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Pharmacy Laws

Laws and Amendments

Which law made label requirements for OTC products? FDA-Food, Drug, and Cosmetic Act
When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before becoming commercially available. NDA- New Drug Application
product contains decomposed substance adulterated
the label may be false or misleading mis-branding
The Durham-Humphrey Amendment is also called the prescription drug amendment
proper warning and directions are absent mis-branding
manufacturer name and place of business absent mis-branding
stock label fails to say "warning-may be habit forming" if med is habit forming mis-branding
product has been packaged under unsanitary conditions adulterated
product has different strength or purity than whats indicated on label adulterated
What is the amendment that requires manufacturers to dispense medications with labels to the patient? Kefauver-Harris Amendment
What are requirements for manufacturers as outlined by the Kefauver-Harris Amendment? 1. requires manufacturers to register annually 2. be inspected every 2 years 3. report any drug interactions
requires all medication on the U.S market to be pure, safe, and effective Kefauver-Harris Amendment
PPI's are regulated by the FDA. What are these? Patient Package Inserts
PPI's MUST be supplied to patients receiving what medications? oral contraceptives estrogen progestin isotetinoin (accutane) intrauterine devices ( IUD's) inhalers
Information on the PPI MUST include: product description indications for use contraindications (when/ and what it interacts with) warnings (extreme side-effects) precautions (less sever side-effects) Dose (how much and how often)
The Occupational and Safety Act of 1970 gave rise to OSHA- Occupational Safety and Health Administration
What does OSHA do? ensures job safety and an injury reporting system for job related injuries or illnesses
OSHA requires the pharmacy to post the number to poison control have a reference guide for toxicities must have Material Safety Data Sheets (MSDS) for any "hazardous materials" in pharmacy
The Poison Prevention Packaging Act was enacted to reduce accidental poisonings in children
The Poison Prevention Act requires pharmacies to use child resistant containers
Exceptions to the PPA medical emergency meds written requests from DRs or patients
According to the PPA, OTC meds must be labeled "package not child resistant" of the package is not child-resistant.
Examples of medication exempt from the PPA include: nitroglycerin sublingual (for chest pain) betamethasone, mebendazole, methylprednisolone (<85 mg), oral contraceptives, pancrelipase, cholestyramine
A Poison Log must include: date of sale name and address of purchaser name and quantity of poison dispensed full name of dispenser
Poisonous substances must be labeled with: complete name of poison the word "POISON" boldly imprinted on label place of business of the seller proper directions of use
What is Syrup of Ipecac and how much should be ingested? used in the emergency treatment of certain kinds of poisoning 15ml or 1 tablespoon
What does activated Charcoal do? absorbs and eliminates poison in the body (not to be taking with Syrup of Ipecac as this will either not work or make the person vomit)
Who enforces the Controlled Substances Act of 1970? And what do they do? The DEA- regulates use and distributes drugs with high abuse potential and/or addiction into one of the five schedules
Every pharmacy must make a complete inventory of controlled substances every ___ years and kept on record for ___ years. two, two
A DEA number contains how many letter and numbers? Two letters, seven numbers
DEA letters usually start with A, B or M for residents 2nd letter is Drs initial to last name
Is this DEA number valid? Why? BB10066123 Do math and answer.
Can CII medications be refilled? No, new prescription is required with every fill
CIII and CIV scripts cannot be filled more than ___ times in a ____ month period. Five, Six (also CVs)
CII and CIV scripts can be filled verbally with what exception? A written script follows verbal.
CV meds can be dispensed without script is state allows but this must be recorded in the CV log.
Schedule I medications are not accepted for medical use in the U.S lack of accepted safety use under medical supervision, and a high potential for abuse
Some examples of CI meds include: crack heroin lysergic acid (LSD) marijuana peyote methaqualone (Ecstasy)
Schedule II medications have a high potential for abuse which may lead to sever psychological or physical dependence.
Some examples of CII meds include: hydromorphone methadone meperidone oxycodone fentanyl morphine opium codeine hydrocodone
Schedule III medications has a potential for abuse, less than CI and CII. May lead to moderate or low physical dependence or high psychological dependence.
Some examples of CIII meds include: products containing not more than 90 milligrams of codeine per dosage unit --Tylenol 3 & 4, Suboxone
Schedule IV medications low potential for abuse
Some examples of CIV meds include: Xanax, Klonopin, Valium, Ativan, Restoril
Schedule V medications have a low potential for abuse, contain limited quantities of certain narcotics
Some examples of CV meds include: Robitussin AC Phenergan w/ codeine Ezogabine cough preparations containing note more than 200 mg of codeine per 100 ml or per 100 grams
Limitations of Pharmacy Technician duties: -varies by state cannot take verbal scripts cannot give consultations cannot take or transfer prescriptions
Drugs are recalled if it was improperly made or labeled and causes severe adverse reactions
Class I drug recall: exposure will cause extreme health hazards or death
Class II drug recall: exposure may cause temporary health hazards
Class III drug recall: not likely to cause health hazards
OBRA is also known as the Omnibus Reconciliation Act of 1990
The function of OBRA: directed toward pharmacists but require technician assistance improves quality of drug therapy and saves healthcare costs (requires pharmacists to give consultations)
OBRA requires counseling that must include: name and description of medication dosage form, dose, route of administration, and duration of therapy special directions, precautions side effects and ways to prevent techniques for self-monitoring storage refill info action to take if missed dose
Created by: braswell1994



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