Pharmacy Laws And Regulations Flashcards
Food and Drug Act:
Require government pre approval of drugs.
Poison Prevention Packaging Act
Requires childproof packaging on all controlled and most prescription medications.
You can change the cap at the request of the patient or prescriber.
Darham Humphrey Amendment
Identifies which drugs require prescriptions by doctor.
Caution: Federal Law prohibits dispensing without a prescription. (RX Only)
Orphan Drug Act
Provides incentives to promote research, approval, and marketing of drugs needed for treatment of rare diseases.
Ominbus Budget Reconciliation Act (OBRA)
Requires pharmacists to offer counseling to Medicaid patients regarding medications.
Health Insurance portability and accountability act (HIPPA)
Defined the scope of healthier formation that may and may not be shared among health care providers without patients concent.
Provides strict regulations to protect patients right to privacy.
Harrison Drug Act
Regulated drugs that produce physical or psychological dependance. (Opiates)
Everyone should be licensed and required to pay a tax
Food and Drug Cosmetic Act
Requires new drugs to be shown as safe before marking
Kefauver Harris Ammendment
Requires drug companies to provide proof of safety and effectiveness before marketing
Fair packaging and labeling act
Requires all products in interstate commerce to be honestly and informatively labeled
Controlled substance
Classifies drugs that have potential for abuse into 5 levels of crontrolled substances
Medical device amendment
Requires pre market approval for safety and effectiveness of life sustaining and life supporting devices
Drug price competition and patient term restoration act (hatch waxman)
Established the modern system of generic drugs
Prescription drug marketing
Restricted distribution of prescription drugs to legitimate commercial channels and require drug wholesalers to be licensed
Anabolic steroid act
Places any drug or hormonal substance related to testosterone under regulatory provisions of the CSA
