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
For which scheduled drug(s) can the records be stored in the medical record or separate but must be stored in a fashion where they can be readily retrieved.
Schedule III, IV, V
Two options for record keeping of Controlled Substances
- Form that allows for running totals of drugs to be maintained but requires a separate record for each drug (1 drug per form)
- Form that minimizes the number of separate record forms but makes it more difficult to produce running totals of controlled drug inventories (multiple drugs on 1 form)
What is the process for Lending controlled drugs to other practitioners
For schedule III, IV, V
Transfer the quantity of drug to another registrant and obtain a receipt signed by the registered vet who received the drug. Store the invoice in your controlled drug record keeping system.
The receiving vet should keep copies of the receipts showing the drug was received from another vet instead of a supplier
Drugs can be returned to the vet from whom they were borrowed, using the same record keeping methods
What is the process for Lending controlled drugs to other practitioners
For schedule II
Must use the DEA 222 Form. Copy 3 of the form stays with the vet who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
Inventory of CS in a new practice
According to the CSA When a vet acquires an existing practice, an initial inventory of CS must be taken
When should this inventory take place?
DEA regulations require that this be done as of the date practitioners first engage in dispensing or administering CS.
True/False
An estimated count of Schedule II can be performed when transferring inventory to a new owner
False It must be an exact count
Estimated counts for substances in Schedule III, IV, V are permitted unless the container hold more than _____ tablets or capsules, in which case an exact count is needed when transferring inventory to a new owner
1000
Every ___ years following the initial inventory date the registrant must take a new inventory of all CS on hand. The records of these inventories are to be kept with other DEA records at the registrant’s business location and retained for ___ years.
2 years
2 years
How many employees should have access to the drug safe?
Absolute minimum
Which Scheduled drugs may be stored with other NON controlled drugs so long as they are securely locked in a cabinet.
Schedule III, IV, V
Where should Schedule II drugs be stored?
In a securely locked, substantially constructed cabinet or safe.
Registrants are required to notify the _________ and ______ of the theft or significant loss of any CS upon discovery loss/theft.
Regional Office of the DEA and Local Police Department
Fill out DEA Form ____ at the time of the notification of stolen or lost controlled drugs to DEA
106
True / False
Any breakage or spillage of CS bottle should also be reported to DEA
True
Prescriptions for which Scheduled drug(s) must be written and must bear the full name and address of the patient, plus the name, address, and registration number of the practitioner
Schedule II
Try/False
A Schedule II drug prescription can be digitally signed by the practitioner
False, it must be manually signed
How many refills can be given on Schedule II drug prescriptions?
None, It is prohibited to refill schedule II Drugs.
True/False
Prescription orders for schedules III, IV, V may be provided in writing or they may be issued to pharmacists orally.
True
How many times can prescriptions be refilled for Schedule III, IV, V drugs?
Schedule III, IV, V may be refilled up to 5 times within 6 months after the date of issue.
What is it called when A practice cannot employ an individual who has had their DEA application revoked or denied if, as a result of their employment, they will have access to controlled drugs.
Employee Prohibition Required
Employees working in a controlled substance environment may be screened and rejected for reasons described by the DEA. What questions are permissible by law to ask a candidate?
Within the past 5 years have you been convicted of a felony.
In the last 2 years a misdemeanor?
Are you presently charged? If yes, they need to furnish the details of conviction
In the past 3 years have you knowingly used any narcotics, amphetamines, or barbiturates, other than those prescribed to you by a physician? If yes, furnish details.
When screening a candidate for Controlled Substance Abuse/Violations prior to hiring, Does An employer have to have an authorization in writing that allows inquiries to be made of courts and law enforcement agencies for possible pending charges or convictions
Hell Yes
True / False
Employees are responsible for reporting drug diversions of any fellow employees
True: The employer will treat all such information confidential. Failure by the employee to report drug diversions by fellow employees will be considered a determining factor in the feasibility of the employee continuing to work in a drug secure area.
Employers are responsible for informing all employees about his policy
True / False
The Code of Federal Regulations states that a representative of the DEA is authorized to enter Controlled premises and conduct inspections for the purpose of copying and verifying accuracy of records, reports and other documents related to controlled substances
True
True / False
During a DEA inspection the Compliance Officer can inspect, without permission of the practice owner, any financial, sales and pricing data
False, They must receive permission to inspect these records from the practice owner.
True / False
A DEA inspection can be performed at any time of the day and is permissible to disrupt workflow and staff duties.
False: The inspection must be at reasonable times and in a reasonable manner
What primary factor does the CSA divide controlled substances into schedules?
primarily according to their potential for abuse:
Controlled Substance SCHEDULE ____
Highest potential for abuse and severe dependence
Lowest potential for accepted medical use (currently none)
Lack of accepted safety for use of the drug or other substance under medical supervision
Ie: heroin and LSD
SCHEDULE I
Controlled Substance SCHEDULE ___
High potential for abuse and severe dependence
Currently accepted medical use in the US - with severe restrictions
Abuse of drug may lead to severe dependence
Ie: Morphine, Oxymorhone
Schedule II
Controlled Substance SCHEDULE ___
Less potential for abuse than I and II and may lead to low to moderate dependence
Currently accepted medical use in the US
Ie: Tylenol with Codeine, Nalline
Schedule III
Controlled Substance SCHEDULE ___
Low Potential for abuse, may lead to limited dependence
Currently accepted medical use in US
Ie: Diazepam and Tramadol
Schedule IV
Controlled Substance SCHEDULE ___
Low potential for abuse and may lead to limited dependency
Currently accepted medical use in the US
Ie: Robitussin A-C, Lomotil
Schedule V
A section of the CSA states the ___ and ____ have broad powers to reschedule a drug, bring an unscheduled drug under control or remove the controls on a drug.
DEA and the Attorney General
Drugs that contain unsanitary components, lack adequate control in manufacture, differ in strength from official compendium, or that are mixed with another substance.
Adulterated Drugs
DVM takes 2 or more FDA approved drugs and mixes them into one syringe or bottle. Now the drugs have been adulterated and administering such a drug is a violation of the FD&C Act (Food Drug & Cosmetic)
This is an example of what kind of drug
Adulterated Drug
True / False
Under current law an unapproved drug is in itself, adulterated.
True
Drugs in which the labeling is false or misleading, including any drug in a package form that does not bear a label that contains the name and place of business of the manufacturer/packer/distributor and an accurate statement on quantity in terms of weight, measure and numerical count..
Misbranded Drugs
True / False
A drug is Considered adulterated if the label does not include adequate directions for use by which a lay person can use a drug safely and for the purpose for which it was intended.
False, this is called a Misbranded Drug
Prescription drugs:
Used only by or under the supervision of a veterinarian.
To be qualified as a Prescription drug the drug must be in the possession of a person or agent of, who is regularly and lawfully engaged in the manufacture, transportation, storage, or sale of veterinary drugs - or on the prescription or order of a licensed vet.
Is in the possession of a licensed vet for use in lawful business
Prescription / Legend Drugs
Where are these statements required?
The statement “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”.
Recommended dose and route of admin
Quantity or proportion of each active ingredient
Names of all inactive ingredients if the drug is non oral use
Identifying lot or control number from which it is possible to determine the complete manufacturing hx of the drug.
LABEL REQUIREMENTS FOR RX DRUGS
True / False
Notations such as “Sold only to licensed Veterinarians” or “for veterinary use only” must be notated on prescription bottles as stated by law
False: Notations such as “Sold only to licensed Veterinarians” or “for veterinary use only” have no legal basis, merely represent a sales policy by drug manufacturers. This is merely an OTC drug
Directions for use can be readily understood and followed by the ordinary individual.
Products that are available by ordinary retail purchase, with no need for a prescription or license.
OTC Drug
The use of FDA approved drugs in a manner other than what is approved on the label. Different species, different indications or dose, or human drugs we use on animals
Extra Label Use
FDA approved, which requires a demonstration of bioequivalence of safety and efficacy with the original pioneer drug product
Generic Drug
The brand name or patented version of a drug, later copied to make generic drugs after the patent expires
Pioneer Drug
Customized manipulation of an approved drug by a veterinarian or pharmacist to meet the needs of a particular patient
Compounded Drug
True / False
A compounded drug is considered an Extralabel Drug use
True
Most state laws and FDA regulations allow the compounding of drugs for animal use under these four conditions:
- The DVM believes there is a need to alter the approved drug to adequately medicate a non-food animal with a diagnosed medical condition
- There is an established VCPR
- The individual patient has a medical condition for which a prescribed medication is needed
- The DVM determines that a compounded drug is needed for the animal
Can you compound a drug that mimics an FDA approved product
No
True / False
Products compounded from bulk active ingredients are deemed approved new animal drugs by the FDA
False, they are UNapproved
Can DVMs purchase compounded drugs from a pharmacy and then resell that drug to a client?
No, DVMs may either compound the drug themselves, or the pharmacy can sell the compounded drug directly to the client via a rx from the DVM.
True / False
By law, Veterinarians in the US must inform the FDA-CVM of any adverse events involving their marketed products.
False. Only Drug Companies must inform the FDA-CVM. Though not mandatory, veterinarians and animal owners are encouraged to report adverse experiences and product failures of FDA approved drugs to the drug sponsor.
Any adverse event associated with the use of an animal drug, whether or not considered to be drug related, and whether or not the drug was used in accordance with the approved indication, species, or dosage. An ADE can also include lack of expected efficacy, product defect, or human exposure to the product either directly or due to residue violations and exposure in food.
Adverse Drug Event Reporting
True / False
There is no mandatory reporting requirement for manufacturers of unapproved drugs, including compounded drugs or drugs approved for human use that are prescribed for veterinary patients in an extralabel manner.
True
In order to provide data for unapproved product safety profiles, adverse events involving these products should be reported directly to the manufacturer or distributor. This helps build a database on non-FDA approved products for practitioners reference.
An event can be reported via a phone call to the FDA or by filling out an FDA form 1932a and mailing it in. The report must include what 4 items?
The reporter or person familiar with the event who can provide additional info
Clinic sign(s) or symptom occurring right after product exposure, regardless of perceived causality
Product name and lot number if available
Patient, an identifiable animal or human
An instrument, apparatus, implement, machine or implant, in-vitro reagent or similar article used in the diagnosis of dz or condition and /or the treatment of such
Examples: Needles, syringes, surgical instruments, prosthetic devices, x-ray equipment, diagnostic test kits, dental appliances, etc.
Animal Medical Devices
True / False
Manufacturers and distributors of Animal Medical Devices are not required to report Adverse Drug Events (ADE) nor register their devices
True
However, the FDA does have regulatory oversight over vet devices and can take appropriate regulatory action if a vet device is misbranded or adulterated.
True / False
Dietary supplements and food may be considered a drug if intended to treat a condition (ie joint pain/arthritis)
True
True/False
USDA’s Center for Veterinary Biologics CVB defines an event as any undesirable occurrence after the use of an immunobiological product whether or not the event was caused by the product.
True
Why Report Adverse Events
The primary purpose for maintaining the CVM ADE database is to identify adverse effects not detected during the approval process and to monitor the performance of drugs not approved for use in animals.
Pharmacovigilance helps to maintain current, complete and relevant labels in order for practicing veterinarians to make informed choices for their patients
The reporting system provides beneficial information to vets, pet owners, drug companies and the FDA, and ultimately benefits the animals by ensuring that prescribed drugs are both safe and efficacious.
USDA or FDA
has authority over the regulation of the entire biological products market such as antitoxins, vaccines, live microorganism and antigenic or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of disease in animals.
USDA
Who is is responsible for regulating animal foods/feeds, most animal health products such as drugs, medicated animal feeds, pet foods. They are subject to the requirements of the Food, Drug and Cosmetic Act (FD&C Act).
FDA -CVM
True / False
A Hospital Safety Manual is not required in the workplace
False, it absolutely is necessary.
This law Requires that all team members who come into contact with potentially hazardous materials in the workplace are aware of those hazards and be instructed on how to protect themselves.
The Right to Know law (aka Hazardous Communication)
How often should a hazard analysis inspection be performed
Annually
To be compliant with The Right to Know Law, every practice must have the following list of requirements:
A designated Safety Manager / Officer
An annual hazard analysis inspection
Safety plans in place for all identified hazards
A chemical list and safety plans for immediately dangerous to life and health chemicals
Safety data sheets on all chemicals and components
Secondary labeling as needed and explanation and training on the labeling system
A protocol in place for emergency evacuation
A training program focusing on PPE, monitoring devices, and hazards of the practice (11 or more employees)
A regulation that requires a formal assessment of every workplace, in every department, to determine the nature of the hazards that are present.
Based on the assessment of the possible hazards, the leadership of the practice must determine exactly what tasks require additional protection and select the appropriate PPE for the situation.
Hazard Assessment
True / False
Multi-Employer Workplaces (ex: cardiology practice who leases space within a general vet practice) only need a hazard assessment for their area if they are separate entities, but in one building
False:
All separate businesses within a shared space must create a hazard assessment for the entire area.
The cardiologist would create a hazard assessment for the GP and visa versa.
Each separate entity within the hospital will need to provide the other entity with their SDS Sheets, or store the safety info in a central location.
Which regulatory agency publishes It’s The Law posters?
OSHA
If there is a state and federal OSHA poster available, which one should be displayed?
State. If there is a state poster available it should be on display INSTEAD of the federal poster
How long should an OSHA inspection citation report be posted and where should it be posted?
Inspection citations posted for 3 days or until corrected, whichever is longer in a common area.
Fact:
OSHA requires Written Plans for preventing fire, handling hazardous chemicals, preventing injury with PPE, and informing workers of dangers in their workplace - required for 10 or more employees.
OSHA posters and notices
True / False
OSHA requires practices to post Appropriate warning or identification signs (Exits, radiation)
True
Written Safety Plans should include the following:
An explanation of the hazard or danger
Specific instances where a staff member may be exposed to that hazard
The specific do and don’t steps must take when performing the given procedure
When and how testing or monitoring equipment is used and how the results of those tests are communicated to the staff
The name of the person who can give additional training, assistance or answer questions.
True / False
Employer has the right to be present or designate a representative during any inspection or investigation.
True
True / False
Employers have the right to require that the Compliance Officer obtain a warrant b/f entering or inspecting the business.
True, however, This is not a recommended option.
True / False
Employer has the right to expect the Compliance Officer will not divulge trade secrets to competitors as a result of the inspection. However, the violation itself is open to the public.
True
True / False
Employer does not have the right to consult an attorney or advisor before, during or after an inspection and before responding to any inquiry.
False, the employer does have a right to consult an attorney/advisor at any time
True / False
Employer has the right to see any complaint made against the business, including the person that filed it.
False. The person filing the complaint is confidential
True / False
Employer has the right to insist that staff be interviewed during an investigation at a time that does not unreasonably interfere with the staff member’s job. The business leader/employer does NOT have the right to be present during these interviews.
True
True / False
Employer has the right to appeal findings and/or citations issued by an OSHA Compliance Officer.
True
True / False
It is an employers responsibility to Provide a workplace as much as possible free from recognized or unnecessary hazards and Responsible for minimizing or eliminating hazards
True
True / False
It is the employers responsibility to Set and enforce safety rules in the workplace and to communicate those rules to the staff members in a clear and concise manner. Use written plans, policies and guidelines such as a Hospital Safety Manual.
True
True / False
It is not the employers responsibility, although many do, to provide PPE equipment for the staff, they need to supply their own if they are not made available.
False. Provide Personal Protective Equipment (PPE) and proper instructions for its use so that staff members can perform tasks safely. The business must furnish the PPE that is appropriate to protect the worker from the hazard and must train the worker to use it properly.
Who does OSHA consider as the expert on the operation of the facility and most knowledgeable on the safety aspects of the business.
The practice owner
Does the practice owner need to Provide training and instructions for staff to understand the hazards associated with their jobs and the steps necessary to protect themselves.
Yes
Staff have the right to a workplace free from recognized hazards. Hazards must be controlled through _____ means such as PPE or ______ to lower the risk of injury or illness to an acceptable level.
Engineering and work practices
True / False
Staff members have the right to Be informed of their rights under the OSH Act - But they do not have the right to view and read the OSHA Workplace Rights poster
False: The staff has the right to view and read the OSHA Workplace Rights poster and it must be posted in a common area
What is the basis for the “Right to Know” Law.
The staff has the right to Be informed of known hazards in the workplace and to be trained to safely perform the job duties
Can Employers withhold information about the known hazards in a workplace if the staff does not work in the area of the hazard?
Nope. As long as an employee works in the same building that there is a hazard, it is their right to be made aware of it by the Employer.
True / False
It is the staffs right to have Access to all medical and exposure records that may be maintained as part of the business such as exposure records
True
True/False
It is not necessary to disclose the nature and types of accidents that have occurred in the workplace
False: Staff are Entitled to know about the nature and types of accidents that have occurred in the workplace
True / False
Staff has the right to Be present in the workplace when safety testing or monitoring is performed to ensure the testing was done properly
True
Does the staff have a right to Present complaints to the employer or OSHA when a hazard or suspected hazard requires attention or correction?
Yes
True / False
Staff does not have a right to Speak with a Compliance Officer privately during an inspection of the workplace.
False: Staff have the right to speak to a CO and The business must notify employees of the time and place that the CO will be available for private interviews
OSHA does not cite individual Employees, but each employee is required /responsible under the ____ Act to “comply with all occupational safety and health standards and all rules, regulations, and orders issued under the Act.” This includes OSHA standards and workplace-specific rules established by the employer
OSH Act (Occupational Safety and Health Act)
True / False
Staff can be disciplined for willful violations of any safety rule or standard provided the employer has given proper instruction on the requirement.
True
True / False
It is not the responsibility of the staff member to read the OSHA Poster
False. It is the staff responsibility to read the OSHA poster
True / False
It is the staff responsibility to Comply with all applicable standards and
Follow all lawful employer safety and health rules and regulations
True
True / False
It is the responsibility of the staff member to determine which PPE they need to wear and when to where them.
False: Staff are responsible for wearing proper PPE as instructed by the employer
True / False
Staff are responsible to Report hazardous conditions to the supervisor and
Report any job-related injury or illness to the employer and seek treatment
True
True / False
Staff are not responsible for Cooperating with the OSHA CO during an inspection if he or she inquires about safety and health conditions in the workplace.
False, they are responsible to cooperate with an OSHA CO
The use of a complaint as a vendetta or to get out of work is a violation of the ___ Act
OSH Act (Occupational Safety and Health Act)
Which OSHA form Lists each employee with injury details (multiple employees per page)
and is a Record of every work related death, or injury/illness that involves loss of consciousness, restricted work activity or job transfer, days away from work or medical tx beyond first aid. You must also record significant work related injuries and illnesses that are diagnosed by a physician or licensed health care professional.
Form 300 - Log of Work-Related injuries and illness
How long must OSHA Form 300 be kept?
Form 300 - Log of Work-Related injuries and illness must be kept for 5 years, Same as Form 300A and 301
True / False
When maintaining an OSHA Form 300 Log of Work-Related Injuries and Illness, If there is more than one location then a separate set of records must be maintained for each location - even though the employee count includes both locations together.
True
Which OSHA form is A tallied count of the individuals on Form 300?
OSHA Form 300A Summary of Work-Related Injuries and Illnesses
True / False
A business only needs to fill out an OSHA form 300 or 300A, it is not necessary to fill out both.
False, both the form 300 and 300A are required to be filled out by any business with 11 or more employees
When and where does the OSHA Form 300A need to be posted?
From Feb 1 through April 30 of the following year, posted in a common area / bulletin board
How long must OSHA Form 300A be kept?
5 years, same as Form 300 and 301
Which OSHA form is called the Summary of Work-Related Injuries and Illnesses
Form 300A
Which OSHA form is called the Log of Work-Related injuries and illness
Form 300
Which OSHA form is called the Illness and injury incident report
Form 301
Which OSHA Form does Each individual fill out; 1 form with details of incident (1 employee per page)
Form 301
How long after a recordable work-related injury or illness has occurred, must you fill out OSHA Form 301 or an equivalent.
Within 7 days
How long must you keep Form 301 - Illness and injury incident report
5 years, same as OSHA Forms 300 and 300A
A controlled drug with a high potential for abuse and severe dependence, but does have currently accepted medical uses in the United States, would be in what Schedule of narcotics?
a. Schedule I
b. Schedule II
c. Schedule III
d. Schedule IV
e. Schedule V
b. Schedule II
True / False
A non-veterinary staff member may prescribe any non-controlled drugs if directed to do so by a licensed, veterinarian who employs them, and if that veterinarian directly supervises the staff member.
False. Non veterinary staff members may not prescribe any drug.
True / False
If a non-veterinary staff member is an agent or employee of the registered practitioner, they are allowed to administer controlled drugs.
True
True / False
If a non-veterinary staff member is performing the task in the usual course of business they are allowed to administer controlled drugs.
True
True / False
If a non-veterinary staff member is acting under the direction of a licensed veterinarian they are allowed to administer controlled drugs.
True
True / False
If a non-veterinary staff member is under the direct supervision of a licensed veterinarian.
they are allowed to administer controlled drugs.
True
True / False
In regards to an OSHA inspection; employers have the right to deny access to specific areas of the building to avoid disturbing the business process.
False. Employers have the right to require a warrant, or to request a postponement, but not deny access once the inspection/investigation has begun.
A veterinary acupuncturist leases space from a general practice. Does the general practice need to share the hazard assessments from their department, even if the acupuncturist works in a separate part of the building?
Yes. All separate businesses within a shared space must create a hazard assessment for the entire area.
When lending a controlled drug to another practitioner, what step is unnecessary for schedule III, IV and V drugs, that is necessary for schedule II drugs?
a. Using the DEA 222 form. Copy 3 of the form stays with the veterinarian who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
b. It is illegal to lend a schedule II drug.
c. Using the DEA 222 form, although both the receiving DVM and supplying DVM should log copies, no copy needs to be sent to the DEA.
a. Using the DEA 222 form. Copy 3 of the form stays with the veterinarian who received the drug. Copy 1 stays with the registered practitioner supplying the drug. Copy 2 is sent to the DEA.
True / False
Veterinarians who work at more than one location may administer, dispense, and prescribe controlled drugs provided they have a current DEA registration at a central place of business.
False -May prescribe controlled drugs if they are registered at some principle place of business. To administer or dispense they must be classified as an employee of a registrant, or they must register at each facility where they are employed.
Under what circumstances can a DVM dispense an adulterated drug?
a. When all ingredients are FDA/CVM approved.
b. Under no circumstances.
c. As long as there are no more than two drugs combined and both are FDA/CVM approved.
b. Under no circumstances.
In regards to a DEA inspection, what can the inspector copy without the consent of the practice owner or representative?
a. All records and reports involving controlled drugs.
b. All records, reports, and financial information regarding controlled drugs.
c. They cannot copy any documents without consent.
a. All records and reports involving controlled drugs.
