Food, Drug, and Cosmetic Act of 1938
Due to sulfanilamide elixir deaths
New drugs must be SAFE before marketing
Established the
... [Show More] FDA
Durham-Humphrey Amendment of 1951
Created OTC vs. Legend drugs
Verbal prescriptions
Prescription refills
Kefauver-Harris Amendment of 1962
"Drug Efficacy Amendment"
New drugs must be SAFE and EFFICACIOUS
Established GMPs
FDA oversees prescription drug advertising
Prescription Drug Marketing Act of 1987
Prevents re-importation of a drug into US
Prohibited hospital and healthcare entities from reselling their pharmaceuticals
Bans sale, trade, or purchase of prescription drug samples
Storage, handling, and record-keeping requirements for prescription drug samples
Prohibits re-sale of prescription drugs purchased from hospitals or healthcare facilities
Drug Compounding Quality Act
Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility (503B)
These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions
What is a 503A pharmacy?
traditional pharmacy that compounds for specific patients pursuant to prescriptions (no cGMP required)
***Follow USP 797**
What are requirements for outsourcing facilities?
Have a licensed pharmacist
Register as an outsourcing facility
Report to the Secretary of HHS on registering and every 6 months
Be inspected by the FDA
Report serious adverse events within 15 days
Label products with identifying statement as compounded products
Only compound drugs that have a clinical need a and/or on shortage
Drug Supply Chain Security Act (DSCSA)
"Track and Trace Amendment"
FDA Form 3911
Track and trace form to report illegitimate products to the FDA
**Must also notify trading partners within 24 hours**
What license must pharmacies that are "distributing" have?
Wholesale distribution license
What is adulteration?
- filthy, putrid, decomposed substance
- prepped or stored in unsanitary conditions
- does not meet gmp's
- includes unapproved color additive
-contains drug recognized in or not official compendia, but its strength, purity, or quality is lower than the official standards
- container can leach into product
- substituted active ingredient
What is misbranding?
Label is defaced or misleading
Labeling is missing any of the required information
What information must be on a prescription drug's manufacturer's labeling?
Name and address of manufacturer
Brand and/or generic of drug
Net quantity (units, weight, etc.)
Weight of active ingredients per dose
Federal "Rx Only" for legend drugs
Route of administration (unless taken orally)
Any special storage requirements
Expiration date
Adequate info/directions for use
What information must be on a OTC drug's manufacturer's labeling?
Principal display panel with statement of identity of the product
Name and address of manufacturer
Net quantity
Cautions and warnings for the user
Adequate directions for safe and effective use
Drug Facts panel
What is required on the Drug Facts Panel on OTC drugs?
Active ingredients
Purpose
Warnings
Directions
Any other necessary information
Inactive ingredients (alphabetical order)
Questions? (Optional) w/ telephone number
FD&C Yellow No. 5 (tartrazine) warning statement
"precautions" for allergic reactions in susceptible persons
Aspartame warning statement
"Phenylketonurics: Contains phenylalanine ___ mg per dosage unit"
Sulfites warning statement
Must state that preservatives are used
Mineral Oil warning statement
Any more than 5% methyl salicylate must include warning that it can be deadly to children and must be kept out of reach of children
Sodium phosphates warning statement
Limits the amount of sodium phosphate oral solution to not more than 90 mL per OTC container.
Ipecac warning statement
BOXED AND IN RED LETTERS
"For emergency use to cause vomiting in poisoning. Before using, call physician, the poison prevention center, or hospital ER for emergency advice"
"Warning: Keep out of reach of children. Do not use in unconscious persons"
Dosage must appear (15 mL) in persons above 1 year
May only be sold in 30 mL containers
Phenacetin warning statement
Possible kidney damage when taken in large amounts for long periods of time
Salicylates warning statement
Reye's syndrome in pediatric patients
OTC Drugs for Minor Sore Throat warning statement
"For temporary relief of minor sore throat"
"Warning- Severe or persistent sore throat or sore throat accompanied by fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under the age of 3 unless directed by a physician"
Alcohol warning statement on medications
Used on NSAIDs and other internal analgesics/pyretics
Warning for drinking more than 3 alcoholic beverages a day
OTC spermicides with nonoxynol 9 and vaginal contraceptive warning statement
"STD Alert: This product does not protect against HIV/AIDS or other STDs and may increase risk of getting HIV from an infected partner"
Acetaminophen warning statement
Must have "Acetaminophen" displayed prominantly
Warn about liver toxicity
Must warn to not use with other APAP combo products and/or Warfarin
NSAIDs warning statement
Must include "NSAID" prominently on label
Warn of "stomach bleeding"
OTC Products Containing Iron in Solid Oral Dosage Form warning statement
- Accidental overdose in children <6, keep out of reach of children
- Warning also applies to iron-containing dietary supplements
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Class I FDA recall
Reasonable probability will cause serious AE or death
Class II FDA recall
Temporary or medically reversible adverse health problem, or there is a remote chance that the device will cause serious health problems
Class III FDA recall
Not likely to cause adverse health consequences
OTC advertising is regulated by...
Federal Trade Commission (FTC)
Florida law prohibits pharmacies from advertising the sale of...
Controlled Substances
Patient Package Insert (PPI)
Manufacturer's patient product information included with the product package
Indicated for a layperson
Required for OC's and estrogen containing products
Hospitalized pts= PPI on first admin and every 30 days
Failure to give a PPI = Misbranded
Which drugs currently require a PPI?
Oral contraceptives
Estrogen containing products
What is a medguide?
Addresses issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
What is REMS?
Risk Evaluation and Mitigation Strategy
Helps to manage a known or potential serious risk associated with a drug or biological product
Days supply limit for drugs dispensed by a practitioner from an Emergency Room?
24 hour supply or minimal dispensing quantity
Days supply limit for an emergency verbal schedule II prescription
72 hour supply
Days supply for an emergency refill (Not Governor-declared emergency)
72 hour supply
Days supply for schedule II opioids for acute pain
3 day supply
Days supply for drugs dispensed by a hospital under a Special Limited Community pharmacy permit
3 day supply [Show Less]