOTICS? Also known as “opioids,” the term "narcotic" comes from the Greek word for “stupor” and originally referred to a variety of substances that dulled the senses and relieved pain. Though some people still refer to all drugs as “narcot- ics,” today “narcotic” refers to opium, opium derivatives, and their semi-synthetic substitutes. A more current term for these drugs, with less uncertainty regarding its meaning, is “opioid.” Examples include the illicit drug heroin and pharmaceutical drugs like OxyContin®, Vicodin®, codeine, morphine, methadone and fentanyl. WHAT IS THEIR ORIGIN? The poppy papaver somniferum is the source for all natural opioids, whereas synthetic opioids are made entirely in a lab and include meperidine, fentanyl, and methadone. Semi-synthetic opioids are synthesized from naturally occurring opium products, such as morphine and codeine, and include heroin, oxycodone, hydrocodone, and hydromorphone. Teens can obtain narcotics from friends, family members, medicine cabinets, pharmacies, nursing 2014 homes, hospitals, hospices, doctors, and the Internet. 9, on September archived 13-10048 No. v. Stewart, in U.S. cited What are common street names? Street names for various narcotics/opioids include: ➔ Hillbilly Heroin, Lean or Purple Drank, OC, Ox, Oxy, Oxycotton, Sippin Syrup What are their forms? Narcotics/opioids come in various forms including: ➔ T ablets, capsules, skin patches, powder, chunks in varying colors (from white to shades of brown and black), liquid form for oral use and injection, syrups, suppositories, lollipops How are they abused? ➔ Narcotics/opioids can be swallowed, smoked, sniffed, or injected.