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Law Day 1 > Texas Pharmacy Rules > Flashcards

Texas Pharmacy Rules Flashcards

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1
Q

How many members serve on the TSPB?

A

11

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2
Q

Describe the types of TBSP members and the number of each type?

A

Seven members who are pharmacists
Three members who represent the public
One pharmacy technician

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3
Q

How are members selected for the TSBP and how long are their terms?

A

TSBP members are appointed by the governor with the advice and consent of the senate
Appointed for staggered 6 year terms.
The terms of 3 members expire every other year at midnight on the last day of the state fiscal year in the last year of the member’s term
May not serve more than two consecutive full terms

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4
Q

Qualification for each classification of member of the TSBP

A

The board must include representation for pharmacists who are primarily employed in Class A pharmacies and Class C pharmacies

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5
Q

A pharmacists board member must, at the time of appointment:

A
  • be a resident of this state;
  • have been licensed for the five years preceding appointment;
  • be in good standing to practice pharmacy in this state
  • be actively practicing pharmacy in this state
  • Each person appointed to the board shall, no later than the 15th day after the date of appointment, qualify by taking the constitutional oath of office.
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6
Q

A person is not eligible for appointment as a public member of the board if the person or the person ’s spouse:

A
  • is registered, certified, or licensed by an occupational regulatory agency in the field of health care;
  • is employed by or participates in the management of a business entity or other organization regulated by or receiving funds from the board;
  • owns or controls, directly or indirectly, more than a 10 percent interest in a business entity or other organization regulated by or receiving funds from the board
  • an officer, employee, or paid consultant to a Texas trade association in the healthcare field
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7
Q

The pharmacy technician board member must, at the time of appointment

A
  • Be a resident of Texas
  • Have been registered as a pharmacy technician for the five years preceding appointment
  • Be in good standing to act as a pharmacy technician in Texas
  • Be practicing (I like the word “working” better!—technicians do not practice! ) as a pharmacy technician in Texas
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8
Q

A person may not be a member of the board if?

A

The person is an officer, employee or paid consultant of a Texas trade association
OR
The person’s spouse is an officer, manager or paid consultant
OR
The person or the person spouse is a lobbyist on behalf of a profession regulated by the board

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9
Q

How many consecutive terms is a TSBP board member allowed to serve in a particular office?

A

2 full terms; if they are appointed to an unexpired term it does not count as a full term → they can then serve their own 2 full terms

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10
Q

What offices are elected among the members of the TSBP and how long are the terms of these offices?

A

One-year terms: Vice president, treasurer, and other officers the board considers appropriate and necessary to conduct board business;
A member elected as an officer may not serve more than two consecutive full terms in each office to which the member is elected

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11
Q

How is the president of the TSBP selected?

A

Governor Appointed

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12
Q

Who serves as secretary of the TSBP?

A

The Executive Director

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13
Q

Describe the function of the ex-officio member?

A

Executive director without a vote and may not perform a discretionary or decision-making function for which the board is solely responsible and keep the seal of the board

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14
Q

The executive director is a full-time employee of the board and shall:

A
  • serve as secretary to the board; and

- perform the regular administrative functions of the board and any other duty as the board directs.

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15
Q

What is executive session and when may the TSBP use this option?

A

A closed session in which the board may deliberate relating to discipline of a license holder

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16
Q

Division of Adjudication and Legal Support Services

A
  • monitoring receipt and action on complaints filed with agency
  • prosecuting substantial violations
  • providing adjudicative info to agency customers
  • legal support to the agency
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17
Q

What types of places do TSBP agents have the authority to inspect?

A

A place that:

  • Applied for a licensing as a pharmacist
  • Licensed as a pharmacy
  • Operating as a pharmacy in violation of the Pharmacy Act
  • The practice of pharmacy occurs
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18
Q

What items and documents may a TSBP agent inspect?

A
  • Inspect and copy records, reports and other documents required to be kept or made under the Pharmacy. Controlled substances, or Dangerous Drug Acts, or rules adopted under those acts
  • Inspect a facility’s storage, equipment, security, prescription drugs or devices or records
  • Inventory stock of any prescription drugs or devices
  • Obtain samples of those substances
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19
Q

What documents are TSBP agents not to inspect without a court order or a search warrant?

A
  • Financial data
  • Sales data other than shipment data
  • Pricing data
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20
Q

What must a TSBP agent present to a pharmacist prior to an inspection?

A
  • Appropriate credentials

- Written notice of his inspection authority

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21
Q

Under what circumstances may agents of the TSBP enter an establishment without an administrative warrant or permission of the pharmacist or owner?

A
  • With consent of the person in charge of the facility
  • When there is imminent danger to the public health and safety
  • In any other exceptional situation or emergency involving an act of God or natural disaster
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22
Q

State boards powers and duties and rulemaking authorities

A

Administering enforcing the Texas pharmacy act and rules another laws related to the practice of pharmacy
Regulation of the practice of pharmacy by issuing in renewing licenses, determining an issue in standards for recognizing and approving degree requirements of college of pharmacy’s, specifying in enforcing the requirements for practical training including internships, regulating training, qualifications, and employment a pharmacist and turns and pharmacy technicians

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23
Q

What are the qualifications for an applicant who applies for licensure to practice pharmacy in Texas?

A

o Good moral character
o 18/+ YO
o completed internship
o graduated and receive professional practice degree
o passed NAPLEX and MPJE
o Has not had a pharmacist license in another state restricted, suspended, revoked, or surrendered

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24
Q

How many internship hours are required for licensure in the State of Texas?

A

1500

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25
Q

How often do pharmacists renew their licenses in Texas?

A

Every 2 years

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26
Q

How many hours of continuing education and what type of hours are required for license renewal in Texas?

A

30 per renewal period
3.0 CEUs
At least one contact hour related to Texas pharmacy laws and rules (0.1 CEU)

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27
Q

What are the continuing education requirements for pharmacy preceptors?

A

1 preceptor program per renewal period (3hr program)

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28
Q

When does a pharmacist license expire?

A

On the last day of the assigned month which is the birth month. There is no grace period after the last day of expiration

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29
Q

What are the continuing education requirements for pharmacy immunizers?

A

1 immunization update program per renewal period

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30
Q

What tasks are interns prohibited from performing?

A

o Present or identify herself as a pharmacist
o Sign/initial any doc needed to be signed / initialed by pharmacist UNLESS preceptor cosigns it.
o Independently supervise techs or tech trainees

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31
Q

What is the ratio of interns to preceptors?

A

1:1

Does not apply to intern trainees are student interns that are part of a Texas school of pharmacy program

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32
Q

If a pharmacist’s license is disciplined in the state of Missouri, can the pharmacist move to Texas and begin to lawfully practice?

A

No, the State Board requires you to be in good standing in all states

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33
Q

If a co-worker’s license is suspended or revoked, can he/she continue to work in the pharmacy as a technician?

A

No, you must be in good standing with the State Board to work at all in a pharmacy

34
Q

What are the qualifications required to become a pharmacy technician?

A

High School diploma/pass a test

35
Q

How long may a pharmacy technician remain a trainee?

A

2 years

36
Q

What tasks are certified technicians prohibited from performing?

A

Labeling/counseling/taking a script over the phone

37
Q

Pharmacy Technicians renew their registration how often?

A

2 years

38
Q

How many hours of CE are required to renew technician registration?

A

20 CE hours

39
Q

Ratio of Pharmacists to Technicians

A
  • The ratio of pharmacists to pharmacy technicians may be 1:4 provided that one of the technicians is certified.
  • The ratio of pharmacist to technician trainees may not exceed 1:3
  • 1:5 ratio for pharmacies that compound non-sterile pharmaceuticals and dispense no more than 20 different prescription drugs
40
Q

Class A

A

Community Pharmacy
• Authorizes a facility to dispense a drug or device to the public under a prescription drug order. no sterile compounding. includes “closed door” pharmacy

41
Q

Class A-S

A

• Class A that can do sterile compounding

42
Q

Class B

A

Nuclear Pharmacy

• Authorizes a facility to dispense a radioactive drug or device

43
Q

Class C

A

Institutional/Hospital/Ambulatory Surgery Center Pharmacy

• Authorizes a facility located in an inpatient facility. no sterile compounding

44
Q

Class C-S

A

Class C that can do sterile compounding

45
Q

Class D

A

Clinic Pharmacy

Authorizes a facility to dispense a limited type of drug or device under prescription order

46
Q

Class E

A

Non-Resident (Out of State) Pharmacy
• Application for a facility located in a state other than Texas whose primary business is to dispense a prescription drug or device under prescription order; and deliver to drug or device to a patient, including a patient in this state, by US mail, common carrier, or delivery service. no sterile compounding

47
Q

Class E-S

A

Class E that can do sterile compounding

48
Q

Class F

A

Freestanding Emergency Medical Care Center
• Facility with primary purpose of PROCESSING prescription drug orders.
Shall not store bulk drugs, or dispense a prescription drug order

49
Q

What is special about Class G and H?

A

They do NOT fill prescriptions
Do not inventory drugs
G: data entry only
H: delivery only

50
Q

What documents must be supplied to the TSBP prior to the issuance of a license for a new pharmacy?

A

o Federal tax ID number
o Description of business services to be offered
o Malpractice insurance carrier or self-insured statement
o Certificate of authority if corporation from out-of-state
o Articles of incorporation
o Current Texas Franchise Tax Certificate of Good Standings

51
Q

What if it is a Class A or C pharmacy?

A

 Birth certificate or passport of each individual owner + managing officers
 List of all owners
 Approved credit application from a primary wholesaler
 Current driver’s license or state issued ID for each executive officer

52
Q

What pharmacies have to be under complete supervision?

A 
Class A
Class B
Class C with >100 beds
Class D
Class E
53
Q

What about Class G?

A

Can have a pharmacists electronically supervise technicians but must be on-site

54
Q

What pharmacies have part time supervision?

A

Class F and H

55
Q

What sign must be posted in pharmacies according to Texas Law?

A

A substitution disclaimer in english and spanish with letters at least 1 inch tall

56
Q

Is it lawful in Texas to dispense a product not included in the Orange Book?

A

Yes

Pharmacists may use their own judgement but must be same dosage form and same active ingredients in same amounts

57
Q

What must a prescriber do to prohibit substitution on a written prescription, a verbal prescription, and electronic prescription?

A
  • Written Rx: “brand necessary” or ‘brand medically necessary”
  • Verbal Rx: prescribers may verbally “brand medically necessary”; pharmacist should make note of this request.
  • Electronic Rx: May sub unless prescriber clearly indicates brand name necessary
58
Q

Emergency Weekend Rule is?

A

When all refills are exhausted, the first thing a pharmacist does is attempts to contact the prescriber for a refill authorization. After making a reasonable attempt to contact the prescriber and deciding that an interruption of a therapeutic regimen might cause the patient harm or create patient suffering, the pharmacist is allowed to dispense up to a 72 hour supply of medication to the patient without authorization from the prescriber

59
Q

License by Reciprocity

A

Must provide proof of initial license or by examination and that current license has not been suspended, restricted, revoked, surrender, or otherwise restricted
Must pass the Texas MPJE

60
Q

Define pharmacist intern

A

An intern training, a student intern, or resident intern, or an extended intern who is participating in a board approved internship program

61
Q

Define intern trainee

A

An individual registered with the board who is enrolled in the first professional year in a Texas college or school pharmacy and who may work in a side assigned by the school

62
Q

Define student intern

A

An individual registered with the board has successfully completed the first professional year with a minimum of 30 credit hours

63
Q

When does a student intern designation expire?

A

1) ceases enrollment at an accredited school or college
2) fails NAPLEX and or Texas MPJE
3) fails to take NAPLEX and or Texas MPJE within six calendar months after graduation

64
Q

Define resident intern

A

An individual registered with the board who has graduated from a school of pharmacy and is completing an accredited residency program

65
Q

Define extended intern

A

Individuals registered with the board who are no longer student interns and other individuals in a specific circumstance such as a foreign pharmacy graduate or those seeking re-issuance of a pharmacy license

66
Q

What are the duties of a pharmacist intern?

A

May perform any duties of a pharmacist provided they are working under the supervision of a pharmacist registered as a preceptor or a healthcare professional preceptor

67
Q

What are the intern trainee duties?

A

May perform any duties of a pharmacist just as other interns but they can only do so at locations where they’ve been assigned by a school pharmacy

68
Q

Preceptor requirements

A

Have a current active pharmacist license
Have at least one year of experience or six months of residency training
Have completed three hours of preceptor training
Have completed three hours of preceptor training every two years
No license disciplinary actions

69
Q

If a license is expired for fewer than 90 days…

A

The license may renew by paying a renewal fee that is equal to 1 1/2 the renewal fee and report required hours of continuing education

70
Q

If a license is expired for more than 90 days but less than one year…

A

The licensee may pay a renewal fee equal to two times a renewal and report required number of continuing education hours

71
Q

After one year, The license…

A

Cannot be renewed and re-examination may be necessary

72
Q

Define inactive status

A

A pharmacist who cannot renew their license because they do not have the required continuing education requirements can place their license and in active status

73
Q

Methods for obtaining CEs

A

Completion of courses that are part of the professional degree program of a college of pharmacy
Completion of a cardio pulmonary resuscitation CPR course 1 hr
Advanced cardiac life support courses leading to initial certification 12 hours
Advanced cardiac life support courses leading to recertification 4 hours
Attending a Texas state board of pharmacy 3 hours
Participating in a Texas state board of pharmacy appointed task force 3 hours
Attending programs presented by the Texas state board of pharmacy
Completion of an ISMP medication safety self-assessment 3 hours
Passing a certain board of pharmaceutical specialty certification examinations 3 hours

74
Q

CPE Monitoring System

A

Joint effort of the ACPE and NABP which allows pharmacist to electronically tract CE credits

75
Q

A pharmacy that compound sterile products cannot be licensed by the board until…

A

The pharmacy has been inspected by the board

76
Q

A pharmacy that fails to engage in the business as described in the application for license within six months of the date of issuance…

A

Is subject to disciplinary actions

77
Q

What do you do if there’s a change of location or change of name of the pharmacy?

A

Pharmacy license are not transferable. The pharmacy must file a new application and return the old license with the same license number

78
Q

Telepharmacy requires what kind of pharmacist supervision?

A

Continuous but not site physically but by audio and video communications

79
Q

Whatever pharmacies location changes?

A

TSBP must be notified in writing at least 30 days before the change

80
Q

What can an intern not do?

A

Present themselves as a pharmacist, sign documents that require a pharmacist to sign such as a controlled substance inventory or supervise technicians

81
Q

TSBP does not regulate?

A

Wholesalers which are regulated by the Texas department of state health services and pharmaceutical manufacturers representatives

82
Q

How many years must a pharmacist retain his/her records of continuing education?**

A

3 years at primary practice site

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