Pharmacy Law Flashcards
Food and Drug Act 1906
First federal law to regulate drugs
Sherley Amendment
Therapeutic claims regulated
Federal Food, Drug, Cosmetic Act 1938
Requires thorough toxicologic testing
FDA created to enforce laws
Prohibits distribution of new drug w/o New Drug Application (NDA) and FDA approval
Durham-Humphrey Amendment
Legal distinction between OTC and prescription
‘Rx Only’
New drugs require a prescription
Prescription can’t be refilled w/o prescribers consent
Drug Abuse Control Amendment and Comprehensive Drug Abuse Prevention and Control Act
Prevent drug abuse
Kefauver-Harris Amendment
Congress strengthened laws
Ensures greater degree of safety for approved drugs
Requires proof of safety and effectiveness before FDA approval
Investigational New Drug Application (IND) before human trials
FDA authority to issue Good Manufacturing Practice (GMP)
Comprehensive Drug Abuse Prevention and Control Act of 1970
Controlled substance act
Consolidate and codify control authority over drugs of abuse
Schedule I
No accepted medicinal use
Any non-medical substance being abused
Schedule II
Accepted medical use, high potential for abuse
Schedule III
Accepted medical use, potential of abuse less than I or II
Moderate psychological or physical dependence
Schedule IV
Accepted medical use, low potential of abuse, limited dependence
Schedule V
Accepted medical use, low potential of abuse, limited dependence relative to IV
Pregnancy Cat. A
Failed to demonstrate risk to fetus in 1st trimester, no risk in later trimesters
Pregnancy Cat. B
Animal reproduction studies failed to demonstrate risk, no adequate and well-controlled studies in pregnant women
Pregnancy Cat. C
Animals have adverse effect, no adequate/well-controlled studies in pregnant women
Potential benefits may warrant use despite risk
Pregnancy Cat. D
Positive evidence of human fetal risk
Potential benefits may warrant use despite risk
Pregnancy Cat. X
Animals and humans demonstrate fetal abnormalities and/or human fetal risk, risk outweigh potential benefit
Black Box Warning
Adverse reaction serious in proportion to benefit, consider in assessing
Orphan Drug Act
For rare diseases and conditions, tax credits and designated years of marketing exclusivity
Drug Price Competition and Patent Term Restoration Act of 1984
Speed generic approval and extending innovating patents
Generics get Abbreviated New Drug Application (ANDA)
Patent extensions for FDA review time, 1/2 testing phase not to exceed usual 20 yr patent term
Prescription Drug Marketing Act
New safeguards on integrity to reduce risk of adulterated, misbranded, repackaged, or mislabeled drugs through 2nd sources
Reimportation, Sales Restrictions, Distribution of Samples, Wholesale Distributors
Prescription Drug User Fee Act
FDA can accept user fees from companies in return to commit to review new drug within time frames
Dietary Supplement Health and Education Act
Supplements can’t have claims to prevent or cure specific diseases and have a disclaimer
Submit to FDA to being truthful and not misleading
GMP for dietary supplements
FDA Modernization Act
FDA sets policy, establishes standards, issues guidelines, enforces rules
Gatekeeper to new drugs, tests, medical devices by application and review
Development to approval
Discovery, Pre-clinical, IND, FDA review, Clinical, NDA?BLA Pre-approval inspection, FDA response
Phase 1 Clinical Trials
Healthy Patients
Phase 2 Clinical Trials
Efficiency and short term safety
Phase 3 Clinical Trials
Safety and Efficiency with risk/benefit assessment
Phase 4 Clinical Trials
Long term effects (after marketing)
Recall Class I
Kills people
Recall Class 2
Probability of reversible or temporary effects
Recall Class 3
No adverse effects
Solid State Degradation
- Loosening at reaction site
- Bond breaking/making
- Solid solution formation of degradation product
- Separation and crystallization of degradation product within parent solid
CoCrystals
homogeneous with fixed stoichiometry
Amorphous Solids
No order, defined by glass transition temperature, more soluble than crystal
Colligative Properties
Depend on number of solute particles Vapor pressure lowering Boiling point elevation Freezing point depression Osmotic pressure
