Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols
Under the current schedules of controlled substances in the DEA regulations, among the substances listed in schedule III is a synthetic isomer of tetrahydrocannabinols (THC) contained in a specific formulation of a drug product approved by the U.S. Food and Drug Administration (FDA). As currently written, the DEA regulation would not necessarily include drug products approved by the FDA under section 505(j) of the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355) (commonly referred to as generic drugs) that cite the drug product currently listed in schedule III as the reference listed drug. DEA is hereby proposing to modify the regulation so that certain generic drug products are also included in the schedule III listing.
Designation of Oripavine as a Basic Class of Controlled Substance
This is a final rule issued by the Drug Enforcement Administration (DEA) designating oripavine (3-O-demethylthebaine or 6,7,8,14-tetradehydro-4,5-alpha-epoxy-6-methoxy-17-methylmorp hinan-3- ol) as a basic class in schedule II of the Controlled Substances Act (CSA). Although oripavine was not previously listed in schedule II of the CSA, it has been controlled in the United States as a derivative of thebaine and, as such, is controlled as a schedule II controlled substance which includes ``Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate.'' Oripavine is a derivative of thebaine, a natural constituent of opium, hence oripavine has been and continues to be, by virtue of the definition of ``narcotic drug'', a schedule II controlled substance. International control of oripavine in schedule I of the 1961 Single Convention on Narcotic Drugs (1961 Convention) during the 50th session of the Commission on Narcotic Drugs (CND) in 2007 prompted the DEA to specifically designate oripavine as a basic class of controlled substance in schedule II of the CSA.
Record Requirements for Chemical Distributors
In March 2006, Congress enacted the Combat Methamphetamine Epidemic Act of 2005, which mandates that regulated sellers of scheduled listed chemical products self- certify with DEA before they are allowed to sell these products at retail. DEA is proposing to revise its recordkeeping requirements to include a requirement that manufacturers, distributors, and importers obtain and maintain the certification number issued by DEA to regulated sellers in their records of sales. This change will ensure that registrants verify that the regulated sellers to whom they distribute have successfully completed the mandatory self-certification process imposed by the CMEA for sales of scheduled listed chemical products.
Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners
The Drug Enforcement Administration (DEA) is proposing to conform its regulations to recent statutory amendments to the Controlled Substances Act that changed certain patient limitations for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment.
Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008: Proposed
This notice proposes the initial year 2008 assessment of annual needs for certain List I chemicals in accordance with the Combat Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006. The Act required DEA to establish production quotas and import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. This was done to prevent the illicit use of these three chemicals in the clandestine manufacture of methamphetamine. The enactment of the CMEA places additional regulatory controls upon the manufacture, distribution, importation, and exportation of the three List I chemicals.
Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2007
This notice establishes the initial year 2007 assessment of annual needs for certain List I chemicals in accordance with the Combat Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.
Controlled Substances: Final Revised Aggregate Production Quotas for 2007
This notice establishes final 2007 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA). The DEA has taken into consideration comments received in response to a notice of the proposed revised aggregate production quotas for 2007 published May 3, 2007 (72 FR 24608).
Controlled Substances: Proposed Aggregate Production Quotas for 2008
This notice proposes initial year 2008 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).