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CHAPTER TWO PHARMACY LAW PTCE QUESTIONS AND CORRECT ANSWERS

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CHAPTER TWO PHARMACY LAW PTCE QUESTIONS AND CORRECT ANSWERS

Institution
PTCE
Course
PTCE

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CDAPCA 1970 - Theft of Controlled Substances


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After the discovery of a theft of controlled substances, the pharmacy must
notify the nearest DEA diversion office, local police, and complete DEA
Form 106, the pharmacy must send the original copy of the DEA Form 106
to the DEA and retain one copy for records




CDAPCA 1970 - Prescription Monitoring Programs


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In 2005, the federal National All Schedules Prescription Electronic
Reporting Act was introduced. The act established an electronic system for
practitioner monitoring if the dispensing of controlled substances in
Schedules II-IV. The act would have required specific information to be
reported, such as a patient identifier, drug dispensed, and quantity

, dispensed, as well as the prescriber and dispenser. Although the act was
never enacted, the majority of states have enacted this or similar legislation.




CDAPCA 1970 - Emergency Filling of Schedule II Drug Prescriptions


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Oral prescriptions are allowed if: the pharmacist makes a good-faith
attempt to identify the physician, prescription is limited to a quantity to treat
the patient during the emergency period, pharmacist must reduce order to
writing, physician must write a prescription for this emergency quantity, and
the pharmacy must receive it within 7 days of the oral order, if the
pharmacy doesn't receive the written prescription, the DEA must be
notified immediately




FDCA 1938 - Manufacturer Drug Labeling


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Name and place of business of manufacturer, packer, or distributor, NDC
number, adequate directions for use, no misleading statements, statement
of ingredients, prominence of required label statements, Spanish-language
version of certain required statements, expiration date, manufacturer lot or
control numbers, declaration of presence of FD&C Yellow No. 5 or FD&C
Yellow No. 6 in certain drugs for human use, declaration of presence of
phenylalanine as a component of aspartame in OTC and prescription drugs
for human use, prescription drugs containing sulfates; required warning
statements, bar code label requirements, exceptions or alternatives to
labeling requirements for human drug products held by the Strategic
National Stockpile

, CDAPCA 1970 - Defective DEA Form 222


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Considered defective if it is incomplete, illegible, or shows signs of
alteration, erasure, or change, must be kept for at least two years and be
readily retrievable




Dietary Supplement Health an Education Act of 1994 (DSHEA)


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Herbal products are dietary supplements rather than drugs. The
manufacturers of supplements are allowed to make claims with regard to
general health promotion but not disease claims. Herbal products must
meet the following requirements: be labeled as a dietary supplement, have
labeling that identifies all ingredients by name, have labeling that identifies
the plant and plant part from which the ingredient is derived, comply with
any standards set by an official compendium, meet the quality, purity, and
compositional specification, and have Good Manufacturing Practices
followed by the manufacturer.




Prescription Drug Marketing Act of 1987


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