CHAPTER 556. ADMINISTRATIVE INSPECTIONS AND WARRANTS

OCCUPATIONS CODE

TITLE 3. HEALTH PROFESSIONS

SUBTITLE J. PHARMACY AND PHARMACISTS

CHAPTER 556. ADMINISTRATIVE INSPECTIONS AND WARRANTS

SUBCHAPTER A. GENERAL PROVISIONS

Sec. 556.001. DEFINITION. In this chapter, "facility" means a

place:

(1) for which an application has been made for a pharmacy

license under this subtitle;

(2) at which a pharmacy licensed under this subtitle is located;

(3) at which a pharmacy is being operated in violation of this

subtitle; or

(4) where the practice of pharmacy occurs.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

SUBCHAPTER B. INSPECTIONS

Sec. 556.051. AUTHORIZATION TO ENTER AND INSPECT. The board or

a representative of the board may enter and inspect a facility

relative to the following:

(1) drug storage and security;

(2) equipment;

(3) components used in compounding, finished and unfinished

products, containers, and labeling of any item;

(4) sanitary conditions; or

(5) records, reports, or other documents required to be kept or

made under this subtitle, Chapter 481 or 483, Health and Safety

Code, or the Comprehensive Drug Abuse Prevention and Control Act

of 1970 (21 U.S.C. Section 801 et seq.) or rules adopted under

one of those laws.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2005, 79th Leg., Ch.

28, Sec. 2, eff. September 1, 2005.

Sec. 556.052. REQUIREMENTS BEFORE ENTRY AND INSPECTION. (a)

Before an entry and inspection of the facility, the person

authorized to represent the board must:

(1) state the purpose for the inspection; and

(2) present to the owner, pharmacist, or agent in charge of the

facility:

(A) appropriate credentials; and

(B) written notice of the authority for the inspection.

(b) If an inspection is required by or is supported by an

administrative inspection warrant, the warrant is the notice for

purposes of Subsection (a)(2)(B).

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.053. EXTENT OF INSPECTION; CONFIDENTIALITY. (a)

Except as otherwise provided in an inspection warrant, the person

authorized to represent the board may:

(1) inspect and copy documents, including records or reports,

required to be kept or made under this subtitle, Chapter 481 or

483, Health and Safety Code, or the Comprehensive Drug Abuse

Prevention and Control Act of 1970 (21 U.S.C. Section 801 et

seq.) or rules adopted under one of those laws;

(2) inspect, within reasonable limits and in a reasonable

manner, a facility's storage, equipment, security, prescription

drugs or devices, components used in compounding, finished and

unfinished products, or records; or

(3) perform an inventory of any stock of prescription drugs or

devices, components used in compounding, or finished and

unfinished products in a facility and obtain samples of those

substances.

(b) Reports, records, formulas, and test results of samples of

products compounded by pharmacies obtained by the board may be

provided to the pharmacy that compounded the product but

otherwise are confidential and do not constitute public

information for purposes of Chapter 552, Government Code. The

board may create, use, or disclose statistical information from

the test results of samples of compounded products.

(c) The board may disclose information confidential under

Subsection (b):

(1) in a disciplinary hearing before the board or in a

subsequent trial or appeal of a board action or order;

(2) to a pharmacist licensing or disciplinary authority of

another jurisdiction; or

(3) under a court order.

(d) The board shall require a pharmacy to recall a compounded

product and may release the results of the tests of the samples

of the compounded product if the board determines that:

(1) the test results indicate a patient safety problem that may

involve potential harm to a patient; and

(2) the release of the test results is necessary to protect the

public.

(e) The board shall release the test results described by

Subsection (d) if a pharmacy is unable to or does not recall the

compounded product within 48 hours after the board's request

under that subsection.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Amended by:

Acts 2005, 79th Leg., Ch.

28, Sec. 3, eff. September 1, 2005.

Acts 2009, 81st Leg., R.S., Ch.

785, Sec. 1, eff. June 19, 2009.

Sec. 556.054. LIMITATION ON INSPECTION. Unless the owner,

pharmacist, or agent in charge of a facility consents in writing,

an inspection of the facility authorized by this chapter may not

extend to:

(1) financial data;

(2) sales data, other than shipment data; or

(3) pricing data.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.055. INSPECTIONS WITH WARNING NOTICE. Before a

complaint may be filed with the board as the result of a written

warning notice that is issued during an inspection authorized by

this chapter and that lists a specific violation of this subtitle

or a rule adopted under this subtitle, the license holder must be

given a reasonable time, as determined by the board, to comply

with this subtitle or rules adopted under this subtitle.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.0555. INSPECTIONS. (a) At least annually, the board

shall conduct random inspections of Canadian pharmacies

designated under Section 554.016 as necessary to ensure

compliance with the safety standards and other requirements of

this subtitle and board rules.

(b) Notwithstanding the requirements of this chapter, the board

by rule may establish the standards and procedures for

inspections under this section.

(c) The board may enter into a written agreement with another

state for an agency or employee of the state to perform services

for the board related to inspecting a Canadian pharmacy

designated by the board under Section 554.016 to dispense

prescription drugs to residents in this state. This subsection

does not apply to the initial inspection of the pharmacy.

Added by Acts 2005, 79th Leg., Ch.

1345, Sec. 38, eff. September 1, 2005.

Sec. 556.056. CODE OF PROFESSIONAL RESPONSIBILITY. (a) The

board shall adopt a code of professional responsibility to

regulate the conduct of a representative of the board authorized

to inspect and survey a pharmacy.

(b) The code must contain:

(1) a procedure to be followed by a person authorized to

represent the board:

(A) on entering a pharmacy;

(B) during inspection of the pharmacy; and

(C) during an exit conference; and

(2) standards of conduct that the person must follow in dealing

with the staff and management of the pharmacy and the public.

(c) The board shall establish a procedure for receiving and

investigating a complaint of a code violation. The board shall

investigate each complaint of a code violation. The board shall

forward results of an investigation to the complainant.

(d) The board may adopt rules establishing sanctions for code

violations.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

SUBCHAPTER C. WARRANTS

Sec. 556.101. WARRANT NOT REQUIRED. A warrant is not required

under this chapter to:

(1) inspect books or records under an administrative subpoena

issued under this subtitle; or

(2) enter a facility or conduct an administrative inspection of

a facility if:

(A) the owner, pharmacist, or agent in charge of the facility

consents to the inspection;

(B) the situation presents imminent danger to the public health

and safety;

(C) the situation involves inspection of a conveyance, if there

is reasonable cause to believe that the mobility of the

conveyance makes it impracticable to obtain a warrant; or

(D) any other exceptional situation or emergency exists

involving an act of God or natural disaster in which time or

opportunity to apply for a warrant is lacking.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.102. COMPLIANCE WITH CHAPTER. An administrative

inspection warrant may be issued and executed only in accordance

with this chapter.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.103. ISSUANCE OF WARRANT. (a) In this section,

"probable cause" means a valid public interest exists in the

effective enforcement of this subtitle or a rule adopted under

this subtitle that is sufficient to justify an administrative

inspection of the facility, area, building, or conveyance, or its

contents in the circumstances specified in the application for

the warrant.

(b) A district judge may, on proper oath or affirmation that

shows probable cause, issue a warrant to:

(1) conduct an administrative inspection authorized by this

chapter or rules adopted under this subtitle; and

(2) seize property appropriate to the inspection.

(c) A warrant may be issued only on an affidavit that:

(1) is given by a board representative who has knowledge of the

facts alleged;

(2) is sworn to before the judge; and

(3) establishes the grounds for issuance of the warrant.

(d) The judge shall issue a warrant if the judge is satisfied

that grounds for the application exist or that there is probable

cause to believe they exist.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.104. CONTENTS OF WARRANT. The warrant must:

(1) identify:

(A) the facility, area, building, or conveyance to be inspected;

(B) the purpose of the inspection;

(C) the type of property to be inspected, if appropriate; and

(D) each item or type of property to be seized, if any;

(2) state the grounds for issuance of the warrant and the name

of each person whose affidavit has been taken in support of the

warrant;

(3) be directed to a person authorized under this chapter to

execute the warrant;

(4) command the person to whom the warrant is directed to

inspect the facility, area, building, or conveyance identified

for the purpose specified;

(5) direct the seizure of the property specified, if

appropriate;

(6) direct that the warrant be served during normal business

hours; and

(7) designate the judge to whom the warrant is to be returned.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.105. EXECUTION AND RETURN OF WARRANT. (a) A warrant

issued under this chapter must be executed and returned not later

than the 10th day after the date of the warrant's issuance unless

the judge allows additional time in the warrant after a showing

by the board of a need for additional time.

(b) A person who seizes property under a warrant shall provide a

copy of the warrant and a receipt for the property taken by:

(1) giving the copy and receipt to the person from whom or from

whose facility the property was taken; or

(2) leaving the copy and receipt at the facility from which the

property was taken.

(c) The return of the warrant shall be made promptly and be

accompanied by a written inventory of any property taken. The

inventory shall be:

(1) prepared in the presence of the person executing the warrant

and of:

(A) the person from whose possession or facility the property

was taken, if present; or

(B) at least one credible person other than the person preparing

the inventory; and

(2) verified by the person executing the warrant.

(d) The judge, on request, shall deliver a copy of the inventory

to:

(1) the person from whose possession or facility the property

was taken; and

(2) the applicant for the warrant.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.106. FILING WITH DISTRICT COURT. (a) A judge who

issues a warrant under this chapter shall attach to the warrant:

(1) a copy of the return; and

(2) the papers filed in connection with the warrant.

(b) The judge shall file the copy of the return and the papers

with the clerk of the district court with jurisdiction of the

area in which the inspection was conducted.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 556.107. DISPOSAL OF SEIZED PROPERTY. Property seized

under this chapter must be disposed of in a manner considered

appropriate by the board if the board has jurisdiction over the

property or the district court if the court has jurisdiction over

the property.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.