Regulatory Agencies Flashcards
Primary federal law enforcement agency charged with the responsibility of combating the abuse of controlled substances
DEA Drug Enforcement Administration (1973)
The DEA was established to more effectively control narcotic and dangerous drug abuse through a nationally organized enforcement and prevention system
DEA cooperates with other federal agencies, as well as state and local governments, private industry and other organizations
regulates, by way of federal registration, all persons involved in the legitimate chain of manufacture, distribution or dispensing of controlled drugs
It is title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Designed to provide a “closed system” for legitimate handlers of controlled drugs and reduce opportunities to enter into the illicit drug market
CSA Controlled Substance Act (1970
Under Title 21 of the US Code, also known as the FD&C act, the ___ CVM has been given the authority to govern the manufacture, distribution, and use of vet drugs that are distributed between states. The federal code also give ___ the authority to write regulations on how it will enforce the FD&C Act. The ___CVM (Center for Veterinary Medicine) is responsible for regulating animal foods/feeds and most animal health products
FDA Food and Drug Administration
Created to enact and enforce safety rules for the american workplace
Applies to all workplaces in the US & Territories
Many states have their own version, most are more stringent
Hospital Safety Manual (HSM) is required
OSHA Occupational Safety and Health Administration
The controlled Substance Act requires that anyone who manufactures, distributes or dispenses a CS must register with the ___?
DEA
Drug Enforcement Administration
True/False
Vets working at more than one location may PRESCRIBE controlled drugs if they are registered at some principal place of business.
True
True / False
To Administer or Dispense each vet must be classified as an employee of a registrant, or they must register at each location where they are employed
True
Cannot legally prescribe any drug under state practice act laws
NON vet staff
Many states allow employees to administer drugs at the direction and under the direct supervision of a licensed vet under the following conditions
They are under the direct supervision of a licensed vet - vet is on the premises
If they are agents or employees of the registered practitioner
They are performing the task in the usual course of business
They are acting under the direction of a licensed vet - directly observes them
How should this situation be handled? Administration of controlled drugs by independent contractors
Should contact DEA divisional office for guidance
If any doubt exists, it is best to require independent contractor vets to maintain separate registrations. This will assure compliance with the CSA and tax authorities.
Whatis it called if a registrant dies, goes out of business, discontinues in professional practice or ceases legal existence, the DEA must be notified immediately so the registration can be terminated. Any unused drug order forms must be returned to the nearest DEA office.
Practitioners or representatives of their estates having controlled substances in their possession at the time the practice is discontinued should contact their regional DEA office to determine how to dispose of unused controlled substances. These substances should not be sent to the DEA unless specific instructions have been received to do so.
Termination of Registration
What form is needed to order Schedule II Drugs
DEA Form 222
True / False
Practitioners do not need to be licensed in the states where they are practicing or have a valid DEA registration to order CS from distributors
False
What special form is needed for orders of drugs in Schedules III, IV, V.
No special form needed, order direct from distributor or manufacturer
What do you do if DEA Forms are lost or stolen?
Used or unused order forms that are stolen or lost by the registered vet the DEA should be notified immediately with the serial numbers of the missing forms. If not known, the DEA should be contacted for instructions.
Who may sign a DEA Form 222
Only a registered vet or a person with a valid POA may legally sign the order forms
On DEA Form 222, who gets copies 1, 2 and 3?
Federal regulations require that copies 1 and 2 of Form 222 be submitted to the supplier. Copy 3 is retained by the registrant.
When Schedule II drug orders are received, where should the receipt be recorded?
When drug shipments arrive from the distributor, the date of receipt and the number of containers of each drug received should be recorded on Copy 3 of the original order form.
How do you cancel a Schedule II drug order
You may cancel part or all of an order by notifying the supplier in writing. The supplier indicates the cancellation by drawing a line through the items and printing “canceled” in the space provided for the number of items shipped.
What can be produced to allow veterinarians who are agents of the principal veterinarian to order CS under the registration of the principal. (Schedule II drugs)
Power of Attorney
True/False
POA for ordering Schedule II drugs also applies to prescribing, agents do not need to have their own DEA registration number.
False
True / False
For POA’s the people ordering must be agents or employees of the registrant in order to administer or dispense CS. It may be restricted to a certain time frame.
True
The rationale for maintaining records regarding drugs received from suppliers and drugs dispensed to patients is to complete the DEA’s “_______” for monitoring possibilities of diversion into illicit channels
Closed System
True/False
Schedule II drugs must be recorded and stored separately from the medical record of the patient
True