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CHAPTER 291 – PHARMACIES
SUBCHAPTER A – ALL CLASSES OF PHARMACIES
§291.1 Pharmacy License Application (a) To qualify for a pharmacy license, the applicant must submit an application which includes any information requested on the application. (b) The applicant may be required to meet all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and being responsible for all associated costs. The criminal history information may be required for each individual owner, or if the pharmacy is owned by a partnership or a closely held corporation for each managing officer. (c) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance of a pharmacy license. (d) For purpose of this section, 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. (e) Prior to the issuance of a license for a pharmacy located in Texas, the board shall conduct an on-site inspection of the pharmacy in the presence of the pharmacist-in-charge and owner or representative of the owner, to ensure that the pharmacist-in-charge and owner can meet the requirements of the Texas Pharmacy Act and Board Rules. (f) If the applicant holds an active pharmacy license in Texas on the date of application for a new pharmacy license or for other good cause shown as specified by the board, the board may waive the pre-inspection as set forth in subsection (e) of this section.
§291.2 Definitions Any term not defined in this chapter shall have the definition set out in the Act, §551.003.
§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) The previously issued license must be returned to the board office. (C) An amended license reflecting the new location 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 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
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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) The previously issued license must be returned to the board office. (3) An amended license reflecting the new name of the pharmacy will be issued by the board; and (4) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance of the amended license. (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 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). In addition, a copy of the purchase contract or mutual agreement between the buyer and seller must be submitted. (2) The license issued to the previous owner must be returned to the board. (3) 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.
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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:
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(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.
§291.5 Closing a Pharmacy (a) Prior to closing. At least 14 days prior to the closing of a pharmacy that dispenses prescription drug orders the pharmacist-in-charge shall:
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§291.6 Pharmacy License Fees (a) Initial License Fee. The fee for an initial license shall be $459 for the initial registration period. (b) Biennial License Renewal. The Texas State Board of Pharmacy shall require biennial renewal of all pharmacy licenses provided under the Act §561.002. (c) Renewal Fee. The fee for biennial renewal of a pharmacy license shall be $456 for the renewal period. (d) Duplicate or Amended Certificates. The fee for issuance of a duplicate pharmacy license renewal certificate shall be $20. The fee for issuance of an amended pharmacy license renewal certificate shall be $100.
§291.7 Prescription Drug Recalls by the Manufacturer (a) The pharmacist-in-charge shall develop and implement a written procedure for proper management of drug recalls by the manufacturer. Such procedures shall include, where appropriate, contacting patients to whom the recalled drug products have been dispensed. (b) The written procedure shall include, but not be limited to, the following: (1) the pharmacist-in-charge shall reasonably ensure that a recalled drug has been removed from inventory no more than 24 hours after receipt of the recall notice, and quarantined until proper disposal or destruction of the drug; and (2) if the drug that is the subject to a recall is maintained by the pharmacy in a container without a lot number, the pharmacist-in-charge shall consider this drug included in the recall.
§291.8 Return of Prescription Drugs (a) General prohibition on return of prescription drugs. As specified in §431.021(w), Health and Safety Code, a pharmacist may not accept an unused prescription or drug, in whole or in part, for the purpose of resale or re-dispensing to any person, after the prescription or drug has been originally dispensed, or sold except as provided in subsection (b) of this section. (b) Return of prescription drugs from health care facilities. (1) Purpose. The purpose of this subsection is to outline procedures for the return of unused drugs from a health care facility or a penal institution to a dispensing pharmacy as specified in the §562.1085 of the Occupations Code. Nothing in this section shall require a consultant pharmacist, health care facility, penal institution, or pharmacy to participate in the return of unused drugs. (2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (A) Consultant pharmacist--A pharmacist who practices in or serves as a consultant for a health care facility in this state. (B) Health care facility--A facility regulated under Chapter 242, Health and Safety Code. (C) Licensed health care professional--A person licensed by the Texas Medical Board, Texas Board of Nurse Examiners, or the Texas State Board of Pharmacy. (D) Penal institution--A place designated by law for confinement of persons arrested for, charged with, or convicted of an offense. A penal institution includes a city, county or state jail or prison. (3) Responsibilities. A licensed health care professional in a penal institution or a consultant pharmacist may return to a pharmacy certain unused drugs, other than a controlled substance as defined by Chapter 481, Health and Safety Code, purchased from the pharmacy. (A) The unused drugs must: (i) be approved by the federal Food and Drug Administration and be: (I) sealed in unopened tamper-evident packaging and either individually packaged or packaged in unit-dose packaging; (II) oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration;
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(III) topical or inhalant drugs in sealed unit-of-use containers approved by the federal Food and Drug Administration; or (IV) parenteral medications in sealed multiple-dose containers approved by the federal Food and Drug Administration from which doses have not been withdrawn. (ii) not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer; and (iii) have not been in the physical possession of the person for whom it was prescribed. (B) A healthcare facility or penal institution may not return any drug product that: (i) has been compounded; (ii) appears on inspection to be adulterated; (iii) requires refrigeration; or (iv) has less than 120 days until the expiration date or end of the shelf life. (C) The consultant pharmacist or licensed health care professional in a penal institution shall be responsible for assuring an inventory of the drugs to be returned to a pharmacy is completed. The following information shall be included on this inventory: (i) name and address of the facility or institution; (ii) name and pharmacist license number of the consultant pharmacist or name and license number of the licensed health care professional; (iii) date of return; (iv) date the prescription was dispensed; (v) unique identification number assigned to the prescription by the pharmacy; (vi) name of dispensing pharmacy; (vii) name, strength, and quantity of drug; (viii) signature of consultant pharmacist or licensed healthcare professional responsible for the administration of drugs in a penal institution. (D) The health care facility/penal institution shall send a copy of the inventory specified in subparagraph (C) of this paragraph to: (i) the pharmacy with the drugs returned; and (ii) the Health and Human Services Commission. (4) Dispensing/Receiving pharmacy responsibilities. If a pharmacy accepts the return of unused drugs from a health care facility/penal institution, the following is applicable. (A) A pharmacist employed by the pharmacy shall examine the drugs to ensure the integrity of the drug product. (B) The pharmacy shall reimburse or credit the entity that paid for the drug including the state Medicaid program for an unused drug returned to the pharmacy. The pharmacy shall maintain a record of the credit or reimbursement containing the following information: (i) name and address of the facility or institution which returned the drugs; (ii) date and amount of the credit or reimbursement was issued; (iii) name of the person or entity to whom the credit or reimbursement was issued; (iv) date the prescription was dispensed; (v) unique identification number assigned to the prescription by the pharmacy; (vi) name, strength, and quantity of drug; (vii) signature of the pharmacist responsible for issuing the credit. (C) After the pharmacy has issued credit or reimbursement, the pharmacy may restock and redispense the unused drugs returned under this section. (5) Limitation on Liability. (A) A pharmacy that returns unused drugs and a manufacturer that accepts the unused drugs under §562.1085, Occupations Code, and the employees of the pharmacy or manufacturer are not liable for
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§291.11 Operation of a Pharmacy (a) For the purposes of §565.002(7) of the Texas Pharmacy Act, the following words and terms shall be defined as follows. (1) "Failure to engage in the business described in the application for a license" means the holder of a pharmacy license has not commenced operating the pharmacy within six months of the date of issuance of the license. (2) "Ceased to engage in the business described in the application for a license" means the holder of a pharmacy license, once it has been in operation, discontinues operating the pharmacy for a period of 30 days or longer unless the pharmacy experiences a fire or disaster, in which case the pharmacy must comply with §291.3(f) of this title (relating to Notifications). (b) For the purposes of this section, the term "operating the pharmacy" means the pharmacy shall demonstrate observable pharmacy business activity on a regular, routine basis, including a sufficient number of transactions of receiving, processing, or dispensing prescription drug orders or medication drug orders. (c) No person may operate a pharmacy in a personal residence.
§291.14 Pharmacy License Renewal (a) Renewal requirements. (1) A license to operate a pharmacy expires on the last day of the assigned expiration month. (2) The provision of the Act, §561.005, shall apply if the completed application and a renewal fee is not received in the board's office on or before the last day of the assigned expiration month. (3) An expired license may be renewed according to the following schedule: (A) If the license has been expired for 90 days or less, the license may be renewed by paying to the board a renewal fee that is equal to one and one-half times the required renewal fee as specified in §291.6 of this title (relating to Pharmacy License Fees). (B) If the license has been expired for 91 days or more, the license may not be renewed. The pharmacy may apply for a new license as specified in §291.1 of this title (relating to Pharmacy License Application). (b) If the board determines on inspection at the pharmacy's address on or after the expiration date of the license that no pharmacy is located or exists at the pharmacy's address (e.g., the building is vacated or for sale or lease, or another business is operating at the location), the board shall not renew the license. (c) Additional renewal requirements for Class E pharmacies. In addition to the renewal requirements in subsection (a) of this section, a Class E pharmacy shall have on file with the Board an inspection report issued: (1) not more than three years before the date the renewal application is received; and (2) by the pharmacy licensing board in the state of the pharmacy's physical location except as provided in §291.104 of this title (relating to Operational Standards).
§291.15 Storage of Drugs All drugs shall be stored at the proper temperature and conditions as defined by the following terms: (1) Freezer--A place in which the temperature is maintained thermostatically between minus 25 degrees Celsius and minus 10 degrees Celsius (minus 13 degrees Fahrenheit and 14 degrees Fahrenheit). (2) Cold--Any temperature not exceeding 8 degrees Celsius (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 degrees Celsius and 8 degrees Celsius (36 degrees Fahrenheit and 46 degrees Fahrenheit). (3) Cool--Any temperature between 8 degrees Celsius and 15 degrees Celsius (46 degrees Fahrenheit and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph. (4) Room temperature--The temperature prevailing in a working area. (5) Controlled room temperature--A temperature maintained thermostatically between 15 degrees Celsius and 30 degrees Celsius (59 degrees Fahrenheit and 86 degrees Fahrenheit).
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(6) Warm--Any temperature between 30 degrees Celsius and 40 degrees Celsius (86 degrees Fahrenheit and 104 degrees Fahrenheit). (7) Excessive heat--Any temperature above 40 degrees Celsius (104 degrees Fahrenheit). (8) Protection from freezing--Where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing. (9) Dry place--A place that does not exceed 40% average relative humidity at controlled room temperature or the equivalent water vapor pressure at other temperatures.
§291.16 Samples Unless otherwise specified, a pharmacy may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions: (1) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (2) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost; (3) the samples are for dispensing or provision at no charge to patients of such health care entity; and (4) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1987.
§291.17 Inventory Requirements (a) General requirements. (1) The pharmacist-in-charge shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person(s). (2) The inventory shall be maintained in a written, typewritten, or printed form. An inventory taken by use of an oral recording device must be promptly transcribed. (3) The inventory shall be kept in the pharmacy and shall be available for inspection for two years. (4) The inventory shall be filed separately from all other records. (5) The inventory shall be in a written, typewritten, or printed form and include all stocks of all controlled substances on hand on the date of the inventory (including any which are out-of-date). (6) The inventory may be taken either as of the opening of business or as of the close of business on the inventory date. (7) The inventory record shall indicate whether the inventory is taken as of the opening of business or as of the close of business on the inventory date. If the pharmacy is open 24 hours a day, the inventory record shall indicate the time that the inventory was taken. (8) The person(s) taking the inventory shall make an exact count or measure of all controlled substances listed in Schedule II. (9) The person(s) taking the inventory shall make an estimated count or measure of all controlled substances listed in Schedules III, IV, and V, unless the container holds more than 1,000 tablets or capsules in which case, an exact count of the contents must be made. (10) The inventory of Schedule II controlled substances shall be listed separately from the inventory of Schedules III, IV, and V controlled substances. (11) If the pharmacy maintains a perpetual inventory of any of the drugs required to be inventoried, the perpetual inventory shall be reconciled on the date of the inventory. (b) Initial inventory. (1) A new Class A, Class A-S, Class C, Class C-S, or Class F pharmacy shall take an inventory on the opening day of business. Such inventory shall include all stocks of all controlled substances (including any out-of-date drugs). (2) In the event the Class A, Class A-S, Class C, Class C-S, or Class F pharmacy commences business with no controlled substances on hand, the pharmacy shall record this fact as the initial inventory.
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(g) Change of pharmacist-in-charge of a pharmacy. (1) On the date of the change of the pharmacist-in-charge of a Class A, Class A-S, Class C, Class C-S, or Class F pharmacy, an inventory shall be taken. Such inventory shall include all stocks of all controlled substances (including any out-of-date drugs). (2) This inventory shall constitute, for the purpose of this section, the closing inventory of the departing pharmacist-in-charge and the beginning inventory of the incoming pharmacist-in-charge. (3) 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. (4) The incoming pharmacist-in-charge shall be responsible for notifying the board within 10 days, as specified in §291.3 of this title (relating to Required Notifications), that a change of pharmacist-in-charge has occurred.
§291.18 Time Limit for Filing a Complaint For the purposes of the Act, §556.055, the board determines that a "reasonable time" to be no less than 10 days from the date of an inspection giving rise to a possible complaint; provided, however, in situations presenting imminent danger to the public health and safety, the board may obtain an injunction under the Act, §566.051, to restrain or enjoin a person from continuing to violate the Act or rules promulgated pursuant to the Act without waiting the 10-day period set out in this section.
§291.19 Administrative Actions as a Result of a Compliance Inspection As a result of a compliance inspection or compliance reinspection of a pharmacy wherein violations of the Texas Pharmacy Act, Controlled Substances Act, Dangerous Drug Act, Texas Food, Drug and Cosmetic Act, or rules adopted pursuant to such acts are observed: (1) an agent of the board may issue a written report of areas of non-compliance that need improvement; (2) an agent of the board may issue a written warning notice listing specific violations to which the licensee shall respond in writing to the board by the date stated on the warning notice, indicating that the violations listed in the warning notice will be corrected; (3) an agent of the board may recommend the institution of disciplinary action against a licensee if such agent determines that: (A) previously cited violations are continuing to occur; or (B) violations observed are of a nature that written notice of non-compliance or a written warning notice would not be in the best interest of the public; or (4) an agent of the board, upon determination that the violations observed are of a nature that pose an imminent peril to the public health, safety, or welfare, may recommend to the director of compliance, the institution of action by a district court in Travis County, Texas, to restrain or enjoin a licensee from continuing the violation, in addition to recommending the institution of disciplinary action against a licensee.
§291.22 Petition to Establish an Additional Class of Pharmacy (a) Purpose. The purpose of this section is to specify the procedures to be followed in petitioning the board to establish an additional class of pharmacy as authorized by §560.053 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas Occupations Code). In reviewing petitions, the board will only consider petitions that provide pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any petition intended only to provide a competitive advantage. (b) Procedures for petitioning the board to establish an additional class of pharmacy. A person who wishes the board to consider establishing an additional class of pharmacy shall submit to the board a petition that contains at least the following information: (1) name, address, telephone number, and pharmacist's license number of the pharmacist responsible for submitting the petition;
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(2) a detailed summary of the additional class of pharmacy which includes: (A) a description of the type of pharmacy and the pharmaceutical care services provided to the public; (B) if a pharmacy of this type currently exists, the name, address, and license number of the pharmacy; (C) a full explanation of the reasons: (i) the existing classifications of pharmacy licenses are not appropriate for this practice setting; and (ii) that establishment of a new classification of pharmacy license is necessary to protect the public health, safety, and welfare. (c) Review and approval or denial of the petition. (1) On receipt of a petition to establish an additional class of pharmacy, board staff shall initially review the petition for completeness and appropriateness. If the petition is incomplete or inappropriate for board consideration for any reason, board staff shall return the petition with a letter of explanation. Such review shall be completed within 30 working days of receipt of the petition. (2) Once board staff has determined that the petition is complete and appropriate, a task force composed of board staff, at least one board member and, if deemed necessary, resource personnel appointed by the board president, shall review the petition and make a written recommendation to the board regarding approval. Such recommendation shall be presented to the board at the next regularly scheduled meeting of the board that occurs at least three weeks after completion of the review and written recommendation. (3) A copy of the recommendation shall be provided to the petitioner and the board at least two weeks prior to the board meeting. (4) Both the petitioner and a representative of the task force shall be given equal time for presentations to the board. (5) Upon hearing the presentations, the board shall approve or deny the petition. If the board approves the petition, the board shall direct staff to develop rules for the new class of pharmacy or appoint a task force to work with the staff to assist in developing rules for the new class of pharmacy. The board shall approve or deny any petition to establish an additional class of pharmacy not later than the board meeting following the meeting at which the petition is heard.
§291.23 Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy (a) Purpose. The purpose of this section is to specify the procedures to be followed in applying for approval of a pilot or demonstration research project for innovative applications in the practice of pharmacy as authorized by §554.011 of the Texas Pharmacy Act (Chapters 551- 566 and 568 - 569, Texas Occupations Code). In reviewing projects, the board will only consider projects that expand pharmaceutical care services which contribute to positive patient outcomes. The board will not consider any project intended only to provide a competitive advantage. (b) Scope of pilot or demonstration research projects and the board's approval of such projects. (1) Pilot or demonstration research projects may not: (A) expand the definition of the practice of pharmacy as provided in the Act; or (B) include therapeutic substitution or substitution of medical devices used in patient care. (2) The board's approval of pilot or demonstration research projects may include the granting of an exception to the rules adopted under the Texas Pharmacy Act, but may not include an exception from any law relating to the practice of pharmacy. Such exception to the rules shall be for a specified period of time and such period may not exceed 18 months. (3) The board may extend the time an exception to a rule is granted as necessary for the board to adopt an amendment or modification of the rule. (c) Procedures for applying for approval of pilot or demonstration research projects. A person who wishes the board to consider approval of a pilot or demonstration research project shall submit to the board a petition for approval which contains at least the following information:
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For the purposes of Subchapter T, Chapter 61, Education Code, the standards for pharmacy residency programs shall be the standards required by the American Society of Health-System Pharmacists' Commission on Credentialing. The pharmacy residency programs approved by the Board shall be published periodically in the minutes of the Board.
§291.27 Confidentiality (a) A pharmacist shall provide adequate security of prescription drug orders, medication orders, and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. If prescription drug orders, requests for refill authorization, or other confidential health information are not transmitted directly between a pharmacy and a physician but are transmitted through a data communication device, confidential health information may not be accessed or maintained by the operator of the data communication device unless specifically authorized to obtain the confidential information by this section. (b) Confidential records are privileged and may be released only to: (1) the patient or the patient's agent; (2) a practitioner or another pharmacist if, in the pharmacist's professional judgement, the release is necessary to protect the patient's health and well being; (3) the board or to a person or another state or federal agency authorized by law to receive the confidential record; (4) a law enforcement agency engaged in investigation of a suspected violation of 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.); (5) a person employed by a state agency that licenses a practitioner, if the person is performing the person's official duties; or (6) an insurance carrier or other third party payor authorized by a patient to receive such information. (c) A pharmacy shall provide written polices and procedures to prohibit the unauthorized disclosure of confidential records.
§291.28 Access to Confidential Records (a) Access to confidential records. A pharmacy shall comply with the request of a patient or a patient's agent to inspect or obtain a copy of the patient's confidential records maintained by the pharmacy, as defined in §551.003(10) of the Act. A pharmacy shall comply with all relevant state and federal laws regarding release of confidential records to third party requestors. (b) Form of request. The pharmacy may require a patient or a patient's agent or any authorized third party to make requests for confidential records in writing, provided such a requirement has been communicated to the requestor. (c) Timely action by pharmacy. The pharmacy must respond to a request for confidential records in a timely manner. (1) The pharmacy must respond to a request for confidential records no later than fifteen days after receipt of the request by providing a copy of the records or, with the consent of the requestor, a summary or explanation of such information. (2) The pharmacy must provide confidential records as requested in a mutually agreed upon format. (3) Access to confidential records may be expedited at the request of a patient or a patient's agent if there is a medical emergency. The pharmacy must respond to a request for expedited access to confidential records within 24 hours if the records are maintained at the pharmacy or within 72 hours if the records are stored off- site. The pharmacy may charge a reasonable fee, in addition to the fees outlined in subsection (d) of this section, of no more than $25.00 for expediting a request for access to confidential records. (d) Fees. The pharmacy may charge a reasonable, cost-based fee for providing a copy of confidential records or a summary or explanation of such information. (1) A reasonable fee shall be a charge of no more than $50.00 for the first twenty pages and $0.50 per page for every page thereafter. A reasonable fee shall include only the cost of: (A) copying, including the cost of supplies for and labor of copying;
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(B) postage, when the individual has requested the records be mailed; and (C) preparing an explanation or summary of the protected health information, if appropriate and consented to by the patient or patient's agent. (2) If an affidavit is requested certifying that the information is a true and correct copy of the records, a reasonable fee of no more than $15.00 may be charged for executing the affidavit. (3) If an affidavit or questionnaire accompanies the request, the pharmacy may charge a reasonable fee of no more than $50.00 to complete the written response.
§291.29 Professional Responsibility of Pharmacists (a) A pharmacist shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order dispensed. If the pharmacist questions the accuracy or authenticity of a prescription drug order, the pharmacist shall verify the order with the practitioner prior to dispensing. (b) A pharmacist shall make every reasonable effort to ensure that any prescription drug order, regardless of the means of transmission, has been issued for a legitimate medical purpose by a practitioner in the course of medical practice. A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued without a valid pre-existing patient-practitioner relationship as defined by the Texas Medical Board in 22 Texas Administrative Code (TAC) §190.8 (relating to Violation Guidelines) or without a valid prescription drug order. (1) A prescription drug order may not be dispensed or delivered by means of the Internet unless pursuant to a valid prescription that was issued for a legitimate medical purpose in the course of medical practice by a practitioner, or practitioner covering for another practitioner. (2) A prescription drug order may not be dispensed or delivered if the pharmacist has reason to suspect that the prescription drug order may have been authorized in the absence of a valid patient-practitioner relationship, or otherwise in violation of the practitioner's standard of practice to include that the practitioner: (A) did not establish a diagnosis through the use of acceptable medical practices for the treatment of patient's condition; (B) prescribed prescription drugs that were not necessary for the patient due to a lack of a valid medical need or the lack of a therapeutic purpose for the prescription drugs; or (C) issued the prescriptions outside the usual course of medical practice. (3) Notwithstanding the provisions of this subsection and as authorized by the Texas Medical Board in 22 TAC §190.8, a pharmacist may dispense a prescription when a physician has not established a professional relationship with a patient if the prescription is for medications for: (A) sexually transmitted diseases for partners of the physician's established patient; or (B) a patient's family members if the patient has an illness determined by the Centers for Disease Control and Prevention, the World Health Organization, or the Governor's office to be pandemic. (c) If a pharmacist has reasons to suspect that a prescription was authorized solely based on the results of a questionnaire and/or in the absence of a documented patient evaluation including a physical examination, the pharmacist shall ascertain if that practitioner's standard of practice allows that practitioner to authorize a prescription under such circumstances. Reasons to suspect that a prescription may have been authorized in the absence of a valid patient-practitioner relationship or in violation of the practitioner's standard of practice include: (1) the number of prescriptions authorized on a daily basis by the practitioner; (2) a disproportionate number of patients of the practitioner receive controlled substances; (3) the manner in which the prescriptions are authorized by the practitioner or received by the pharmacy; (4) the geographical distance between the practitioner and the patient or between the pharmacy and the patient; (5) knowledge by the pharmacist that the prescription was issued solely based on answers to a questionnaire; (6) knowledge by the pharmacist that the pharmacy he/she works for directly or indirectly participates in or is otherwise associated with an Internet site that markets prescription drugs to the public without requiring the patient to provide a valid prescription order from the patients practitioner; or
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(11) multiple persons with the same address present substantially similar controlled substance prescriptions from the same practitioner; (12) persons consistently pay for controlled substance prescriptions with cash or cash equivalents more often than through insurance; (13) persons presenting controlled substance prescriptions are doing so in such a manner that varies from the manner in which persons routinely seek pharmacy services (e.g., persons arriving in the same vehicle with prescriptions from same practitioner; one person seeking to pick up prescriptions for multiple others; drugs referenced by street names; (14) the pharmacy charges and persons are willing to pay significantly more for controlled substances relative to nearby pharmacies; (15) the pharmacy routinely orders controlled substances from more than one drug supplier; (16) the pharmacy has been discontinued by a drug supplier related to controlled substance orders; (17) the pharmacy has a sporadic and inconsistent dispensing volume (including zero dispensing); (18) the pharmacy does not maintain normal operational hours each week from Monday through Friday; and (19) the pharmacy has been previously warned or disciplined by the Texas State Board of Pharmacy for inappropriate dispensing of controlled substances.
