| (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.
|
| Source Note: The provisions of this §291.3 adopted to be effective September 18, 2007, 32 TexReg 6318; amended to be effective June 7, 2009, 34 TexReg 3390; amended to be effective March 10, 2011, 36 TexReg 1511; amended to be effective June 7, 2012, 37 TexReg 4046; amended to be effective March 15, 2015, 40 TexReg 1086; amended to be effective December 6, 2015, 40 TexReg 8765; amended to be effective June 11, 2017, 42 TexReg 2931; amended to be effective January 4, 2018, 42 TexReg 7691; amended to be effective September 16, 2018, 43 TexReg 5779; amended to be effective March 5, 2020, 45 TexReg 1423; amended to b e effective December 4, 2023, 48 TexReg 7047 |
