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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....
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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...
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Combat Methamphetamine Epidemic Act of 2005: Fee for Self-Certification for Regulated Sellers of Scheduled Listed Chemical Products
As part of its implementation of the Combat Methamphetamine Epidemic Act of 2005 (CMEA), ``regulated sellers'' or persons and entities selling scheduled listed chemical products at retail locations are required to self-certify with DEA relative to certain requirements of the CMEA. The Diversion Control Program is required to recover the full...
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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...
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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,...
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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.
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Schedules of Controlled Substances: Placement of Lisdexamfetamine into Schedule II
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance lisdexamfetamine, including its salts, isomers, and salts of isomers, into schedule II of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of...
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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...
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Authorized Sources of Narcotic Raw Materials
DEA proposes to amend its regulations to update the list of non-traditional countries authorized to export narcotic raw materials (NRM) to the United States. This change would replace Yugoslavia with Spain. This proposed rule seeks to maintain a consistent and reliable supply of narcotic raw materials from a limited number of countries...
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Issuance of Multiple Prescriptions for Schedule II Controlled Substances
DEA is hereby proposing 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...
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Changes in the Regulation of Iodine Crystals and Chemical Mixtures Containing Over 2.2 Percent Iodine
This Notice of Proposed Rulemaking (NPRM) proposes changes in the regulation of the listed chemical iodine pursuant to the chemical regulatory provisions of the Controlled Substances Act (CSA). The Drug Enforcement Administration (DEA) believes that this action is necessary in order to remove deficiencies in the current regulatory controls,...
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Definition of “Positional Isomer” as It Pertains to the Control of Schedule I Controlled Substances
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...
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Controlled Substances and List I Chemical Registration and Reregistration Application Fees
DEA is proposing to adjust the fee schedule for DEA registration and reregistration application fees relating to the registration and control of the manufacture, distribution and dispensing of controlled substances and listed chemicals to appropriately reflect all costs associated with its Diversion Control Program as mandated by 21 U.S.C. 822....
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Schedules of Controlled Substances: Placement of Embutramide Into Schedule III
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance embutramide, including its salts, into Schedule III of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the Department of Health and...
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Schedules of Controlled Substances: Placement of Pregabalin into Schedule V
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid], including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA). This proposed action is based on a recommendation...
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Control of Sodium Permanganate as a List II Chemical
The Controlled Substances Act (CSA) provides the Attorney General with the authority to specify, by regulation, additional chemicals as ``List II'' chemicals if they are used in the manufacture of a controlled substance in violation of the CSA. The Drug Enforcement Administration (DEA) is proposing the addition of sodium permanganate as a List...
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Schedules of Controlled Substances: Placement of Zopiclone Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance zopiclone, including its salts, isomers and salts of isomers into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Acting Assistant Secretary for Health of the...
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Clarification of Registration Requirements for Individual Practitioners
The Drug Enforcement Administration (DEA) proposes to amend its registration regulations to make it clear that when an individual practitioner who practices and is registered in one state seeks to practice and prescribe controlled substances in another state, he/she must obtain a separate DEA registration for the subsequent state. The current...
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Security Requirements for Handlers of Pseudoephedrine, Ephedrine, and Phenylpropanolamine
DEA is proposing to require that manufacturers, distributors, importers, and exporters of pseudoephedrine, ephedrine, and phenylpropanolamine (PPA) implement security procedures to prevent the theft and diversion of these List I chemicals. These chemicals are available in over-the-counter medications and are widely used in the illicit production...
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Schedules of Controlled Substances: Placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine Into Schedule I of the Controlled Substances Act
The Acting Deputy Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of proposed rulemaking to place alpha-methyltryptamine (AMT) and 5-methoxy-N,N- diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA). This proposed action is based on data gathered and reviewed by the DEA. If...