Controlled Substances: Established Initial Aggregate Production Quotas for 2008
This notice establishes initial 2008 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA).
Established Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008
This notice establishes 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.
Reexportation of Controlled Substances
The Controlled Substances Export Reform Act of 2005 amended the Controlled Substances Import and Export Act to provide authority for the Drug Enforcement Administration (DEA) to authorize the export of controlled substances from the United States to another country for subsequent export from that country to a second country, if certain conditions and safeguards are satisfied. DEA is amending its regulations to implement the new legislation.
Designation of Oripavine as a Basic Class of Controlled Substance; Correction
On September 24, 2007, the Drug Enforcement Administration (DEA) published in the Federal Register a final rule (72 FR 54208) designating oripavine (3-O-demethylthebaine or 6,7,8,14-tetradehydro- 4,5-alpha-epoxy-6-methoxy-17-methylmorphinan-3-ol) as a basic class in schedule II of the Controlled Substances Act (CSA). The drug code for oripavine was inadvertently designated as 9335, a drug code which is already used to identify a schedule I controlled substance. This correction corrects that error and assigns a different drug code to oripavine.
Definition of “Positional Isomer” as It Pertains to the Control of Schedule I Controlled Substances
On May 25, 2006, DEA published a Notice of Proposed Rulemaking which proposed the addition of a specific definition for the term ``positional isomer'' to allow for the systematic determination of which isomers of schedule I substances would be considered to be ``positional,'' and therefore, subject to schedule I control. This rulemaking finalizes that definition. The Controlled Substances Act (CSA) and its implementing regulations specify which hallucinogenic substances are considered schedule I controlled substances. The CSA states that all salts, isomers, and salts of isomers of these substances are also schedule I controlled substances. In non-technical terms, an isomer of a substance is a different compound, but a compound which has the same number and kind of atoms. The terms ``optical isomer'' and ``geometric isomer'' are specific scientific terms and it is easy to determine whether one substance is an optical or geometric isomer of another. The term ``positional isomer,'' however, is subject to scientific interpretation. The addition of a definition for the term ``positional isomer'' will assist legitimate research[ers] and industry in determining the control status of materials that are ``positional isomers'' of schedule I hallucinogens. While the DEA will remain the authority for ultimately determining the control status of a given material, providing a specific definition for ``positional isomer'' will ensure consistent criteria are utilized in making these determinations. This rule does not change existing laws, regulations, policies, processes, and procedures regarding the determination of control status for schedule I hallucinogenic substances. This rule merely makes available to the public the longstanding definition of ``positional isomer'' which DEA has used when making these scheduling determinations. This rule is relevant only to specialized forensic or research chemists. Most of these individuals are existing DEA registrants who are authorized by the DEA to handle schedule I hallucinogenic substances.
New Single-Sheet Format for U.S. Official Order Form for Schedule I and II Controlled Substances (DEA Form 222)
The Drug Enforcement Administration (DEA) is proposing to amend its regulations to implement a new format for order forms (DEA Form 222) which are issued by DEA to DEA registrants to allow them to order schedule I and/or II controlled substances. The present format utilizes a three-part, carbon-copy form with Copies 2 and 3 replicating Copy 1. The proposed format will employ a single-sheet form. The new form will have enhanced security features and will be easier for DEA registrants to use.
Removal of Thresholds for the List I Chemicals Pseudoephedrine and Phenylpropanolamine
The Drug Enforcement Administration (DEA) is proposing to remove the thresholds for importation, exportation, and domestic distributions of the List I chemicals pseudoephedrine and phenylpropanolamine. This rulemaking is being conducted as part of DEA's implementation of the Combat Methamphetamine Epidemic Act of 2005 and is needed to implement the Act's requirements for import and production quotas and to address the potential diversion of these chemicals. DEA is also clarifying that all transactions of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, except retail transactions, are considered to be regulated transactions.
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
The Drug Enforcement Administration (DEA) is finalizing a Notice of Proposed Rulemaking published on September 6, 2006 (71 FR 52724). In that document, DEA proposed to amend its regulations to allow practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90- day supply of that controlled substance.