chapter 1: FDCA PPPA other Flashcards
Which year was the federal food drug and cosmetic act
1938
What major amendment and what year of FDCA
Durham-Humphrey amendments of 1951
Kefauver- Harris- 1962
RX drug marketing act- 1987
drug quality and security act- 2013
- drug compounding quality act
- drug supply chain security act
Durham-Humphrey amendments of 1951
established RX vs OTC
verbal rx and refills
kefauver-Harris amendments of 1962
required new drugs to be proven safe and effective for use
increased safety requirements with GMPs for manufacturing
gave fda jurisdiction over rx drug advertising
prescription drug marketing act 1987
bans the reimportation of RX and insulin produced in the US except by the manufacturer
bans the sale, trade or purchase of Rx drug samples
mandates the storage, handling and record keeping requirements for rx drug samples
prohibits resale of Rx purchased by hospitals or healthcare facilities with some exceptions since they get lower prices
- pharmacies owned by nonprofit or by city state or county can provide samples at reduced or no cost
drug quality and security act DQSA of 2013
large scale. compounding
uniform track and trace system for rx through the suply chain
DQSA-1: DCQA drug compounding quality act
maintains 503A
- 503A can only compound products for individuals - USP 797
- limited distribution of compounded products to 5% of total drug dispensed unless MOU- memorandum of understanding
- a pharmacy is considered to have distributed >50% of compounded product out of state and dispensed- MOU is required*
established 503B- facilities that compound sterile products not patient specific to register as an outsourcing facility
- outsourcing facilities are exempt form new drug provisions (505)
- exempt from adequate directions for use (502f1)
- exempt from drug track and trace provisions (582)
503B is primarily regulated by the FDA and are subject to cGMPs
- requires a licensed rph
- register as outsourcing facility
- report to the health and human services upon registering and every six months and keep records for 6 months before
- be inspected by FDA and pay annual fees
- report serious adverse event within 15 days and conduct a followup investigation
- label products as “compounded
- can only use a bulk drug product that is found in the bulk drug list or is in shortage from the FDA bulk drug list or FDA drug shortage list
DQSA2- DSCSA- drug supply chain security act
- rack and trace
- national framework for electronic track and trace system for RX
- for all rx except blood , radioactive/imaging, IV for fluid replacement, dialysis solution, medical gases, compounded drugs , certain combination products, sterile water and irrigation - manufactures to provide transaction data for each product sold which goes to the wholesaler who are required to receive and provide that to the buyer
- pharmacies are required to to receive and provide if they further distribute it ( if distributing need a distribution license) - pharmacies can only receive dugs with product identifiers but no need to authorize it (an SNI with lot number and expiration)
- pharmacies must handle suspect or illegal product- not enforced until 2023
- suspect products - counterfeit, stolen, fraud, adulterated or unfit for distribution
- illegitamate products - same as suspected with credible evidence
- must analyze 3 products or 10% of the products if suspected
- must notify sith form 3911 and trading partners within 24 hours
transaction data from DSCSA
transaction information
- product name strength adn dosage form
- ndc number container size and number of containers
- date of transaction name and address for both parties
- SNI- serialiezed numerical identifier
Transaction history
- prior transaction information of each prior transaction back to the manufacturer
transaction statement
- statement that the seller is authorized and. recieved form an authorized person, recieved both TI and TH and did not knowingly ship an illegal product or false TI
distribution exemptions
- distribution is under common ownership
- dispenser is providing product to another dispenser on a patient specific basis (think of randon mill)
3 dispenser is distributing under emmergency medical reasons - minimal quantities to a licensed practioner for office use
Prohibited under the FDCA
adulteration
misbranding
adulterations
filthy, putrid decomposed substance, poinous , unsanitary
- contamination
- did not follow CGMP- if manufacture refused to permit entry or inspection
- unsafe color additives
- strength differs from the label or strength is below the USP (can be misbranded too)
misbranding
- labeling is false or misleading
- manufactures label fails to contain- name, address of the packer distributor,
- - brand and generic missing, also missing the net quality, “RX only”
- specific routs of administration, storage information, lot number and expiration date
- adequate information for use PPI BBW to alert health care professionals
ALL these for manufature’s container
OTC must have adquate diterections for use and RX should have adequate information PPI
-3. OTC which fails to display:
- a principlal display anel, statement of identity
- name and address of the manufacture , packaging and distributor
- net quantity of contents
- caution and warnings for safe and effective use
- it is a drug liable for deterioration unless packaged or labeled accordingly
- container is made, formed or filled to be misleading
- drug is the exact imitation of another drug
- dangerous to health
format for OTC product labeling under “drug facts”
active ingredients purpose use- indications warnings directions other information inactive ingredients (in alphabetical order) questions followed by telephone number
adulterataion and misbranding
dispensing a rx without authorization is misbranding
- misfilling a rx with wrong drug, stregth, or direction is misbranding
- additionally wrong sttrength would mean adultered
- if it is rems and it dooes not meet rems than also misbranding
- advertising of drug that is false or misleading can be misbranding
- expired drug product is adulterated, if dispensed it can be misbranded
- counting on a tray with residue from other medication can cause the new product to be adulterated
- if temp is not controlled is adulterated
- if it is not dispensed in a child resistant container when required this would be misbranded
