Law Review - Dr. Morrow Flashcards
Food Drug Administration (FDA)
- Federal
- Regulate: food, drugs, cosmetics, biologics, and blood products
Functions of FDA
- Drug approval based on safety, efficacy, and purity
- Regulate labeling
- Regulate generics
Drug Enforcement Agency (DEA)
- Federal
- Works mainly with controlled substances
Code of Federal Regulations (CFR)
- Federal
- Divided into 50 titles
- Where many federal laws can be found
Pure Food and Drug Act of 1906
- Prohibited adulteration and misbranding
- This act FAILED
- Did not cover false claims
- Did not regulate cosmetics or devices
Pure Food and Drug Act of 1912
- Prohibited the use of false efficacy claims
- Proved to be difficult to enforce
- Hard to prove fraudulent claims or intent
Food Drug and Cosmetic Act of 1938
- All marketed drugs must be SAFE
- Labels must have adequate directions and warnings
- Drugs that were marketed before 1938 were excluded
Durham-Humphrey Amendment of 1951
- Prescription drug amendment
- Established two distinct drug classes
- Legalized verbal orders
- Prohibits dispensing without a prescription
Kefauver-Harris Amendment of 1962
- Drug EFFICACY
- Thalidomide issue
- Drugs need to be safe AND efficacious
Orphan Drug Act 1983
-Incentives to produce drugs for rare diseases/conditions
Drug Price Competition Act (1984)
-Made generic drugs more accessible to the public
Dietary Supplement Health and Education Act 1994
-Regulates supplements more as food; not as drugs
Statute
- Written law passed by legislature on the state OR federal level
- Changes to statutes require amendment by the legislative body
Federal vs. State Law
- States may be more restrictive than federal statute (but never less)
- 10th amendment grants the STATE government the right to regulate pharmacy practice
The Interstate Commerce Law
-Gives federal authority to regulate drug distribution
Where can you find the statutes for New Mexico
-New Mexico Statutory Authority (NMSA)
NM Drug, Device, and Cosmetic Act
- Very similar to Federal Food, Drug, and Cosmetic Act
- Empowers BoP to enforce these rules
- Prohibits adulteration, misbranding, counterfeiting
NM Pharmacy Act
- Established BoP
- Gives BoP power
- RPh licensing by examination
- Intern licensing requirements
- Nonresident pharmacy licensure
- Grounds for disciplinary actions
Impaired Pharmacist Act
- Created program to help rehabilitate pharmacists unable to practice safely due to substance abuse, aging, mental illness, etc
- Voluntary participation by impaired pharmacist
States Examples
- Pharmacist prescriptive authority
- Controlled substances
- Impaired pharmacists act
Regulations
- 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
New Mexico Board of Pharmacy (BoP)
- Pharmacy authority
- New/ amended regulation go through the NM BoP
Reciprocity
- Establish criteria for licensure as a pharmacist
- Requires applicant to be licensed in a state that grants NM reciprocity
- Requires NM MPJE
What Pharmacists MUST do to Earn/ Maintain their license
- Graduate from an accredited college
- Pass the NAPLEX
- Pass the MPJE
- Renew license every 2yrs
- Obtain 30hr CE every 2yrs
Continuing Education (CE) Requirements
- 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
Pharmacy Intern Can Do Everything Except
- Final check
- Formulary selection
- Supervise other staff
- Ensure that supportive personnel have been properly trained
- Change patient’s drug therapy
Rules in a Pharmacy
- 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”
Computerized Rx Information Requirements
- 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
Hospital Pharmacies
- Have a process to access medications when pharmacist is not on duty
- Pharmacist must verify these orders within 72hrs
- Must have a CII safe
Wholesale Prescription Drug Distribution
- Must be licensed with the state
- Must be suitable size and have appropriate venting and lighting
- Must have secure entry
- Authentication of pedigree
Minimum Standards for Manufacturers and Repackaging Firms
-MINIMUM standards Storage cGMP Stability protocols (USP) Radiopharmaceuticals
Limited Drug Clinics
-Animal control clinics Locked storage Consulting RPh required -Public Health Clinics Limited drug permit Consultant RPh required
Nursing Home Drug Control
- Must maintain a MAR
- Must have a pharmacist
- Detailed drug destruction records
Sample Drug Distribution
- Regulate distribution of pharmaceutical samples not intended for resale
- Not acceptable standard of practice anymore
Controlled Substances
- Control and monitor access to control substances
- Prevent diversion of controlled drugs
Support Personnel and Pharmacy Technicians
- 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
Emergency Medical Services Dangerous Drugs
- 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
