Pharmacy Law and Regulations

Question 1

FDA

Answer 1

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.

Question 2

DEA

Answer 2

The drug enforcement administration enforces the Controlled Substance Act

Question 3

True or False: The Controlled Substance Act requires manufactures, distributors, or dispensers of controlled substances to register with the DEA

Answer 3

True

Question 4

True or False: Schedule III, IV, and V drugs may be kept openly on storage shelves

Answer 4

True

Question 5

True or False: All states require schedule II drugs to be kept in a locked narcotics cabinet

Answer 5

False, only some states

Question 6

Schedule I

Answer 6

Drugs that have a high risk for abuse and have no medical use. Cannot be prescribed.

Question 7

Schedule II

Answer 7

Drugs that have a high risk for abuse, but also have accepted medical use. Example: amphetamines, methadone, cocaine, morphine.

Question 8

Schedule III

Answer 8

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

Question 9

Schedule IV

Answer 9

Drugs that have less risk than schedule III, but have accepted medical use and may lead to limited dependence.

Question 10

Schedule V

Answer 10

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

Question 11

True or False: Schedule III, IV, and V do not need special forms

Answer 11

True

Question 12

Which form is needed to receive, order and return Schedule II substances

Answer 12

DEA form 222

Question 13

True or False: The DEA form 222 is a triplicate form

Answer 13

True

Question 14

True or False: The DEA form 222 must be signed in ink by the person registered with the DEA

Answer 14

True

Question 15

True or False: If a mistake is made on a DEA form, one must edit it to the correct information

Answer 15

False, start a new form

Question 16

Who keeps each triplicate copy of the DEA 222 form

Answer 16

Copy 1 stays with the supplier, copy 2 is sent to the DEA, and copy 3 is retained by the purchaser (the pharmacy).

Question 17

True or False: Copy 2 of the DEA 222 form must contain the number of containers received and date it was received

Answer 17

False, Copy 3 which stays with purchaser

Question 18

True or False: All forms, even those that are incomplete or illegible, must by kept for 2 years

Answer 18

True

Question 19

Which form is needed to destroy controlled substances

Answer 19

DEA 41 form

Question 20

What information is needed on the DEA 41 form?

Answer 20

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

Question 21

If a controlled substance is stolen, the pharmacy must call which two agencies?

Answer 21

The DEA and the local police department

Question 22

What form must be filled out in the event of a stolen controlled substance?

Answer 22

DEA form 106

Question 23

True or False: A copy of the DEA form 106 must be sent to the DEA

Answer 23

False, the original must be sent and a copy is left with the pharmacy

Question 24

True or False: Prescriptions for all controlled substances must contain the prescriber’s signature in ink or a digital signiture

Answer 24

True

Question 25

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

Answer 25

True

Question 26

Schedule II prescriptions must be re-written after how many days?

Answer 26

7

Question 27

What is the maximum supply that can be written for a schedule II substance?

Answer 27

30 days, no refills

Question 28

What changes to schedule II prescriptions may be made over the phone from the prescriber to the pharmacist?

Answer 28

Dosage form
Strength
Quantity
Directions

Question 29

What changes to schedule II prescriptions may NOT be made over the phone from the prescriber to the pharmacist?

Answer 29

Patient’s name (even spelling)

Name of controlled substance

Question 30

If the pharmacy only fills partial of a schedule II, the remainder must be filled within how many hours?

Answer 30

72

Question 31

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

Answer 31

True

Question 32

True or False: For a schedule II, the prescriber must be notified if the prescription is not picked up within 72 hours

Answer 32

True

Question 33

True or False: Schedule III or V prescriptions may be refilled 5 times within 6 months after the issue date

Answer 33

True