Exam 1 Flashcards
The office for civil rights is the departmental component responsible for implementing and enforcing—-
A. The drug price competition and patent term restoration act of 1984.
B. Obra90
C. Anabolic steroids control act of 1970
D. Poison prevention packaging act of 1970
E. HIPAA 1996
E. Hipaa
The Texas state board of pharmacy issues ---- in order to carry out the policy and procedures of the Texas pharmacy act. A. Regulations B. Ethical standards C. Statues D. Judicial laws
A. Regulations
Risk evaluation and mitigation strategies and drug supply chain security (track & trace technologies) and both post-marketing safety initiative put forth in which piece of legislation?
A. Poison prevention packaging act
B. Food and drug modernization act
C. Food and drug administration amendments act (FDAAA)
D. Prescription drug marketing act
C. Food and drug administration amendments act (FDAAA)
With respect to 2 bulk bottles of Crestor, one #100 10mg tabs abs one #100 20mg tabs. Which section if the NDC would be different?
Second section
OBRA90 requires which of the following of pharmacists regarding patient records?
A. Make a reasonable effort to obtain info about the patient
B. Need o my take a medical/drug history When they feel the knowledge is significant
C. Must phone the patients prescriber to obtain any health/medication info if the patient omits or refuses
D. Must not fill s RX for a patient that refuses to supply info to the pharmacist regarding health and medication history.
A. Make a reasonable effort to obtain info about the patient
In Texas, beginning January 1,2015, all pharmacists must complete every renewal period 1 hour of CE in the area of:
Pharmacy law
A cosmetic manufacturer may market a product as a cosmetic without FDA approval as long as the company makes no therapeutic claims. True or false
True
Texas legislature meets when?
Every OTHER year beginning in JANUARY
A pharmaceutical company that is attempting to market a generic version of an approved drug product whose patent has expired will submit to the FDA:
Abbreviated new drug application (ANDA)
A pharmacy technician appears before the TSBP on a disciplinary measure. How can the TSBP handle this situation?
The TSBP may elect to discuss the charges in executive session.
Any votes pertaining to charges must be held in public
Texas law allows pharmacists to use their professional judgement in substituting products not listed In the orange Book. Products must: (1) be in the same dosage form and (2) contain the same active ingredients in the same amounts. True/false
True
Examples of drug products which are not regulated by it except from the RX drug regulation pertaining to the PPPA are:
Oral contraceptives containing both estrogen and progestins
Steroid containing ointments
Aerosol inhalers
In Texas a pharmacist preceptor must renew their preceptor certification every — and produce — hours of preceptor CE
2,3
The — created the food and drug administration (FDA)
Food drug and cosmetic act (1938)
In Texas the ration if pharmacists to technicians in class A is –
1:4 ( only 3 can be trainees)
The orange book can be found on what website?
FDA.gov
Members of the Texas state board of pharmacy are selected by
Appointment by the governor
Basic form of regulatory action the FDA can impose in the event a product needs to be removed from use.
Restraining order to prevent distribution of the product.
Regulatory letter
Seizure of embargo.
NOT FDA-ordered recall
Defines the limitations of the relationship between the individual and society
Criminal law
Which pharmacies in Texas can be described as having no pharmacy inventory at the worksite?
Class G- central prescription drug of medication order processing pharmacy
Class H- limited RX delivery pharmacy
TSBP requires — hours of internship for licensure.
1500
The FDA recommends that a consumer phone number be included in/on what?
Drug facts pamphlet accompanying an OTC product
Dietary supplements are defined as a —- by the dietary supplement health and education act.
A special class of foods
A drug is considered to be — if the methods of manufacture do not confirm with the good manufacturing practices
Adulterated
A drug is considered to be health endangering if used in the manner suggested by the labeling. This drug is considered to be —
Misbranded
A drug is subject to the PPPA and is not packaged accordingly. This drug is considered to be —
Misbranded
In Texas, a tech trainee may remain a trainee for a max of — until the tech successfully passes the national certification exam.
2 years.
Which clinical trial phase includes the smallest number of study subjects
Phase 1
Membership of the TSBP
11 members. 7 pharmacists, 3 public or non-pharmacists and 1 technician
Texas sunset act meets every
12 years.
When is the Texas sunset act scheduled to meet next?
2017
Which amendment to the food drug and cosmetic act established that drug products must be proven both safe and effective for use?
Kefauver-Harris amendments 1962
Which amendment to the federal food drug and cosmetic act established the legal difference between RX and OTC drugs?
Durham-Humphrey
What piece of legislation addressed rare diseases and provided a pathway to develop drugs to treat rare diseases?
The orphan drug act 1983
Obra90 required that dispensing pharmacists must offer to counsel Medicaid patients and :
Established a prospective drug review Program by each state
What class of pharmacy requires the pharmacist to oversee drug-related activities but the pharmacist need only be available on s consultant basis?
Class D- clinic pharmacy
Definition for drugs
Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals
What legislative act provides for the expedited study and approval of fast track drugs ?
Food and drug modernization act (FDAMA)
Laws enacted by congress at the federal level or by the legislature at the state level
Statutes
Members of the TSBP serve — terms and are limited to — full terms
6 years; 2 consecutive
Members of the board become ineligible if:
A board never purchased s percentage (40%) of a company that supplies copiers and office supplies to Texas state agencies, including TSBP
The mender us absent from more than half of the regularly scheduled board meetings and is not excused.
The anabolic steroid control act of 1990 required anabolic steroids to be placed In what category?
Schedule III
In Texas, a pharmacist must renew their license every — each renewal, the pharmacist must have completed — of CE. These records of CE must be kept for —
2 years; 30 hours; 3 years
Which act required retrospective review panel in each state to conduct a periodic examination of claims data in order to detect fraud, overuse or inappropriate or medically unnecessary care billed by physicians, pharmacies and other provides for Medicaid and Medicare patients?
Obra
How long does a pharmacist have to notify the TSBP of chance in employment?
10 days
The 1906 federal food and drug act was considered inadequate because:
False statements made about a drug by a manufacturer were held by the courts NOT to be mis branding.
Did not extend to cosmetics.
Did not grant authority to ban unsafe drugs.
Labels are not required to ID contents.
What amendment to the food drug and cosmetic act crated the ANDA
Drug price competition and patent restoration act (wax man-hatch)
