Study guide for PTCB exam
Quiz yourself by thinking what should be in
each of the black spaces below before clicking
on it to display the answer.
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Pure Food and Drug Act of 1906 | show 🗑
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Food, Drug and Cosmetic Act of 1938 (FDCA 1938) | show 🗑
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show | Created RX (legend) and OTC (nonlegend) drug categories. Labels needed directions for use unless they contained "Caution: Federal law prohibits dispensing without a prescriptions" Verbal prescriptions over phone legalized.
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show | All medications need to be pure, safe and effective.
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show | DEA created. Controlled Substances placed in one of 5 categories
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show | No accepted medical use and posses extremely high potential for abuse.
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show | Has medical use but high abuse potential with severe psychological or physical dependency.
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Schedule III | show 🗑
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Schedule IV | show 🗑
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show | Abuse potential is less than with Schedule IV dugs. Includes exempt narcotics.
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show | Ordered by completing DEA Form 222. Valid for 60 days. Maximum of 10 items per form. Receipts, invoice, shipping, package numbers must be kept for 2 years.
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show | Ordered by any method (written, faxed or verbal). Packing slips/invoice must be signed, dated, and stamped with a red "C" and kept for 2 years
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show | Complete and accurate inventory of all controlled substances before the opening of the first day of business
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Biennial inventory | show 🗑
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show | Realtime inventory. Shows controlled substances received by the facility, supplied to other locations, returned to pharmacy and dispensed to patients.
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show | DEA for 41. Retail has one per year. Hospitals have "blanket authorization"
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show | Notify DEA diversion office, local police and complete DEA Form 106
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Filling Schedule II prescriptions | show 🗑
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Emergency filling of Schedule II | show 🗑
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show | Faxed Scheduled II RX allowed. Partial filling allowed for terminal patients. Filed for 60 days from date of issue. "Long-term care facility patient" or "terminally ill patient" noted on RX.
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show | 5 refills in 6 months. Partial fills allowed if refills ordered.
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Exempt narcotics | show 🗑
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show | "VOID" written on the face of invalidated RX. Name, address, DEA number of receiving pharmacy, and pharmacist receiving prescription written on back of RX. Date of transfer and name of transferring pharmacist recorded.
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show | "Transfer" written on received prescription. Date of issue, Original number of refills, date of original dispensing, number of refills left, pharmacy name, address, DEA number, and RX number of previous pharmacy as well as pharmacist's name. (old and new)
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show | Child resistant packing
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Occupational Safety and Health Act of 1970 (OSHA) | show 🗑
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Drug Listing Act 1972 | show 🗑
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show | 11 digits. First 5 identify manufacturer. Next 4 identify the drug product. Final 2 represent the package size and packaging.
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Orphan Drug Act of 1983 | show 🗑
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show | Encouraged creation of generic and new medications by streamlining for generic drug approval and extending patent licenses
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show | Revisions to Medicare/Medicaid conditions of Participation in long-term care facilities
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Anabolic Steroid Control Act of 1990 | show 🗑
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show | Manufacturers provide lowest price to Medicaid patient with rebating Medicaid state agencies the difference in price. Must offer patients "offer to counsel"
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FDA Safe Medical Devices Act of 1990 | show 🗑
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show | Prevents discrimination against possible employees who may have a disability. Businesses must make "reasonable accommodation"
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show | EPA produced federal guidelines regarding disposal of hazardous waste.
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FDA Modernization Act | show 🗑
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show | Herbal products are allowed health claims but not disease claims.
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show | Protects patient information.
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HIPPA: Title I | show 🗑
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show | Administrative Simplification. Established computerized ways of processing data while keeping patient privacy.
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show | Increased number of steroids by removing the requirement to show muscle growth. Most Schedule III drugs.
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Any Willing Provider Law | show 🗑
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Freedom of Choice Law | show 🗑
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Freedom of Choice with regard to Long-Term Care | show 🗑
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Prescription Drug Equity Law | show 🗑
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show | Changed payments for outpatient Part B drugs. Part D allowed people to enroll in either regional- or national-based plans.
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show | Put a limit on age of buyer and amount bought of ephedrine, pseudoephedrine, and phenylpropanolamine. 3.6g/day or 9g/30day
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Medicaid Tamper-Resistant Prescription Act | show 🗑
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