Federal Laws And Regulations Flashcards
Agencies governing Pharmacy Law
1) FDA
- Manages the drug approval process for both prescription and non-prescription drugs
- Manages drug manufacturing and distribution
- Drug Safety
2) DEA - Drug Enforcement Administration
- Responsible for enforcing the Controlled Substances Act
- Placing drugs into their schedules
3) Consumer Product Safety Commission
- Regulates OTC drug labeling and child resistant packaging
4) Federal Trade Commission
- Regulates OTC drug ads
5) Centers for Medicare and Medicaid Services (CMS)
- Regulates state and federally funded health programs
6) Department of Health and Human Services
- Oversees the FDA and CMS
7) State Board of Pharmacy
- Grant and Revoke Licenses
- Alter Federal laws to meet state-specific needs
- Enforce pharmacy practice regualtions
What is a misbranded drug?
1)A LABEL is:
-False or misleading
-Missing name, active ingredients, quantity
-Label is missing required information
2) The drug is made in a non-registered facility
3) Not in compliance with laws or regulations
4) Packed without regard to Poison Prevention Packaging Act
Misbranding “Something is wrong with the labeling”
-Label is lacking required information or illegible
-False or misleading label or advertising
-Improper packaging
-Ingredients differ form USP monograph standards
*Dispensing adulterated or misbranded drugs is considered illegal
What is an adulterated drug?
1) Contains any unapproved, unsafe substance
2) Exposed to unsanitary conditions or lack of cGMPs
3) Strength, purity or quality standard is false
4) Used in substitution of another substance
Adulteration “Something is wrong with the drug”
-Product is filthy, putrid, decomposed or contaminated
-Drug is prepared or stored under unsanitary conditions
-Lack of quality control or purity testing
-Strength or quality is different than official standards or labeling
Largest of FDA’s 6 centers
Center for Drug Evaluation and Research (CDER)
*Drug approval is based on safety and efficacy
Prescription Drug Approval Process
1) Pre-clinical
- This is testing on animals
- Must prove safety with potential therapeutic use
- If yes to above, the manufacturer will file an IND (Investigational New Drug)
2) Phase 1
- Needs IND approval to move into Phase 1
- 20-100 HEALTHY volunteers or people without the disease
- Used to determine toxicology, safety, metabolism, MOA, and early evidence of effectiveness.
3) Phase 2
- 100’s of subjects from the PATIENTS WITH THE DISEASE
- Used to determine the compound’s effectiveness against the targeted disease and safety
4) Phase 3
- 1000’s of patients from multiple drug centers
- The drug is compared to Placebo/Standard of Care
- Goal: Adverse events
- Application for FDA approval begins. NDA (New Drug Application) or BLA (Biologics License Application)
5) Phase 4 (aka. Post Marketing Surveillance)
- Long term surveillance
- Long-term safety and efficacy
- High-risk patient monitoring
*ALL PHASES ASSESSES THE DRUG’S SAFETY
OTC Drug Approval
Can be approved by:
1) NDA - full review by the FDA
2) OTC Monograph Process
-FDA has standard monographs for drugs generally recognized as safe and effective
-FDA review not required if monograph for therapeutic class followed
How to get a Generic Drug Approval?
1) Abbreviated New Drug Application (aNDA)
*Excipients/inactive ingredients can vary
-Must be proven bioequivalent
2) 505b2 Application
-In this application, the strength or formulation can be different than the reference drug
Is it possible for unapproved drugs to be on the market?
YES
This may be because it was available before 1938
-The FDA is working on bringing the unapproved drugs through the approval process
Is there a way the FDA monitors the drugs Post-Approval?
YES
1) MedWatch
2) FDA Adverse Event Reporting System (FAERS)
3) Risk Evaluation and Mitigation Strategy (REMS)
Why are withdrawal of drugs done?
*Done by manufacturer
1) Safety or efficacy concerns
2) Lack of profitability
3) Manufacturing problems
*Manufacturer should notify the FDA
Who regulates Prescription drug advertising?
FDA
Items required by the FDA:
-Name of Drug
-At least 1 approved use
-Most significant risk
Who regulates OTC drug advertising?
Federal Trade Commission (FTC)
List of All Pharmacy Acts
1) 1906 - Pure Food and Drug Act (The Wiley Act)
2) 1914 - The Harrison Narcotic Act
3) 1938 - Food, Drug and Cosmetic Act
4) 1945 - Penicillin Amendment
5) 1951 - Durham-Humphrey Act
6) 1962 - Kefauver-Harris Act
7) 1965 - Drug Abuse Control Amendment
8) 1970 - Drug Abuse Prevention and Control Act (Controlled Substances Act)
9) 1972 - Drug Listing Act
10) 1982 - Federal Anti-tampering Act
11) 1983 - Orphan Drug Act
12) 1984 - Hatch-Waxman Act (Drug price competition and Patent term restoration Act)
13) 1988 - Prescription Drug Marketing Act (PDMA)
14) 1990 - Omnibus Budget Reconciliation Act (OBRA ’90)
15) 1994 - Dietary Supplement Health and Education Act (DSHEA)
16) 1997 - FDA Modernization Act (FDAMA)
17) 1998 - Pediatric Rule
18) 2000 - The Drug Addiction Treatment Act (DATA 2000)
19) 2009 - The Biologics Price Competition and Innovation Act
20) 2010 - Affordable Care Act
21) 2013 - Drug Quality and Security Act (DQSA)
22) 2016 - The Comprehensive Addiction and Recovery Act (CARA)
23) 2018 - Lowest Price Act
24) 2020 - Drug Supply Chain Security Act (DSCSA)
25) 2020 - COVID-19 and PREP Act
26) 2023 - Consolidated Appropriations Act
What is the Pure Food and Drug Act (Wiley Act)?
1906
-Food/drug label cannot be false or misleading
-No adulterated or misbranded drugs through interstate commerce
-Recognition that USP and NF are standards
What is The Harrison Narcotic Act?
1914
-Requires prescriptions for products exceeding the allowable limit of narcotics
-Mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
What is the Food, Drug and Cosmetic Act?
1938
-Passed because of 107 deaths due to Sulfonamide Elixir
-Requiring new drugs to be proven safe before marketing; starting a new system of drug regulation.
-FDA given authority to approve drugs and conduct inspections
-Labeling requirements
-Extends control to cosmetics and therapeutic devices.
-Eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases.
-Adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.
