22 Tex. Admin. Code § 291.3 - Required Notifications
(a) Change of
Location.
(1) When a pharmacy changes
location, the following is applicable:
(A) A
new completed pharmacy application containing the information outlined in
§
291.1 of this title (relating to
Pharmacy License Application) must be filed with the board not later than 30
days before the date of the change of location of the pharmacy;
(B) An amended license reflecting the new
location of the pharmacy will be issued by the board; and
(C) A fee as specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for processing the application for
change of location.
(2)
At least 14 days prior to the change of location of a pharmacy that dispenses
prescription drug orders, the pharmacist-in-charge shall post a sign in a
conspicuous place indicating that the pharmacy is changing locations. Such sign
shall be in the front of the prescription department and at all public entrance
doors to the pharmacy and shall indicate the date the pharmacy is changing
locations.
(3) Disasters,
accidents, and emergencies which require the pharmacy to change location shall
be immediately reported to the board. If a pharmacy changes location suddenly
due to disasters, accidents, or other emergency circumstances and the
pharmacist-in-charge cannot provide notification 14 days prior to the change of
location, the pharmacist-in-charge shall comply with the provisions of
paragraph (2) of this subsection as far in advance of the change of location as
allowed by the circumstances.
(4)
When a Class A-S, C-S, or E-S pharmacy changes location, the pharmacy's
classification will revert to a Class A, Class C, or Class E unless or until
the board or its designee has inspected the new location to ensure the pharmacy
meets the requirements as specified in §
291.133 of this title (relating to
Pharmacies Compounding Sterile Preparations).
(5) When a Class B pharmacy changes location,
the board shall inspect the pharmacy at the new location to ensure the pharmacy
meets the requirements as specified in subchapter C of this title (relating to
Nuclear Pharmacy (Class B)) prior to the pharmacy becoming
operational.
(b) Change
of Name. When a pharmacy changes its name, the following is applicable:
(1) A new completed pharmacy application
containing the information outlined in §
291.1 of this title (relating to
Pharmacy License Application) must be filed with the board within 10 days of
the change of name of the pharmacy;
(2) An amended license reflecting the new
name of the pharmacy will be issued by the board; and
(3) A fee as specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for processing the application for
change of name.
(c)
Change of Managing Officers.
(1) The owner of
a pharmacy shall notify the board in writing within 10 days of a change of any
managing officer of a partnership or corporation which owns a pharmacy. The
written notification shall include the effective date of such change, an
updated sworn disclosure statement as required by §560.052(b) of the Act
and as specified in §
291.4 of this title (relating to
Sworn Disclosure Statement), and the following information for all managing
officers:
(A) name and title;
(B) home address and telephone
number;
(C) date of
birth;
(D) a copy of social
security card or other official document showing the social security number as
approved by the board; and
(E) a
copy of current driver's license, state issued photo identification card, or
passport.
(2) For
purposes of this subsection, managing officers are defined as the top four
executive officers, including the corporate officer in charge of pharmacy
operations, who are designated by the partnership or corporation to be jointly
responsible for the legal operation of the pharmacy.
(d) Change of Ownership.
(1) When a pharmacy changes ownership, a new
pharmacy application must be filed with the board following the procedures as
specified in §
291.1 of this title (relating to
Pharmacy License Application), including, as required by §560.052(b) of
the Act, the submission of a sworn disclosure statement as specified in §
291.4 of this title (relating to
Sworn Disclosure Statement). In addition, a copy of the purchase contract or
mutual agreement between the buyer and seller must be submitted.
(2) A fee as specified in §
291.6 of this title will be
charged for issuance of a new license.
(e) Change of Pharmacist Employment.
(1) Change of pharmacist employed in a
pharmacy. When a change in pharmacist employment occurs, the pharmacist shall
report such change in writing to the board within 10 days.
(2) Change of pharmacist-in-charge of a
pharmacy. The incoming pharmacist-in-charge shall be responsible for notifying
the board within 10 days in writing on a form provided by the board that a
change of pharmacist-in-charge has occurred. The notification shall include the
following:
(A) the name and license number of
the departing pharmacist-in-charge;
(B) the name and license number of the
incoming pharmacist-in-charge;
(C)
the date the incoming pharmacist-in-charge became the pharmacist-in-charge;
and
(D) a statement signed by the
incoming pharmacist-in-charge attesting that:
(i) an inventory, as specified in §
291.17 of this title (relating to
Inventory Requirements), has been conducted by the departing and incoming
pharmacists-in-charge; if the inventory was not taken by both pharmacists, the
statement shall provide an explanation; and
(ii) the incoming pharmacist-in-charge has
read and understands the laws and rules relating to this class of
pharmacy.
(f) Notification of Theft or Loss of a
Controlled Substance or a Dangerous Drug.
(1)
Controlled substances. For the purposes of the Act, §562.106, the theft or
significant loss of any controlled substance by a pharmacy shall be reported in
writing to the board immediately on discovery of such theft or loss. A pharmacy
shall be in compliance with this subsection by submitting to the board a copy
of the Drug Enforcement Administration (DEA) report of theft or loss of
controlled substances, DEA Form 106, or by submitting a list of all controlled
substances stolen or lost.
(2)
Dangerous drugs. A pharmacy shall report in writing to the board immediately on
discovery the theft or significant loss of any dangerous drug by submitting a
list of the name and quantity of all dangerous drugs stolen or lost.
(g) Fire or Other Disaster. If a
pharmacy experiences a fire or other disaster, the following requirements are
applicable.
(1) Responsibilities of the
pharmacist-in-charge.
(A) The
pharmacist-in-charge shall be responsible for reporting the date of the fire or
other disaster which may affect the strength, purity, or labeling of drugs,
medications, devices, or other materials used in the diagnosis or the treatment
of injury, illness, and disease; such notification shall be reported to the
board, within 10 days from the date of the disaster.
(B) The pharmacist-in-charge or designated
agent shall comply with the following procedures.
(i) If controlled substances, dangerous
drugs, or Drug Enforcement Administration (DEA) order forms are lost or
destroyed in the disaster, the pharmacy shall:
(I) notify the DEA and the board of the loss
of the controlled substances or order forms immediately upon discovery;
and
(II) notify the board in
writing of the loss of the dangerous drugs by submitting a list of the
dangerous drugs lost.
(ii) If the extent of the loss of controlled
substances or dangerous drugs is not able to be determined, the pharmacy shall:
(I) take a new, complete inventory of all
remaining drugs specified in §
291.17(c) of
this title (relating to Inventory Requirements);
(II) submit to the DEA a statement attesting
that the loss of controlled substances is indeterminable and that a new,
complete inventory of all remaining controlled substances was conducted and
state the date of such inventory; and
(III) submit to the board a statement
attesting that the loss of controlled substances and dangerous drugs is
indeterminable and that a new, complete inventory of the drugs specified in
§
291.17(c) of
this title was conducted and state the date of such
inventory.
(C)
If the pharmacy changes to a new, permanent location, the pharmacist-in-charge
shall comply with subsection (a) of this section.
(D) If the pharmacy moves to a temporary
location, the pharmacist shall comply with subsection (a) of this section. If
the pharmacy returns to the original location, the pharmacist-in-charge shall
again comply with subsection (a) of this section.
(E) If the pharmacy closes due to fire or
other disaster, the pharmacy may not be closed for longer than 90 days as
specified in §
291.11 of this title (relating to
Operation of a Pharmacy).
(F) If
the pharmacy discontinues business (ceases to operate as a pharmacy), the
pharmacist-in-charge shall comply with §
291.5 of this title (relating to
Closing a Pharmacy).
(G) The
pharmacist-in-charge shall maintain copies of all inventories, reports, or
notifications required by this section for a period of two years.
(2) Drug stock.
(A) Any drug which has been exposed to
excessive heat, smoke, or other conditions which may have caused deterioration
shall not be dispensed.
(B) Any
potentially adulterated or damaged drug shall only be sold, transferred, or
otherwise distributed pursuant to the provisions of the Texas Food Drug and
Cosmetics Act (Chapter 431, Health and Safety Code) administered by the Bureau
of Food and Drug Safety of the Texas Department of State Health
Services.
(h)
Notification to Consumers.
(1) Pharmacy.
(A) Every licensed pharmacy shall provide
notification to consumers of the name, mailing address, Internet site address,
and telephone number of the board for the purpose of directing complaints
concerning the practice of pharmacy to the board. Such notification shall be
provided as follows.
(i) If the pharmacy
serves walk-in customers, the pharmacy shall either:
(I) post in a prominent place that is in
clear public view where prescription drugs are dispensed:
(-a-) a sign which notifies the consumer that
complaints concerning the practice of pharmacy may be filed with the board and
list the board's name, mailing address, Internet site address, telephone
number, and a toll-free telephone number for filing complaints; or
(-b-) an electronic messaging system in a
type size no smaller than ten-point Times Roman which notifies the consumer
that complaints concerning the practice of pharmacy may be filed with the board
and list the board's name, mailing address, Internet site address, telephone
number, and a toll-free number for filing complaints; or
(II) provide with each dispensed prescription
a written notification in a type size no smaller than ten-point Times Roman
which states the following: "Complaints concerning the practice of pharmacy may
be filed with the Texas State Board of Pharmacy at: (list the mailing address,
Internet site address, telephone number of the board, and a toll-free telephone
number for filing complaints)."
(ii) If the prescription drug order is
delivered to patients at their residence or other designated location, the
pharmacy shall provide with each dispensed prescription a written notification
in type size no smaller than ten-point Times Roman which states the following:
"Complaints concerning the practice of pharmacy may be filed with the Texas
State Board of Pharmacy at: (list the mailing address, Internet site address,
telephone number, and a toll-free telephone number for filing complaints)." If
multiple prescriptions are delivered to the same location, only one such notice
shall be required.
(iii) The
provisions of this subsection do not apply to prescriptions for patients in
facilities where drugs are administered to patients by a person required to do
so by the laws of the state (i.e., nursing homes).
(B) A pharmacy that maintains a generally
accessible site on the Internet that is located in Texas or sells or
distributes drugs through this site to residents of this state shall post the
following information on the pharmacy's initial home page and on the page where
a sale of prescription drugs occurs.
(i)
Information on the ownership of the pharmacy, to include at a minimum, the:
(I) owner's name or if the owner is a
partnership or corporation, the partnership's or corporation's name and the
name of the chief operating officer;
(II) owner's address;
(III) owner's telephone number; and
(IV) year the owner began operating
pharmacies in the United States.
(ii) The Internet address and toll free
telephone number that a consumer may use to:
(I) report medication/device problems to the
pharmacy; and
(II) report business
compliance problems.
(iii) Information about each pharmacy that
dispenses prescriptions for this site, to include at a minimum, the:
(I) pharmacy's name, address, and telephone
number;
(II) name of the pharmacist
responsible for operation of the pharmacy;
(III) Texas pharmacy license number for the
pharmacy and a link to the Internet site maintained by the Texas State Board of
Pharmacy; and
(IV) the names of all
other states in which the pharmacy is licensed, the license number in that
state, and a link to the Internet site of the entity that regulates pharmacies
in that state, if available.
(C) A pharmacy whose Internet site has been
verified by the National Association of Boards of Pharmacy to be in compliance
with the laws of this state, as well as in all other states in which the
pharmacy is licensed shall be in compliance with subparagraph (B) of this
paragraph.
(2) Texas
State Board of Pharmacy. On or before January 1, 2005, the board shall
establish a pharmacy profile system as specified in §
2054.2606, Government
Code.
(A) The board shall make the pharmacy
profiles available to the public on the agency's Internet site.
(B) A pharmacy profile shall contain at least
the following information:
(i) name, address,
and telephone number of the pharmacy;
(ii) pharmacy license number, licensure
status, and expiration date of the license;
(iii) the class and type of the
pharmacy;
(iv) ownership
information for the pharmacy;
(v)
names and license numbers of all pharmacists working at the pharmacy;
(vi) whether the pharmacy has had prior
disciplinary action by the board;
(vii) whether the pharmacy's consumer service
areas are accessible to disabled persons, as defined by law;
(viii) the type of language translating
services, including translating services for persons with impairment of
hearing, that the pharmacy provides for consumers; and
(ix) insurance information including whether
the pharmacy participates in the state Medicaid program.
(C) The board shall gather this information
on initial licensing and update the information in conjunction with the license
renewal for the pharmacy.
(i) Notification of Licensees or Registrants
Obtaining Controlled Substances or Dangerous Drugs by Forged Prescriptions. If
a licensee or registrant obtains controlled substances or dangerous drugs from
a pharmacy by means of a forged prescription, the pharmacy shall report in
writing to the board immediately on discovery of such forgery. A pharmacy shall
be in compliance with this subsection by submitting to the board the following:
(1) name of licensee or registrant obtaining
controlled substances or dangerous drugs by forged prescription;
(2) date(s) of forged
prescription(s);
(3) name(s) and
amount(s) of drug(s); and
(4)
copies of forged prescriptions.
(j) Notification of Disciplinary Action. For
the purpose of the Act, §562.106, a pharmacy shall report in writing to
the board not later than the 10th day after the date of:
(1) a final order against the pharmacy
license holder by the regulatory or licensing agency of the state in which the
pharmacy is located if the pharmacy is located in another state; or
(2) a final order against a pharmacist who is
designated as the pharmacist-in-charge of the pharmacy by the regulatory or
licensing agency of the state in which the pharmacy is located if the pharmacy
is located in another state.
(k) Temporary Closing for Loss of
Pharmacist-in-Charge. A pharmacy that temporarily closes for loss of a
pharmacist-in-charge as provided by §
291.5(d)(2) of
this title shall notify the board in writing on a form provided by the board.
The pharmacy shall submit the notification not later than the next business day
after the date of departure of the pharmacist-in-charge.
Notes
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