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56 Cards in this Set

  • Front
  • Back
it prohibits the distribution or sale of adulterated or misbranded foods and drugs.

When was it enacted?
Food, Drug, and Cosmetic Act(FDCA) - 1906
This legislation oversees the marketing of all new drugs.
Food, Drug, and Cosmetic Act(FDCA) - 1906
the presence of any decomposed substance, packaging under unsanitary conditions, or if the product's strength, quality, or purity is different from what is indicated on the label.
false or misleading labeling or when proper warnings and directions are absent.
Must be filed to prove effcacy and safety before any drug is available commercially.
New Drug Application (NDA)
An amendment to the Food, Drug, and Cosmetic Act(FDCA) separating drugs into 2 categories:
Legend & Non-legend drugs
Durham-Humphrey Amendment (1951)
The following info must appear on the label of a drug approved for OTC distribution

D - directions for use
I - Ingredients (active & nonactive)
M - Manufacturer name & address

C - net contents
H - habit forming drugs in product
o - omit
W - warnings & cautions
N - name of product
amendment to FDCA that standardized labeling requirements for the manufacturer and dispenser to the patients.

In what year was in established?
Kefauver-Harris Amendment (1962)
regulates proper drug advertising and package inserts issued by the manufacturer.
Kefauver-Harris Amendment (1962)
Manufacturers must register annually, be inspected at least once every 2 yrs and must report any drug reactions to the agency.
Must also follow standard investigational procedures for drug testing.
Kefauver-Harris Amendment (1962)
GMP were established with this legislation
Kefauver-Harris Amendment (1962)
THIS FEDERAL LAW WAS ENACTED TO TRY AND REDUCE ACCIDENTAL POISONINGS IN CHILDREN by requiring all pharmacy dispensed meds in child resistant containers.

What year was it established?
Poison Prevention Packaging Act (1970)
Exceptions to the PPPA ( 1970)

E - emergency medications (nitroglycerin)
A - arthritic patients
R - requests written from patient/prescriber
L - labeled as non-child proof on OTC products
contains amendments to the Medicare/Medicaid programs funded by the fed govt.

What year?
OBRA - Omnibus Budget Reconciliation Act (1990)
This act requires that only drugs that are approved as safe and effective will be reimbursed
OBRA (1990)
This act requires that pharmacists must provide consulting services when dispensing medications.
OBRA (1990)
Federal lesiglation regulating the use and distribution of drugs and other substances of abuse.

Year enacted?
CSA - Controlled Substance Act (1970)
Agency of the US Dept. of Justice and is responsible w/ the FDA for administering the provisions of the CSA.
DEA - Drug Enforcement Agency
Following activities requires registration w/ the DEA

C - compounding CS's
R - research & activities w/ CS's
I - Importing CS's
M - manufacturing, distributing, & dispensing CS's
E - Exporting CS's
N - Narcotic treatment programs
Congress established 5 schedules of CS's based on
abuse potential (mental & phsyical)

accepted medical use
Which schedule of drugs has high potential for abuse?
Schedule I
Which schedule of drugs have low potential for abuse?
Schedule V
To secure (purchase or transfer) a supply of schedule I or II substances, a registrant must complete
DEA Form 222 triplicate order form
Who is permitted to sign the order forms?
Only the person who signed the app for registration w/ the DEA
In 1990, anabolic steroids were added to which schedule?
Schedule III
any drug or hormonal substance, chemically and pharmacologically related to testosterone that promotes muscle growth.
anabolic steroids
Why do some states sell controlled substances OTC?
They contain small amount of CS's (primarily C-V) and the FDA feels that a prescription is not required.
Which states require prescription for CV Substances?
Colorado and New York
guidelines for sale of CV's
- sale made by pharmacist
- 18yrs + identification
- no more than 8 ounces (48 dosage units) in 48 hours for opium containing substances

no more than 4 ounces (24 dosage units) for any other controlled substance in any 48 hr period may be dispensed.
The pharmacist must maintain record of all such noprescription sales (ex: CV's) in a bound book that contains:

-name and address of purchaser
-name and quantity of controlled substance
-date of purchase
-initials of dispenser
Fed regulations provide for 3 methods for filing prescriptions
3 sep
-all others

2 sep
-CII-CV; CIII-CV must have red "C" lower left
-all others

2 sep
-CII only
-CIII-CV(must have red "C" stamp lower left) + all others
Requires that each pharmacy registrant make a complete and accurate inventory of all controlled substances every 2 yrs.
Controlled Substance Act (CSA)
How many months may the biennial inventory be delayed past the biennial date (May 1)
6 months
Second letter of the DEA # corresponds to what?
Prescribers last name
Two Limitations of pharmacy technicians
1) recieve oral prescriptions
2) excercise professional judgement
If a patient needs additional medication for a CII drug what must happen?
A new prescription must be issued by the prescriber
3 safety considerations all pharmacies must have

- number of poision control center in dispensing area

- reference guide to toxicities of ingestion or topical exposure

-MSDS sheets for hazardous materials
How many years must a poison log be kept?
5 years
What must a poison log include after a sale?

- Date of purchase
-Name and address of purchaser
-name and quantity of product
-reason for purchase
-full name of dispenser
All poisonous substances labels must include:
- the complete name of poison
-the word POISON boldly printed
- place of business of the seller
- directions for use
What 2 things should every pharmacy be stocked with for safety when a toxin is ingested
One once bottles of syrup of Ipecac

Activated Charcoal
Should be used to induce vomitting (emesis) for noncaustic substances only.
Syrup of Ipecac
How can you dilute the caustic effects of an ingested toxin?
Milk or any other suitable substance
What is the dose of syrup of ipecac and how often should it be taken if vomiting hasn't occurred?
15ml (1 tbsp)

every 10-15mins
Where exposure to the product is not likely to cause adverse health hazard.
Class III drug recall
Where exposure to the product will cause a severe health hazard or death.
Class 1 Drug recall
ensures a safe and healthful workplace for all employees
Occupational and Safety Act of 1970
The Occupational Safety and Health Admin was created to
- develop job safety standards
- report job related injuries/illnesses
- decrease hazards
- enforce mandatory standards
Standards that relate to pharmacy practice
- Air contaminants
- Flammable liquids
- Eye and Skin protection
- Hazard Communication Standard (HCS)
Each repackaged drug must contain a label with the following:

-generic name
-dosage form
-manufacturer name + lot #
-expiration date after repackaging
A repackaging log must include
- date of prepacking
-name of drug
-manufacturers name
-manufacturers expiration date + lot #
- quantity of drug repackaged
-sig of pharmacist
Lists all sources of drug products grouped as pharmaceutical equivalents
Orange Book
Orange Book
Drug products with this first letter code are considered therapeutic equivalents
Orange Book
Drugs products w/ this letter code indicate that the products have a documented therapeutic in-equivalence
federal agency part of Dept of health and human resources which sets national standards for disease control and prevention.
CDC (Center for Disease Control)
Provides statistics and info to health professionals on the treatment of common and rare diseases. Primary function is to issue regulations for infection control.
CDC (Center for Disease Control)