Pharmacy Law and Regulations Flashcards
FDA
The food and drug administration assures the safety, efficacy, and quality of drugs, medical devices, food, cosmetics, dietary supplements, and products that give off radiation.
DEA
The drug enforcement administration enforces the Controlled Substance Act
True or False: The Controlled Substance Act requires manufactures, distributors, or dispensers of controlled substances to register with the DEA
True
True or False: Schedule III, IV, and V drugs may be kept openly on storage shelves
True
True or False: All states require schedule II drugs to be kept in a locked narcotics cabinet
False, only some states
Schedule I
Drugs that have a high risk for abuse and have no medical use. Cannot be prescribed.
Schedule II
Drugs that have a high risk for abuse, but also have accepted medical use. Example: amphetamines, methadone, cocaine, morphine.
Schedule III
Drugs that have less risk than schedule I and II but have accepted medical use and may lead to low or moderate dependence. Example: steroids and ketamine
Schedule IV
Drugs that have less risk than schedule III, but have accepted medical use and may lead to limited dependence.
Schedule V
Drugs that have less risk than schedule IV but have accepted medical use and may lead to limited dependence. Example: Drugs with no more than 200 mg/g of codeine
True or False: Schedule III, IV, and V do not need special forms
True
Which form is needed to receive, order and return Schedule II substances
DEA form 222
True or False: The DEA form 222 is a triplicate form
True
True or False: The DEA form 222 must be signed in ink by the person registered with the DEA
True
True or False: If a mistake is made on a DEA form, one must edit it to the correct information
False, start a new form
Who keeps each triplicate copy of the DEA 222 form
Copy 1 stays with the supplier, copy 2 is sent to the DEA, and copy 3 is retained by the purchaser (the pharmacy).
True or False: Copy 2 of the DEA 222 form must contain the number of containers received and date it was received
False, Copy 3 which stays with purchaser
True or False: All forms, even those that are incomplete or illegible, must by kept for 2 years
True
Which form is needed to destroy controlled substances
DEA 41 form
What information is needed on the DEA 41 form?
DEA registration number, name, address, phone #
NDC number, names, strengths, forms, and quantity
Date, location, and method of destruction
Signatures of 2 witnesses who are authorized employees
If a controlled substance is stolen, the pharmacy must call which two agencies?
The DEA and the local police department
What form must be filled out in the event of a stolen controlled substance?
DEA form 106
True or False: A copy of the DEA form 106 must be sent to the DEA
False, the original must be sent and a copy is left with the pharmacy
True or False: Prescriptions for all controlled substances must contain the prescriber’s signature in ink or a digital signiture
True
True or False: Schedule II prescriptions must be brought to the pharmacy in person and be signed manually in ink unless the patient is in hospice or long term care or is receiving IV pain therapy
True
Schedule II prescriptions must be re-written after how many days?
7
What is the maximum supply that can be written for a schedule II substance?
30 days, no refills
What changes to schedule II prescriptions may be made over the phone from the prescriber to the pharmacist?
Dosage form
Strength
Quantity
Directions
What changes to schedule II prescriptions may NOT be made over the phone from the prescriber to the pharmacist?
Patient’s name (even spelling)
Name of controlled substance
If the pharmacy only fills partial of a schedule II, the remainder must be filled within how many hours?
72
True or False: For partial fills on a schedule II, the partial quantity must be written on the front of the prescription, and a new prescription must presented for the remainder
True
True or False: For a schedule II, the prescriber must be notified if the prescription is not picked up within 72 hours
True
True or False: Schedule III or V prescriptions may be refilled 5 times within 6 months after the issue date
True
