EXCPT Pharmacy Laws and Regulations

Pure Food and Drug Act of 1906

Prohibits interstate transportation or sale of adulterated or misbranded food and drugs

Occupational Safety and Health Act of 1970 (OSHA)

To assure safe and healthful working conditions for working men and women

Durham-Humphrey Amendment

Requires the label "caution: federal law prohibits dispensing without prescription"

Made distinction between legend and no legend drugs

Food, Drug & Cosmetic Act

Legalized the FDA

Required all controlled substances to be labeled with "Warning: may be habit forming" and prohibited misbranding

Harrison Narcotic Act

Prevented the sale of opium without a prescription

Kefauver-Harris Amendment

Attempts to ensure the safety and effectiveness of all new drugs

Poison Prevention Package Act

Requires childproof caps

Orphan Drug Act

Allowed some Companies to bypass some time requirements and costs of testing a new drug for orphan diseases

Comprehension Drug Abuse Prevention & Control Act

DEA formed Control drugs can be addictive and are placed in one of 5 categories

Omnibus Budget Reconciliation Act

Pharmacist must offer to counsel all patients who receive new drugs

Medical Device Amendments of 1976

Called for all devices to be divided into classes (3), with varying amounts of control required in each one

Federal Anti-Tampering Act of 1983

Made tampering with, or adulterating OTC and cosmetic products a federal criminal offense

Drug Price Competition and Patent-Term Restoration Act of 1984

Streamlines the process for granting approval of generic drugs.

Anabolic Steroids Control Act of 1990

To apply penalties to the distribution of anabolic steroids

Dietary Supplement Health and Education Act of 1994

Herbal products and dietary supplements must be labeled as dietary supplements and identify all ingredients and quantities of the ingredient on the label

Food and Drug Administration Modernization Act of 1997

Must have Rx on the label

Medicare Modernization Act of 2003

Drug discount card available to low-income medicare patients.

Combat Methamphetamine Epidemic Act of 2005

Only a licensed pharmacist or technician may dispense, sell, or distribute pseudoephedrine

Patient Protection and Affordable Care Act of 2010

Allows young adults to stay on their parents' private health insurance policies until they turn 26 years old and thousands of adults will be able to buy affordable coverage

HIPAA

Patient privacy

Drug Addiction Treatment Act

Permits prescription of controlled substances to addicts for detoxification

Combat Methamphentamine

Pseudoephedrine must be sold behind the counter

iPledge Program

Requirements for dispensing isotretinoin (accutane)

FDA

Food & Drug Administration

Ensures the safety & effectiveness of med

MedWatch

Program of the FDA to report any adverse reactions to meds

Form 41

authorization to destroy damaged, outdated, or unwanted controlled substances {this form can be used once a year}

Form 222

needed to order or transfer C-II substances

Form 224

needed to dispense controlled substances {must be renewed every 3 years}

Form 225

needed to manufacture or distribute controlled substances

Form 363

needed to operate a controlled substance treatment program or compound controlled substance

Form 106

for the loss or theft of controlled substances

Controlled substance transfer regulations (DEA)

C-II drugs cannot be transferred

C-III, IV, and V may be transferred once

Isotretinoin REMS

Isotretinoin linked to severe birth defects when used iPledge program ensures patients are not pregnant and preventing pregnancy in patients who receive isotretinoin therapy

Thalidomide REMS

Thalidomide causes severe birth defects and venous thromboembolic

prevents the use of thalidomide in women who are pregnant or may become pregnant

Clozapine REMS

Clozapine may cause fatal side effect of suppression of white blood cell production

White blood cells must be measured by a medical lab and recorded in the Clozaril National Registry

Class 1 Recall

products that could cause serious adverse health consequences or death

Class 2 Recall

products that cause temporary problems or medically reversible adverse health consequences

Class 3 Recall

products that have a minor defect that is not likely to cause adverse health consequences.