Section 2.01 Flashcards
DEA
Drug Enforcement Administration - Controlled Substance Act requires anyone who manufactures, distributes , or dispenses controlled substances must register with the DEA
Controlled Drug Administration by non-vet staff
Can’t legally prescribe any drug
Can administer drugs at the direction, or under direct supervision of a licensed vet IF:
1. They are agents/employees of registered practitioner
2. Preforming task in usual course of business
3. Acting under direction of licensed vet
4. Under direct supervision of licensed vet
Administration of controlled drugs by independent contractor/relief vet
CYA - require them to have own separate DEA registration. Helps with compliance of controlled substance act and support contractor status to tax authorities
Termination of DEA registration
Notify DEA immediately & return unused drug order forms to the DEA
Practitioners/reps of the estate with controlled substance in possession at time of practice dissolving should contact DEA
Ordering Controlled Substances
Must be validly licensed & registered in state of practice
Form 222 is needed only for class 2 not 3-5
If used or unused forms or lost or stolen notify the DEA immediately
DEA 222 forms
Must have 3 copies. 1&2 shipped to supplier 3 is kept by registrant. Document received inventory on 3rd copy.
Record Keeping
Scheduled II drugs must be recorded and stored separately from medical file
Schedule 3-5 drugs can be stored in medical records or separately. Preferred is separate.
Lending of Controlled Drugs
For schedule 3-5 drugs:
- transfer quantity to another registrant and obtained signed receipt from receiving registered vet and store invoice with controlled Drug log.
-receiving vet should keep a copy of receipt showing obtained from other registrant not supplier
-drugs can be returned to original vet using same method.
Schedule 2:
Must use 222 form copy 1 stays with supplying vet, copy 2 goes to the DEA, copy 3 goes to receiving vet
Inventory of Controlled Drugs in a New Practice
- Take initial inventory
- Practitioner transferring drugs should prepare an invoice of all drugs being delivered signed and dated (including time of day the count is taken) by both parties.
- Exact count if scheduled 2 drugs is required
- Estimated counts of schedule 3-5 drugs is acceptable unless container holds more than 1000. Records must be maintained along with distributor receipts
- Every 2 years following initial inventory registrant must take a new inventory and retain records for 2 years.
Storing controlled drugs
-Securely locked in substantially constructed cabinet or safe
-stock should be kept at a minimum
-access should be restricted to absolute minimum
-schedule 3-5 drugs can be stored with other non controlled but must be is substantially constructed safe or caninet
Theft or Loss of controlled drugs
Notify DEA with form 106
Notify police
Same rules apply for loss, breakage or spills
Employee Prohibition
Required - can’t employ an individual who has had DEA application revoked or denied if they will have access to those drugs while on duty
Employee responsibility to report drug diversion
Employees are responsible for reporting drug diversions of any fellow employee. All info is treated confidentially. Failure to report fellow employee can be factor in determining feasibility of that employee working in drug secure area
DEA Inspections
Code of Federal Regulation states: DEA can inspect premise for purpose of copying and verifying accuracy of records/reports/other documents related to controlled subs.
They cannot inspect without permission of the owner financial sales & pricing data.
Inspectors must ID themselves and purpose and provide written notice of authority to inspect with informed consent of the owner or warrant.
Inspection must be in a reasonable time and manner.
Controlled Substances Act
CSA (estd. 1970) - is title 2 of the Comprehensive Drug Abuse and Control Act - regulates all personnel involved in chain or manufacture, distribution, and dispensing of controlled subs - designed to provide “closed system” to reduce opportunities for drugs to enter the illicit market.
