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Law

TermDefinition
Food and Drug Act 1906 Prohibit the interstate transportation or sale of adulterated and misbranded food or drugs.
Food, Drug, and Cosmetic Act 1938 New drug applications be filed with the FDA. Defined adulteration and misbranding of drugs and food products.
Adulteration Prepared, packed, or held under unsanitary conditions. Prepared in containers part of poisonous or deleterious substances.
Misbranding Labeling that is false. Packaging that does not have a label containing name of business, warnings etc.
Manufacture drug label requirements Name of manufacturer, NDC, directions for use, no misleading statements, ingredients, Exp date, lot or control number, bar code.
OTC label requirements Name of manufacturer, NDC, active ingredient, inactive ingredient, use or uses, warnings, directions,
Durham-Humphrey Act of 1951 Requires all products to have adequate directions for use unless they contain the federal legend caution on it.
Legend drugs are Prescription drugs
Nonlegend drugs are Over-the-counter drugs
Kefauvr-Harris Amenment Act of 1962 Requires all drugs to be pure, safe, and effective.
Comprehensive Drug Abuse prevention and control act 1970 Controlled drugs are placed in a category based on the potential for abuse.
Schedule I Posses an extremely high potential for abuse such has crack, meth, heroin, opium.
Schedule II Have a medical use and the abuse potential with severe psychological or physical dependence such as Adderall, cocaine, Demerol, diladid, morphine sulfate, oxycontin.
Schedule III Have a medical use and the abuse potential is less than schedule I and II drugs like Lorcet, Lortab, Tylenol with codeine, Vicodin.
Schedule IV Less than with schedule III drugs but administration may lead to limited physical or psychological dependence like ambien, Ativan, Klonopin, Robitussin A-C, Xanax.
Form 224 Must be submitted to DEA when dispensing controlled substances.
Form 222 Schedule II drugs need to have a 222 form filled out when being ordered.
How many days is a DEA form 222 valid 60 days
How long must the completed 222 form be kept in the pharmacy 2 years
What must be on the invoice for schedule III, IV, V red C
Initial inventory Completed accurately before the opening of the first day of business.
Biennial inventory Taken every 2 years after initial inventory is done.
Perpetual inventory Shows controlled substances received by the facility, supplied to other locations, returned to the pharmacy, and dispensed to patients.
Form 41 Used for damaged or outdated controlled substances once a year.
Form 106 Filled out for theft of a controlled substance after he local police has been notified.
How many days does a pharmacy have to fill a partial prescription. 72 hours, after 72 hours a new prescription must be written.
How many refills can schedule III to V be given up to 5 refills within 6 months from the date the prescription was written.
Exempt schedule V narcotics Must be 18 years or older, original container and 1 container per 24 hour period.
Faxed prescriptions Schedule III, IV, and V
What schedules can be transferred to another pharmacy Schedule III, IV, and V on a one-time basis unless the pharmacies share the same computer system IE walgreens then refills can be filled as many times per drug allowed by law.
How long should the transferred and original prescription be kept 2 years from the date of last refill.
Poison prevention packaging act of 1970 Enacted to reduce accidental poisoning in children and packaged in child-resistant containers.
If patient does not want child resistant container what must they do. Sign the back of the prescription.
Occupational Safety and Health act of 1970 Created OSHA, safe and healthful workplace, attempts to reduce hazards in the workplace, requires use of SDS.
Hatch-Waxman (The drug price competition and patent term restoration act of 1984) Encouraged the creation of both generic and new medications.
Prescription drug marketing act of 1987 Prohibits the reimportation of a drug into the US by anyone except the manufacturer. Requires the following label to appear on all medications administered to animals: Caution federal law restricts this drug to use by or on an order of a licensed veteri
Omnibus Budget Reconciliation Act of 1987 Revisions to Medicare and Medicaid conditions of participation regarding long-term care facilities and pharmacy.
Anabolic steroid control act of 1990 Enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes.
Food and Drug Administration safe medical devices act of 1990 All medical devices are to be tracked and records maintained for durable medical equipment.
Resource conservation and recovery act Is a U.S. law that provides, in broad terms, the general guidelines for the waste management program envisioned by congress.
Dietary supplement Health and education Act of 1994 Herbal products are dietary supplements rather than drugs. Must be labeled as dietary, list all ingredients
Health Insurance Portability and Accountability act of 1996 HIPPA Patient confidentiality, written privacy procedure, written consent of the patient.
Medicare prescription drug improvement and modernization act of 2003 Preventative medical benefits to senior citizens, lowers reimbursement rates for medicare payments,
Isotretinoin safety and risk management of 2004 Powerful medication to treat acne, can cause birth defects, spontaneous abortions. Legislation requires registry of all patients, practitioners must be educated, monthly education of patients. Female patients must have monthly pregnancy tests
Combat methamphetamine epidemic act of 2005 Placed ephedrine, pseudoephedrine, and phenylpropanolamine in the controlled substance act category. limit a 3.6 g/day and a 9g/month sale and must be logged.
Medicaid tamper-resistant prescription act Tamper resistant pad and must include prevention of copying of a blank or completed prescription, prevent the erasure or modification of info written on a prescription and prevent the use of counterfeit prescription forms.
United States Pharmacopeia 757 Provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations
United States Pharmacopeia 797 Designed to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff
Laminar flow hood maintenance wash bar than side starting from area closest to filter working outward wiping left to right all the way down to the bench. Bench should be cleaned side to side wiping outwards.
Drug Enforcement agency Registers pharmacies, Issues DEA forms, places medications in the appropriate schedules and monitors the destruction of controlled substances.
Environmental protection agency Sets guidelines for the disposal of hazardous waste.
The joint commission Addresses the quality of patient care and patient safety.
The national boards of pharmacy BOP meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy.
State boards of pharmacy Oversees the practice of pharmacy in a given state.
Created by: bryanta37