Pharmacy Laws, Federal Requirements, & Regulations

Question 1

Class II recall

Answer 1

A class II recall occurs when medication may cause temporary adverse health effects that are reversible or if there is a small risk of serious adverse effects.

Question 2

class I recall

Answer 2

A class I recall occurs when a medication is likely to cause severe adverse effects or even death.

Question 3

class III recall

Answer 3

A class III recall occurs when a medication is not likely to cause a patient to have adverse effects.

Question 4

class IV recall

Answer 4

A class IV recall does not exist—there are only three classes of FDA recalls.

Question 5

acceptable way to store prescription records

Answer 5

Prescription records can be stored in only three possible ways:

2 files: (CII) and (non-controlled + CIII-V)
2 files: (CII-V) and (non-controlled)
3 files: (CII) and (CIII-V) and (non-controlled)

Question 6

DEA 222 form

Answer 6

The DEA 222 form is used to order medications from a pharmacy supplier or another pharmacy.

Question 7

DEA 224 form

Answer 7

The 224 form is used to register a retail pharmacy with the DEA.

Question 8

DEA 106 form

Answer 8

The DEA 106 form is used to report the lost or theft of controlled substances

Question 9

DEA 41 form

Answer 9

The 41 form is to describe the destruction of controlled substances.

Question 10

Validity of DEA number

Answer 10

Following the steps below, the sum at the end of step 4 is 56, and so the last digit of the DEA number needs to be 6 to be considered a valid DEA number.

Step 1: Add the first, third, and fifth numbers together ( 2 + 6 + 8 =16).

Step 2: Add the second, fourth, and sixth numbers together (4 + 7 + 9=20).

Step 3: Multiply the sum in the second step by 2 (20 x 2 =40).

Step 4: Add the total from steps 1 and 3 together (40 +16 =56).

Please note: There are ongoing revisions in the letters that can appear first in a DEA number. Changes have been made over the years to accommodate the increasing number of practitioners. C, as well as other letters, can now be the first letter and is usually used for specialists rather than general practitioners.

Question 11

How long do prescription records need to be retained onsite by a pharmacy?

Answer 11

Pharmacies must keep records onsite of all prescriptions for a minimum of 2 years and they must be organized in such a way that they can easily be inspected by the DEA or state BOP.

There are other relevant regulations to keep in mind, however:

Under federal law alone the prescription records should be kept for at least 5 years. See the last regulation, below.

The FDA has also stated that it will look at prescriptions records dating back 5 years.

Under the Medicare Modernization Act of 2003, prescriptions for Medicare are required to be retained for 10 years.

There is a different requirement for being kept in the pharmacy (onsite) versus being retained in general. There are a whole set of laws for central storage of prescriptions (and other pharmacy records) at an offsite location. Under this regulation, the pharmacy itself needs to retain records for at least 2 years onsite but a total of 5 years.

Question 12

Combat Methamphetamine Epidemic Act of 2005 (CMEA)

Answer 12

CMEA limits the quantity of pseudoephedrine that can be purchased by an individual customer. The limit is 3.6 grams at one time and a 9 gram total over a 30-day period. Limits may be different for mobile vendors or for mail orders. For example, only 7.5 grams in a monthly purchase may be by mail order.

Question 13

What needs to be documented by the receiving pharmacy of a transferred controlled substance (CIII-V) prescription?

Answer 13

All transferred controlled substance prescriptions must contain the following:

Original prescription date and dispensing date
Original # of refills authorized and current # remaining
Transferring pharmacy’s DEA number and demographics
Original prescription number
Name of transferring pharmacist

Question 14

When purchasing products containing pseudoephedrine, what needs to be documented in the logbook (hand-written or electronic)?

Answer 14

According to the CMEA of 2005, the logbook needs to contain the personal information of the person purchasing the product and quantity, strength, date, and time of the product sale. The day of the week, last purchase date, and purchaser’s date of birth are not required.

Question 15

The Occupational Safety and Health Administration (OSHA)

Answer 15

The Occupational Safety and Health Administration (OSHA) has standards to protect employees who work with hazardous materials. It also outlines the proper personal protective equipment needed in various pharmacy practice settings such as compounding.

Question 16

HIPAA

Answer 16

HIPAA relates to confidentiality and the PPA governs the practice of pharmacy but does not explicitly cover employee safety.

Question 17

USP 795

Answer 17

USP 795 focuses only on non-sterile compounding.

Question 18

Safety Data Sheets (SDS)

Answer 18

Safety Data Sheets (SDS) outline appropriate handling, storage requirements, and cleanup procedures for the hazardous product. They are specific for the product listed.

Question 19

When a state pharmacy law and federal pharmacy law conflict, which law should be followed?

Answer 19

the more strict law
Explanation:
In the event a state law conflicts with or contradicts a federal law, the law that is more strict is the one that should be followed. This is not optional if a pharmacy is to operate within legal boundaries.

Question 20

What is the maximum number of refills that is allowed on a Schedule III-V controlled substance prescription?

Answer 20

A controlled substance in the Schedules of III-V is allowed a maximum of 5 refills, within 6 months of the date of issue.

Question 21

Common reasons for a medication recall

Answer 21

Common reasons for a medication recall include product mislabeling, presence of impurities, and contamination. A medication with a high cost or copay does not warrant a medication recall.

Question 22

CSOS (Controlled Substance Ordering System)

Answer 22

CSOS (Controlled Substance Ordering System) is the online platform for Schedule II controlled substance ordering that has largely replaced the traditional paper format.

Question 23

PMP

Answer 23

PMP stands for Prescription Monitoring Program.

Question 24

REMS

Answer 24

REMS stands for Risk Evaluation and Mitigation Strategies.

Question 25

Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA)

Answer 25

The act requires all products to include a list of ingredients, directions, and safety warnings. It also states that all drugs must be approved by the FDA prior to being marketed and used by patients. It outlines the labeling requirements for all prescription and over-the-counter medications

Question 26

Risk Evaluation and Mitigation Strategies (REMS) program between the FDA and drug manufacturers

Answer 26

REMS help limit inappropriate dispensing and protects patients. Each drug has different criteria that must be met, and this can include patient education, elements for safe use of the medication, a communication plan between healthcare providers and the patient, laboratory tests, etc.

Question 27

Scheduled drugs transfer

Answer 27

Schedule III-V drugs can be transferred between pharmacies one time, unless the pharmacies share an online, real-time database. Schedule II drugs cannot be transferred.

Question 28

take back programs

Answer 28

Take back programs provide a safe way to dispose of unwanted prescription medications. These programs help prevent unwanted medications from getting into the wrong hands, on the streets, or in our waterways.

Question 29

Personal Protective Equipment (PPE)

Answer 29

PPE should always be worn when handling or cleaning up hazardous materials. This is to keep yourself safe and reduce your risk of exposure.

Question 30

Class III recall

Answer 30

Class III is the least severe type of recall. The medication in question is not likely to cause a patient to have adverse effects.

Question 31

Durham-Humphrey Amendment

Answer 31

The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor’s supervision.

Question 32

Red Book

Answer 32

leading resource for information on drug pricing

Question 33

Omnibus Budget Reconciliation Act of 1990

Answer 33

OBRA-90 placed regulations on the pharmacist in how to interact with the patient, with a goal of improving therapeutic outcomes. The law includes prospective drug utilization review (ProDUR) requirements, counseling obligations, and record-keeping mandates.

Question 34

Orange Book

Answer 34

Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA. It also contains therapeutic equivalence evaluations for generic drugs, using Therapeutic Equivalence codes such as AA, AB, BC, and BD. If the first letter of the code is an ‘A’, the FDA has concluded that the generic formulation is therapeutically equivalent to the reference drug. If the first letter is a ‘B’, the FDA has concluded that the compared drugs are not equivalent. The second letter of the code gives more detailed information about formulations. The Orange Book also lists the patents which are purported to protect each drug.

Question 35

Kefauver Harris Amendment

Answer 35

known as the ‘Drug Efficacy Amendment.’ It is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It introduced requirements for drug manufacturers to provide proof of the effectiveness and safety of their drugs before they could be approved. It also required drug advertising to disclose accurate information about side effects and efficacy of treatments.

Question 36

How often must pharmacy scales and weights be evaluated and calibrated?

Answer 36

Pharmacy balances, scales, and weights must be evaluated and calibrated every 12 months

Question 37

Pure Food and Drug Act of 1906

Answer 37

The Pure Food and Drug Act of 1906 prohibits interstate sales of adulterated or misbranded drugs

Question 38

Omnibus Reconciliation Act of 1987

Answer 38

The Omnibus Reconciliation Act of 1987 established revisions to Medicare and Medicaid Conditions of Participation regarding long term care facilities and pharmacy, requires that resident drug regimen’s be free of unnecessary medications, requires that medications be labeled according to accepted professional principles, requires that behavioral modification and drug holidays be used to evaluate discontinuation, and requires that emergency and routine drugs be provided to patients

Question 39

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 39

The Drug Price Competition and Patent Term Restoration Act of 1984 was created to establish the modern system for generic drugs

Question 40

United States Pharmacopeia

Answer 40

Establish standards for medication identity, purity, and strength

Question 41

Orphan Drug Act of 1983

Answer 41

Medications for treatment of diseases or conditions of which there are fewer than 200,000 cases in the world

Question 42

Prescription Drug Marketing Act of 1987

Answer 42

requires that a manufacturer provide Safety Data Sheets (SDS formerly known as MSDS) 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

Question 43

drug development phases

Answer 43

The appropriate dose concerning safety and toxicity is determined by Phase I.

Phase II is performed in 100 to 300 patients who have the disease or condition to be treated.

Phase III is conducted in larger (several hundred to several thousand) patients in groups that the medication is finally intended.

A comparison is between the new treatment and the standard therapy or placebo. The medication is used in the manner in which it will be used after approval.