TITLE 22.EXAMINING BOARDS

Part 15. TEXAS STATE BOARD OF PHARMACY

Chapter 281. ADMINISTRATIVE PRACTICE AND PROCEDURES

Subchapter A. GENERAL PROVISIONS

22 TAC §281.19

The Texas State Board of Pharmacy proposes new §281.19, concerning Restrictions on Assignment of Vehicles. The new rule, if adopted, implements the rule-making provisions of the Texas Government Code, §2171.1045, concerning Restrictions on Assignment of Vehicles.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five- year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be compliance with the provisions of the Texas Government Code, §2171.1045. There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under §2171.1045 of the Texas Government Code. The Board interprets §2171.1045 as requiring the Board to adopt rules concerning restrictions on the assignment of vehicles.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§281.19.Restrictions on Assignment of Vehicles.

(a)

Each agency vehicle, with the exception of the agency pool car, will be assigned to an individual field employee.

(b)

The agency may assign a vehicle to a board member or an individual administrative or executive employee:

(1)

on a temporary basis if field personnel are not available to assume responsibility for the car; or

(2)

on a regular basis only if the agency makes a written documented finding that the assignment is critical to the needs and mission of the agency.

(c)

The agency pool car is assigned to the agency motor pool and is available for checkout.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103267

Gay Dodson, R. Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028


Chapter 291. PHARMACIES

Subchapter A. ALL CLASSES OF PHARMACIES

22 TAC §291.6

The Texas State Board of Pharmacy proposes amendments to §291.6 concerning Pharmacy License Fees. The proposed amendment, if adopted, will delete obsolete language, correct citations to the reflect the new codified Act, and increase the biennial pharmacy license fee from $324 to $363, for a license that has an expiration date on or after October 1, 2001. Included in this $363 total is $351 for processing and issuance or renewal of a pharmacist license, and a $12 surcharge to fund a program to aid impaired pharmacists and pharmacy students. The surcharge to fund this program has increased from a biennial fee of $10 to a biennial fee of $12 for each pharmacy license. The increase in the licensing fee is necessary to generate sufficient revenue that is collected by the agency through licensure fees, fines, and other miscellaneous revenue to support agency operations.

Gay Dodson, R.Ph., Executive Director/Secretary has determined that for the first five-year period the rule is in effect, there will be fiscal implications for state or local government as a result of enforcing or administering the rule. The effect on state government for the first five years the rule is in effect is an estimated increase in licensing revenue to the Texas State Board of Pharmacy fund of $101,417 in FY2002 and $105,598 in each FY2003-2006. In addition, an estimated increase of $5,664 in FY2002 and $5,808 in each FY2003-2006 will be used to administer a program to aid impaired pharmacists and pharmacy students.

A business is defined for the purpose of this preamble as a single licensed Texas pharmacy. The cost for compliance with this section for a small business will be an additional $39 every two years, to obtain a pharmacy license or renew a pharmacy license. The cost for large businesses will be the same as for small businesses. Based on the cost per employee, an estimated comparison of the cost of compliance for a small and large business can be made, if the number of employees for a small business and large business is known. The agency has no data on the total number of employees (pharmacists, technicians, support staff) in each pharmacy; however, the agency does have data on the number of pharmacists employed at each pharmacy. Based on this data, the following assumptions are made for this comparison.

Small business = Pharmacy that employs less than 10 pharmacists. The majority of licensed pharmacies fall into this category. Largest business = Pharmacy that employs 216 pharmacists.

This comparison shows that the cost of compliance for a small business is $3.90 per employee every two years, and the cost of compliance for the largest business is $0.18 per pharmacist employee every two years.

The anticipated economic cost to individuals who are required to comply with the section as proposed will be an additional $39 every two years if the individual is a pharmacy owner, to obtain or renew a pharmacy license.

Ms. Dodson also has determined that for each year of the first five-year period the rule as proposed is in effect, the public benefit anticipated as a result of enforcing the rule will be to ensure the safety of public health and welfare by assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission, and assuring the funding of a program to aid impaired pharmacists and pharmacy students.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under §554.006 and §564.051 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The Board interprets §554.006 as authorizing the agency to establish reasonable and necessary fees to produce sufficient revenue to cover the cost of administering the Texas Pharmacy Act. The Board interprets §564.051 as authorizing the agency to add a surcharge to a license or license renewal fee to fund a program to aid impaired pharmacists and pharmacy students.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§291.6.Pharmacy License Fees

(a)

The Texas State Board of Pharmacy (board) shall require [ annual or ] biennial renewal of all licenses provided under the Pharmacy Act, §561.002 and §8 of Acts 1999, 76th Leg., ch. 1518, eff. Sept. 1, 1999, which amends §29(a) of Vernon's Ann.Civ.St. Art. 4542a-1 (now §561.002) without reference to the repeal of said article by Acts 1999, 76th Leg., Ch. 388, §6(a). [ §31. In order to evenly distribute the revenue received from license fees, a pharmacy license fee may renew on an annual or biennial basis during the first 12 months of the implementation of the biennial renewal cycle, beginning March 1, 2000. After the implementation of the biennial renewal system, all pharmacy licenses shall renew on a biennial basis. ]

[ (b) ]

[ The board shall charge the following fees for the issuance or renewal of a pharmacy license. ]

[(1)

Renewals prior to March 1, 2000. The fee for initial or annual renewal of a pharmacy license shall be $164 for licenses with an expiration date on or after January 1, 1996. (This $164 fee includes $157 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §39, and a $7.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §27A.)]

[(2)

Annual Renewal Cycle. The fee for initial or annual renewal of a pharmacy license shall be $162 for licenses with an expiration date on or after March 1, 2000. (This $162 fee includes $157 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §39, and a $5.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §27A.)]

[ (3) ]

[ Biennial Renewal Cycle. ] The fee for initial or biennial renewal of a pharmacy license shall be as follows:

(1)

$324 for licenses with an expiration date on or after March 1, 2000. (This $324 fee includes $314 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §554.006 [ §39 ], and a $10 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051 and §6 of Acts 1999, 76th Leg., ch. 1518, eff. Sept. 1, 1999, which amends §27A(g) of Vernon's Ann.Civ.St. Art. 4542a-1 (now §564.051) without reference to the repeal of said article by Acts 1999, 76th Leg., Ch. 388, §6(a).); or [ §27A.) ]

(2)

$363 for licenses with an expiration date on or after October 1, 2001. (This $363 fee includes $351 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §554.006, and a $12.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051 and §6 of Acts 1999, 76th Leg., ch. 1518, eff. Sept. 1, 1999, which amends §27A(g) of Vernon's Ann.Civ.St. Art. 4542a-1 (now §564.051) without reference to the repeal of said article by Acts 1999, 76th Leg., Ch. 388, §6(a).)

(b)

[ (c) ] New pharmacy licenses shall be assigned an expiration date.

(c)

[ (d) ] The fee for issuance of an amended pharmacy license shall be $20.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103268

Gay Dodson, R. Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028


Subchapter B. COMMUNITY PHARMACY (CLASS A)

22 TAC §291.32, §291.36

The Texas State Board of Pharmacy proposes amendments to §291.32, concerning Personnel, and §291.36, concerning Class A Pharmacies Compounding Sterile Pharmaceuticals. The amendments, if adopted, will require certified pharmacy technicians to display their current certification certificates.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five- year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to provide the public a method to verify a pharmacy technician's level of training (certification). There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under §§551.002, 554.051, and 554.053 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051 as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §554.053 as authorizing the Board to adopt rules for the use and duties of pharmacy technicians in a pharmacy.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§291.32.Personnel.

(a) - (b)

(No change.)

(c)

Pharmacy technicians.

(1)

Qualifications.

(A) - (B)

(No change.)

(C)

Certified Pharmacy Technicians.

(i)

All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board and maintain a current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the Board.

(ii)

A certified pharmacy technician shall publicly display their current certification certificate in the technician's primary place of practice.

(2) - (5)

(No change.)

(d)

(No change.)

§291.36.Class A Pharmacies Compounding Sterile Pharmaceuticals.

(a) - (b)

(No change.)

(c)

Personnel.

(1) - (2)

(No change.)

(3)

Pharmacy technicians.

(A)

Qualifications.

(i) - (ii)

(No change.)

(iii)

Certified Pharmacy Technicians.

(I)

All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board and maintain a current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the Board.

(II)

A certified pharmacy technician shall publicly display their current certification certificate in the technician's primary place of practice.

(B) - (E)

(No change.)

(4) - (5)

(No change.)

(d) - (f)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103269

Gay Dodson, R. Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028


Subchapter C. NUCLEAR PHARMACY (CLASS B)

22 TAC §291.53

The Texas State Board of Pharmacy proposes amendments to §291.53, concerning Personnel. The amendments, if adopted, will require certified pharmacy technicians to maintain current certification and display their current certification certificates.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five- year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to provide the public a method to verify a pharmacy technician's level of training (certification). There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under §§551.002, 554.051, and 554.053 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051 as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §554.053 as authorizing the Board to adopt rules for the use and duties of pharmacy technicians in a pharmacy.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§291.53.Personnel.

(a)-(b)

(No change.)

(c)

Pharmacy Technicians.

(1)

General.

(A)-(D)

(No change.)

(E)

Effective January 1, 2001, all pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board or be a pharmacy technician trainee.

(F)

All certified pharmacy technicians shall maintain a current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the Board.

(G)

A certified pharmacy technician shall publicly display their current certification certificate in the technician's primary place of practice.

(2)-(3)

(No change.)

(d)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103270

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028


Subchapter D. INSTITUTIONAL PHARMACY (CLASS C)

22 TAC §291.73

The Texas State Board of Pharmacy proposes amendments to §291.73, concerning Personnel. The amendments, if adopted, will require certified pharmacy technicians to display their current certification certificates.

Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to provide the public a method to verify a pharmacy technician's level of training (certification). There is no fiscal impact anticipated for small or large businesses or to other entities who are required to comply with this section.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under sections 551.002, 554.051, and 554.053 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The Board interprets section 551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets section 554.051 as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets section 554.053 as authorizing the Board to adopt rules for the use and duties of pharmacy technicians in a pharmacy.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§291.73.Personnel.

(a)-(d)

(No change.)

(e)

Pharmacy technicians.

(1)

Qualifications.

(A)-(B)

(No change.)

(C)

Certified Pharmacy Technicians.

(i)

All certified pharmacy technicians shall have taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board and maintain a current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the Board.

(ii)

A certified pharmacy technician shall publicly display their current certification certificate in the technician's primary place of practice.

(2)-(5)

(No change.)

(f)-(g)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103271

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028


Chapter 295. PHARMACISTS

22 TAC §295.5

The Texas State Board of Pharmacy proposes amendments to §295.5 concerning Pharmacist License or Renewal Fees. The proposed amendment, if adopted, will delete obsolete language, correct citations to the reflect the new codified Act, and increase the biennial pharmacist license fee from $188 to $227, for a license that has an expiration date on or after October 1, 2001. Included in this $227 total is $215 for processing and issuance or renewal of a pharmacist license, and a $12 surcharge to fund a program to aid impaired pharmacists and pharmacy students. The surcharge to fund this program has increased from a biennial fee of $10 to a biennial fee of $12 for each pharmacist license. The increase in the licensing fee is necessary to generate the revenue that is collected by the agency through licensure fees, fines, and other miscellaneous revenue to support agency operations.

Gay Dodson, R.Ph., Executive Director/Secretary has determined that for the first five-year period the rule is in effect, there will be fiscal implications for state or local government as a result of enforcing or administering the rule. The effect on state government for the first five years the rule is in effect is an estimated increase in licensing revenue to the Texas State Board of Pharmacy fund of $369,038 in FY2002 and $401,376 in each FY2003-2006. In addition, an estimated increase of $19,748 in FY2002 and $21,496 in each FY2003-2006 will be used to administer a program to aid impaired pharmacists and pharmacy students.

Ms. Dodson also has determined that for each year of the first five-year period the rule as proposed is in effect, the public benefit anticipated as a result of enforcing the rule will be to ensure the safety of public health and welfare by assuring that the Texas State Board of Pharmacy is adequately funded to carry out its mission, and assuring the funding of a program to aid impaired pharmacists and pharmacy students.

There will be no cost of compliance with the section for small or large businesses (pharmacies), because a pharmacy is not required to pay the licensing fee for pharmacists that are employed at a pharmacy. A business is defined in for the purpose of this preamble as a single Texas pharmacy License.

The anticipated economic cost to individuals who are required to comply with the section as proposed will be an additional $39 every two years, to obtain or renew a pharmacist license.

Comments on the proposal may be submitted to Steve Morse, R.Ph., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Box 21, Austin, Texas, 78701-3942, FAX (512) 305-8082. Comments must be received by 5 p.m., August 2, 2001.

The amendments are proposed under sections 554.006 and 564.051 of the Texas Pharmacy Act (Chapters 551-566, Texas Occupations Code). The Board interprets section 554.006 as authorizing the agency to establish reasonable and necessary fees to produce sufficient revenue to cover the cost of administering the Texas Pharmacy Act. The Board interprets section 564.051 as authorizing the agency to add a surcharge to a license or license renewal fee to fund a program to aid impaired pharmacists and pharmacy students.

The statutes affected by this rule: Chapters 551-566, Texas Occupations Code.

§295.5.Pharmacist License or Renewal Fees.

(a)

The Texas State Board of Pharmacy (board) shall require [ annual or ] biennial renewal of all licenses provided under the Pharmacy Act, §559.002. [ §31. In order to evenly distribute the revenue received from license fees, a pharmacist license fee may renew on an annual or biennial basis during the first 12 months of the implementation of the biennial renewal cycle, beginning March 1, 2000. After the implementation of the biennial renewal system, all pharmacist licenses shall renew on a biennial basis. The fee for issuance of a pharmacist license and for each renewal shall be as follows. ]

[(1)

Renewals prior to March 1, 2000. The fee for initial or annual renewal of a pharmacist license shall be $96 for licenses with an expiration date on or after January 1, 1996. (This $96 fee includes $89 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §39, and a 7.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §27A).]

[(2)

Annual Renewal Cycle. The fee for initial or annual renewal of a pharmacist license shall be $94 for licenses with an expiration date on or after March 1, 2000. (This $94 fee includes $89 for processing the application and issuance of the pharmacy license or renewal as authorized by the Act, §39, and a $5.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act §27A.)]

[ (3)

Biennial Renewal Cycle. ] The fee for initial or biennial renewal of a pharmacist license shall be as follows:

(1)

$188 for licenses with an expiration date on or after March 1, 2000. (This $188 fee includes $178 for processing the application and issuance of the pharmacist license or renewal as authorized by the Act, 554.006 [ §39 ], and a $10 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051 and §6 of Acts 1999, 76th Leg., ch. 1518, eff. Sept. 1, 1999, which amends §27A(g) of Vernon's Ann.Civ.St. Art. 4542a-1 (now §564.051) without reference to the repeal of said article by Acts 1999, 76th Leg., Ch. 388, §6(a).); or [ §27A.) ]

(2)

$227 for licenses with an expiration date on or after October 1, 2001. (This $227 fee includes $215 for processing the application and issuance of the pharmacist license or renewal as authorized by the Act, §554.006, and a $12.00 surcharge to fund a program to aid impaired pharmacists and pharmacy students as authorized by the Act, §564.051 and §6 of Acts 1999, 76th Leg., ch. 1518, eff. Sept. 1, 1999, which amends §27A(g) of Vernon's Ann.Civ.St. Art. 4542a-1 (now §564.051) without reference to the repeal of said article by Acts 1999, 76th Leg., Ch. 388, §6(a).)

(b)

[ Pursuant to Texas Civil Statutes, Article 4542a-1, §39(5), effective September 1, 1985, the ] The license of a pharmacist who has been licensed by the Texas State Board of Pharmacy for at least 50 years and which such pharmacist is not actively practicing pharmacy, shall be renewed without payment of a fee. The renewal certificate of such pharmacist issued by the board shall reflect an inactive status. A person whose license is renewed pursuant to this subsection may not engage in the active practice of pharmacy without first paying the fee as set out in subsection (a) of this section.

(c)

The fee for issuance of an amended pharmacist's license renewal certificate shall be $20.

(d)

The fee for issuance of an amended license to practice pharmacy (wall certificate) only, or renewal certificate and wall certificate shall be $35.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on June 11, 2001.

TRD-200103272

Gay Dodson, R.Ph.

Executive Director/Secretary

Texas State Board of Pharmacy

Earliest possible date of adoption: July 22, 2001

For further information, please call: (512) 305-8028