Law 2

vitohuxo's version from 2016-05-10 23:07


Question Answer
three ways to violate the food drug and cosmetic actmisbranding, adulteration, unnaproved drug into interstate commerce
must be on the container for outpatient prescription drug labelpharmacy name and address, prescription number, date prescription most recently dispensed, patients name, name of doctor, directions for use, quantity, name of med and strength (unless doc says no label), if drug product selecton then name of manufacterur, , exipration statementDiscard this medication 1 year after the date it is dispensed” or earlier beyond use date
OTC label requirementsactive ingredient, inactive ingreds, use, warnings, purpose, directions, expiration date, name and adress of manu packager or distributor, net quantity of contents, waht to do if overdose, NDC required.
orange book reference druglisted drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA.
orange book A meanstherapeutically equivalent
orange book B meansnot therapeutically equivalent
DAW must behandwritten or verbally indicates. can not just check a box or sign.
traditional compounding • Compounding by licensed pharmacist in state licensed pharmacy • Compound per prescription for specific patient • Compound limited quantities before receipt of prescription based on history (but patient must bring in before can dispense) • Compounded in compliance with USP chapters on pharmacy compounding.• Shall not distribute samples of compounded pharmaceutical to a health professional • May advertise or promote the fact that they provide compounding services • Cannot compound and manufacture drug products at same location
hospitals compounding sterile pharmaceuticals must beaccredited USP standards or show compliance.
outsourcing facility does whatcompound sterile and nonsterile drugs on the FDA shortage list without prescription.
outsourcing facility must have what licenses?pharmacy license (michigan requires them to), and FDA registration (says voluntary but not really). CGMP requirements....must report adverse events and provide FDA certain info about what compounding. label says compounded
controlled substances leaving and entering the countrymay bring 50 dosage units from foreign country back plus whatever brought in with them.
off label use of drugcan dispense approved drug for non approved use...exception is methadone 40mg dispersible tablet
side effects statementCall your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”
side effects statement no apply toinpatients in a hospital or health care facility under an order of licensed practitioner.
side effects statement for OTC products• Not required if the product’s packaging includes a manufacturer’s or distributor’s toll-free number for reporting complaints
medicare part D requires prescriptions be kept for10 years.
under public health code keep prescriptions for5 years
DEA requires keep scripts for2 years
exclusion listus department of health and human services, office of inspector general--must check all people dealing with the pharmacy or pharmacy money.Medicare, Medicaid, and all other Federal plans and programs that provide health benefits funded directly or indirectly by the United States will provide no payment for any items or services furnished, ordered, or prescribed by an excluded individual or entity.
nursing home medication kit use• Accessed only on the direct order of a physician • Maintained in a locked cabinet • Accessible only to the licensed nurse in charge
nursing home kit requirement labeling• Kit shall be prepared and sealed by a pharmacist • Kit shall contain a list of its contents and expiration date on the outside surface of the lid
nursing home medications dispensing and storageno sharing of drugs!!!!!• Shall be contained in properly labeled individual containers • Kept in a locked cabinet • Shall be accessible only to the nurse in charge • Labeling and relabeling of all drugs shall only be by a RPH • Controlled substance shall be kept in a separate locked box within the locked medication cabinet EXCEPT drugs requiring refrigeration in a separate locked box within a refrigerator • A medication for external use only shall be kept in a locked cabinet separate from other medications
nursing home discharge• A medication shall not be released or sent with a patient upon discharge, except on the written order of the physician
long term care regulation med review must be donemonthly! by licensed pharmacist
pharmacy intern requirements18 years of age at least, fingerprints for criminal background check, admitted and enrolled college pharmacy, be of good moral character
pharmacy intern name change or permananet address notify board within30 days
pharmacist license requirements18 years or older, good moral character, working knowledge English, fingerprints, internship of 1600 hours, pass NAPLEX and MPJE score not less than 75 -5 attempts,