Federal Law: Dispensing Flashcards
Durham-Humphrey Amendment
establishes the criteria for distinguishing prescription drugs from OTC drugs
legally establishes oral Rxs and refills
What determines who may prescribe independently or in collaborative practice
Federal law leaves it up to states to decide
Prescription Drug Marketing Act of 1987
bans the sale, trade, or purchase of prescription drug samples
To prevent counterfeiting, what does PDMA prohibit
reimportation of prescription drugs
Who instituted a policy to allow certain medications to be imported from other countries
FDA
Drug Quality and Security Act of 2013
addresses issues with meningitis outbreak that killed over 60 patients
What are the 2 major sections of the drug quality and security act of 2013
Title I: compounding Quality Act
Title II: Drug Supply Chain Security Act
Title I: Compounding Quality Act
preserves and protects the practice of traditional pharmacy compounding in community pharmacies (made it legal to compound in community pharmacies)
Definition of compounding
taking 2 or more ingredients and combining them into a dosage form of a drug
Who can compound according to traditional pharmacy compounding (503A)
a licensed pharmacist in a licensed pharmacy or a licensed physician authorized by state law to prescribe drugs
Traditional compounding
compounding a sterile or nonsterile drug for a specific patient based on a prescription
Is it lawful to compound in anticipation of receiving prescriptions?
Yes, but only in limited quantities, Can only be dispensed with a valid prescription
Which USP chapters must compounds comply with?
USP 795: non-sterile
USP 797: sterile
USP 800: hazardous drugs
Is it lawful to use a bulk substance to compound?
Yes, if it complies with the standards of an applicable USP or NF monograph, if a monograph exists
What is the 503A Bulks List
a list being developed by the FDA that lists acceptable bulk drug substances which do not fall into the USP or NF monograph
What are outsourcing facilities?
facility that compounds sterile drugs (can also compound non-sterile drugs); registration is voluntary
What are outsourcing facilities allowed to do?
manufacture and send interstate shipments of larger quantities of compounded drugs without prescriptions being issued
Are outsourcing facilities required to be a licensed pharmacy?
no, but they must be under the direct supervision of a licensed pharmacist
Can outsourcing facilities use bulk drugs to compound?
yes, if the drug appears on a list published by the FDA OR the drug compounded from the bulk appears on the FDA drug shortage list
Manufacturers of bulk substances used to compound must be registered with who?
the FDA. They must send a valid certificate of analysis with each bulk drug substance
All ingredients used to compound must comply with what?
USP/NF standards
Is it legal to compound a copy of a commercially available drug?
Depends; cannot compound copies of commercial drug product regularly or in inordinate amounts
Can pharmacies compound “for office use only”
no, it’s illegal
If you want to compound medications without a prescription, you must register as what?
an outsourcing facility
Do hospitals need to register as outsourcing facilities?
No
Title II: Drug Supply Chain Security Act
places unique product identifiers on individual drug packages and provide product and transaction information at each sale with lot level info, in paper, or electronic format
What is the main goal of the Drug Chain Security Act
employ a track and trace program for prescription drugs only
3 T’s of product tracing info
transaction history, transaction information, transaction statements
How long must transaction records be maintained?
6 years
Can a dispenser accept drugs from a trading partner who does not provide the transaction history?
no
When is it appropriate for a dispenser to not provide any tracing information?
when the transfer is for a specific patient’s prescription, product returns, or intracompany distributions
Which drug class did the FDA first issue regulations for providing patient package inserts?
oral contraceptive drugs
What do patient package inserts require?
drug use, risks, and precautions
Who’s duty is it to supply package inserts to patients?
the manufacturer and the pharmacist
Are hospital pharmacies required to give patient package inserts?
Yes, the law still applies to hospital and inpatient settings
How often are community pharmacies required to give patient package inserts?
each time the patient recieves their medication
How often are institutional pharmacies required to give patient package inserts?
each time a medication is given; or with the first dose and every 30 days after
What is Consumer Medication Information?
the drug leaflets/patient information materials provided with prescriptions dispensed by pharmacies
What are MedGuides
patient information material for drugs posing a serious and significant concern to public health
Who is responsible to dispense medguides?
the manufacturer and the pharmacist
beyond-use date
the date after which a drug should not be used
USP rules on beyond-use dates
the dispenser (pharmacy) shall place on the label of the prescription container a suitable BUD
What is the expiration date on dispensed drugs?
1 year from the date dispensed or the expiration date from the manufacturer, whichever is first
Is off-labe prescribing legal?
yes under the FDCA
