Other Flashcards
Prescription drug advertising is regulated by?
FDA
Over-the-counter drug advertising is regulated by the?
Federal Trade Commission (FTC)
Advertising is exempt from FDA advertising regulations provided that the following conditions are met:
Only purpose is to provide information on pricing
Advertising contains the proprietary name of the drug, the generic name of the drug, the drug strength, the dosage form, and the price charged for a specific quantity
May include availability of professional or other types of services as long as it is not misleading
Price stated in the advertising shall include all charges to the consumer excluding mailing and delivery fees
Patient package inserts when and what drugs?
Must be given with first script and every 30 days after
These are different than the ones attached to the bottles
Drugs: oral contraceptives, estrogen-containing products, progesterone containing products
Elements to ensure safe for use with REMS may include:
Special training, experience, or certification
Drug is dispensed to patient only in certain healthcare settings
Drug is dispensed to patient with evidence or other documentation of safer used condition such as laboratory results
Each patient using the drug is subject to certain monitoring
Each patient uses the drug is enrolled in a registry
Example of REMS
Isotretinoin Accutane
iPledge program for contraceptives
Product is dispensed in blister packages which cannot be broken and a 30 day supply is the maximum quantity no refills
NDC number
First 4 to 5 digits = manufacturer
Next four digits = specific drug
Last two digits = package size
Not required under federal law
Compounding versus manufacturing
Compounding pharmacy’s only compound products for specific individual prescriptions or medication orders but are allowed to do limited anticipatory compounding and are subject to USP chapter 797
Pharmacy must comply with the following to not be considered a manufacturer:
Drug product is compounded for an identified individual patient
Compounding of the drug is performed by a licensed pharmacist for an individual patient from the prescription by a licensed position or by a licensed pharmacist or physician in limited quantities before the receipt of a valid prescription based on a history of receiving prescriptions or with an established relationship with a physician
Licensed pharmacist does not compound regularly
Drug product is not identified as a drug product represents demonstratable difficulties
Drug product is compounded in a state that has entered into a memorandum of understanding
Drug product is compounded using book drug substances
FDA orange book
Approved drug products with therapeutic equivalence evaluation
AKA generic equivalency
FDA purple book
List biological products that are considered bio similars and provide interchangeability evaluations
CMS requirements
Tamper resistant prescriptions and medication regimen reviews every 30 days for long-term care patients and all patients at least every six months, monthly for patients with psychotropic drugs, antibiotic or any other drug request
