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Food, Drug, and Cosmetic Act (FDCA) notes that certain products requires a ___
and with ___. - 🧠ANSWER ✔✔a batch process with instructions for use and
warnings for abuse.
FDCA requires ___ documentation for drugs. - 🧠ANSWER ✔✔SAFETY
The FDCA is the the FDA's ______. - 🧠ANSWER ✔✔primary federal law
Three major Limitations to the FDCA? - 🧠ANSWER ✔✔1. Need to document
safety only
2. Created an Rx only class of medications
3. Application to INTRASTATE commerce
also, created a loophole for current products (i.e., levothyroxine)
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,Durham-Humfrey Amendment of 1951 , which served as an update to the FDCA,
clarified the role of ____ and ____. - 🧠ANSWER ✔✔prescription and pharmacist
Durham-Humfrey classified drugs into two different categories ___ vs ___.
Prescriptions were allowed in both ____ forms by authorized personnel. -
🧠ANSWER ✔✔Rx (prescription) vs OTC
oral and written (must write immediately)
Kefauver-Harris Amendement of 1962 required ____. Drugs must be proven ____,
in accordance to safety. - 🧠ANSWER ✔✔1. Extensive animal testing prior to use
in humans
2. EFFECTIVE
____ requires submission of an IND followed by a NDA. - 🧠ANSWER
✔✔Kefauver-Harris
IND (Investigational New Drug)
NDA (New Drug Application)
According to Kefauver-Harris Amendment:
OTC medications are regulated by the ___.
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,Prescription Medications are regulated by the ____,
FDA trials require _________________ - 🧠ANSWER ✔✔FTC (Federal Trade
Commission)
FDA
(1) informed consent (2) reporting of SE (3) GMPs*
According to the FDCA prescriptions need to be stored for a minimum of ___. -
🧠ANSWER ✔✔5 years
According to the Medicare Modernization Act of 2003 prescriptions need to be
stored for a minimum of ___. - 🧠ANSWER ✔✔10 years
Who is authorized to Prescribe in LA? - 🧠ANSWER ✔✔MD
DO (Osteopathic Medicine)
PA
NP
TO (therapeutic Optometrist)
T or F? Self prescribing in LA is okay? if so, why? - 🧠ANSWER ✔✔True, you
*must* document the note, exam, or test.
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, Avoid Filling a prescription if ___.
NOTE: *LA does not have CONSCIENTIOUS OBJECTION* - 🧠ANSWER ✔✔1.
Forgery (signature, written, voice w/o permission)
2. Fictitious (Fake patient or MD)
3. Violation of the law
4. Harmful to a patient
Original Prescription, prior to filling, belongs to the ___. After filling, it belongs to
____. Patients can only receive a ___ of the prescription after it is filled. *NEVER
GIVE BACK THE ORIGINAL.* - 🧠ANSWER ✔✔patient
pharmacy
copy
Louisiana Rx Labeling Requirements - 🧠ANSWER ✔✔1. Prescriber's name,
licensure designation, address, telephone number, and if for a controlled
substance, the Drug Enforcement Administration (DEA) registration number;
2. Patient's name, and if for a controlled substance, address;
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