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Federal, state, or practice site regulations, codes of ethics, and standards.
| Question | Answer |
|---|---|
| Ensures that all products are pure, safe, and effective. | Kefauver - Harris Amendment of 1962. |
| Separated OTC from RX. Allowed RX's over phone and refills. | Durham-Humphry Act of 1951. |
| Requires all new drug applications be filed with the FDA. Misbranding and Adulteration. | Food, Drug, and Cosmetic act of 1938. |
| Theft of a controlled substance. | DEA form 106. |
| Form submitted by pharmacy to register with the DEA to dispense controlled substances. | DEA form 224. |
| Medical use with a high abuse potential with severe psychological or physical dependency. No refills. | CII |
| Order forms for controlled substances must be kept for a min. of ___ yrs. | Two. |
| Includes exempt narcotics. | CV |
| Form used to order CII's. | DEA form 222. |
| Pharmacies must renew their 224 every ____ yrs. | Three. |
| Defective forms must be kept for a min. of ___ yrs. | Two. |
| Initial Inventory | Count of all controlled substances before the opening of the pharmacy. |
| Biennial Inventory | Inventory every two years. Exact count of all CII's and estimates for III - V's. |
| Perpetual Inventory | Shows the actual number of units of a drug at a particual moment in time. |
| Form used to transfer CII's. | DEA form 222. |
| Form used when destorying controlled substnaces. | DEA form 41. |
| How many times per year may a retail pharmacy submit form 41? | Once. Hospitals may have blanket authorization. |
| What information must be on a DEA form 41? | Name, strength, and quanties of the CS. Date of destruction, method, and witnesses present. |
| No acepted medical use and pssesses an extremely high potential for abuse. | CI |
| An oral prescription can be issued to a pharmacy for a CII under the following conditions: | Good faith attempt to identify physician.Limited to quantity to treat the patient during this period.Pharmacist reduce order to writing.Physician writes a rx for the emergency quantity and pharmacist must recive within 7 days. |
| A prescription for CII's can be: | hadwritten or Computer Generated and sighned in ink by physian. |
| A partial filling of a CII is allowed if the remaining quantity is available to the patient within: | 72 hours. If not provided within this time a new rx is needed. |
| How many refills for CIII to CVs are allowed? When do they expire? When do CII rx's expire? | 5 refills expires 6 months.CIIs expire in 60 days. |
| What information is needed from someone purchasing an exempt narcotic? | Date, name, address, product, quantity, price, and pharmacist signature. |
| What is the limit for buying exempt narcotics? | One container per 48 hours. |
| When is the only time a rx for a cII may be faxed as the original? | It is to be compounded for parenteral use.For a long term care facility.For a hospice patient. |
| What does OSHA stand for? | The Occupational Safety and Health Administration |
| What is the purpouse of OSHA? | To ensure a safe and healthful workplace for all employees. |
| What do the numbers in an NDC number stand for?----- ---- -- | Manufacturer, Drug, and Package size. |
| The drug listing act of 1972 created what? | NDC numbers for every drug. |
| Established extensize revisions to Medicare adn Medicaid conditions regarding long term care facilities and pharmacy. | Omnibus Budges Reconcililiation act of 1987 (OBRA-87) |
| What does HIPPA stand for? | Health Insurance portability and accountability act of 1996. |
| What is the purpouse of HIPPA? | To improve portability and continuity of health insurance and requires that health care providers ensure that patient confidentiality be maintained. |
| What are the two parts of HIPPA? | Title I - Insurance Reform. Protects health insurance coverage for people when they change or loose jobs. Title II Administrative Simplification. |
| What is the purpose of the Osotretinoin Safety and risk management act of 2004? | Put extremly strict guidelines on Accutane prescriptions. |
| What is the purpose of USP <797>? | To cut down on infections transmitted to patients throuh pharmaceutical products and to protect pharmacy staff. |