Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law 2022

Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law - Federal Food and Drug Act This act prohibits the sale of adulterated or mislabeled food, drinksand drugs 1914 - Harrison Narcotic Act This act limits the transport of opium. In order to purchase opium, a prescription is required. 1938 - Food Drug and Cosmetic 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 1951 - Durham Humphrey Amendment 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 prescrition", 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 1962 - Kefauver-Harris 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. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse effects of drugs. 1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA) Drug enforcement agency (DEA) was formed. Also controlled substanced 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 - Poison Prevention packaging act 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. 1983 - Orphan Drug Act This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases. 1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment) 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. 1988 - Food and Drug Administration Act 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 - Prescription Drug Marketing Act This act banned the sale, trade, or purchase of drug samples 1990 - Omnibus Budget Reconciliation Act (OBRA) This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharmacist must provide anem and 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. 1996 - Health Insurance Portability and Accountability Act (HIPAA) 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. 2006 - Combat Methamphetamine Epidemic Act (CMEA) This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days Class I Recall An attempt must be made to notify the patient that the drug he/she may be taking could cause serious harm or death Class II recall The probability of serious harm is not likely and the effects may be temporary or reversable. This recall does not go to the customer level and is usually due to problems with consistency of potency Class III recall Not likely to cause any serious adverse effects and does not go to the customer level OTC labeling must contain: Product Name, manufacturer address, net contents, all ingredients(active or inactive), habit-forming drugs contained within, caution/warning labels, directions for use(drug's purpose, dosage, frequency of administration in accordance to meals, symptoms, etc, route of administration) Food, Drug, and cosmetic act requires precription drugs to contain: Name/address/phone# of dispensing pharmacy, patient and doctor's name, prescription number and the date filled, drug name/strength/quantity/directions for use, name/initials of dispensing pharmacist or technician, patient address, expiration date, refill information, precautions, the statement "federal law prohibits dispensing without a prescription", package insert on selected drugs. Package inserts must contain: Description of the drug, Clinical pharmacology, indications and usage, contraindications/precautions/warnings/adverse reactions, drug abuse/dependance/overdosage information, dosage/administration information, the date of the most recent label revision Package inserts must be distributed with the following drug classes: Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers National Drug Code (NDC) Each drug produced by a manufacturer is identified with a specific NDC number. THe NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size. NDC first set (five numbers) indicate what? Manufacturer NDC second set/middle set (four numbers) indicates what? Specific drug - each drug has its own number NDC last two numbers indicate what? Package size - (100 tablets may be 01, 500 tablets may be 05) Schedule I drugs These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential Schedule II drugs These drugs may NOT be refilled. The ordering of these drugs requires a DEA 222 form. The returning of out-of-date schedule II drugs requires a DEA 222 form. These drugs have a high abuse potential that may lead to sever physical or psychological dependence Schedule III drugs These drugs may be refilled 5 times in a six month period. These drugs have less potential for abuse/dependence than schedule I or schedule II drugs Schedule IV drugs These drugs may be refilled 5 times in a 6 month period. These drugs have less potential for abuse/dependence than schedule II/III drugs. Schedule V drugs These drugs have less potential for abuse than schedule II, III, and IV drugs. Heroin Schedule I Peyote Schedule I LSD Schedule I Marijuana Schedule I Mescaline Schedule I Cocaine Schedule II Morphine Schedule II Amphetamines Schedule II Codeine Schedule II Opium Schedule II Methadone Schedule II Oxycodone Schedule II Hydromorphone Schedule II Fentanyl Schedule II Meperidine Schedule II Methylphenidate Schedule II Secobarbital Schedule II Codeine w/ acetaminophen (tylenol No. 3) Schedule III