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PHARMACY PHARMACY LAWSLAWS

Pharmacy LawsPharmacy LawsFederal law takes precedence Federal law takes precedence

over state law unless the over state law unless the state law is stricter than the state law is stricter than the

federal law.federal law.

The most restrictive law will The most restrictive law will take precedence.take precedence.

Enacted in 1906 to prohibit Enacted in 1906 to prohibit the interstate the interstate transportation or sale of transportation or sale of adulterated and adulterated and misbranded food and misbranded food and drugs.drugs.

Pure Food and Drug At 1906Pure Food and Drug At 1906

Adulteration: the mishandling of Adulteration: the mishandling of medication that can lead to medication that can lead to contamination and cause injury or contamination and cause injury or illness to the consumer.illness to the consumer.

Misbranding: deceptive or misleading Misbranding: deceptive or misleading labeling of a product that may lead the labeling of a product that may lead the consumer to believe that the product consumer to believe that the product will cure an illness (illegally labeled).will cure an illness (illegally labeled).

TERMSTERMS

FDA was created under this FDA was created under this act.act.

Required that all new drugs be Required that all new drugs be filed with FDA.filed with FDA.

Clearly defined adulteration Clearly defined adulteration and misbranding of drug and and misbranding of drug and food products.food products.

FOOD, DRUG AND COSMETIC ACT FOOD, DRUG AND COSMETIC ACT

(FDCA 1938)(FDCA 1938)

Required all products to have adequate Required all products to have adequate directions for use unless they contain the directions for use unless they contain the federal legend: federal legend: “Caution: Federal law “Caution: Federal law prohibits dispensing without prescription.”prohibits dispensing without prescription.”

It separated drugs into 2 categories:It separated drugs into 2 categories: Legend – requires a prescriptionLegend – requires a prescription Nonlegend – OTC not requiring a prescription.Nonlegend – OTC not requiring a prescription.

Allows verbal prescriptions over the telephone.Allows verbal prescriptions over the telephone. Allows refills to be called in from a physician’s Allows refills to be called in from a physician’s

office.office.

DURHAM-HUMPHREY ACT DURHAM-HUMPHREY ACT of 1951 of 1951

Requires that all Requires that all medication on the medication on the market in the US be market in the US be pure, safe and effective.pure, safe and effective.

Kefauver-Harris Kefauver-Harris Amendment of 1962Amendment of 1962

The Drug Enforcement The Drug Enforcement Agency (DEA) was created Agency (DEA) was created under this act.under this act.

Controlled substances were Controlled substances were placed into one of five placed into one of five schedules.schedules.

Comprehensive Drug Abuse Comprehensive Drug Abuse Prevention and Control Prevention and Control

Act of 1970 Act of 1970

Enacted to reduce the Enacted to reduce the accidental poisoning in accidental poisoning in children.children.

Most OTC and legend drugs Most OTC and legend drugs must be child-resistant.must be child-resistant.

Poison PreventionPoison Prevention Packaging Act of 1970 Packaging Act of 1970

EnsuresEnsures Job safety and health standards for employeesJob safety and health standards for employees Maintain a reporting system for job-related injuries Maintain a reporting system for job-related injuries

and illnessand illness Reduce hazards in the workplaceReduce hazards in the workplace Conduct audits to guarantee compliance with act Conduct audits to guarantee compliance with act

It addressed air contaminants, flammable and It addressed air contaminants, flammable and combustible liquids, eye and skin protection, and combustible liquids, eye and skin protection, and hazard communication standards in the pharmacy.hazard communication standards in the pharmacy.

Require usage of the MSDS.Require usage of the MSDS.

Occupational Safety and Health Act Occupational Safety and Health Act (OSHA) of 1970(OSHA) of 1970

Created an 11-digit number to identify each Created an 11-digit number to identify each drug.drug.

This is the NDC (National Drug Code) number.This is the NDC (National Drug Code) number.

The The first five first five digits identify the:digits identify the: ManufacturerManufacturer

The The next four next four digits identify the:digits identify the: Drug productDrug product

The The final two final two digits represent the:digits represent the: Package size and packagingPackage size and packaging

Drug Listing Act of 1972Drug Listing Act of 1972

Orphan drugs are medications Orphan drugs are medications for rare diseases (<200,000 for rare diseases (<200,000 cases in the world).cases in the world).

The law provides tax The law provides tax incentives and exclusive incentives and exclusive licensing to develop and licensing to develop and market orphan medications.market orphan medications.

Orphan Drug Act of 1983Orphan Drug Act of 1983

Encouraged the creation of Encouraged the creation of both generic and new both generic and new medication.medication.

Streamlined the process for Streamlined the process for generic drug approval and generic drug approval and extended patent licenses.extended patent licenses.

Drug Price Competition and Drug Price Competition and Patent Term Restoration Act of Patent Term Restoration Act of

19841984

Prohibits the reimportation of a drug into the Prohibits the reimportation of a drug into the United States by anyone except the United States by anyone except the manufacturer.manufacturer.

Prohibits the sale or distribution of samples to Prohibits the sale or distribution of samples to anyone other than those licensed to prescribe anyone other than those licensed to prescribe them.them.

Requires that all medications for animals Requires that all medications for animals are to be labeled with: are to be labeled with: “Caution: Federal “Caution: Federal law restricts this drug to use by or on law restricts this drug to use by or on an order of a licensed veterinarian.”an order of a licensed veterinarian.”

Prescription Drug Prescription Drug Marketing Act of 1987Marketing Act of 1987

Created more strict penalties Created more strict penalties for the abuse of anabolic for the abuse of anabolic steroids and their misuse by steroids and their misuse by athletes. athletes.

Anabolic Steroid Control Act Anabolic Steroid Control Act of 1990of 1990

Establishes Medicare and Establishes Medicare and Medicaid Conditions of Medicaid Conditions of Participation (regulations for Participation (regulations for drug use and guidelines).drug use and guidelines).

Requires manufacturers to Requires manufacturers to provide the lowest prices to any provide the lowest prices to any customer or Medicaid patient.customer or Medicaid patient.

Omnibus Budget Reconciliation Omnibus Budget Reconciliation Act (OBRA) of 1987Act (OBRA) of 1987

Requires that all medical Requires that all medical devices be tracked and devices be tracked and records be maintained for records be maintained for durable medical equipment, durable medical equipment, such as infusion pumps.such as infusion pumps.

FDA Safe Medical Devices ActFDA Safe Medical Devices Act of 1990 of 1990

Prevents discrimination against Prevents discrimination against potential employees who may potential employees who may possess a disability.possess a disability.

The business must make The business must make reasonable accommodations for reasonable accommodations for the employee.the employee.

Americans with Disabilities Americans with Disabilities Act (ADA) of 1990Act (ADA) of 1990

There are two parts of HIPAA:There are two parts of HIPAA:1.1.Protects health insurance coverage Protects health insurance coverage

for workers and families when they for workers and families when they change or lose their jobs.change or lose their jobs.

2.2.Administrative Simplification – Administrative Simplification – electronic transactions and required electronic transactions and required Health Information Privacy.Health Information Privacy.

Health Insurance Portability Health Insurance Portability and Accountability Act (HIPAA)and Accountability Act (HIPAA)