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    RESOURCES > Federal Register Notices > Rules - 2021

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    Rules - 2021

    Rules - 2021 DEA Form 222

    Direct Final Rule: Clarification Regarding the Supplier's DEA Registration Number on the Single-Sheet DEA Form 222 (July 20, 2021)

    Drug Scheduling Actions

    Final Rule: Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical (PDF) (November 18, 2021)

    Final Order: Placement of Isotonitazene in Schedule I (PDF) (November 4, 2021)

    Final Rule: Placement of 4,4'-DMAR in Schedule I (August 12, 2021)

    Extension of Temporary Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-ethylaminopentiophenone, 4'-Methyl-alpha-pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-alpha-pyrrolidinovalerophenone in Schedule I of the Controlled Substances Act (July 16, 2021)

    Final Rule: Registration Requirements for Narcotic Treatment Programs With Mobile Components (PDF) (June 28, 2021)

    Final Rule: Placement of para-Methoxymethamphetamine (PMMA) in Schedule I (June 25, 2021)

    Final Rule: Specific Listing for 4F-MDMB-BINACA, a Currently Controlled Schedule I Substance (June 22, 2021)

    Final Rule: Placement of N-Ethylpentylone in Schedule I (June 14, 2021)

    Final Rule: Placement of Oliceridine in Schedule II (June 10, 2021)

    Final Rule: Placement of NM2201, 5F-AB-PINACA, 4-CN-CUMYL-BUTINACA, MMB-CHMICA, and 5F-CUMYL-P7AICA in Schedule I (June 10, 2021)

    Designation of 3,4-MDP-2-P Methyl Glycidate (PMK Glycidate), 3,4-MDP-2-P Methyl Glycidic Acid (PMK Glycidic Acid), and Alpha-Phenylacetoacetamide (APAA) as List I Chemicals; Correction (June 7, 2021)

    Final Rule: Placement of Remimazolam in Schedule IV (June 2, 2021)

    Final Rule: Placement of Lasmiditan in Schedule V (May 24, 2021)

    Final Rule: Designation of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA) as List I Chemicals (May 10, 2021)

    Interim Final Rule: Placement of Serdexmethylphenidate in Schedule IV (May 7, 2021)

    Final Rule: Placement of Four Specific Fentanyl-Related Substances in Schedule I (May 4, 2021)

    Final Rule: Placement of 10 Specific Fentanyl-Related Substances in Schedule I (April 27, 2021)

    Final Rule: Removal of Samidorphan From Control (April 19, 2021)

    Final Rule: Placement of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl in Schedule I; Correction (March 31, 2021)

    Extension of Temporary Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I of the Controlled Substances Act (March 31, 2021)

    Final Rule: Placement of Lemborexant in Schedule IV (March 3, 2021)

    Temporary Placement of Brorphine in Schedule I (March 1, 2021)

    Exempt Chemical Preparations Under the Controlled Substances Act

    Order with Opportunity for Comment: Exempt Chemical Preparations Under the Controlled Substances Act (PDF) (July 22, 2021)

    Exempt Chemical Preparations Under the Controlled Substances Act (PDF) (April 23, 2021)

    Proposed Rules

    Proposed Amendment: Temporary Placement of Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-pyrrolidino etonitazene, and Protonitazene in Schedule I (PDF) (December 7, 2021)

    Proposed Rule: Placement of Methoxetamine (MXE) in Schedule I (PDF) (December 7, 2021)

    Proposed Rule: Transfer of Electronic Prescriptions for Schedules II-V Controlled Substances between Pharmacies for Initial Filling (PDF) (November 19, 2021)

    Proposed Rule: Regulation of Telepharmacy Practice (PDF) (November 17, 2021)

    Proposed Rule: Removal of [\18\F]FP-CIT From Control (PDF) (November 4, 2021)

    Proposed Rule: Placement of Methiopropamine in Schedule I (September 2, 2021)

    Proposed Rule: Placement of Mesocarb in Schedule I (August 11, 2021)

    Proposed Rule: Placement of Amineptine in Schedule I (July 22, 2021)

    Proposed Rule: Placement of N-Ethylhexedrone, alpha-Pyrrolidinohexanophenone, 4-Methyl-alpha-ethylaminopentiophenone, 4'-Methyl-alpha-pyrrolidinohexiophenone, alpha-Pyrrolidinoheptaphenone, and 4'-Chloro-alpha-pyrrolidinovalerophenone in Schedule I (July 16, 2021)

    Proposed Rule: Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical (March 30, 2021)

    Proposed Rule: Placement of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 in Schedule I (March 30, 2021)

    Source : www.deadiversion.usdoj.gov

    DEA Makes Changes to Prescribing Rules Due to Pandemic

    Clinical Drug Monitoring

    Helping you stay current in drug monitoring

    DEA Makes Changes to Prescribing Rules During Pandemic

    The Drug Enforcement Agency (DEA) has made several important changes to the rules that govern prescription of controlled substances, in response to the public health emergency posed by the COVID-19 pandemic.

    The initial evaluation of the patient may now occur by telemedicine “using a real-time, two-way, audio-visual communications device”, rather than in person. Previously, telemedicine visits were only allowed for maintenance appointments.

    Under certain circumstances, the prescriber may call in the prescription to the pharmacy, rather than providing a written prescription. For Schedule II drugs, the phone-in prescription is allowed if the proper treatment requires immediate administration, if there is no alternative treatment available, and it is not “reasonably possible for the prescribing practitioner to provide a written Rx to the pharmacy prior to dispensing.” A written prescription, electronic prescription, or photograph of the written prescription should be delivered to the pharmacy within 15 days of the phone-in prescription, rather than the 7 days specified in the regulations that authorize emergency oral prescribing.

    “Whether an emergency situation exists is a determination made by a practitioner based on the individual facts of a particular medical situation,” according to guidance issued by the DEA. “Thus, an emergency situation does not necessarily exist with regard to every prescription of a Schedule II controlled substance issued during the Public Health Emergency: this determination must still be made by practitioners on a case-by-case basis.”

    The full guidance is here:

    Dear Practitioner Registrants and Pharmacists

    A useful flow chart summarizing the current regulations is here:

    How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency

    In a separate Guidance Letter, the DEA reiterated its policy regarding early refills of Schedule II substances considering the pandemic. The Controlled Substances Act prohibits refilling a prescription, but does allow issuing multiple prescriptions “authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance,” provided the prescriptions are signed and dated, and indicate the earliest date for which each successive prescription can be filled.

    That letter can be found here:

    Dear Registrant Community

    In a third Guidance Letter, the DEA waived a portion of its regulations requiring state-by-state registrations for physicians who prescribe across state lines. DEA notes that many states have granted medical licensing reciprocity to practitioners in neighboring states, but DEA regulations would normally require a physician to register with the DEA in both the state in which the physician practices and the state in which the prescription is filled. In light of the pandemic, DEA has changed this regulation as follows: “DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs.”

    That letter can be found here:

    Dear Registrant

    Further policy and guidance documents pertinent to COVID-19 are available from DEA here:

    https://www.deadiversion.usdoj.gov/coronavirus.html

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    Source : www.questdrugmonitoring.com

    Limits on Prescription Drug Dispensation and Sales

    Limits on Prescription Drug Dispensation and Sales

    Description

    Limits on prescription drug dispensation and sales were suggested by the federal Controlled Substances Act (CSA), which outlines specific guidelines. However, some states (and health insurance companies) have further regulations regarding the dispensation of controlled substances.

    Objective(s)

    To limit access to controlled substances that have the potential for misuse and abuse

    Typical Elements

    Sub-federal restrictions on prescription drug dispensation and sales fall into several broad categories:

    The time after a prescription is issued during which a pharmacist can fill a prescription

    The quantity of a drug that may be prescribed and/or dispensed

    The ability to prescribe refills and/or the quantity of those refills

    Prescriptions issued orally (“called in”)

    The quantity of a drug that may be prescribed by health practitioners other than doctors (physician assistants, nurse practitioners, etc.)

    The identification required to collect a prescription

    Note: State laws are documented by the Centers for Disease Control and Prevention: http://www.cdc.gov/phlp/publications/topic/prescription.html

    Health insurers (including Medicaid) can impose limitations on the time between prescriptions based on the days’ supply (for example, Medicaid will not pay for a new prescription until 85% of the days’ supply has elapsed; Centers for Disease Control and Prevention [CDC], 2015).

    While federal law does not set a time limit within which controlled substance prescriptions must be filled after being signed by the practitioner, some states and insurance companies have instituted such limits (Rannazzisi & Caverly, 2006; CDC, 2015).

    There are no specific federal limits on the quantity of drugs dispensed via a prescription, but states and some insurance carriers have created specific quantity limitations based on a host of factors, including drug schedule, drug type, and patient diagnosis (Rannazzisi & Caverly, 2006). These laws limit the drug by days’ supply, by dosage units, or both. Five states have set limits for all prescription drugs or all controlled drugs, while 23 states and the District of Columbia have restrictions for specific schedules of drugs (CDC, 2015). For example (CDC, 2015):

    Missouri limits Schedule II prescriptions to a 30-day supply, while limiting Schedules III, IV, and V prescriptions to a 90-day supply

    South Carolina limits Schedules III-V to a 30-day supply

    Seven states and the District place special restrictions on oral prescriptions

    Under federal law, prescriptions for Schedule II substances cannot be refilled. Prescriptions for Schedule III and IV controlled substances can be refilled up to five times in six months, and prescriptions for Schedule V controlled substances can be refilled as authorized by the practitioner. However, a practitioner can issue multiple prescriptions for a Schedule II drug, allowing a patient up to a 90-day supply, if the following conditions are met (Leonhart, Rannazzisi, & Caverly, 2010):

    Each separate prescription is issued for a legitimate medical purpose by a practitioner acting in the “usual course of professional practice” (Leonhart, Rannazzisi, & Caverly, 2010, p. 3)

    The practitioner provides written instructions on each prescription indicating the earliest date that a pharmacy can fill it

    The practitioner concludes that there is not excessive risk of diversion or abuse

    Multiple prescriptions are allowable under applicable state laws

    The practitioner complies fully with all other applicable requirements under the CSA and Code of Federal Regulations, as well as any additional state laws

    Additional regulations regarding prescription refills can be based on a variety of factors, for example (FSMB, n.d.):

    In Oklahoma, a new prescription for a specific controlled substance voids any existing refills or other prescriptions for the same drug, and refills cannot be granted at the same time as the initial filling of the prescription for Schedule III or IV controlled substances

    In South Carolina, no prescription can be refilled sooner than 48 hours prior to the time that the prescription should be consumed, if the prescribed daily dosage is divided into the total prescribed amount

    In Utah, the dispensing date of a second or third prescription can be no less than 30 days from the dispensing date of the previous prescription (though some exceptions apply)

    Under federal law, oral (“call in”) prescriptions for Schedule II controlled substances are allowable only in emergency situations, and significant restrictions apply to faxed prescriptions. However, oral prescriptions are allowed for Schedule III and IV controlled substances (Rannazzisi & Caverly, 2006).

    Limitations can be imposed on prescribers who are not doctors. While prescriptions for controlled substances can be issued by a Drug Enforcement Administration-registered practitioner (including physicians, dentists, and mid-level practitioners) under specific conditions, some states limit the prescribing abilities of non-doctors. Kentucky, North Carolina, and Pennsylvania, for example, limit the prescription of controlled substances by nurse practitioners (CDC, 2012).

    Health plans (both private and public) can impose quantity or days’ supply limitations and refill limitations on their enrollees. For example, Arizona, Delaware, and New Jersey’s Medicaid programs impose limitations on prescription quantity and days’ supply and refills, which apply to all prescription medications, including controlled substances (Arizona Health Care Cost Containment System Administration, 2014; General Assembly of the State of Delaware, 2006; New Jersey Division of Medical Assistance and Health Services, 2004).

    Source : preventionsolutions.edc.org

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