DEA Pharmacist’s Manual – Flashcards

Drug Enforcement Administration (DEA)

1. prevent diversion and abuse of controlled substances 2. ensure there is an adequate and uninterrupted supply of controlled substances to meet the country's needs

Ephedrine Pseudoephedrine Phenylpropanolamine Combat Methamphetamine Epidemic Act of 2005 (CMEA)

I - high potential for abuse + no currently accepted medical use in the US II - high potential for abuse which may lead to severe psychological or physical dependence but have has accepted medical use III - potential for abuse is less than schedule I/II and abuse may lead to moderate or low physical dependence or high psychological dependence IV - low potential for abuse relative to schedule III V - low potential for abuse relative to schedule IV and consist of preps containing limited quantities of certain narcotics (generally for antitussive, antidiarrheal and analgesic purposes)

DEA form 224

I - each must be registered with the DEA through form 224

DEA Form 223

3 years 224a

no more than 60 days prior to the current expiration date

True - DEA form 224b; along with the affidavit, a list of the corporation's registrations must be provided in lieu of a separate registration application for each pharmacy registration

contact the DEA registration specialist in your area in writing or request modification of registration online -if moving to a different state, must obtain a controlled substances registration prior to approval of modification of the federal registration. once modified, DEA will issue new schedule II forms

2 years

-certificate of registration -DEA forms unwanted controls should be disposed of in accordance with DEA regulations

1.name, address, registration number and authorized business activity of both the registrant d/c'ing the business and the person acquiring the business 2. indicate whether location of the business will continue or move to another location 3. date which transfer of controlled substances will occur (complete inventory must be taken/recorded and given to person acquiring) Must be submitted at least 14 days prior to the date of proposed transfer - can be in person or by registered/certified mail

222 schedule III-V must be documented in writing (name, dosage form, strength, quantity, date transferred) - need names, addresses, DEA registrations of both parties involved All controlled substance records will also be transferred along with the business

DEA Form 222 or electronic equivalent then must maintain a written record of: 1. date of transaction 2. name, strength, dosage form, and quantity of the controlled substance 3. supplier/manufacturer's name, address, and registration #

Pharmacy may transfer to a DEA registered reverse distributor that handles the disposal of controlled substances - contact the local DEA diversion field office for a list of reverse distributor (same procedures = form 222 + maintain record for III-V) cannot forward drugs directly to DEA for disposal unless received prior approval from DEA

DEA Form 41 (anyone that destroys controlled substances including DEA registered reverse distributor)

1. convicted of felony related to controlled substances 2. DEA registration denied, revoked or surrendered due to the individual's handling of controlled substances though a waiver can be requested to be exempt from this requirement

1. Notify DEA (writing within one business day of discovery) and local police 2. Complete DEA Form 106

There is no definition - responsibility of the registrant to use best judgment and take appropriate action If not significant - does not need to be reported but should be noted in a separate log

-supplier must report to DEA if it does not reach intended destination -purchaser if loss occurs after signed for or taken custody of shipment

-can dispose of any recoverable controlled substances and report to DEA on DEA Form 41 -or can dispose of through shipment to reverse distributor or by DEA approved process

at least 2 years for inspection and copying by duly authorized DEA officials

1. Kept by automatic data or other electronic/mechanized recordkeeping systems in a manner they can be separated from other records in a reasonable time And/or 2. Kept in a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records (Like the red C)

1. executed/unexecuted order forms (222) 2. POA 3. Receipts and/or invoices for schedule III-V 4. all inventory records dated as beginning or close of business 5. records of controls distributed (returns/sales) 6. records of dispensed 7. reports of theft/loss (Form 106) 8. Inventory of drugs surrendered/disposed (Form 41) 9. Records of controls transferred b/t pharmacies 10. DEA registration certificate 11. self-certification certificate and logbook required under CMEA

Yes, they are able to maintain records at a central location after submitting a written notification to DEA of its intention. The registrant may begin maintain records at central location 14 days after DEA receives notification if DEA has not denied request

1. one separate file for schedule II, a file for schedules III-V, and a file for noncontrolled drugs 2. one file for schedule II and another file for all other drugs (but a red "C" not less than 1 inch must be stamped on schedule III-V; this is waived if electronic system) 3. electronic prescription records - must be readily retrievable from other records, easily readable or easily rendered into a format that a person can read

CII - must determine actual physical count CIII-V - may be estimated if container holds