Pharmacy Law

Question 1

What do the middle four numbers represent in an NDC number?

Answer 1

• The first five numbers identify the drug manufacturer.
• The middle four numbers identify the drug product.
• The last two numbers identify the packaging.

Question 2

The pharmacist fails to place a prescription label on the medication container. Which law is being broken?

Answer 2

The Food, Drug, and Cosmetic Act of 1938 defined adulteration and misbranding (which involves labeling).

Question 3

An employee injures his back while lifting a carton of medication in pharmacy. What law allows the employee to collect damages from the employer?

Answer 3

The Occupational Safety and Health Act of 1970 required that work sites be safe for the employees.

Question 4

A patient requests that the pharmacist place his medication in an easy-open container. Which law allows the pharmacist to dispense the prescription in this manner?

Answer 4

The Poison Prevention Act of 1970 required that all prescriptions be prepared in child-resistant containers except in five different situations. The patient requesting an easy-open container is one of the situations.

Question 5

A pharmacist prepares a prescription with a mortar and pestle that have been contaminated by an anti-neoplastic agent and dispenses the prescription to a patient. Which law is he violating?

Answer 5

This is an example of adulteration according to the Food, Drug, and Cosmetic Act of 1938

Question 6

Which law allows a pharmacist to accept a telephoned prescription from a physician’s office?

Answer 6

The Durham-Humphrey Act of 1950 allowed a prescription for a noncontrolled substance to be telephoned from a physician’s office.

Question 7

Which law allows a pharmacist to dispense nitroglycerin tablets in a non-child-resistent container?

Answer 7

Nitroglycerin is one of the medications that does not need to be a child-resistant container according to the Poison Control Act.

Question 8

Which law resulted in clearly distinguishing an over-the-counter medication from a prescription medication?

Answer 8

The Durham-Humphrey Act clearly defined legend and OTC medications.

Question 9

Which law required that the federal legend appear on all prescriptions?

Answer 9

The Durham-Humphrey Act stated that all legend medications must bear the following : “Federal law prohibits the dispensing of this medication without a prescription.”

Question 10

For how long is a DEA Form 222 valid?

Answer 10

The Controlled Substances Act allows a DEA Form 222 to be valid for 60 days after it is signed by the pharmacist in charge or an individual with the power of attorney.

Question 11

Which law requires that a manufacturer provide Material Safety Data Sheets (MSDSs) to a pharmacy for products that are combustible, are flammable, or can cause injury to an individual if he or she comes in contact with the substance?

Answer 11

The Occupational Safety and Health Act of 1970 was written to protect the worker from hazards in the workplace. Material Safety Data Sheets are required to inform an individual of the hazards of handling a particular product and the appropriate treatment if one comes in contract with the substance.

Question 12

A pharmacist receives a prescription for 40 Percocet tablets, but the pharmacy has only 15 tablets in stock. The patient accepts the 15 tablets. How much time does the pharmacist have to provide the remaining 25 tablets?

Answer 12

Within 72 hours or the quantity becomes void

The Controlled Substances Act allows for partial filling of Schedule II medication prescription, with the remaining medication to be provided to the patient within 72 hours or the quantity becomes void.

Question 13

If a patient requests a partial filling of her Tylenol with Codeine #3 prescription, what can the pharmacist do for the patient?

Answer 13

The pharmacist may provide the patient with the requested amount but can give her the balance only if there is a refill indicated on the prescription.

The Controlled Substances Act allows for the partial filling of a Schedule III to V medication on the request of the patient. The remaining balance of medication can be dispensed only if the physician has indicated a refill on the prescription. The total number of units of medication or refills cannot exceed what is indicated on the prescription.

Question 14

Which of the following is a correct DEA number for a Dr. Andrea J. Shedlock, who was Dr. Andrea Costello when she requested her DEA number before she was married?

a. AC1234563
b. AS1234563
c. JC1234563
d. JS1234563

Answer 14

a. AC1234563

The first letter of a physician’s DEA number will be A, B, F, or M.

The second letter is the first letter of the physician’s last name at the time he or she applied for the DEA number.

The last digit of the DEA number is the same as the last digit of the total number of the digits (1st+3rd+5th) + 2x(2nd+4th+6th)

EX: DEA number AC1234563
1+3+5 + 2x(2+4+6) = 33
=> last digit [3] of 33 = last digit [3] of DEA number

Question 15

You are working for a chain pharmacy and another member of the chain has run out of DEA Form 222s, They ask to borrow one of your DEA Form 222s. What would you do?

Answer 15

DEA Forms 222s are for a specific pharmacy and can be used only by the pharmacy to which they were used

The Controlled Substances Act requires that a pharmacy use DEA Form 222 to purchase Schedule II medications.

Question 16

You receive a request from another pharmacy for 100 Percocet tablets. What do you do?

Answer 16

You may transfer to them the 100 tablets of Percocet, a Schedule II medication, through the use of a DEA Form 222.

Question 17

What form is used to report the theft of controlled substances?

Answer 17

DEA Form 106 needs to be submitted to the local law enforcement agency.

Question 18

Is “insurance reform” a part of HIPAA?

Answer 18

HIPAA is concerned with insurance reform, patient confidentiality,and security of computer systems.

Question 19

Which organization oversees Medicare and Medicaid service?

Answer 19

Centers for Medicare and Medicaid Services (CMS) oversees the operation and reimbursement of these two federal programs.

Question 20

Who reviews INDs?

Answer 20

Food and Drug Administration (FDA)

Question 21

Which law required opium to have a prescription?

Answer 21

The Harrison Narcotic Act required a prescription for opium-containing products.

Question 22

Which law required that all narcotics be labeled “Warning: May be Habit Forming”?

Answer 22

Comprehensive Drug Abuse Prevention and Control Act

Question 23

Which law requires drug utilization evaluation to be performed on all prescriptions?

Answer 23

The Omnibus Reconciliation Act of 1990 (OBRA 90) required drug utilization on all prescriptions and medication orders and an offer to counsel patients on their prescriptions.

Question 24

Which law allowed pharmacists to take prescriptions over the telephone from a physician’s office?

Answer 24

The Durham-Humphrey Act allowed prescription to be called to the pharmacy from a physician’s office.

Question 25

Which law established tax-free saving accounts?

Answer 25

Medicare Drug Improvement and Modernization Act of 2003 created Tax-free saving accounts.

Question 26

Which law stated that a resident’s drug regimen must be free of unnecessary medications?

Answer 26

The Omnibus Reconciliation Act of 1987 was concerned with care in long-term care facilities; one of the items it addresses is the use of unnecessary medications.

Question 27

Which law allows nasal inhalers to be dispensed without a child-resistant container?

Answer 27

The Poison Control Act of 1970 allows certain medications to be dispensed without a child-resistant container.

Question 28

Which law lowers the reimbursement rate for durable medical equipment?

Answer 28

The Medicare Drug Improvement and Modernization Act of 2003 lowered the reimbursement rate for durable medical equipment..

Question 29

Which law prevents reimportation of medication into the United States other than by a manufacturer?

Answer 29

The Prescription Drug Marketing Act prohibits the reimportation of medication into the United States. This law is being re-examined.

Question 30

Which agency oversees the practice of pharmacy?

Answer 30

The state Boards of Pharmacy (BOP) oversee the practice of pharmacy in their respective states.