Federal Legislation & Agencies Flashcards
Pure Food & Drug Act of 1906
Prohibited the adulteration & misbranding of foods & drugs in interstate commerce
What were the loopholes to the Pure Food & Drug Act of 1906
- Labels not required to list ingredients
- Misbranding provisions did not prevent false or misleading efficacy claims, it only prevented false statements as to the drug’s identity (i.e., strength, quality and purity)
- Did not provide authority to ban unsafe drugs
- Did not regulate cosmetics or medical devices
The 1906 Pure Food and Drugs Act only authorized two methods of enforcement to remove violative products from the market:
Seizure & Criminal prosecution
Food, Drugs & Cosmetics Act of 1938
Requires that new drugs cannot be marketed until proven safe for use under the conditions described on the label and approved by the FDA
Expanded misbranding and adulteration definitions
Labels must contain adequate directions for use and warnings about habit-forming properties (if applicable)
Expanded coverage to cosmetics and devices
Unites States Pharmacopeia (USP)
Official compendia established in 1820 which contains monographs of active ingredients which include the approved titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability, and labeling for a drug
NF (National Formulary)
Monographs of inactive ingredients
Homeopathic Pharmacopeia of the United States (HPUS)
An official compendium for homeopathic products
Durham-Humphrey Amendment (1951)
Authorized oral prescriptions and refills, and established two classes of drugs:
- Prescription drugs (a.k.a. “legend drugs”)
- OTC or non-prescription drugs
Under the Durham-Humphrey Amendment (1951), prescription drugs must contain
- “adequate information for use”: (indications, effects, dosages, routes, methods, frequency, warnings, hazards, contraindications, side-effects, etc.)
- “Caution: Federal law prohibits dispensing without a prescription”
Under the Durham-Humphrey Amendment (1951), OTC drugs must contain
“adequate directions for use” for the layperson: purposes for use, dose, frequency of administration, duration of use, route, etc.
Kefauver-Harris Amendment of 1962
- Required drugs be proven safe and also effective
- Established good manufacturing practices
- Established new drug approval process
- Established advertising oversight: FDA over legend drugs, FTC over OTC drugs
Medicare Part A
Hospital (inpatient)
Medicare Part B
Medical (Outpatient)
Medicare Part C
Advantage (Gap coverage)
Medicare Part D
Prescription Drug
Anti-Kickback Statute
it is a crime to knowingly and willfully offer remuneration for patient referrals
Stark Law
Prohibits physicians from referring patients for designated services to an entity which the physician has a financial relationship
Poison Prevention Packaging Act of 1970
Requires all OTC and prescription drugs utilize child-resistant containers, with some exceptions (i.e. nitroglycerin)
Child resistant packaging not required if:
(1) prescriber authorizes OR
(2) patient requests
Orphan Drug Act
Provided tax and licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of “rare disease or conditions” affecting less than 200,000 people is US
Prescription Drug Marketing Act of 1987
Regulated the use of drug samples
Required drug distributors to have a state license
Omnibus Budget Reconciliation Act of 1990 3 main components
- Rebate programs (Best price on pharmaceuticals to Medicaid)
- Demonstration projects (Encourage innovative therapy programs to save money)
- Drug Utilization Review (DUR) Programs (Prospective review DUR, education programs, retrospective DUR)
What is prospective DUR under OBRA 90
Screening prescriptions prior to dispensing (DDI, drug disease interaction, drug allergy, therapeutic duplication, right dose and duration, evidence of abuse or misuse)
Pharmacist requirements under OBRA 90
Patient counseling
Documenting patient info (demographics, contact info, medical conditions, allergies and ADR history, comprehensive med list)
Dietary Supplement Health Education Act of 1994
- Defined dietary supplements as products that are intended to supplement the diet including vitamins, minerals, herbs, botanicals, and amino acids
- Allowed certain claims of benefit (i.e. nutritional deficiencies, descriptions of the role of the supplement in maintaining structure or function of the body)
- Requires labeling to include: This statement has not been reviewed by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
HIPAA (1996)
Governs the privacy and security of patients’ protected health information by covered entities
What is a covered entity
Healthcare providers, health plans, healthcare clearinghouses, and business associates
What is the HIPAA privacy rule
addresses the use and disclosure of information between covered entities and requires covered entities to provide patients with a notice of privacy practices
What is the HIPAA security rule
addresses the security of electronic protected health information that a covered entity creates, receives, maintains, or transmits
Drug Quality & Safety Act of 2013
Provided FDA additional authority to regulate and monitor compounded medications and to track and trace prescription drugs through the distribution chain
