Federal Regulations

Question 1

Pure Food and Drug Act (1906)

Answer 1

• Prohibits interstate commerce of misbranded and adultered drugs and foods
  Misbranded: A drug product is mislabeled if it is inaccurate, incomplete, or misleading

Question 2

Federal Food, Drug, and Cosmetic Act (1938)

Answer 2

• Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application
• If the FDA does not take action within 60 days, the drug is automatically approved

Question 3

Durham-Humphrey Amendment (1951)

Answer 3

• Defines two specific categories for drug products: legend (Rx) drugs and over-the-counter (OTC) medication
• Legend (Rx) drugs must be labeled with “Caution: Federal law prohibits dispensing without a prescription.”

Question 4

Kefauver-Harris Amendment (1962)

Answer 4

• Established a framework that requires drug manufacturers to scientifically prove that a medication is not only safe but effective
• Before this amendment, drug manufacturers only had to prove that the drug was safe

Question 5

Controlled Substance Act (CSA) (1970)

Answer 5

• Federal drug policy that regulates the manufacture, importation, possession, use, and distribution of controlled substances: certain narcotics, stimulants, depressants, hallucinogens, and anabolic steroids
• CSA classifies controlled substances into five schedules: I, II, III, IV, V
• Drugs are placed in different schedules depending on their medical and potential for abuse or dependence

Question 6

Schedule I Controlled Substances

Answer 6

• Have a high potential for abuse and physical/psychological dependence
• Currently have no accepted medical use and are considered investigational or illicit drugs

Question 7

Schedule II Controlled Substances

Answer 7

• Have a high potential for abuse and physical/psychological dependence. However, they are acceptable for medicinal use
• CSA has more strict regulations on prescribing, distribution, and dispensing of CII substances

Question 8

Schedule III Controlled Substances

Answer 8

• Have a moderate to low potential for physical dependence but a high potential for psychological dependence

Question 9

Schedule IV Controlled Substances

Answer 9

• Have a low potential for abuse and dependence but can still lead to addiction and have dangerous effects if combined with other substances of abuse

Question 10

Schedule V Controlled Substances

Answer 10

• Have a low potential for abuse and dependence. These products may contain limited quantities of certain narcotics

Question 11

T or F: C-II refills are permitted

Answer 11

FALSE
C-II refills are NOT permitted. A new prescription must be issued for each fill

Question 12

How many refills are permitted for CIII-CIV medications?

Answer 12

5 refills or refills for up to six months from the date of issuance, whichever comes first

Question 13

How many refills are permitted for CV medications?

Answer 13

Can be refilled as many times as authorized by the prescriber per federal law but states may differ

Question 14

What is the expiration date of CII medications?

Answer 14

No expiration per federal law but states may differ

Question 15

What is the expiration date of CIII-CIV medications?

Answer 15

Valid for six months from the date of issuance

Question 16

What is the expiration date of CV medications?

Answer 16

No expiration per federal law but states may differ

Question 17

How many partial fills are permitted for CII medications?

Answer 17

Partial fill is permitted as long as the remainder is filled within 72 hours

Question 18

How many partial fills are permitted for CIII-CIV medications?

Answer 18

Partial fills are permitted with no time limit as long as the prescription has not expired

Question 19

Is transferring CII medication refills permitted?

Answer 19

Transfer is prohibited

Question 20

Is transferring CII-V medication refills permitted?

Answer 20

Allow one-time transfer between two pharmacies

Question 21

What is DEA Form 41 used for?

Answer 21

Reporting destruction of CS

Question 22

What is DEA Form 104 used for?

Answer 22

Reporting pharmacy closure or surrender of a pharmacy permit

Question 23

What is DEA Form 106 used for?

Answer 23

Reporting loss of theft of CS

Question 24

What is DEA Form 222 used for?

Answer 24

Ordering CI and CII CS

Question 25

What is DEA Form 222a used for?

Answer 25

Ordering more of Form DEA 222

Question 26

What is DEA Form 224 used for?

Answer 26

Applying for a DEA registration number

Question 27

What is DEA Form 224a used for?

Answer 27

DEA registration renewal, must be renewed every 3 years

Question 28

What letters are valid for DEA numbers?

Answer 28

A, B, F: Physicians, dentists, veterinarians, pharmacies, and hospitals M: Allied health practitioners P and R: Manufacturers, distributors, narcotic treatment programs, and researchers

Question 29

How to verify a DEA number?

Answer 29

- Add the first, third, and fifth digit of the DEA number - Add the second, fourth, and sixth digit of the DEA number, then multiply the sum by 2 - Add the result of step one and step two - The sum from step 3 will be a two-digit number, the second number will match the seventh number of the DEA number

Question 30

Poison Prevention Packaging Act (PPPA) (1070)

Answer 30

- Aims to protect young children from poisonings and deaths that can occur if they gain access to hazardous products including medications - Requires most over-the-counter and Rx drugs to be packaged in child-resistant containers to make it significantly hard for five-years-old to open

Question 31

Federal Anti-Tampering Act (1983)

Answer 31

- Mandates that OTC medications must have a tamper-evident seal

Question 32

Prescription Drug Marketing Act (1987)

Answer 32

- Prohibits the selling, purchasing, and trading of prescription drug samples

Question 33

Omnibus Budget Reconciliation Act (OBRA) (1990)

Answer 33

- Drug utilization review (DUR), patient counseling standards, and patient record maintenance

Question 34

What is a Drug Utilization Review (DUR)?

Answer 34

- DUR requires pharmacists to review if the prescription is necessary and appropriate - There are two types: Prospective DUR and Retrospective DUR

Question 35

What is a Prospective DUR?

Answer 35

- Performed by a pharmacist before a drug is dispensed and considers therapeutic duplications, drug interactions, drug allergies, over/underutilization, and potential misuse

Question 36

What is a Retrospective DUR?

Answer 36

- Performed after the patient has received the medication and is often used to detect prescribing or dispensing patterns

Question 37

What are Patient Counseling Standards?

Answer 37

- An offer to counsel must be made to every patient

Question 38

What is Patient Record Maintenance?

Answer 38

- Patient records or profiles should be accurately maintained by all pharmacy staff

Question 39

Dietary Supplement Health and Education Act (DSHEA) (1994)

Answer 39

- Dietary supplements such as vitamins and herbal supplements are considered "food"

Question 40

Health Insurance Portability and Accountability Act (HIPPA) (1996)

Answer 40

- Limits the use and disclosure of protected health information - Provides an option for the patient to obtain a copy of their health information

Question 41

Food and Drug Administration Modernization Act (FDAMA) (1997)

Answer 41

- This act eliminates certain labeling requirements, "Caution: Federal Law prohibits dispensing without a prescription" may be stated as "Rx only"

Question 42

Drug Addiction Treatment Act (DATA) (2000)

Answer 42

- Allows qualified prescribers to complete training and register for a Narcotic Addiction DEA Number (NADEAN) - NADEAN begins with X

Question 43

Combat Methamphetamine Epidemic Act (CMEA) (2005)

Answer 43

- Regulates the sale of over-the-counter products containing pseudoephedrine and ephedrine which can be used to make methamphetamine (meth=illegal) - Patients are required to present a valid government-issued photo ID - Daily limit: 3.6g per customer - No more than 9g per 30 days if purchased in-store, 7.5g per day if online - Pharmacies must keep a written or electronic record (to be kept for 2 years) of all OTC sales containing pseudoephedrine and ephedrine