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TEXAS ADMINISTRATIVE CODE
TITLE 22. EXAMINING BOARDS
PART 15. TEXAS STATE BOARD OF PHARMACY
CHAPTER 291. PHARMACIES
SUBCHAPTER A. ALL CLASSES OF PHARMACIES
Date:
04/25/2014
Document:
§ 291.3. Required Notifications
(a) Change of Location and/or Name.
(1) When a pharmacy changes location and/or name, 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 within 10 days of the change of location of the pharmacy.
(B) The previously issued license must be returned to the board office.
(C) An amended license reflecting the new location and/or name of the pharmacy will be issued by the board; and
(D) A fee as specified in § 291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance of the amended license.
(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 cir-cumstances 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.
(b) 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 and the following information for all managing officers:
(A) name and title;
(B) home address and telephone number;
(C) date of birth; and
(D) social security number.
(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.
(c) Change of Ownership.
(1) When a pharmacy changes ownership, a new/completed pharmacy application must be filed with the board and the licensed issued to previous owner shall be returned to the board.
(2) The new application shall include the following information:
(A) the name and address of pharmacy;
(B) the type of ownership;
(C) the names, home addresses, dates of birth, phone numbers, and social security numbers of all owners; if a partnership or corporation, the name, title, home address, home phone number, date of birth, and social security number of all managing officers;
(D) the name and license number of the pharmacist-in-charge and of other pharmacists employed by the phar-macy;
(E) a copy of lease agreement or if the location of the pharmacy is owned by the applicant, a notarized statement certifying such location ownership;
(F) a copy of the purchase contract or mutual agreement between the buyer and seller, or a notarized statement of intent to convey ownership signed by both the buyer and seller, stating the proposed date of ownership change;
(G) the signature of the pharmacist-in-charge;
(H) the notarized signature of the owner, or if the pharmacy is owned by a partnership or corporation, the nota-rized signature of an owner or managing officer;
(I) federal tax ID number;
(J) description of business services that will be offered;
(K) name and address of malpractice insurance carrier or statement that the business will be self-insured;
(L) the certificate of authority, if applicant is an out-of-state corporation;
(M) the articles of incorporation, if the applicant is a corporation;
(N) a current Texas Franchise Tax Certificate of Good Standing; and
(O) any other information requested on the application.
(3) Paragraph (4) of this subsection applies to all change of ownership applications for Class A (Community) phar-macies, Class C (Institutional) pharmacies, or Class F (Freestanding Emergency Medical Care Center) pharmacies, owned by a management company with the following exceptions.
(A) Paragraph (4) of this subsection does not apply to a change of ownership application submitted by an entity which already owns a pharmacy licensed in Texas.
(B) Paragraph (4)(A) and (C) of this subsection do not apply to each individual owner or managing officer listed on a new pharmacy application if the individual possesses an active pharmacist license in Texas.
(4) If the pharmacy is to be licensed as a Class A (Community) Pharmacy, a Class C (Institutional) pharmacy, or a Class F (Freestanding Emergency Medical Care Center) pharmacy owned by a management company, the applicant must submit copies of the following documents in addition to the information required in paragraph (2) of this subsec-tion:
(A) the birth certificate, passport, or other document proving the date of birth of the owner, or, if the pharmacy is owned by a partnership or a closely held corporation: (i) one of these documents for each managing officer; and (ii) a list of all owners of the corporation;
(B) an approved credit application from a primary wholesaler or other documents showing credit worthiness as approved by the board; and
(C) a current driver license or state issued photo ID card of each individual owner, or, if the pharmacy is owned by a partnership or a closely held corporation, a current driver license or state issued photo ID card for each managing officer.
(5) A fee as specified in § 291.6 of this title will be charged for issuance of a new license.
(d) Change of Pharmacist Employment.
(1) Change of pharmacist employed in a pharmacy. When a change in pharmacist employment occurs, the phar-macist shall report such change in writing to the board within 10 days.
(2) Change of pharmacist-in-charge of a pharmacy.
(A) On the date of change of the pharmacist-in-charge of a Class A (Community), Class C (Institutional), or Class F (Freestanding Emergency Medical Care Center) pharmacy, an inventory specified in § 291.17 of this title (relating to Inventory Requirements) shall be taken.
(B) This inventory shall constitute, for the purpose of this section, the closing inventory of the departing pharma-cist-in-charge and the beginning inventory of the incoming pharmacist-in-charge.
(C) If the departing and the incoming pharmacists-in-charge are unable to conduct the inventory together, a closing inventory shall be conducted by the departing pharmacist-in-charge and a new and separate beginning inventory shall be conducted by the incoming pharmacist-in-charge.
(D) 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: (i) the name and license number of the departing pharmacist-in-charge; (ii) the name and license number of the incoming pharmacist-in-charge; (iii) the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and (iv) a statement signed by the incoming pharmacist-in-charge attesting that:
(I) an inventory 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 phar-macy.
(e) 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 Ad-ministration (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 signif-icant loss of any dangerous drug by submitting a list of the name and quantity of all dangerous drugs stolen or lost.
(f) Fire or Other Disaster. If a pharmacy experiences a fire or other disaster, the following requirements are appli-cable.
(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 the injury, illness, and disease; such notification shall be immediately reported to the board, but in no event shall exceed 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 dis-aster, the pharmacy shall:
(I) notify the DEA, Department of Public Safety (DPS), and Texas State Board of Pharmacy (board) of the loss of the controlled substances or order forms. A pharmacy shall be in compliance with this section by submitting to each of these agencies a copy of the DEA's report of theft or loss of controlled substances, DEA Form-106, immediately on discovery of the loss; and
(II) notify the Texas State Board of Pharmacy 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 DEA and DPS 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 inde-terminable 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 Operating 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 sec-tion 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 dete-rioration 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.
(g) 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 phar-macy 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 sign furnished by the board 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 of the board, and if appli-cable a toll-free telephone 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 if applicable 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 of the board, and if applicable 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 dis-tributes 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 phar-macy, 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 tel-ephone 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 awarded a Verified Internet Pharmacy Practice Site (VIPPS) certifica-tion by the National Association of Boards of Pharmacy shall be in compliance with subparagraph (B) of this paragraph by displaying the VIPPS seal on the pharmacy internet site.
(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 pro-gram.
(C) The board shall gather this information on initial licensing and update the information in conjunction with the license renewal for the pharmacy.
(h) Notification of Licensees or Registrants Obtaining Controlled Substances or Dangerous Drugs by Forged Pre-scriptions. 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.
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