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.