Federal Food Drug Cosmetic Act, Poison Prevention Act, Other Misc Federal Laws Flashcards
Federal Food Drug and Cosmetic Act (1938)
Why was is established?
What did it do?
Why - Sulfanilamide elixir caused deaths in 1938.
What - Established the FDA, required new drugs to be proven safe before marketing.
** Know Pharmaceuticals that require a prescription**
Kefauver Harris Amendment (1962)
What did it do?
What did it establish? (2)
Required new drugs to be proven safe & effective,
Established GMP
Gave FDA Jurisdiction over advertising of drugs.
Prescription Drug Market Act (1987) – PDMA
What did it do? (3)
Banned re-importation of prescription drugs/insulins except by manufacturer
Banned the sale, trade, or purchase of prescription drug samples
Mandates storage, record keeping, handling of samples.
TSBP Rules on Drug Samples?
Consistent with federal laws.
Exception: Pharmacies owned by charitable organizations, city, state, or county gov’t and are part of a healthcare entity providing care to indigent or low income patients at no or reduced cost may provide samples at no charge to patients.
Drug Quality & Security Act (2013) - DCQA
Amendments to FDCA – Two topics addressed
Large Scale compounding: Allows facilities compounding sterile pharmaceuticals to register as an “outsourcing facility”
Establishment of uniform trace and trace system throughout the supply chain
What are 503B facilities?
Outsourcing Facilities: They are permitted to compound sterile products w/o receiving patient specific Rx’s. Primarily regulated through the FDA and subject to CGMP.
What are 503A facilities?
Compounding pharmacies not registered with the FDA as an outsourcing facility - can only compound pursuant to an Rx/order. May do limited anticipatory compounding per state regs and are subject to 797 quality standards.
Drug Supply Chain Security Act (DSCSA)
“Track and Trace”
Uniform national framework to electronically track & trace prescriptions drug movements through supply chain.
Applies to Rx drugs used for humans in finished dosage forms but exempt blood, blood components, radiopharmaceuticals, gases, compounds, sterile water, ect.
DSCSA Requires?
Transaction data passed along b/t parties for each product sold.
Transaction Data Includes?
Product
Name Strength Dosage Form NDC Container Size # of containers Date of transaction name & address of tranferer name & address of recipient Unique serialized numerical identifier (SNI)
Transaction History (DSCSA)
Paper or electronic statement including prior transaction information for each sale back to manufacturer.
Transaction Statement (DSCSA)
Paper or electronic statement by seller that the seller is authorized to receive the product between two licenses individuals.
Suspect Products (DSCSA)
Products that one has reason to believe are counterfeit, diverted, stolen, purposefully adulterated.
Illegitimate Products (DSCSA)
Products which credible evidence shows is counterfeit, diverted, stolen, subject to fraud, or intentionally adulterated.
What must a pharmacy do if a product is illigitimate?
Must notify FDA using a “Form FDA 3911” and notify trading partners within 24 hours
Distributing Pharmacies
What must they have/do? What are the exceptions?
Must have a wholesale distribution license and mass DSCSA transaction data with distribution.
Exceptions:
- Distribution between two entities under common ownership.
- Dispenser is providing product to another dispenser on a patient-specific basis
- Distributing under-emergency for medical reasons.
- Distributing “minimal quantities” to a licensed practitioner.
Prohibited Acts under FDCA - Key focuses?
Adulteration & Misbranding
Adulteration
- Any drug that is filthy, putrid, or decomposed.
- Prepared in unsanitary conditions,
- Methods of manufacturing don’t conform to CGMPs.
- Container is composed of a poisonous substance which may contaminate the drug.
- Addition of an unsafe color additive
- Represented as a drug in the Official Compendium, but it’s strength differs or quality falls below the Compendium standard (unless clearly marked on label)
- It is not in a compendium.
- Mixed or packed with any substance that degrades quality/purity.
Misbranding
- Labeling is false or misleading
This is for a manufacturers container.... Label fails to contain the following: - Name & Address of manufacturer, packer, distributor - Brand and/or generic name - Net quantity - Weight of active ingredient per dose - "Rx Only" - Specific route of administration - Special storage instructions - Lot # (Control #) - Expiration Date - Package Insert/Med Guide (info for use)
