TEXAS LAW QUESTIONS AND ANSWERS
How many filing systems? - Answers :1 for tx
How long to keep all records? - Answers :Minimum 2 yrs
How long to keep CE record? - Answers :3 years
Pure food and drug act - Answers :Purity standards only, no efficacy
Federal food, drug, and cosmetic act - Answers :Safety standards only, no efficacy
Durham-Humphrey Amendments - Answers :Created OTC and prescription categories
Kefauver-Harris Amendment - Answers :EFFICACY requirements
Drug price competition and patent restoration act - Answers :Patent holders received 5
years of patent life
FDA modernization act - Answers :Requires "rx only" on prescription legend
Adultered - Answers :Refers to actual makeup or composition of drug
Clean, not contaminated, and within 5% strength, no unsafe additive
Misbranded - Answers :Refers to drug labeling
If labeling false or misleading
Filled without prescription
Counterfeit drug
Packaging does not meet required standards
Manufacturers labeling requirements - Answers :Name/address of manufacturer
Quantity
Generic and brand name(if applicable)
Strength
Information for use
Warnings against use
Expiration date
Class A Pharmacy - Answers :Community
Class B Pharmacy - Answers :Nuclear
Class C Pharmacy - Answers :Institutional/hospital
Class D Pharmacy - Answers :Clinic
, Class E Pharmacy - Answers :Non-resident
OTC label requirements - Answers :Adequate DIRECTIONS for use! (Rx is adequate
INFO)
Name of product
Name/address manufacturer/packer/distributor
Quantity
Cautions and warnings
Drug facts
Drug facts must contain: - Answers :Active ingredients
Purpose
Uses-indications
Warnings
Directions
Other info
Inactive ingredients
Optional- number for questions
OTC written as rx - Answers :Must be filled as rx but pharmacist can sell OTC if they
feel in best interest of pt
IF higher dose than OTC limits then must be filled as rx
Who recalls drugs? - Answers :Manufacturer
Not FDA!
Class I Recall - Answers :Reasonable probability exposure will cause serious adverse
effects or death
Class II Recall - Answers :May cause temporary or medically reversible adverse fx
Class III Recall - Answers :Not likely to cause adverse health fx
Advertising regulated by: - Answers :RX by FDA
OTC by FTC
Plan B Rules - Answers :OTC for consumers(M/F) 17 and up
Rx only for 16 and younger
Only sell in stores staffed by license RPH
Schedule III - Answers :Products containing not more than 90 mg codeine per dosage
unit
Products to tx opioid addiction-buprenorphine(Suboxone and Subutex)
Benzphetamine (Didrex)
Phendimetrazine
Ketamine
How many filing systems? - Answers :1 for tx
How long to keep all records? - Answers :Minimum 2 yrs
How long to keep CE record? - Answers :3 years
Pure food and drug act - Answers :Purity standards only, no efficacy
Federal food, drug, and cosmetic act - Answers :Safety standards only, no efficacy
Durham-Humphrey Amendments - Answers :Created OTC and prescription categories
Kefauver-Harris Amendment - Answers :EFFICACY requirements
Drug price competition and patent restoration act - Answers :Patent holders received 5
years of patent life
FDA modernization act - Answers :Requires "rx only" on prescription legend
Adultered - Answers :Refers to actual makeup or composition of drug
Clean, not contaminated, and within 5% strength, no unsafe additive
Misbranded - Answers :Refers to drug labeling
If labeling false or misleading
Filled without prescription
Counterfeit drug
Packaging does not meet required standards
Manufacturers labeling requirements - Answers :Name/address of manufacturer
Quantity
Generic and brand name(if applicable)
Strength
Information for use
Warnings against use
Expiration date
Class A Pharmacy - Answers :Community
Class B Pharmacy - Answers :Nuclear
Class C Pharmacy - Answers :Institutional/hospital
Class D Pharmacy - Answers :Clinic
, Class E Pharmacy - Answers :Non-resident
OTC label requirements - Answers :Adequate DIRECTIONS for use! (Rx is adequate
INFO)
Name of product
Name/address manufacturer/packer/distributor
Quantity
Cautions and warnings
Drug facts
Drug facts must contain: - Answers :Active ingredients
Purpose
Uses-indications
Warnings
Directions
Other info
Inactive ingredients
Optional- number for questions
OTC written as rx - Answers :Must be filled as rx but pharmacist can sell OTC if they
feel in best interest of pt
IF higher dose than OTC limits then must be filled as rx
Who recalls drugs? - Answers :Manufacturer
Not FDA!
Class I Recall - Answers :Reasonable probability exposure will cause serious adverse
effects or death
Class II Recall - Answers :May cause temporary or medically reversible adverse fx
Class III Recall - Answers :Not likely to cause adverse health fx
Advertising regulated by: - Answers :RX by FDA
OTC by FTC
Plan B Rules - Answers :OTC for consumers(M/F) 17 and up
Rx only for 16 and younger
Only sell in stores staffed by license RPH
Schedule III - Answers :Products containing not more than 90 mg codeine per dosage
unit
Products to tx opioid addiction-buprenorphine(Suboxone and Subutex)
Benzphetamine (Didrex)
Phendimetrazine
Ketamine
