Term
| What year were the Durham-Humphrey Amendments passed? |
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Definition
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Term
| What did the Durham-Humphrey act do? |
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Definition
| Established 2 classes of drugs (Legend and OTC), Authorized oral prescriptions and refills |
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Term
| What year were the Kefauver-Harris Amendments passed? |
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Definition
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Term
| What did the Kefauver-Harris Amendment do? |
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Definition
| Required drugs to be proven effective, established good manufacturing practices, required informed consent of research subjects in investigational drug trials |
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Term
| What prompted the Kefauver-Harris Amendments? |
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Definition
| Thalidomide causing birth defects in Europe |
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Term
| What is an Adulterated drug? |
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Definition
| Drug that contains filthy, putrid or decomposed material or held under unsanitary conditions |
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Term
| What is a misbranded drug? |
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Definition
| drugs not containing necessary labeling |
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Term
| Do drug manufacturers have to register with the FDA? |
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Definition
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Term
| Prescription drugs and refills can only be dispensed with a prescription from? |
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Definition
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Term
| Who is responsible for Food, Drug and Cosmetic Act (FDCA) employee violations? |
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Definition
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Term
| What qualifies a drug as misbranded? |
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Definition
| labeling is false or misleading, labeling is inadequate, fails to have required statements prominently displayed and easily understood |
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Term
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Definition
articles recognized in USP, Homeopathic Pharm, or National Formulary
articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals |
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Term
| Items required on a prescription label. |
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Definition
1.Pharmacy name and address
2.Rx number
3.Fill date
4.Prescriber
5.patient
6.Sig
7.Cautionary statements |
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Term
| Rules governing compounding under the FDCA. |
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Definition
1.Regulated by state board
2.prepared for one patient
3.immediate demand
4.advertising of drug is ok
5.exempt from NDA and GMP
6.traditional pharmacy function |
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Term
| Rules governing manufacturing under FDCA. |
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Definition
1.FDA inspected and regulated
2.resale to 3rd parties
3.manufacture for future demand
4.can make inordinate amounts
5.can distribute out of state
6.can sell wholesale |
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Term
| how are Schedule I Drugs defined? |
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Definition
| High potential for abuse, no accepted medical us in the United States. |
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Term
| how are schedule II drugs defined? |
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Definition
High potential for abuse
Have an accepted medical use in the US
Severe physical or psychological dependence potential |
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Term
| What can be changed or added by a pharmacist on schedule II prescription? |
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Definition
1.Dosage form
2.drug strength
3.drug qty
4.directions
5.issue date |
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Term
| What can NOT be changed by a pharmacist on a schedule II prescription? |
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Definition
1.Patient name
2.Substance written for
3.Signature |
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Term
| How are schedule III drugs defined? |
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Definition
1.less potential for abuse then schedule II
2.accepted medical use in US
3.moderate to low physical dependence or HIGH psychological dependence potential |
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Term
| How are schedule IV drugs defined? |
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Definition
1.less potential for abuse then schedule III
2.accepted medical use in US
3.low or limited physical or psychological dependence potential |
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Term
| How are schedule V drugs defined? |
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Definition
1.low potential for abuse
2.accepted medical use
3.extremely low physical or psychological dependence potential |
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Term
| Who must register with the DEA to dispense controlled substances, the pharmacy or the pharmacist? |
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Definition
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Term
| Which entities must register with FDA when dealing with controlled substances? |
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Definition
1.Pharmacies
2.Manufacturers
3.Distributors
4.Prescribers
5.Exporters and Importers
6.Researchers |
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Term
| Are separate registrations required for each pharmacy in a chain? |
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Definition
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Term
| Under what circumstances must the DEA be notified in regards to registration? |
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Definition
1.Change of name or address of pharmacy
2.Pharmacy going out of business |
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Term
| What is required for a controlled substance prescription to be legitimate? |
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Definition
legitimate medical purpose
prescribed by an individual practitioner acting within scope of practice |
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Term
| Who is responsible for the proper prescribing and dispensing of a controlled substance? |
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Definition
1.Prescriber
2.Pharmacist that fills the prescription |
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Term
| Violations of legitimate purpose/Corresponding Duty |
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Definition
1.False or Forged prescription
2.abetting a narcotic habit
3.rx for fake person
4.rx for person other then person named
5.rx for office use |
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Term
| What statement must be on all CII-IV prescription labels? |
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Definition
| Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed. |
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Term
| How long must controlled substance records be retained? |
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Definition
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Term
| When must an initial controlled substance inventory be completed? |
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Definition
| First date of controlled substance activity |
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Term
| When conducting an inventory of controlled substances which medications must have exact counts? |
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Definition
| only CII and CIII-V bottles that hold <1000 units |
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Term
| How often is a controlled substance inventory required? |
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Definition
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Term
| What are the Colorado requirements for file storage? |
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Definition
| separate files for CII, CIII-V, and Non-controlled prescriptions |
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Term
| What are the three options for prescription dispensing files? |
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Definition
1.Three separate files (CII, CIII-V, non CS)
2.two separate files (CII/all others)
3.two separate files (all CS/non CS) |
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Term
| Who may prescribe controlled substances? |
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Definition
Practitioners authorized by state or license.
Practitioners registered under CSA (unless exempt) |
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Term
| How many times can a CIII-V be transferred? |
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Definition
| Once, unless shared real time without change in rx number then can transfer to max refills |
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Term
| How many times can a CIII-V be refilled? |
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Definition
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Term
| Can CII prescriptions be refilled |
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Definition
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Term
| Can a CII be dispensed based on a faxed or oral authorization? |
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Definition
| Only in emergency situations |
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Term
| What are the requirements for an emergency CII prescriptions that was received by fax or oral authorization? |
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Definition
1.Rx written down immediately
2.Qty limited to treatment during emergency period
3.pharmacist attempts to verify authenticity
4.Prescriber must provide signed, written rx within 7 days (federal, 3 days Colorado) |
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Term
| What is the only narcotic that can be dispensed to a patient in a Narcotic Treatment Program? |
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Definition
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Term
| When must drug loss or theft be reported to the DEA? |
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Definition
| immediately upon discovery. |
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Term
| Who can pharmacies with DEA numbers distribute to? |
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Definition
| Practitioners or pharmacies with DEA numbers |
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Term
| Which is a controlled substance, Fioricet or Fiorinal? |
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Definition
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Term
| In Colorado, is it legal to sell schedule V drugs over the counter? |
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Definition
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Term
| Are unlimited refills valid on schedule V drugs in Colorado? |
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Definition
| No, only 5 refills in 6 months |
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Term
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Definition
| transfer, delivery or distribution of Rx drugs to noncustomers |
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Term
| What percent of total drugs dispensed annually can be casual sale? |
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Definition
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Term
| Define Pharmaceutical Care. |
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Definition
1.drug therapy and patient care
2.preparation and dispensing of medications
3.assessment, evaluation of patient medical needs
4.therapeutic plans
5.prevention, detection and resolution of patient medical problems |
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Term
| What is a pharmacy manager? |
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Definition
| Pharmacist in direct control of 1 prescription drug outlet |
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Term
| Define pharmacy technician |
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Definition
| Unlicensed person who performs duties under the supervision of pharmacist |
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Term
| Define Pharmacist supervision |
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Definition
| must be on site and readily available to consult with and assist pharmacy technicians |
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Term
| What are the Duties of the State Board of Pharmacy? |
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Definition
1.investigate violations; inspect and fine PDOs
2.Grant and renew licenses and registrations
3.Deny, suspend, or revoke licenses or registrations
4.promulgate compounding rules |
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Term
| When reporting malpractice claims who must be notified? |
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Definition
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Term
| What are the qualifications of a Pharmacy manager? |
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Definition
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Term
| How long does a PDO have to transfer registration to a new manager? |
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Definition
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Term
| When must a pharmacy manager notify the state board after termination of employment? |
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Definition
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Term
| What must be displayed at every prescription drug outlet? |
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Definition
Board registration with owners and managers name
pharmacist and intern licenses |
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Term
| When can a 24 hour supply of medication be dispensed in an ER |
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Definition
1.If ordered by practitioner
2.patient is registered in ER
3.Employee authorized to dispense or administer medications |
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Term
| Rules of professional conduct pertaining to pharmacy |
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Definition
1.Pharmacist cannot be employed and dispense for a prescriber
2.No PDO referral fees can be paid to health professionals or entities
3.Can not interfere with pharmacist patient counseling
4.Must comply with board orders
5.Rx drugs must be procured from registered entities |
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Term
| How long must refill information be retained? |
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Definition
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Term
| How long are prescriptions valid for? |
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Definition
| one year from date of issue by practitioner |
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Term
| Who must make the initial and final evaluations of a prescription? |
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Definition
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Term
| Pharmacist may not dispense a prescription if the prescription was issued based on an internet survey, consultation, or telephonic consultation. |
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Definition
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Term
| What constitutes a legitimate doctor patient relationship as defined by the DEA? |
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Definition
1.Patient has medical complaint
2.medical history taken
3.physical exam performed
4.logical connection between complaint, history, exam and prescription |
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Term
| Can drugs be returned to a PDO for redispensing? |
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Definition
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Term
| What defines a Preceptor? |
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Definition
1.oversees pharmacy intern
2.licensed for 2 years and in practice
3.No discipline in previous 5 years
4.approved by State Board or Pharmacy School |
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Term
| What are the some of the required professional references in Colorado? |
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Definition
1. Colorado Pharmacy Practice Act
2. Colorado Controlled Substance Act
3. State Board Rules and Regs
4. DEA Controlled Substance Rules
5. Sterile/Cytotoxic compounding references (if applicable) |
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Term
| How many continuous square feet are required for compounding and dispensing areas in a pharmacy? |
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Definition
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Term
| How wide must work surfaces be within a pharmacy? |
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Definition
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Term
| How far apart must shelving be in a pharmacy? |
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Definition
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Term
| When must written reports be submitted to the State Board in regards to security breaches? |
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Definition
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