Law Review - Dr. Morrow

Question 1

Food Drug Administration (FDA)

Answer 1

• Federal

- Regulate: food, drugs, cosmetics, biologics, and blood products

Question 2

Functions of FDA

Answer 2

• Drug approval based on safety, efficacy, and purity
• Regulate labeling
• Regulate generics

Question 3

Drug Enforcement Agency (DEA)

Answer 3

• Federal

- Works mainly with controlled substances

Question 4

Code of Federal Regulations (CFR)

Answer 4

• Federal
• Divided into 50 titles
• Where many federal laws can be found

Question 5

Pure Food and Drug Act of 1906

Answer 5

• Prohibited adulteration and misbranding
• This act FAILED
• Did not cover false claims
• Did not regulate cosmetics or devices

Question 6

Pure Food and Drug Act of 1912

Answer 6

• Prohibited the use of false efficacy claims
• Proved to be difficult to enforce
• Hard to prove fraudulent claims or intent

Question 7

Food Drug and Cosmetic Act of 1938

Answer 7

• All marketed drugs must be SAFE
• Labels must have adequate directions and warnings
• Drugs that were marketed before 1938 were excluded

Question 8

Durham-Humphrey Amendment of 1951

Answer 8

• Prescription drug amendment
• Established two distinct drug classes
• Legalized verbal orders
• Prohibits dispensing without a prescription

Question 9

Kefauver-Harris Amendment of 1962

Answer 9

• Drug EFFICACY
• Thalidomide issue
• Drugs need to be safe AND efficacious

Question 10

Orphan Drug Act 1983

Answer 10

-Incentives to produce drugs for rare diseases/conditions

Question 11

Drug Price Competition Act (1984)

Answer 11

-Made generic drugs more accessible to the public

Question 12

Dietary Supplement Health and Education Act 1994

Answer 12

-Regulates supplements more as food; not as drugs

Question 13

Statute

Answer 13

• Written law passed by legislature on the state OR federal level
• Changes to statutes require amendment by the legislative body

Question 14

Federal vs. State Law

Answer 14

• States may be more restrictive than federal statute (but never less)
• 10th amendment grants the STATE government the right to regulate pharmacy practice

Question 15

The Interstate Commerce Law

Answer 15

-Gives federal authority to regulate drug distribution

Question 16

Where can you find the statutes for New Mexico

Answer 16

-New Mexico Statutory Authority (NMSA)

Question 17

NM Drug, Device, and Cosmetic Act

Answer 17

• Very similar to Federal Food, Drug, and Cosmetic Act
• Empowers BoP to enforce these rules
• Prohibits adulteration, misbranding, counterfeiting

Question 18

NM Pharmacy Act

Answer 18

• Established BoP
• Gives BoP power
• RPh licensing by examination
• Intern licensing requirements
• Nonresident pharmacy licensure
• Grounds for disciplinary actions

Question 19

Impaired Pharmacist Act

Answer 19

• Created program to help rehabilitate pharmacists unable to practice safely due to substance abuse, aging, mental illness, etc
• Voluntary participation by impaired pharmacist

Question 20

States Examples

Answer 20

• Pharmacist prescriptive authority
• Controlled substances
• Impaired pharmacists act

Question 21

Regulations

Answer 21

• STATE law give authority to executive agencies to develop regulations that support the statues
• Increase flexibility and efficiency in the operation of laws
• Indirectly enforceable laws

Question 22

New Mexico Board of Pharmacy (BoP)

Answer 22

• Pharmacy authority

- New/ amended regulation go through the NM BoP

Question 23

Reciprocity

Answer 23

• Establish criteria for licensure as a pharmacist
• Requires applicant to be licensed in a state that grants NM reciprocity
• Requires NM MPJE

Question 24

What Pharmacists MUST do to Earn/ Maintain their license

Answer 24

• Graduate from an accredited college
• Pass the NAPLEX
• Pass the MPJE
• Renew license every 2yrs
• Obtain 30hr CE every 2yrs

Question 25

Continuing Education (CE) Requirements

Answer 25

• 30 hrs every 2yrs
• 10 hrs must be live
• 2 hrs must be pt safety
• 2 hrs must be law
• 2 hrs must be opioids

Question 26

Pharmacy Intern Can Do Everything Except

Answer 26

• Final check
• Formulary selection
• Supervise other staff
• Ensure that supportive personnel have been properly trained
• Change patient’s drug therapy

Question 27

Rules in a Pharmacy

Answer 27

• Must have a pharmacist in charge (PIC) recorded with the BoP
• Define minimum equipment standards
• Display: pharmacy license, controlled substance license, patients bill of rights, current BoP inspection report, “Prohibition of return of drugs”

Question 28

Computerized Rx Information Requirements

Answer 28

• all specific Rx information with in 72hrs
• Hard copy of non controls for 120 days
• Hard copy of controls on premises for 2yrs
• Hard copy available somewhere 3yrs

Question 29

Hospital Pharmacies

Answer 29

• Have a process to access medications when pharmacist is not on duty
• Pharmacist must verify these orders within 72hrs
• Must have a CII safe

Question 30

Wholesale Prescription Drug Distribution

Answer 30

• Must be licensed with the state
• Must be suitable size and have appropriate venting and lighting
• Must have secure entry
• Authentication of pedigree

Question 31

Minimum Standards for Manufacturers and Repackaging Firms

Answer 31

-MINIMUM standards
Storage
cGMP
Stability protocols (USP)
Radiopharmaceuticals

Question 32

Limited Drug Clinics

Answer 32

-Animal control clinics
Locked storage
Consulting RPh required 
-Public Health Clinics
Limited drug permit
Consultant RPh required

Question 33

Nursing Home Drug Control

Answer 33

• Must maintain a MAR
• Must have a pharmacist
• Detailed drug destruction records

Question 34

Sample Drug Distribution

Answer 34

• Regulate distribution of pharmaceutical samples not intended for resale
• Not acceptable standard of practice anymore

Question 35

Controlled Substances

Answer 35

• Control and monitor access to control substances

- Prevent diversion of controlled drugs

Question 36

Support Personnel and Pharmacy Technicians

Answer 36

• Renew tech license ever 2 years
• Ratio of techs to pharmacist decided by the pharmacist in charge
• ID badge required in restricted areas
• May not perform final checks or receive verbal orders and deduce to writing

Question 37

Emergency Medical Services Dangerous Drugs

Answer 37

• Must have a consultant pharmacist and review every 90 days
• All instances when controlled substances were used
• All or sample of cases when noncontrolled meds were used
• All records of controlled substances for C5 for minimum of 3 years