Laws of Pharmacy

This act prohibits the sale of adulterated or mislabeled food, drinks and drugs
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Terms in this set (14)
This act prohibits the sale of adulterated or mislabeled food, drinks and drugs
1906 - Federal Food and Drug Act
This act limits the transport of opium. In order to purchase opium, a prescription is required.
1914 - Harrison Narcotic Act
This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit forming" , requires that a new drug has to be proven safe under FDA guidelines before marketing
1938 - Food Drug and Cosmetic Act
This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution:Federal law prohibits dispensing without a prescription", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label: Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not
1951 - Durham Humphrey Amendment
All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturers Must now register annually, be inspected ever 2 years, and report adverse effects of drugs.
1962 - Kefauver-Harris Amendment
Drug enforcement agency (DEA) was formed. Also controlled substance were placed in schedules I-V based on abuse potential.Schedule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential.
1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA)
This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hard a child under 5 years old.
1970 - Poison Prevention packaging act
This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
1983 - Orphan Drug Act
This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug after the expiration of the patent.
1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)
This act established the FDA as an agency of the Department of Health and Human Services. Any adverse drug reactions and outcomes should be reported to the FDA
1988 - Food and Drug Administration Act
This act banned the sale, trade, or purchase of drug samples1988 - Prescription Drug Marketing ActThis act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharmacist must provide a description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage, refill information, and what to do if a dose is missed.1990 - Omnibus Budget Reconciliation Act (OBRA)This act created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. This act also includes provisions that make health care information processing more cost effective by requiring standardized electronic submissions of claim information.1996 - Health Insurance Portability and Accountability Act (HIPAA)This act limits the purchase of pseudoephedrine(pse) products to 3.6g of pse per day or 9g per 30 days2006 - Combat Methamphetamine Epidemic Act (CMEA)