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)
A drug has a strength that is less than what is represented on the label. What is this?
Misbranding AND Adulteration
Misbranding is…
Labeling is false or misleading
What must a Rx Drug Manufacturer container label have to not be considered misbranded?
Name, Address of Manu./Packer/Distributor Brand & Generic Name Net Quantity Weight of active ingredient "Rx Only" If not oral the route of administration Special storage instructions Lot # Expiration Date Adequate information for use (IE: Package insert)
What must an OTC drug manufacturer label have to not be considered misbranding?
Statement of ingredients
Name, Address of Manu/Packer/Distributor
Net quantity of contents
Cautions & warnings to protect user
Adequate directions for safe/effective use
Content & Format of "Drug Facts" label.
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions #
Storage requirements including medications liable for deteriorationWhat are OTC violations that lead to misbranding?
Misleading market label
Imitation of a drug that it is not
Dangerous to health in displayed uses
Packaged in violation to Poison Prevention Packaging act
Special Warning Requirements: FD&C Yellow No. 5 (tartrazine)
Must disclose presence in precautions - may cause allergic reactions
Special Warning Requirements: Aspartame
Must include “Phenylketonurics: Contains phenylalanine ___ mg per ____ dose unit.
Special Warning Requirements: Sulfites
Must contain allergy warning
Special Warning Requirements: Mineral Oil
“Not to be used in infants”
“Only to be taken at bedtime”
Cannot encourage during pregnancy
Special Warning Requirements: Wintergreen Oil
“Use other than directed may be dangerous”
“Keep out of reach of children”
Special Warning Requirements: Sodium Phosphates
Limits to amount of sodium phosphate oral solution to no more than 90 ml per container.
Special Warning Requirements: Isoproterenol Inhalation Preparations
“Do not exceed prescribed dose”
“Contact physician is difficulty breathing persist”
Special Warning Requirements: Potassium Salt Preps for Oral Ingestion
Nonspecific small bowel stenosis with or w/o ulceration associated with administration
Special Warning Requirements: Ipecac Syrup (4**)
“For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice.”
“Warning: Keep out of reach of children. Do not use on unconscious persons.”
Dosage of medication must appear (15ml) >1 yo
May only be sold in 1 oz (30ml) containers
Special Warning Requirements: Phenacetin
“Possible kidney damage when taken in large amounts over a long period of time”
Special Warning Requirements: Salicylates
Use in children - Reye’s syndrome.
Cannot sell retail children ASA (1 1/4 grain) in >36 tablets.
Special Warning Requirements: Alcohol Warning
Internal analgesics (NSAIDS & APAP) are require to have a warning for persons consuming >3 alcoholic beverages per day.
Special Warning Requirements: OTC Pain Relievers (APAP)
Must have “Acetaminophen” prominently displayed
Warning on liver toxicity
“Do not use with other products containing APAP”
Special Warning Requirements: OTC Pain Relievers (NSAID)
Must have “NSAID” displayed prominently on the label.
“Stomach bleeding” warning
OTC Packaging Warning Requirements
OTC’s must be packaged in tamper proof packaging
- RPH’s repacking OTC’s are subject to GMP requirements INCLUDING tamper proof packaging.
If an OTC is sold as prescription do labeling requirements apply?
No
FDA Drug & Device Recall Classifications
Class 1 - Reasonable probability usage will cause serious adverse effects on health or death
Class 2 - Temporarily or medically reversible adverse effects. Probability of serious adverse effects is remote.
Class 3 - Not likely to cause adverse effects.
Does the FDA have the authority to recall medications
Technically no except for controls, foods, medical devices. However most manufacturers will comply with request because the FDA can take actions such as seizing product.
Who regulates Rx Drug Advertising
FDA
Who regulates OTC Drug Advertising
FTC
Advertising around Rx Drug Prices
Considered “reminder advertising” - is exempt from normal advertising as long as…
- Only purpose is to provide information on the price
- Contains proprietary and generic name of drug, strength, dosage form, price charged for a qty.
- May include availability of professional
- Price includes all charges to the customer.
Patient Package Inserts (PPI) are supplied by who?
Manufacturer and required to be given to pt when dispensed
Medications that require a Patient Package Insert (PPI)
Oral Contraceptives
Estrogens
Patient Package Insert requires for a hospital
Must be given with 1st dosage and every 30 days thereafter
Failure to give a patient a Patient Package Insert is….
Misbranding
