MPJE - FEDERAL CONTROLLED SUBSTANCE LAW -
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| Period of registration Every person who manufactures or distributes any controlled substance or list I chemical | shall obtain annually a registration
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| Period of registration Every person who dispenses, or who proposes to dispense, any controlled substance | shall such registrations be issued for less than one year nor for more than three years.
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| The following persons shall not be required to register with the DEA | 1. An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance or list I chemical if such agent or employee is acting in the usual course of his business or employment.
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| The following persons shall not be required to register with the DEA | 2. A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance or list I chemical is in the usual course of his business or employment.
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| The following persons shall not be required to register with the DEA | 3. An ultimate user who possesses such substance for a purpose specified in section 802(25)
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| Every pharmacy which dispenses any controlled substance must be registered with the | DEA
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| To obtain a DEA registration, a pharmacy can request a DEA Form .... | DEA Form-224 (Application for New Registration)
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| Pharmacy registrations must be renewed every ______ years | three years
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| Every pharmacy currently registered with DEA will receive a | renewal application approximately 45 days before the registration expiration date.
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| Chemical Registration Requirements Under DEA’s Chemical Control regulations there is an exemption from | the registration requirement for a retail distributor
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| Federal law requires any person who is engaged in the wholesale distribution of drug products containing List I chemicals to obtain | a registration as a chemical distributor
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| Retail pharmacies that are registered to handle controlled substances need not obtain a separate DEA chemical registration for retail distribution of the drug products containing | pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and single-entity ephedrine which are regulated as List I chemicals.
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| DEA Form-510 | DEA Chemical Distributor registration
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| Attorney General has the authority to suspend or revoke a DEA registration upon a finding that the registrant has: | Materially falsified any application filed.
Been convicted of a felony relating to a controlled substance or a List I Chemical.
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| Attorney General has the authority to suspend or revoke a DEA registration upon a finding that the registrant has: | Had his/her state license or registration suspended, revoked or denied.
Committed an act which would render his registration inconsistent with the public interest.
Been excluded from participation in a Medicaid or Medicare program.
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| Termination of Registration | Records involving controlled substances must be kept available for two years for inspection and copying by the DEA. This requirement applies even though the business has been discontinued.
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| Transfer of Business A registrant transferring a pharmacy business to another registrant shall notify the nearest DEA Registration Field Office at least ____ days before | 14
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| Transfer of Business On the day the controlled substances are transferred | a complete controlled substances inventory must be taken and a copy of the inventory must be included in the records of both the person transferring the business and the person acquiring the business.
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| The records involving the transfer or destruction of controlled substances must be kept readily available for | two years for inspection and copying by the DEA.
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| The transfer of Schedule III-V controlled substances must be documented in writing to show | drug name, dosage form, strength, quantity and date transferred. The document must include the names, addresses and DEA registration numbers of the parties involved in the transfer of the controlled substances.
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| If a DEA registered pharmacy, transfers to DEA registrants an amount of controlled substances that is ≥ 5% of all controlled substances dispensed during a one-year period, then the DEA registered pharmacy must also register as a | “distributor” with the DEA.
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| Destruction of Controlled Substances DEA Form _____ | DEA Form 41
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| SECURITY REQUIREMENTS The DEA requires pharmacies to keep Schedules II, III, IV and V controlled substances in | a locked cabinet or dispersed through the non-controlled stock to deter theft. An electronic alarm system is recommended
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| Controlled Substance Theft or Significant Loss DEA Form _____ | DEA Form-106
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| Controlled Substance Theft or Significant Loss Time frame to notify DEA & Local police | Immediately upon discovery (within 1 business day)
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| The DEA Form 106 must include | Name / address of pharmacy
DEA registration #
Date of theft
Name / phone number of local police department notified
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| The DEA Form 106 must include | Type of theft
Listiof symbols or cost code used by pharmacy in marking containers.
List of controlled substances missing from theft or significant loss
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| “Significant Loss” Some factors to consider for determining significant loss include: | 1. The schedule of the missing items.
2. The abuse potential of the missing items.
3. The abuse potential in your area of the missing substance.
4. The quantity missing (one tablet vs. one bottle or container).
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| “Significant Loss” Some factors to consider for determining significant loss include: | 5. Is this the first time this loss has occurred? Has a similar loss occurred before?
6. Was this loss reported to local law enforcement authorities?
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| "In-Transit Loss" | the supplier is responsible for reporting the in-transit loss of controlled substances to DEA. A pharmacy is responsible for reporting any loss of controlled substances after a pharmacist has signed for or taken custody of a shipment.
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| "Breakage/Spillage " | breakage or spillage of controlled substances does not constitute a “loss” of controlled substances. When this disposal occurs, it must be reported to DEA on a DEA Form-41
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