Prescription Regulations

Acts of Legislation

100

As a result from the sulfanilamide disaster, this Act brought rise to the FDA and required that manufacturers prove a drug is safe for human consumption

Food, Drug and Cosmetic Act

200

Written in response to the Thalidomide scare, this act of legislation required that drugs be effective for what they are being marketed for

Kefauver Harris Amendment

300

This acts purpose was to prevent and reduce the amount of childhood poisoning  by mandating the use of child safety caps for most drugs

Poison Prevention Packaging Act

400

This Act mandated that a pharmacist must perform a drug utilization review and offer counseling to patients (dosage, refill info, adverse rxns, etc)

Omnibus Budget Reconciliation Act (OBRA 90)

500

This act gave rise to the DEA and regulated the manufacture and sale of narcotics

Controlled Substance Act

Regulatory Agencies

100

This agency is responsible for ensuring safety and efficacy of food and drugs on the market

Food and Drug Administration (FDA)

200

Ensures safety and health of US workers 

Occupational Safety and Health Administration (OSHA)

300

This agency enforces laws regarding legal and illegal addictive substances.

Drug Enforcement Agency (DEA)

400

Sets standards for drug manufacturing and compounding 

United States Pharmacopeial Convention (USP)

500

This agency reviews applications for licensure and inspects all new pharmacies in the state.

State Board of Pharmacy (SBOP)

Controlled Substances

100

This schedule of controlled substances has the highest potential for abuse

Schedule 1

200

This form is used to order C2 Narcotics

DEA form 222

300

This schedule of drugs has a *moderate* potential for abuse and can be refilled 5 times within 6 months from date written

Schedule 3

400

The form is used to dispense C2 controlled substances  

DEA form 224

500

When federal and state law differs, what should you do?

Follow the more strict laws of the two

Drug Safety

100

Child resistant caps must not be able to be opened by this percentage of children under 5

80%

200

This class of recall results when there is a reasonable probability that the use of a product will result in serious adverse health consequences or death

Class 1 Recall

300

Toxilogical studies are done on animals while ______ are done on humans

Clinical trials

400

If a party wants to manufacture or dispense narcotics, they must register with this agency 

DEA

500

This class of drugs must be taken with food to avoid stomach pain

NSAIDs

Pharmacy Knowledge

100

What is the first step when you are notified of a drug recall

Check if item is in stock

200

A unique 10-11 digit identification number  assigned to all drugs

National Drug Code (NDC)

300

In generic drugs, the active ingredients found in the bloodstream must be +/- __?__% of what you would find in the bloodstream after taking the brand name drug

+/- 5%

400

True or False: Legend drugs require the wording "Caution: Federal Law Prohibits Dispensing Without A Prescription"

True

500

The ______ is legally required to check every prescription before it is dispensed to a patient.

Pharmacist