Chapter C_Part2 PDF

Class A or Class C pharmacy. The pharmacist­in­charge of the Class A or Class C pharmacy is responsible for filling and loading the storage containers for med­ ication stored in bulk at the facility. C. An automated pharmacy system is required to be under the continuous super­ vision of a pharmacist...

Class A or Class C pharmacy. The pharmacist­in­charge of the Class A or Class C pharmacy is responsible for filling and loading the storage containers for med­ ication stored in bulk at the facility. C. An automated pharmacy system is required to be under the continuous super­ vision of a pharmacist as determined by Board rule. To qualify as continuous supervision for an automated pharmacy system, the pharmacist is not required to be physically present at the site of the automated pharmacy system and may supervise the system electronically. D. An automated pharmacy system may be located only at a healthcare facility reg­ ulated by the state. K. The Board shall adopt rules regarding the use of an automated pharmacy system under this section including: 1. The types of healthcare facilities at which an automated pharmacy system may be located, which shall include a facility regulated under Chapter 142 (home health and hospice), Chapter 242 (primarily nursing homes), or Chapter 252 (intermediate care facilities for mentally retarded), Health and Safety Code; 2. Recordkeeping requirements; and 3. Security requirements. Summary of Board of Pharmacy Rule 291.121(a) Remote Pharmacy Services Using Automated Pharmacy Systems (primarily used in nursing homes) Mote: The following is a summary of this rule. See the complete official language in Board Rule 291.121(a). 1. This rule allows a Class A or C pharmacy to provide pharmacy services to facilities licensed under Health and Safety Code Chapters 142 (Home and Community Support Service Agencies including hospices), 241 (Hospitals), 242 (Convalescent Homes, Nursing Homes, and Related Institutions), 247 (Assisted Living Facilities), and 252 (Intermediate Care Facilities for the Mentally Retarded) as well as jails or prisons operated by the State of Texas or local government. 2. Drugs may only be maintained in an automated pharmacy system. 3. II controlled substances are to be stored at the remote location using an automated pharmacy system, a DEA registration must be obtained for the remote location in the name of the pharmacy providing the remote phar­ macy services. 4. An application to TSBP is required prior to providing these services. A pharmacist may supervise the operation of the system electronically, and a pharmacist shall control all operations of the automated pharmacy system and approve the release of the initial dose after receiving a valid prescription drug order. 6. Drugs dispensed using the automated pharmacy system must meet the label­ ing requirements or alternative labeling requirements found in Board Rule 291.33(c)7. /. Drugs used in the automated pharmacy system must be in the original man­ ufacturer s container or be prepackaged in the provider pharmacy. Stocking ot drugs in an automated pharmacy system must be done by a phar­ macist, pharmacy technician, or pharmacy technician trainee unless the system uses removable cartridges or containers and other specific require­ ments of Board Rule 291.20(a)(4)(F)(ii) are met. 5. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore 9. A record must be maintained of all drugs sent to and returned from the remote location and should be kept separate from the records of the provider pharmacy and from other remote site records. 10. A perpetual inventory of all controlled substances must be maintained for each remote location. Each remote location's controlled substances must be inventoried on the same day as the provider pharmacy's inventory. Section 562.110 Telepharmacy Systems A. The statutory definitions for "Provider Pharmacy," "Remote Dispensing Site," and "Telepharmacy System" are as follows. 1. A Provider Pharmacy" means a Class A pharmacy that provides pharmacy­ services through a telepharmacy system at a remote dispensing site. Note: By Board rule, a provider pharmacy includes either a Class A or Class C pharmacy that provides pharmacy services through a telepharmacy system at a remote healthcare site or a Class A pharmacy that provides pharmacy ser vices through a telepharmacy system at a remote dispensing site. 2. B. C. D. E. F. A Remote Dispensing Site" means a location licensed as a telepharmacy that is authorized by a provider pharmacy through a telepharmacy system to store and dispense prescription drugs and devices, including dangerous drugs and controlled substances. 3. A "Telepharmacy System" means a system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method, including the use of the follow ing types of technology: a. Audio and video; b. Still image capture; and c. Store and forward. A Class A or Class C pharmacy located in this state may provide pharmacy ser­ vices, including the dispensing of drugs, through a telepharmacy system in loca­ tions separate from the Class A or Class C pharmacy. A telepharmacy system is required to be under the continuous supervision of a pharmacist as determined by Board rule. To qualify as continuous supervision for a telepharmacy system, the pharmacist is not required to be physically pres­ ent at the site of the telepharmacy system. The pharmacist shall supervise the system electronically by audio and video communication. A telepharmacy system may be located only at a healthcare facility in this state that is regulated by this state or the federal government or at a remote dispensing site. The Board shall adopt rules regarding the use of a telepharmacy system under this section, including: 1. The types of healthcare facilities at which a telepharmacy system may be located, which must include the following facilities: a. A clinic designated as a rural health clinic regulated under 42 U.S.C. Section 1395x(aa); b. A health center as defined by 42 U.S.C. Section 254b; and c. A federally qualified health center as defined by 42 U.S.C. Section 1396d(l)(2)(B); 2. The areas that qualify under F. below; 3. Recordkeeping requirements; and 4. Security requirements. Except as provided in F.l. below, a telepharmacy system in a healthcare facility may not be located in a community in which a Class A or Class C pharmacy is located as determined by Board rule. If a Class A or Class C pharmacy is estab­ lished in a community after a telepharmacy system has been located under this section, the telepharmacy system may continue to operate in that community. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore F.l. A telepharmacy system located at a federally qualified health center as defined by 42 U.S.C. Section 1396d(l)(2)(B) may be located in a community in which a Class A or Class C pharmacy is located as determined by Board rule. G. A telepharmacy system in a remote dispensing site may not be located within 22 miles by road of a Class A pharmacy. Summary of TPA Section 562.110 and Board of Pharmacy Rule 291.121(c) Remote Pharmacy Services Using Telepharmacy Systems Note: The following is a summary of this section of the Act and Board rule. See com­ plete official language in TPA Section 562.110 and Board of Pharmacy Rule 291.121(c). 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. These provisions allow certain provider pharmacies to provide telepharmacy services at two types of remote sites—remote healthcare sites and remote dispensing sites. A Class A or C pharmacy may provide pharmacy services through a tele­ pharmacy system, including the dispensing of drugs at remote healthcare sites which include: a. Rural health clinics regulated under 42 U.S.C. Section 1395x(aa); b. Health centers as defined by 42 U.S.C. Section 254b (serving medically underserved populations); c. Federally qualified health centers as defined by 42 U.S.C. Section 1396d(l)(2)(B); d. Healthcare facilitieslocated in a medically underserved area as determined by the United States Department of Health and Human Services; and e. Healthcare facilities located in a health professional shortage area as determined by the United States Department of Health and Human Services. A Class A pharmacy (but not a Class C pharmacy) may provide pharmacy services through a telepharmacy system, including the dispensing of drugs at remote dispensing sites. A telepharmacy system is a system that monitors the dispensing of prescrip­ tion drugs and provides for related drug use regimen and patient counseling services by an electronic method which includes the use of audio and video, still image capture, and store and forward. If controlled substances are to be stored at the remote location, a DEA regis­ tration must be obtained for the remote location. Drugs dispensed at the remote location through a telepharmacy system shall only be delivered to the patient or patient's agent at the remote location. A provider pharmacy may not supervise more than two remote sites. An application to TSBP is required before providing these services. A perpetual inventory of all controlled substances must be maintained for each remote location. Each remote location's controlled substances must be inventoried on the same day as the provider pharmacy's inventory. Original prescription records shall be kept at the remote site, and the pro­ vider pharmacy shall have electronic access to those records. A pharmacy that provides remote pharmacy services through a telephar­ macy system at a remote location shall operate according to a written pro­ gram tor quality assurance of the telepharmacy system. Remote Healthcare Sites. a. Except in federally qualified health centers, a pharmacy may not pro­ vide remote pharmacy services at a remote healthcare site if a Class A or Class C pharmacy that dispenses prescription drug orders to outpatients is located in the same community (as defined in the rule). Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Note: Community is defined by Board rule as within 10 miles if not in a metropolitan statistical area. b. Unlike a remote dispensing site, a remote healthcare site may have Schedule II controlled substances. 13. Remote Dispensing Sites. a. A remote dispensing site is a location licensed as a telepharmacy that is authorized by a provider pharmacy through a telepharmacy system to store and dispense drugs and devices, including dangerous drugs and controlled substances. b. A remote dispensing site must be staffed by an onsite pharmacy techni­ cian who is under the continuous supervision of a pharmacist employed by the provider pharmacy. c. Pharmacy technicians at a remote dispensing site must have worked at least one year at a retail pharmacy during the past three years and must complete a Board­approved training program on the proper use of a telepharmacy system. d. Pharmacy technicians at a remote dispensing site are included in the pharmacist­pharmacy technician ratio of the provider pharmacy, i hex­ may not perform extemporaneous sterile or nonsterile compounding but may prepare commercially available medications for dispensing, including reconstitution of orally administered powder antibiotics. Only a Class A pharmacy may serve as a provider pharmacy for a remote dispensing site. e. f. A remote dispensing site may not be located within 22 road miles of a Class A pharmacy. If a Class A pharmacy opens within that mileage restriction after a remote dispensing site is operating, the remote dis pensing site may continue to operate. g. A remote dispensing site may not dispense Schedule II controlled substances. h. If a remote dispensing site dispenses an average of more than 125 pre scriptions each day the site is open (calculated annually), it must apply for a Class A license. i. A pharmacist employed by a provider pharmacy must make at least monthly onsite visits to a remote dispensing site and must reconcile the perpetual inventory of controlled substances to the on­hand count at the remote dispensing site. 14. The chart below provides a summary and comparison of the two types of "remote sites" where telepharmacy is allowed. Remote Dispensing Sites Remote Healthcare Sites Provider pharmacy may be a Class A or Class C pharmacy. Provider pharmacy must be a Class A pharmacy. Provider pharmacy may not supervise more than two remote sites. Provider pharmacy may not supervise more than two remote sites. No restriction on drug classes. May not dispense Schedule II controlled substances. Does not require a pharmacy technician. Must be staffed by a pharmacy technician. Except in federally qualified health centers, may not be located if a Class A or Class C pharmacy dispensing to outpatients is within 10 miles (if not located in a metropolitan statistical area). May not be located if a Class A pharmacy is within 22 road miles. A DEA registration is required for controlled substances. A DEA registration is required for controlled substances. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Remote Dispensing Sites Remote Healthcare Sites Perpetual inventory of controlled substances is required. No special training for pharmacy technicians (if used). Perpetual inventory of controlled substances is required. Pharmacy technicians must have one year of retail experience and training on a telephar­ macy system. No requirement for pharmacist visits or reconciliation of controlled substances. Pharmacist employed by a provider pharmacy must make at least monthly onsite visits to a remote dispensing site and must reconcile the perpetual inventory of controlled substances to the on­hand count. No limit on prescriptions dispensed. If a remote dispensing site dispenses an average of more than 125 prescriptions each day the site is open (calculated annually), it must apply for a Class A license. Summary of Board of Pharmacy Rule 291.121(d) Remote Pharmacy Services Using Automated Dispensing and Delivery Systems Note: ihe following is a summary of this section of the Board rule. See complete official language in Board Rule 291.121(d). 1. This rule allows a Class A or Class C pharmacy to provide pharmacy ser­ vices using an automated dispensing and delivery system at a remote deliv­ ery site. 2. An automated dispensing and delivery system is a mechanical system that dispenses and delivers prescription drugs to patients at a remote delivery site and maintains related transaction information. Note: These systems may provide prescriptions that have already been labeled, packaged, and dispensed by the provider pharmacy or they may store bulk prescription drugs with the system doing the actual packaging, dispensing, and delivery. 3. 4. A provider pharmacy may only provide remote pharmacy services using an automated dispensing and delivery system at Board­approved remote deliv­ ery sites. An application for approval to provide such services must be sub­ mitted to the Board and be renewed every two years with the provider phar­ macy's pharmacy license. A provider pharmacy shall comply with appropriate controlled substance registrations for each remote delivery site if dispensed controlled substances are maintained within an automated dispensing and delivery system. Note: Pharmacists should be cautious about providing controlled substance prescriptions using an automated dispensing and delivery system at a location that is not registered with DEA or should seek confirmation from DEA that this is allowed. 5. Patients obtaining their prescriptions from an automated dispensing and delivery system shall receive counseling via direct link to audio or video communication by a Texas­licensed pharmacist who has access to the com­ plete patient medication records (patient profile) maintained by the provider pharmacy prior to release of any new prescription. Note: Counseling is not required for refill prescriptions. 6. A pharmacist must be accessible at all times to respond to patients' or other healthcare professionals' questions and needs pertaining to drugs delivered through the use of the system. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore 7. An automated dispensing and delivery system must be locked by key, combi­ nation, or other mechanical or electronic means to prohibit access by unau­ thorized personnel. There must also be a security system including security camei a(s) that records a digital image of the individual accessing the system to pick up a prescription. Notes 8. Access to an automated dispensing and delivery system is limited to phar­ macists and pharmacy technicians or pharmacy technician trainees under the direct supervision of a pharmacist. Stocking of dispensed prescriptions must be completed under the supervision of a pharmacist. 9. A pharmacy providing services through an automated dispensing and deliv ery system at a remote delivery site shall operate according to a written pro­ gram of quality assurance and written policies and procedures which: a. Requires continuous supervision of the automated dispensing and deliv ery system and b. Establishes mechanisms and procedures to routinely test the accuracy of the automated dispensing and delivery system at a minimum of every six months and whenever any upgrade or change is made to the system and documents each such activity. Section 562.112 Practitioner­Patient Relationship Required A. A pharmacy shall ensure that its agents and employees before dispensing a pre­ scription determine in the exercise of sound professional judgment that the pre­ scription is a valid prescription. A pharmacy may not dispense a prescription drug if an agent or employee of the pharmacy knows or should know that the prescription was issued on the basis of an Internet­based or telephone consulta­ tion without a valid practitioner­patient relationship. B. Note: While this section still remains in the Texas Pharmacy Act, the practice of telemedicine/telehealth is a "legal" practice in the state of Texas. The Texas Med­ ical Practice Act allows for the use of an Internet­based or telephone consulta­ tion between the prescriber and a patient. Prescriptions issued in these circum­ stances may be valid; however, pharmacists must still ensure that there is a valid practitioner­patient relationship. Texas Medical Board rules specify two prohibi­ tions on telemedicine: 1. A practitioner­patient relationship is not present if a practitioner prescribes an abortifacient or any other drug or device that terminates a pregnancy and 2. Treatment for chronic pain with scheduled drugs using telemedicine is not allowed. TSBPhasa Telemedicine Frequently Asked Questions document on its website which provides more information about telemedicine for pharmacists. A. above does not prohibit a pharmacy from dispensing a prescription in an emer gency when a valid practitioner­patient relationship is not present. (See Board Rule 291.29 (Professional Responsibility of Pharmacists) in Chapter E of this book.) SUBCHAPTER D. Compounded and Prepackaged Drugs Section 562.151 Definitions (See Chapter H in this book.) Section 562.152 Compounding for Office Use [See Chapter H in this book.) Section 562.153 Requirements for Office Compounding (See Chapter H in this book.) Section 562.154 Distribution of Compounded and Prepackaged Products to Certain Pharmacies (See Chapter H in this book.) Section 562.155 Compounding Service and Compounded Products (See Chapter H in this book.) Section 562.156 Compounded Sterile Preparation; Notice to Board (See Chapter H in this book.) , J „ „ _ Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.81 Chapter 563 Prescription Requirements; Delegation of Administration and Provision of Dangerous Drugs SUBCHAPTER B. Delegation of Administration and Provision of Dangerous Drugs by Physicians Section 563.051 General Delegation of Administration and Provision of Dangerous Drugs A. A physician may delegate to any qualified and properly trained person acting under the physicians supervision the act of administering or providing danger­ ous drugs in the physician's office, as ordered by the physician, that are used or required to meet the immediate therapeutic needs of the physician's patients. Texas Medical Board rules define "immediate need" as a 72­hour supply of a dangerous drug. (See Texas Medical Board Rule 169.2(6).) The administration or provision of the dangerous drugs must be performed in compliance with laws relating to the practice of medicine and state and federal laws relating to those dangerous drugs. A physician may also delegate to any qualified and properly trained person act­ ing under the physician's supervision the act of administering or providing dan­ gerous drugs through a facility licensed by the Board (a Class D pharmacy), as ordered by the physician, that are used or required to meet the immediate ther­ apeutic needs of the physician's patients. The administration of those dangerous drugs must be in compliance with laws relating to the practice of medicine, pro­ fessional nursing, and pharmacy as well as state and federal drug laws. The pro­ vision of those dangerous drugs must be in compliance with: 1. Laws relating to the practice of medicine, professional nursing, and pharmacy; 2. State and federal drug laws; and 3. Rules adopted by the Board. C. The administration or provision of the drugs may be delegated through a phy­ sician's order, a standing medical order, a standing delegation order, or another order defined by the Texas Medical Board. D. This section does not authorize a physician or a person acting under the super­ vision of a physician to keep a pharmacy, advertised or otherwise, for the retail sale of dangerous drugs, other than as authorized under Section 563.053 (excep­ tion for rural physicians) of the Act, without complying with the applicable laws relating to the dangerous drugs. K. A practitioner may designate a licensed vocational nurse or a person having edu­ cation equivalent to or greater than that required for a licensed vocational nurse to communicate the prescriptions of an advanced practice registered nurse or physician assistant authorized by the practitioner to sign prescription drug orders. B. Section 563.052 Suitable Container Required A drug or medicine provided under this Act must be supplied in a suitable container labeled in compliance with applicable drug laws. A qualified and trained person, act­ ing under the supervision of a physician, may specify at the time of the provision of the drug the inclusion on the container of the date of the provision, the patient's name, and the address. Section 563.053 Dispensing of Dangerous Drugs in Certain Rural Areas A. In this section, "reimbursement for cost" means an additional charge, separate from that imposed for the physician's professional services, that includes the cost of the drug product and all other actual costs to the physician incidental to pro­ viding the dispensing service. The term does not include a separate fee imposed for the act of dispensing the drug itself. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore B. This section applies to an area located in a county with a population of 5,000 or fewer or in a municipality or an unincorporated town with a population of fewer than 2,500. The area must be within a 15­mile radius of the physician's office and in which a pharmacy is not located. This section does not apply to a municipal­ ity or unincorporated town that is adjacent to a municipality with a population of 2,500 or more. Notes C. A physician who practices medicine in an area described in B. above may: 1. Maintain a supply of dangerous drugs in the physician's office to be dis­ pensed in the course of treating the physician's patients and 2. Be reimbursed for the cost of supplying those drugs without obtaining a pharmacy license under Chapter 558 of this Act. D. A physician who dispenses dangerous drugs under C. above shall: 1. Comply with each labeling provision under this Act applicable to that class of drugs and 2. Oversee compliance with packaging and recordkeeping provisions applica­ ble to that class of drugs. E. A physician who desires to dispense dangerous drugs under this section shall notify both TSBP and the Texas Medical Board that the physician practices in an area described by B. above. The physician may continue to dispense dangerous drugs in the area until the Board determines after notice and hearing that the physician no longer practices in an area described by B. above. Section 563.054 Administration of Dangerous Drugs (Veterinarians) A. A veterinarian may: 1. Administer or provide dangerous drugs to a patient in the veterinarian's office or on the patient's premises if the drugs are used or required to meet the needs of the veterinarian's patients; 2. Delegate the administration or provision of dangerous drugs to a person who: a. Is qualified and properly trained and b. Acts under the veterinarian's supervision; and 3. Itemize and receive compensation for the administration or provision of the dangerous drugs under A.l. above. B. This section does not permit a veterinarian to maintain a pharmacy for the retailing of drugs without complying with applicable laws. Note: B. above means a veterinarian may dispense dangerous drugs to his or her own patients but may not dispense dangerous drugs prescribed by other veterinar­ ians unless he or she obtains a Class A pharmacy license. C. The administration or provision of dangerous drugs must comply with: 1. Laws relating to the practice of veterinary medicine and 2. State and federal laws relating to dangerous drugs. Chapter 564 Program to Aid Impaired Pharmacists and Pharmacy Students: Pharmacy Peer Review SUBCHAPTER A. Reporting and Confidentiality Section 564.001 Reports A. An individual or entity, including a pharmaceutical peer review committee, who has knowledge relating to an action or omission of a pharmacist in this state or a pharmacy student who is enrolled in the professional sequence of an accredited pharmacy degree program approved by the Board that might provide grounds for disciplinary action under Section 565.001(a)(4) or (7) of the Act may report relevant facts to the Board. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.83 Notes B. A committee of a professional society composed primarily of pharmacists, the staff of the committee, or a district or local intervener participating in a pro­ gram established to aid pharmacists or pharmacy students impaired by chemical abuse or mental or physical illness may report in writing to the Board the name of an impaired pharmacist or pharmacy student and the relevant information relating to the impairment. C. The Board may report to a committee of the professional society or the society's designated staff information that the Board receives relating to a pharmacist or pharmacy student who may be impaired by chemical abuse or mental or physi­ cal illness. Section 564.002 Confidentiality A. All records and proceedings of the Board, an authorized agent of the Board, or a pharmaceutical organization committee relating to the administration of this chapter are confidential and are not considered public information for purposes of Chapter 552, Government Code (Texas Public Information Act). Records con­ sidered confidential under this section include: 1. Information relating to a report made under Section 564.001 above, includ­ ing the identity of the individual or entity making the report; 2. The identity of an impaired pharmacist or pharmacy student participating in a program administered under this Act except as provided by Section 564.003 below; A report, interview, statement, memorandum, evaluation, communication, or other information possessed by the Board, an authorized agent of the Board, or a pharmaceutical organization committee related to a potentially impaired pharmacist or pharmacy student; 4. A policy or procedure of an entity that contracts with the Board relating to personnel selection; and 5. A record relating to the operation of the Board, an authorized agent of the Board, or a pharmaceutical organization committee as the record relates to a potentially impaired pharmacist or pharmacy student. A record or proceeding described by this section is not subject to disclosure, subpoena, or discovery except to a member of the Board or an authorized agent of the Board involved in the discipline of an applicant or license holder. 3. B. Section 564.003 Disclosure of Certain Information A. 'Ihe Board may disclose information that is confidential under Section 564.002 above only: 1. During a proceeding conducted by the State Office of Administrative Hear­ ings, the Board, or a panel of the Board or in a subsequent trial or appeal of a Board action or order; 2. To a pharmacist licensing agency or disciplinary authority of another jurisdiction; Under a court order; 3. 4. 5. To a person providing a service to the Board, including an expert witness, investigator, or employee of an entity that contracts with the Board related to a disciplinary proceeding against an applicant or license holder, if the infor­ mation is necessary for preparation for or presentation in the proceeding; or As provided by B. below. Al. Information that is disclosed under A. above remains confidential and is not subject to discovery or subpoena in a civil suit and may not be introduced as evi­ dence in any action other than appeal of a Board action. A2. Information that is confidential under Section 564.002 above and that is admit­ ted under seal in a proceeding conducted by the State Office of Administrative D.84 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Hearings is confidential information for the purpose of a subsequent trial or appeal. B. The Board may disclose that the license of a pharmacist who is the subject of an order of the Board that is confidential under Section 564.002 above is sus­ pended, revoked, canceled, restricted, or retired or that the pharmacist is in any other manner limited in the practice of pharmacy. The Board may not disclose the nature of the impairment or other information that resulted in the Board's action. Section 564.004 Immunity A. Any person, including a Board employee or member, peer review committee member, pharmaceutical organization committee member, or pharmaceutical organization district or local intervener, who provides information, reports, or records under Section 564.001A. or B. above to aid an impaired pharmacist or pharmacy student is immune from civil liability if the person provides the infor­ mation in good faith. B. A. above shall be liberally construed to accomplish the purposes of this section, and the immunity provided under A. above is in addition to any other immunity provided by law. C. A person who provides information or assistance to the Board under this Act is presumed to have acted in good faith. A person who alleges a lack of good faith has the burden of proof on that issue. Section 564.005 Record of Report On a determination by the Board that a report submitted by a peer review commit­ tee or pharmaceutical organization committee under Section 564.001A. or B. above is without merit, the Board shall expunge the report from the pharmacist's or phar­ macy student's individual record in the Board's office. Section 564.006 Examination of Report A pharmacist, a pharmacy student, or an authorized representative of the pharma­ cist or pharmacy student is entitled on request to examine the peer review or the pharmaceutical organization committee report submitted to the Board and to place into the record a statement of reasonable length of the pharmacist's or pharmacy stu­ dent's view concerning information in the report. SUBCHAPTER B. Program Administration Section 564.051 Program Authorization; Funding The funding for the impaired pharmacists and pharmacy students program is pro­ vided through a surcharge on pharmacists and pharmacy licenses and renewals. These fees cover evaluation but not treatment. SUBCHAPTER C. Pharmacy Peer Review The Act permits pharmacy societies or associations and pharmacy owners to estab­ lish pharmacy peer review committees. The purpose of these committees is to evaluate the quality of pharmacy services and to suggest improvements in pharmacy systems to enhance patient care. Importantly, the statute provides for proceedings and records ot pharmacy peer review committees to remain confidential unless the committee agrees to release or the Board subpoenas the information. Because establishment of these phar­ macy peer review committees is voluntary rather than mandatory, the Board has not issued any rules to implement the legislation. Instead, the Board has adopted guide­ lines for pharmacy organizations or owners to use in developing peer review guide­ lines. These guidelines are available on the Board's website (www.pharmacy.texas.gcv) or Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes by contacting the Board's office. (See Section 564.101­106 of the Texas Pharmacy Act for detailed language of this law.) Chapter 568 Pharmacy Technicians and Pharmacy Technician Trainees Section 568.001 Qualifications A. In establishing rules under Section 568.001 of the Act, the Board shall require that: 1. A pharmacy technician: a. Have a high school diploma or a high school equivalency certificate or be working to achieve an equivalent diploma or certificate and b. Have passed a Board­approved pharmacy technician certification examination. 2. A pharmacy technician trainee have a high school diploma or a high school equivalency certificate or be working to achieve an equivalent diploma or certificate. B. The Board shall adopt rules that permit a pharmacy technician and pharmacy technician trainee to perform only nonjudgmental technical duties under the direct supervision of a pharmacist. Section 568.002 Registration Required A. A person must register with the Board before beginning work in a pharmacy in this state as a pharmacy technician or a pharmacy technician trainee. Ik 'Ihe Board may allow a pharmacy technician to petition the Board for a special exemption from the technician certification requirement if the pharmacy tech­ nician is in a county with a population of fewer than 50,000. Note: For details about this exemption from certification, see Board Rule 297.7 in this chapter. C. An applicant for registration as a pharmacy technician or pharmacy technician trainee must: 1. Be of good moral character and 2. Submit an application on a form prescribed by the Board. 1). A person's registration as a pharmacy technician or pharmacy technician trainee remains in effect as long as the person meets the qualifications established by Board rule. Section 568.003 Grounds for Disciplinary Action (See Chapter Fin this book.) Section 568.0035 Discipline Authorized, Effect on Pharmacy Technician Trainee (See Chapter Fin this book.) Section 568.0036 Submission to a Mental or Physical Examination (See Chapter F in this book.) Section 568.0037 Temporary Suspension or Restriction of Registration (See Chapter Fin this book.) Section 568.004 Renewal of Registration I he Board may adopt a system in which the registrations of pharmacy technicians and pharmacy technician trainees expire on various dates during the year. Section 568.005 Fees Ihe Board may adopt fees as necessary for the registration of pharmacy technicians and pharmacy technician trainees. D.86 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Section 568.006 Ratio of Pharmacists to Pharmacy Technicians and Pharmacy Technician Trainees Hie ratio of onsite pharmacists to pharmacy technicians and pharmacy technician trainees in a Class A pharmacy must be at least one pharmacist for every five phar­ macy technicians or pharmacy technician trainees if the Class A pharmacy dis­ penses no more than 20 different prescription drugs and does not produce intrave­ nous or intramuscular drugs onsite. Note: This law was passed when the pharmacist to pharmacy technician ratio in Class A pharmacies was more restrictive, and it allowed an increased ratio of 1:5 for this unique type of Class A pharmacy. Ironically, the Board recently expanded the ratio for all Class A pharmacies to 1:6. See Class A rules (Chapter G in this book) for general rules relating to ratios of pharmacists to pharmacy technicians. Since this provision (Section 568.006) is in the statute, the Board cannot remove it. Board of Pharmacy Rule 291.32(d)(3)(B) Ratio of Onsite Pharmacists to Pharmacy Technicians and Pharmacy Technician Trainees A Class A pharmacy may have a ratio of onsite pharmacists to pharmacy techni­ cians of 1:5 provided the pharmacy dispenses no more than 20 different prescription drugs, does not produce sterile pharmaceuticals including intravenous or intramus­ cular drugs onsite, and the following conditions are met: 1. At least four of the pharmacy technicians are registered pharmacy techni­ cians and 2. The pharmacy has written policies and procedures regarding the supervi­ sion of pharmacy technicians, including requirements that the registered pharmacy technicians included in a 1:5 ratio may be involved only in one process at a time. For example, a technician who is compounding nonsterile pharmaceuticals or who is involved in the preparation of prescription drug orders may not also call physicians for the authorization of refills. Section 568.007 Registration of a Pharmacy Technician Trainee A. A person must register with the Board before beginning work in a pharmacy in this state as a pharmacy technician trainee. B. An application for registration as a pharmacy technician trainee must be on a form prescribed by the Board. C. A persons registration as a pharmacy technician trainee remains in effect as long as the person meets the qualifications specified by Board rule. D. The Board may, on a determination that a ground for discipline exists under Sec ­ tion 568.003 of the Act, take disciplinary action against a pharmacy technician trainee under Section 568.0035 of the Act. Section 568.008 Pharmacy Technicians in Hospitals with a Clinical Pharmacy Program A. In this section, "clinical pharmacy program" means a program that provides pharmaceutical care services as specified by Board rule. B. A Class C pharmacy that has an ongoing clinical pharmacy program may allow a pharmacy technician to verify the accuracy of work performed by another pharmacy technician relating to the filling of floor stock and unit­dose distribu­ tion systems for a patient admitted to the hospital if the patient s orders have pre­ viously been reviewed and approved by a pharmacist. C. The pharmacist­in­charge of the clinical pharmacy program shall adopt policies and procedures for the verification process authorized by this section. D. A hospital must notify the Board before implementing the verification process authorized by this section. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.87 Notes E. The Board shall adopt rules to implement this section including rules specifying: 1. The duties that may be verified by another pharmacy technician; 2. The records that must be maintained for the verification process; and 3. The training requirements for pharmacy technicians who verify the accu­ racy of the work of other pharmacy technicians. Note: See Board Rule 291.74 in Chapter I of this book. Section 568.009 Change of Address or Employment No later than the 10th day after the date of a change of address or employment, a pharmacy technician or a pharmacy technician trainee shall notify the Board in writing of the change. Board of Pharmacy Rules—Chapter 297 Pharmacy Technicians and Pharmacy Technician Trainees 297.1 Purpose Ihe purpose of this rule is to provide a comprehensive and coherent regulatory scheme for the registration and training of pharmacy technicians and pharmacy technician trainees in Texas. 297.2 Definitions 1. Act—The Texas Pharmacy Act. 2. Board—Texas State Board of Pharmacy. 3. Pharmacy technician—An individual who is registered with the Board and whose responsibility in a pharmacy is to provide technical services that do not require professional judgment regarding preparing and distributing drugs and who works under the direct supervision of and is responsible to a pharmacist. Pharmacy technician includes registered pharmacy technicians and pharmacy technician trainees. 4. Pharmacy technician trainee—An individual who is registered with the Board as a pharmacy technician trainee and is authorized to participate in a pharmacy's technician training program. 5. Registered pharmacy technician—A pharmacy technician who is regis­ tered with the Board. 297.3 Registration Requirements A. General. 1. Individuals who are not registered with the Board may not be employed as or perform the duties of a pharmacy technician or a pharmacy technician trainee. 2. Individuals who have previously applied and registered as a pharmacy tech­ nician, regardless of the pharmacy technician's current registration status, may not register as a pharmacy technician trainee. 3. Individuals who apply and are qualified for both a pharmacy technician trainee registration and a pharmacy technician registration concurrently will not be considered for a pharmacy technician trainee registration. B. Registration for Pharmacy Technician Trainees. An individual may register as a pharmacy technician trainee only once, and the registration may not be renewed. 1. Each applicant for pharmacy technician trainee registration shall: a. Have a high school or equivalent diploma (e.g., GED) or be working to achieve a high school or equivalent diploma. For the purpose of this clause, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years and b. Complete the Texas application for registration that includes the follow­ ing information: 0.88 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore (1) Name; (2) Addresses, phone numbers, date of birth, and social security num­ ber; and (3) Any other information requested on the application; and c. Meet all requirements necessary for the Board to access the criminal history record information, including submitting fingerprint informa­ tion and paying the required fees. 2. Once an applicant has successfully completed all requirements of registra­ tion and the Board has determined there are no grounds to refuse registra­ tion, the applicant shall be notified of registration as a pharmacy technician trainee and of his or her pharmacy technician registration number. 3. Pharmacy technician trainee registrations expire two years from the date of registration or upon notification of registration as a registered pharmacy technician, whichever is earlier. A pharmacy technician trainee registration is not renewable. Initial Registration for Pharmacy Technicians. 1. Each applicant for pharmacy technician registration shall: a. Have a high school or equivalent diploma (e.g., GED) or be working to achieve a high school or equivalent diploma. For the purpose of this clause, an applicant for registration may be working to achieve a high school or equivalent diploma for no more than two years; b. Either have: 2. 3. (1) Taken and passed a pharmacy technician certification examination approved by the Board and have a current certification certificate or (2) Been granted an exemption from certification by the Board as spec ified in Board Rule 297.7 below (Exemption from Pharmacy Techni­ cian Certification Requirements); c. Complete the Texas application for registration that includes the follow ing information: (1) Name; (2) Addresses, phone numbers, date of birth, and social security num­ ber; and (3) Any other information requested on the application; and d. Pay the registration fee specified in Board Rule 297.4 (Fees). New pharmacy technician registrations shall be assigned an expiration date, and the fee shall be prorated based on the assigned expiration date. Once an applicant has successfully completed all requirements of registra tion and the Board has determined there are no grounds to refuse registra tion, the applicant shall be notified of registration as a pharmacy technician and of his or her pharmacy technician registration number. If the pharmacy technician applicant were registered as a pharmacy technician trainee at the time the pharmacy technician registration is granted, the pharmacy techni­ cian trainee registration expires. Renewal. Note: Certification is not requiredfor the renewal of a pharmacy technician registration 1. All applicants for the renewal of a pharmacy technician registration shall: a. Complete the Texas application for registration that includes the follow­ ing (1) (2) (3) information: Name; Addresses, phone numbers, date of birth, and social security number; Meet all requirements necessary for the Board to access the criminal history record information, including submitting fingerprint infor­ mation and paying the required fees; and (4) Any other information requested on the application; Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes b. c. 2. Pay the renewal fee specified in Board Rule 297.4; and Complete 20 contact hours of continuing education per renewal period as specified in Board Rule 297.8 (Continuing Education). A pharmacy technician registration expires on the last day of the assigned expiration month. If the completed application and renewal fee are not received in the Board's office on or before the last day of the assigned expiration month, the person's pharmacy technician registration shall expire. An expired registration shall be renewed according to the following schedule. a. If a pharmacy technician registration has expired for 90 days or fewer, the person may become registered by making application and paying to the Board a renewal fee that is equal to one and one­half times the renewal fee for the registration. b. If a pharmacy technician registration has been expired for more than 90 days but less than one year, the person may become registered by making application and paying to the Board a renewal fee that is equal to two times the renewal fee for the registration. c. If a pharmacy technician registration has expired for more than one year, the pharmacy technician may not renew the registration and must com­ plete the requirements for an initial registration as specified in C. above. 4. After review, the Board may determine that 3.c. above does not apply if the registrant is the subject of a pending investigation or disciplinary action. An individual may use the title "Registered Pharmacy Technician" or "Ph.T.R" if the individual is registered as a pharmacy technician in this state. 3. 1. 297.4 Fees lees are subject to change. (See the Board's website for current fees.) 297.5 Pharmacy Technician Trainees A. A person designated as a pharmacy technician trainee shall be registered with the Board prior to beginning training in a Texas licensed pharmacy. B. A person may be designated as a pharmacy technician trainee for no more than two years. The requirements for registration as a pharmacy technician must be completed within the two­year period. 297.6 Pharmacy Technician and Pharmacy Technician Trainee Training A. Pharmacy technicians and pharmacy technician trainees shall complete ini­ tial training as outlined by the pharmacist­in­charge in a training manual. Such training: 1. 2. B. Shall meet the requirements of Board Rule 297.3D. above and May not be transferred to another pharmacy unless: a. The pharmacies are under common ownership and control and have a common training program and b. The pharmacist­in­charge of each pharmacy in which the pharmacy technician or pharmacy technician trainee works certifies that the phar­ macy technician or pharmacy technician trainee is competent to per­ form the duties assigned in that pharmacy. I he pharmacist­in­charge shall assure the continuing competency of pharmacy technicians and pharmacy technician trainees through in­service education and training to supplement initial training. C. The pharmacist­in­charge shall document the completion of the training pro­ gram and certify the competency of pharmacy technicians and pharmacy tech­ nician trainees completing the training. A written record of initial and in­service training of pharmacy technicians and pharmacy technician trainees shall be maintained and contain the following information: Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore 1. 2. 3. 4. Name of the person receiving the training; Date(s) of the training; General description of the topics covered; A statement that certifies that the pharmacy technician or pharmacy techni­ cian trainee is competent to perform the duties assigned; 5. Name of the person supervising the training; and 6. Signature of the pharmacy technician or pharmacy technician trainee and the pharmacist­in­charge or other pharmacist employed by the pharmacy and designated by the pharmacist­in­charge as responsible for the training of pharmacy technicians and pharmacy technician trainees. A person who has previously completed the training program outlined in E. below, a licensed nurse, or a physician assistant is not required to complete the entire training program outlined in E. below if the person is able to show compe­ tency through a documented assessment of competency. Such competency assess ment may be conducted by personnel designated by the pharmacist­in­charge, but the final acceptance of competency must be approved by the pharmacist­in charge. Pharmacy technician and pharmacy technician trainee training shall be out lined in a training manual. The training manual shall at a minimum contain the following: 1. Written procedures and guidelines for the use and supervision of pharmacy technicians and pharmacy technician trainees. Such procedures and guide lines shall: a. Specify the manner in which the pharmacist responsible for the super vision of pharmacy technicians and pharmacy technician trainees will supervise such personnel and verify the accuracy and completeness of all acts, tasks, and functions performed by such personnel and b. Specify duties which may and may not be performed by pharmacy tech­ nicians and pharmacy technician trainees and 2. Instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians and pharmacy technician trainees in the pharmacy: a. Orientation; b. Job descriptions; c. Communication techniques; d. Laws and rules; e. Security and safety; f. Prescription drugs: (1) Basic pharmaceutical nomenclature and (2) Dosage forms; g. Drug orders: (1) Prescribers; (2) Directions for use; (3) Commonly­used abbreviations and symbols; (4) Number of dosage units; (5) Strengths and systems of measurement; (6) Routes of administration; (7) Frequency of administration; and (8) Interpreting directions for use; h. Drug order preparation: (1) Creating or updating patient medication records; (2) Entering drug order information into the computer or typing the label in a manual system; (3) Selecting the correct stock bottle; Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes (4) Accurately counting or pouring the appropriate quantity of a drug product; Selecting the proper container; Affixing the prescription label; Affixing auxiliary labels if indicated; and Preparing the finished product for inspection and final check by pharmacists; i. Other functions; j. Drug product prepackaging; k. Written policies and guidelines for the use of and supervision of phar­ macy technicians and pharmacy technician trainees; and 1. Confidential patient medication records. K Pharmacy technicians and pharmacy technician trainees compounding non­ sterile pharmaceuticals shall meet the training and education requirements specified in the rules for the class of pharmacy in which the pharmacy techni­ cian or pharmacy technician trainee is working. (i. Pharmacy technicians and pharmacy technician trainees compounding sterile pharmaceuticals shall meet the training and education requirements specified in the rules for the class of pharmacy in which the pharmacy technician or phar­ macy technician trainee is working. (5) (6) (7) (8) 297.7 Exemption From Pharmacy Technician Certification Requirements S'otc: litis is an exemption from certification, not TSBP registration. A. Purpose. The Board encourages all pharmacy technician trainees to become cer­ tified by taking and passing a pharmacy technician certification exam approved by the Board. However, the Board will consider petitions for exemption on a case by case basis. This rule outlines procedures to petition the Board for an exemp­ tion to the certification requirements established by Section 568.002 of the Act (Pharmacy Technician Registration Required). B. Long­term Exempt Pharmacy Technicians. Long­term exempt pharmacy techni­ cians are technicians who on September 1, 2001 had been continuously employed as a pharmacy technician in this state for at least 10 years and who received an exemption from the Board. C. Rural County Exempt Pharmacy Technicians. Rural county exempt pharmacy technicians are pharmacy technicians working in counties with a population of 50,000 or less. (See complete official language in Board Rule 297.7(c) for details on eligibility, the petition process, and limitations of this exemption.) 297.8 Continuing Education Requirements A. B. Pharmacy Technician Trainees. Pharmacy technician trainees are not required to complete continuing education. Pharmacy Technicians. 1. 2. 3. All pharmacy technicians shall be exempt from the continuing education requirements during their initial registration period. All pharmacy technicians must complete and report 20 contact hours of approved continuing education obtained during the previous renewal period in pharmacy­related subjects to renew their registration as a pharmacy technician. A pharmacy technician may satisfy the continuing education requirements by a. Successfully completing the number of continuing education hours nec­ essary to renew a registration as specified in 2. above; b. D.92 Successfully completing during the preceding license period one credit hour for each year of the renewal period in a pharmacy­related college course(s); or Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore c. Taking and passing a pharmacy technician certification exam during the preceding renewal period which shall be equivalent to the number ot continuing education hours necessary to renew a registration as spec­ ified in 2. above. Notes 4. To renew a registration, a pharmacy technician must report on the renewal application the completion of at least 20 contact hours of continuing edu­ cation. The following is applicable to the reporting of continuing education contact hours. a. At least one contact hour of the 20 contact hours specified in 2. above shall be related to Texas pharmacy laws or rules. b. Any continuing education requirements which are imposed upon a pharmacy technician as part of a Board Order or Agreed Board Order shall be in addition to the requirements of this rule. c. For renewals received after August 31, 2020 and before September 1, 2022, a pharmacy technician must have completed the human traffick ing prevention course required in Section 116.002 of the Texas Occupa tions Code. Note: The statute requires that this course be approved by the Texas Health and Human Services Commission and that a list of approved courses be posted on the commission's website. 5. Pharmacy technicians are required to maintain records of the completion of their continuing education for three years from the date of reporting the hours on a renewal application. The records must contain at least the follow ing information: a. Name of participant; b. Title and date of program; c. Program sponsor or provider (the organization); and d. Dated signature of sponsor representative. 6. The Board shall audit the records of pharmacy technicians for verification of reported continuing education credit. The following is applicable for such audits. a. Upon a written request, a pharmacy technician shall provide to the Board copies of the record required to be maintained in 5. above or certificates of completion for all continuing education contact hours reported during a specified registration period. Failure to provide all requested records by the specified deadline constitutes prima facie evi­ dence of a violation of this rule. b. Credit for continuing education contact hours shall only be allowed for programs for which the pharmacy technician submits copies of records reflecting that the hours were completed during the specified registra tion period(s). Any other reported hours shall be disallowed. A pharmacy technician who submits false or fraudulent records to the c. Board shall be subject to disciplinary action by the Board. 7. The following is applicable if a pharmacy technician fails to report the com pletion of the required continuing education. a. The registration of a pharmacy technician who fails to report the com­ pletion of the required number of continuing education contact hours shall not be renewed, and the pharmacy technician shall not be issued a renewal certificate for the license period until such time as the phar­ macy technician successfully completes the required continuing educa­ tion and reports the completion to the Board. b. A person shall not practice as a pharmacy technician without a current renewal registration certificate. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.93 Notes D.94 8. A pharmacy technician who has had a physical disability, an illness, or other extenuating circumstances prohibiting the pharmacy technician from obtaining continuing education credit during the preceding license period may be granted an extension of time to complete the continued education requirement. The following is applicable for this extension. a. The pharmacy technician shall submit a petition to the Board with his or her registration renewal application which contains: (1) The name, address, and registration number of the pharmacy technician; (2) A statement of the reason for the request for extension; (3) If the reason for the request for extension is health related, a state­ ment from the attending physician(s) treating the pharmacy tech­ nician which includes the nature of the physical disability or illness and the dates the pharmacy technician was incapacitated; and (4) If the reason for the request for the extension is for other extenu­ ating circumstances, a detailed explanation of the extenuating cir­ cumstances and, if because of military deployment, documentation of the dates of the deployment. b. After review and approval of the petition, a pharmacy technician may be granted an extension of time to comply with the continuing education requirement which shall not exceed one license renewal period. c. An extension of time to complete continuing education credit does not relieve a pharmacy technician from the continuing education require­ ment during the current license period. d. If a petition for an extension to the reporting period for continuing edu­ cation is denied, the pharmacy technician shall: (1) Have 60 days to complete and report completion of the required continuing education requirements and (2) Be subject to the requirements of 7. above relating to failure to report completion of the required continuing education if the required continuing education is not completed and reported within the required 60­day time period. 9. The following are considered approved programs for pharmacy technicians. a. Any program presented by an Accreditation Council for Pharmacy Edu­ cation (ACPE) approved provider subject to the following conditions. (1) Pharmacy technicians may receive credit for the completion of the same ACPE course only once during a renewal period. (2) Pharmacy technicians who present approved ACPE continuing edu­ cation programs may receive credit for the time expended during the actual presentation of the program. Pharmacy technicians may receive credit for the same presentation only once during a license period. (3) Proof of completion of an ACPE course shall contain the following information: (a) Name of the participant; (b) Title and completion date of the program; (c) Name of the approved provider sponsoring or cosponsoring the program; (d) Number of contact hours awarded; (e) Assigned ACPE universal program number and a "T"designation indicating that the CE is targeted to pharmacy technicians; and (f) Either a dated certifying signature of the approved provider and the official ACPE logo or the Continuing Pharmacy Education Monitor logo. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore b. Pharmacy­related college courses which are part of a pharmacy techni­ cian training program or part of a professional degree program offered by a college of pharmacy. (1) Pharmacy technicians may receive credit for the completion of the same course only once during a license period. A course is equiv­ alent to one credit hour for each year of the renewal period. One credit hour is equal to 15 contact hours. (2) Pharmacy technicians who teach these courses may receive credit toward their continuing education, but such credit may be received only once for teaching the same course during a license period. c. Basic cardiopulmonary resuscitation (CPR) courses which lead to CPR certification by the American Red Cross or the American Heart Associ­ ation or its equivalent shall be recognized as approved programs. Phar macy technicians may receive credit for one contact hour toward their continuing education requirement for completion of a CPR course only once during a renewal period. Proof of the completion of a CPR course shall be the certificate issued by the American Red Cross or the Ameri can Heart Association or its equivalent. d. Advanced cardiovascular life support (ACLS) courses or pediatric advanced life support (PALS) courses which lead to initial ACLS or PALS certification by the American Heart Association or its equivalent shall be recognized as approved programs. Pharmacy technicians may receive credit for twelve contact hours toward their continuing educa­ tion requirement for completion of an ACLS or PALS course only once during a renewal period. Proof of the completion of an ACLS or PALS course shall be the certificate issued by the American Heart Association or its equivalent. e. Advanced cardiovascular life support (ACLS) courses or pediatric advanced life support (PALS) courses which lead to ACLS or PALS recer tification by the American Heart Association or its equivalent shall be recognized as approved programs. Pharmacy technicians may receive credit for four contact hours toward their continuing education require ment for completion of an ACLS or PALS recertification course only once during a renewal period. Proof of the completion of an ACLS or PALS recertification course shall be the certificate issued by the Ameri­ can Heart Association or its equivalent. Attendance at TSBP Board Meetings shall be recognized for continuing education credit as follows: (1) Pharmacy technicians shall receive credit for three contact hours toward their continuing education requirement for attending a full, public Board business meeting in its entirety. (2) A maximum of six contact hours are allowed for attendance at a Board meeting during a renewal period. 0) Proof of attendance for a complete Board meeting shall be a certifi g. cate issued by TSBP. Participation in a TSBP appointed Task Force shall be recognized for continuing education credit as follows: (1) Pharmacy technicians shall receive credit for three contact hours toward their continuing education requirement for participating in a TSBP appointed Task Force. (2) Proof of participation for a Task Force shall be a certificate issued h. by TSBP. Attendance at programs presented by TSBP or courses offered by TSBP shall be recognized as follows: Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes Notes D.96 (1) Pharmacy technicians shall receive credit for the number of hours for the program or course as stated by TSBP. (2) Proof of attendance at a program presented by TSBP or completion of a course offered by TSBP shall be a certificate issued by TSBP. i. Pharmacy technicians shall receive credit toward their continuing edu­ cation requirements for programs or courses approved by other state boards of pharmacy as follows: (1) Pharmacy technicians shall receive credit for the number of hours for the program or course as specified by the other state board of pharmacy. (2) Proof of attendance at a program or course approved by another state board of pharmacy shall be a certificate or other documenta­ tion that indicates: (a) Name of the participant; (b) Title and completion date of the program; (c) Name of the approved provider sponsoring or cosponsoring the program; (d) Number of contact hours awarded; (e) Dated certifying signature of the provider; and (f) Documentation that the program is approved by the other state board of pharmacy. j. Completion of an Institute for Safe Medication Practices (ISMP) Med­ ication Safety Self­Assessment for hospital pharmacies or for commu­ nity/ambulatory pharmacies shall be recognized for continuing educa­ tion credit as follows: (1) Pharmacy technicians shall receive credit for three contact hours toward their continuing education requirement for completion of an ISMP Medication Safety Self­Assessment. (2) Proof of the completion of an ISMP Medication Safety Self­Assessment shall be: (a) A continuing education certificate provided by an ACPE approved provider for the completion of an assessment or (b) A document from ISMP showing the completion of an assessment, k. Programs approved by the American Medical Association (AMA) as Category 1 Continuing Medical Education (CME) and accredited by the Accreditation Council for Continuing Medical Education shall be sub­ ject to the following conditions. (1) Pharmacy technicians may receive credit for the completion of the same CME course only once during a license period. (2) Pharmacy technicians who present approved CME programs may receive credit for the time expended during the actual presentation of the program. Pharmacy technicians may receive credit for the same presentation only once during a license period. (3) Proof of the completion of a CME course shall contain the following information: (a) Name of the participant; (b) Title and completion date of the program; (c) Name of the approved provider sponsoring or cosponsoring the program; (d) Number of contact hours awarded; and (e) Dated certifying signature of the approved provider. 1. In­service education provided under the direct supervision of a pharma­ cist shall be recognized as continuing education as follows: Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore (1) Pharmacy technicians shall receive credit for the number of hours provided by a pharmacist(s) at the pharmacy technician's place of employment. Notes (2) Proof of the completion of in­service education shall contain the following information: (a) Name of the participant; (b) Title or description of the program; (c) Completion date of the program; (d) Name of the pharmacist supervising the in­service education; (e) Number of hours; and (f) Dated signature of the pharmacist providing the in­service education. 10. Pharmacy technicians who are certified by a certification program approved by the Board and maintain this certification shall be considered as having met the continuing education requirements of this rule and shall not be sub ject to an audit by the Board provided one hour of continuing education is related to Texas pharmacy laws or rules. 297.9 Notifications A. Change of Address and/or Name. 1. Change of Address. A pharmacy technician or pharmacy technician trainee shall notify the Board electronically or in writing within 10 days of a change of address, giving the old and new address and registration number. 2. Change of Name. a. A pharmacy technician or pharmacy technician trainee shall notify the Board in writing within 10 days of a change of name by sending a copy of the official document reflecting the name change (e.g., marriage cer tificate, divorce decree, etc.). b. An amended registration and/or certificate reflecting the new name of the pharmacy technician or pharmacy technician trainee will be issued by the Board. B. Change of Employment. A pharmacy technician or pharmacy technician trainee shall report electronically or in writing to the Board within 10 days of a change of employment, giving the name and license number of the old and the new pharmacy and the registration number. 297.10 Registration for Military Service Members, Military Veterans, and Military Spouses This rule establishes alternative and expedited registration procedures for phar­ macy technicians who are military service members, military veterans, and military spouses. It also establishes procedures for a military spouse who is currently regis­ tered in good standing by a jurisdiction with registration requirements that are sub­ stantially similar to Texas's requirements to obtain an interim pharmacy technician registration. (See complete official language of Board Rule 297.10 on the TSBP website.) 297.11 Temporary Emergency Registration A. Definitions. The following words and terms shall have the following meanings unless the context clearly indicates otherwise. 1. Emergency situation—An emergency caused by a natural or man made disaster or any other exceptional situation that causes an extraordinary 2. demand for pharmacist services. State—One of the 50 states in the United States of America, the District of Columbia, and Puerto Rico. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.97 Notes B. Emergency Temporary Pharmacy Technician Registration. In an emergency sit­ uation, the Board may grant a pharmacy technician who holds a current registra­ tion in another state an emergency temporary pharmacy technician registration to practice in Texas. The following is applicable for the emergency temporary pharmacy technician registration. 1. An applicant for an emergency temporary pharmacy technician registra­ tion under this rule must hold a current pharmacy technician registration in another state and that registration and other registrations held by the appli­ cant in any other state may not be suspended, revoked, canceled, surren­ dered, or otherwise restricted for any reason. 2. To qualify for an emergency temporary pharmacy technician registration, the applicant must submit an application to TSBP including the following information: a. Name, address, and phone number of the applicant and b. Any other information required by the Board. 3. An emergency temporary pharmacy technician registration shall be valid for a period as determined by the Board not to exceed six months. The exec­ utive director of the Board in his or her discretion may renew the registra­ tion for an additional six months if the emergency situation still exists. C. Exception. This rule is not applicable to pharmacy technicians enrolled in a volunteer health registry maintained by the Texas Department of State Health Services. Chapter 569 Reporting Requirements for Professional Liability Insurers Section 569.001 Duty to Report A. Every insurer or other entity providing pharmacist's professional liability insur­ ance, pharmacy technician professional and supplemental liability insurance, or druggist's professional liability insurance covering a pharmacist, pharmacy technician, or pharmacy license holder in this state shall submit to the Board the information described in Section 569.002 of the Act at the time prescribed. B. Ihe intormation shall be provided with respect to a notice of claim letter or com­ plaint filed against an insured in a court if the notice or complaint seeks dam­ ages relating to the insured's conduct in providing or failing to provide appropri­ ate service within the scope of pharmaceutical care or services and with respect to settlement of a claim or lawsuit made on behalf of the insured. C. It a pharmacist, a pharmacy technician, a pharmacy technician trainee, or a pharmacy licensed in this state does not carry or is not covered by pharmacist's professional liability insurance, pharmacy technician professional and supple­ mental liability insurance, or druggist's professional liability insurance and is insured by a non­admitted carrier or other entity providing pharmacy profes­ sional liability insurance that does not report under this Act, the duty to report intormation under Section 569.002 of the Act is the responsibility of the phar­ macist, pharmacy technician, pharmacy technician trainee, or pharmacy license holder. Section 569.002 Information to be Reported A. Ihe following information must be furnished to the Board no later than the 30th day after receipt by the insurer of the notice of claim letter or complaint from the insured: 1. D.98 The name ot the insured and the insured's Texas pharmacy technician regis­ tration number, pharmacy technician trainee registration number, or phar­ macist or pharmacy license number; Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore B. 2. The policy number; and 3. A copy ol the notice of claim letter or complaint. The Board shall, in consultation with the Texas Department of Insurance, adopt rules tor reporting additional information as the Board may require. Other claim reports required under state and federal law shall be considered in deter­ mining the information to be reported, the form of the report, and the frequency of reporting under the rules. Additional information that the Board may require may include: 1. 2. The date of any judgment, dismissal, or settlement and Whether an appeal has been taken and by which party. Section 569.003 Immunity from Liability An insurer reporting under this section, its agents or employees, the Board, or the Board's employees or representatives are not liable for damages in a suit brought by any person or entity for reporting as required by this section or for any other action taken under this section. Section 569.004 Restriction on Use of Information Requested A. Information submitted to the Board under this Act and the fact that the infor­ mation has been submitted to the Board may not be: 1. Offered in evidence or used in any manner in the trial of a suit described in this section or 2. Used in any manner to determine the eligibility or credentialing of a phar­ macy to participate in a health insurance plan defined by the Insurance Code. B. Information submitted under this section is confidential and is not subject to disclosure under Chapter 552, Texas Public Information Act. C. The Board shall adopt rules to ensure the confidentiality of information submit­ ted under this section. Section 569.005 Investigation of Report A. Except as otherwise provided in this Act, a report received by the Board under this section is not a complaint for which a Board investigation is required. B. The Board shall review the information relating to a pharmacist, a pharmacy technician, a pharmacy technician trainee, or a pharmacy license holder against whom at least three professional liability claims have been reported within a five­year period in the same manner as if a complaint against the pharmacist, pharmacy technician, pharmacy technician trainee, or pharmacy license holder had been made under Chapter 555 of this Act. Section 569.006 Sanctions Imposed on Insurer The Texas Department of Insurance may impose on any insurer subject to this Act sanctions authorized by Section 7, Article 1.10, Insurance Code, if the insurer fails to report information as required by this section. Board of Pharmacy Rule 281.18 Reporting Professional Liability Claims (a) Reporting Responsibilities. (1) Every insurer or other entity providing pharmacist's professional liabil­ ity insurance, pharmacy technician professional and supplemental liability insurance, or druggist's professional liability insurance covering a pharma­ cist, pharmacy technician, or pharmacy license holder in this state shall sub­ mit to the Board the information described in (b) below at the time prescribed. (2) The information shall be provided with respect to a notice of claim letter or complaint filed against an insured in a court if the notice or complaint seeks damages relating to the insured's conduct in providing or failing to provide Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes appropriate service within the scope of pharmaceutical care or services and with respect to settlement of a claim or lawsuit made on behalf of the insured. (3) If a pharmacist, a pharmacy technician, or a pharmacy licensed in this state does not carry or is not covered by pharmacist's professional liability insur­ ance, pharmacy technician professional and supplemental liability insur­ ance, or druggist's professional liability insurance or if a pharmacist, a pharmacy technician, or a pharmacy licensed in this state is insured by a non­admitted carrier or other entity providing pharmacy professional lia­ bility insurance that does not report under this Act, the duty to report infor­ mation under (b) below is the responsibility of the particular pharmacist, pharmacy technician, or pharmacy license holder. (4) For the purposes of this rule, a professional liability claim or complaint shall be defined as a cause of action against a pharmacist, pharmacy, or pharmacy technician for conduct in providing or failing to provide appropriate ser­ vice within the scope of pharmaceutical care or services, which proximately results in injury to or death of the patient, whether the patient's claim or cause of action sounds in tort or contract, to include pharmacist's interns, pharmacy residents, supervising pharmacists, on­call pharmacists, and con­ sulting pharmacists. (b) Information to be Reported and Due Dates. The following reports are required for claims initiated or resolved on or after September 1,1999. (1) Initial Report. No later than the 30th day after receipt of the notice of claim letter or complaint by the insurer if the insurer has the duty to report or by the pharmacist, pharmacy technician, or a pharmacy if the license holder has the duty to report, the following information must be furnished to the Board on a form provided by the Board: (A) Name and address of the insurer; (B) Name and address of the insured and type of license or registration held (pharmacist, pharmacy, or pharmacy technician); (C) Insured's Texas pharmacist or pharmacy license number or pharmacy technician registration number; (D) Certification if applicable; (E) Policy number; (F) Name(s) of plaintiff(s); (G) Date of injury; (H) County of injury; (I) Cause of injury (e.g., dispensing error); (J) Nature of injury; (K) Type of action (e.g., claim only or lawsuit); (L) Name and phone number of the person filing the report; and (M) A copy of the notice of claim letter or the lawsuit filed in court. (2) Follow­up Report. Within 105 days after disposition of the claim, the follow­ ing information must be provided to the Board on a form provided by the Board: (A) Name and address of the insured and type of license or registration held (pharmacist, pharmacy, or pharmacy technician); (B) Insured's Texas pharmacist or pharmacy license number or pharmacy technician registration number; (C) Name(s) of plaintiff(s); (D) Date of disposition; (E) Type of disposition (e.g., settlement, judgment); (F) Amount of disposition; (G) Whether an appeal has been taken and by which party; and (H) Name and phone number of the person filing the report. D.100 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore (3) Definition. For the purpose of this rule, "disposition of a claim" shall include circumstances where a court order has been entered, a settlement agreement has been reached, or the complaint has been dropped or dismissed. (c) Report Format. (1) Separate reports are required for each defendant licensee or registrant. (2) The information shall be reported on a form provided by the Board. (3) A court order or settlement agreement may be submitted as an attachment to the follow­up report. (d) Claims Not Required to be Reported. Examples of claims that are not required to be reported under this rule are the following: (1) Product liability claims (i.e., where a licensee invented a medical device which may have injured a patient, but the licensee has no personal pharmacist patient relationship with the specific patient claiming injury by the device); (2) Antitrust allegations; (3) Allegations involving improper peer review activities; (4) Civil rights violations; or (5) Allegations of liability for injuries occurring on a licensee's property but not involving a breach of duty (i.e., slip and fall accidents). (e) Liability. An insurer reporting under this rule, its agents or employees, the Board, or the Board's employees or representatives are not liable for damages in a suit brought by any person or entity for reporting as required by this rule or for any other action taken under this rule. (f) Limit on Use of Information Reported. (1) Information submitted to the Board under this rule and the fact that the information has been submitted to the Board may not be: (A) Offered in evidence or used in any manner in the trial of a suit described in this rule or (B) Used in any manner to determine the eligibility or credentialing of a pharmacy to participate in a health insurance plan defined by the Insur ance Code. (2) A report received by the Board under this rule is not a complaint for which a Board investigation is required except that the Board shall review the infor mation relating to a pharmacist, pharmacy technician, or pharmacy license holder against whom at least three professional liability claims have been reported within a five­year period in the same manner as if a complaint against the pharmacist, pharmacy technician, or pharmacy license holder had been made under Chapter 555 of the Act. The Board may initiate an investigation of the pharmacist, pharmacy technician, or pharmacy license holder based on the information received under this rule. (3) The information received under this rule may be used in any Board proceed ings as the Board deems necessary. (g) Confidentiality. Information submitted under this rule is confidential, except as provided in (f)(3) above, and is not subject to disclosure under Chapter 552, Texas Public Information Act. (h) Penalty. The Texas Department of Insurance may impose on any insurer subject to this Act sanctions authorized by Sections 82.051­82.055 (formerly Section 7, Article 1.10) of the Texas Insurance Code if the insurer fails to report informa­ tion as required by this rule. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Chapter D Highlights Texas Pharmacy Act (TPA) 1. ; 4 5. The Texas State Board of Pharmacy (TSBP) is responsible for protecting the public health and safety by regulat­ jng the practice of pharmacy in Texas and administering and enforcing the Texas Pharmacy Act. I sBH is composed of 11 members—seven pharmacists, one pharmacy technician, and three public members. I sHI' may approve pilot and demonstration research projects for innovations in pharmacy practice that may m, hide a \va iver or exemption from a Board rule, but the Board may not waive requirements of state or federal laws. i c \ a s pharmacists who meet certification and continuing education requirements may provide immuniza­ tions and v aginations to patients under a written protocol with a physician... 1. ­i influenza vaccines, patients must be over age seven. b 1 \ iile proof that current licenses in other states have not been restricted, suspended, revoked, or surren­ dered; and c. Pass the Texas MPJE. I'luir m.u is! Interns (includes student interns, resident interns, and extended interns) a All pharmacist interns must be registered with TSBP. i'liai m.u is! interns may perform any duty of a pharmacist provided the duties are delegated by and under t he super \ isron of a pharmacist who is registered as a preceptor. The exception is they may not sign a doc­ ument required to be signed by a pharmacist. \s hen an intern is not working under the supervision of a preceptor, he or she functions as a pharmacy tiuhniiian hut does not count in any ratio of pharmacists to pharmacy technicians, 1'har m.u ist Continuing Education (CE) Requirements a. Hhar nuu ists must obtain 30 contact hours (3.0 CEUs) of approved continuing education every two years to renew their license. b r hie hour of the 30 contact hours must be related to Texas pharmacy laws and rules... 1 here are additional specific CE subject matter requirements that must be obtained on a one­time basis w ith different deadlines. These include courses on pain management, controlled substances, mental health awareness, and human trafficking prevention. (See Board Rule 295.8 in this chapter or summary chart on the Board's website for details.) I here are various approved ways to obtain CE (see Board Rule 295.8C.), but the most common is a program ottered by an Accreditation Council for Pharmacy Education (ACPE) provider, e. Pharmacists shall maintain CE records for three years. a o s D.102 Copyright O 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore 9. Pharmacy Licensure a. b. Class A and A­S—community pharmacies Class B—nuclear pharmacies c. Class C and C­S—institutional pharmacies (hospitals, ambulatory surgical centers, and inpatient h. »sPu es d. Class D—clinic pharmacies e. Class E and E­S nonresident pharmacies that ship prescriptions to patients in Texas f. Class F—freestanding emergency medical facility (FEMC) pharmacies g. Class G central prescription drug or medication order processing pharmacies 10. Substitution of Generic Drugs and Interchangeable (biosimilar) Biological Products a. Substitution is permissive (not mandatory) as long as the patient does not refuse and the pres. i iIht prohibited the substitution through a "dispensing directive" in b. below. b. A practitioner may prohibit the substitution of a generically equivalent drug or interchangeable bi«.1. >gi,... product for a brand name drug product by writing across the face of the written prescription m the pi.n u doner's own handwriting the phrase "Brand Necessary" or "Brand Medically Necessary." c. No later than the third business day after the date of dispensing a biological product that has been subsii tuted, the dispensing pharmacist or the pharmacist's designee shall communicate to the pies, i ibmg pi.w: titioner the specific product provided to the patient, including the name of the product and the m.mnia,:­ turer or national drug code number. This communication can be made electronically. d. Generic equivalency for drugs is determined by the FDA Orange Book. However, a pharni.u i t d , pense a generic for a product not found in the Orange Book using his or her professional uidgment. e. Interchangeability of biological products is determined by the FDA Purple Book although t h e \ , t a n d TSBP rules reference the FDA Orange Book. 11. Substitution of Dosage Form Pharmacists may dispense a dosage form of a drug product different from that prescribed. M i d i a s t a b l e t s instead of capsules or liquid instead of tablets, provided the patient consents to the dosage !rm substnu tion, the dosage form dispensed contains the identical amount of the active ingredients as the d o s a g e pre scribed for the patient and is not an enteric­coated or a timed­release product, and does not alter d e s i r e d d m ical outcomes. 12. Remote Pharmacy Services Rules Texas recognizes four types of remote pharmacy services in which drugs can be stored a n d o r d i s p e n s e d. locations that are not pharmacies and where a pharmacist is not present. They include the following. a. Emergency medication kits (primarily in nursing homes); b. Automated pharmacy systems (primarily in nursing homes); c. Telepharmacy systems (in remote healthcare facilities or remote dispensing sites); and d. Automated dispensing and delivery systems. 13. Physician Dispensing Unlike many states, physicians in Texas generally cannot dispense drugs. The only exceptions.ire as tn the day of closing, the pharmacist­in­charge must take a closing inventory, remove all prescription drugs, and transfer prescription files. Within 10 days of the closing date, the pharmacist­in­charge must forward written notice of closing and return licenses/registrations to TSBP and DEA. Prescription Drug Recalls a Pharmacies must have a written policy and procedure for the proper management of drug recalls, b I he pharmacist­in­charge must ensure that a recalled drug has been removed from inventory no more than 21 hours after the receipt of a recall notice. Return of Prescriptions Drugs 6. 11 : s generally illegal to accept a return of a prescription drug after it has been dispensed and left the control i >t the pharmacy for purposes of resale or redispensing. 1 u ept ions apply tor a voluntary drug donation program under specific conditions and for certain unused drugs in healthcare facilities (primarily nursing homes) if specific conditions are met. Inventory Requirements 3. 4. a b I lu­ pharmacist­in­charge is responsible for taking all required inventories, I in entories include all controlled substances on hand in a pharmacy. Kcquircd inventories include initial inventory, closing inventory, annual inventory, change of ownership , onstitutes closing inventory for the seller and initial inventory for the buyer), and change of pharmacist­ in­charge inventory. All inventories except the initial inventory and change of pharmacist­in­charge inventory must be signed b\ the pharmacist in­charge and dated with the date the inventory was taken. The signature must be nota­ n/ed within three days of the day the inventory was taken, c I'ei pet u.i 1 inventories ot all controlled substances are required in remote pharmacy practice sites, Class C 1 reest.mding Ambulatory Surgical Center pharmacies, and Class F (Freestanding Emergency Medical 1.Kiht\ pharmacies. A perpetual inventory of Schedule II controlled substances is required in Class C (institutional) pharmacies. Centralized Prescription Dispensing \llous the dispensing or filling of a prescription drug order by a Class A, C, or E pharmacy at the request ot a Class A or Class C pharmacy (the outsourcing pharmacy). E.34 Copyright O 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore b. Dispensed prescriptions are returned to the outsourcing pharmacy for delivery to patients or delivered directly to the patient by the central fill pharmacy. c. Requires notification to patients and the prescription label must have a code to indicate that the prescrip­ tion was filled at the central fill pharmacy. 8. Centralized Prescription Drug or Medication Order Processing a. Allows Class A, C, and E pharmacies to perform prescription or medication order processing functions on behalf of another pharmacy. b. Includes activities such as data entry, drug regimen review, claim adjudication, etc., but does not include dispensing. 9. Satellite Pharmacy a. A Class A or C pharmacy is allowed to operate a satellite location that is not separately licensed. b. Prescriptions may be dropped off at the satellite location and sent to the provider pharmacy where they are dispensed and then sent back to the satellite location where the patient picks them up and counseling is performed for new prescriptions. c. The satellite pharmacy may not store bulk drugs and may only store filled prescriptions that have been dis­ pensed by the provider pharmacy. 10. Disposal and Destruction of Drugs a. Dangerous drugs dispensed to patients in healthcare facilities such as nursing homes may be destroyed by the consultant pharmacist following specific requirements including having a witness. The consultant pharmacist may use a waste disposal service following specific procedures that include taking an inventory of the drugs and sealing the drugs before delivery to the waste disposal service. b. Dangerous drugs returned to a pharmacy by a patient and stock dangerous drugs may be destroyed by a pharmacist as long as the drugs are rendered unfit for human consumption. In addition, the destruction must be conducted in compliance with all state and federal laws and proper documentation must be kept. c. Stock controlled substances may only be destroyed in compliance with DEA requirements. (See Chapter B.) d. Pharmacies may not accept controlled substances returned by patients for destruction unless the pharma­ cies meet DEA requirements to serve as an authorized collector. (See Chapter B.) 11. Telemedicine a. The practice of telemedicine is a legal practice in Texas. This allows for the use of an Internet­based or tele­ phone consultation between the practitioner and the patient, but a valid physician­patient relationship b. must still be established. See TSBP website for Telemedicine Frequently Asked Questions. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore E.35 CHAPTER F Complaints, Inspections, Disciplinary Actions, and Procedures Chapter 555 Public Interest Information and Complaint Procedures CHAPTER F Notes Complaints, Inspections, Disciplinary Actions, and Procedures Chapter 555 Public Interest Information and Complaint Procedures Section 555.001 Public Interest Information A. The Board shall prepare information of public interest describing the functions of the Board and procedures by which complaints are filed with and resolved by the Board. B. The Board shall make the information available to the public and appropriate state agencies. C. The Board shall provide on its website a list of all Internet pharmacies licensed by the Board and shall provide information about each pharmacy including the pharmacy's name, license number, and state of physical location. An Internet pharmacy is a pharmacy physically located in this state or another state that: 1. Dispenses a prescription drug or device under a prescription drug order in response to a request received by way of the Internet to dispense the drug or device and 2. Delivers the drug or device to a patient in this state by United States mail, common carrier, or delivery service. D. Information regarding the home address or home telephone number of a per son licensed or registered under this subtitle including a pharmacy owner is confidential and not subject to disclosure under Chapter 552, Government Code (Texas Public Information Act). However, each person licensed or regis­ tered must provide the Board with a business address or address ot record that is subject to disclosure under Chapter 552 and that may be posted on the Board s Internet site or in the Board's licensure verification database. Section 555,002 Complaints A. The Board by rule shall establish methods by which consumers and service recipients are notified of the name, mailing address, and telephone number of the Board for the purpose of directing complaints to the Board. The Board may provide for that notice: 1. On each registration form, application, or written contract for services of a 2. 3. B. person regulated by the Board; On a sign prominently displayed in the place of business of each person reg ulated by the Board; On an electronic messaging system in a font specified by Board rule that is prominently displayed in the place of business of each person regulated b\ the Board; or 4. In a bill for service provided by a person regulated by the Board. The Board shall list with its regular telephone number any toll­free telephone number established under another state law that may be called to present a com plaint about a health professional. C. Any person who has knowledge relating to an action or omission ot a pharma­ cist or pharmacy licensed by the Board that constitutes a ground tor disciplinary action under Section 565.001 or 565.002 of the Act or a rule adopted under one of those sections may provide relevant records, report relevant information, or pro vide assistance to the Board. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore F. \2 Notes D. A complaint directed to the Board under this section may be made through the Internet. Note: The Board has established the following rules to implement this section of the Act. Board of Pharmacy Rule 291.3(h)(1) Notification to Consumers Regarding Filing a Complaint (For Licensed Pharmacies) 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. The notification shall be as follows: 1. If the pharmacy serves walk­in customers, the pharmacy shall either: a. Post in a prominent place that is in clear public view where prescription drugs are dispensed: (1) A sign which notifies the consumer how complaints may be filed with the Board and lists the Board's name, mailing address, Internet site address, telephone number, and a toll­free telephone number for filing complaints or (2) An electronic messaging system in a type size no smaller than 10­ point Times Roman which notifies the consumer that complaints concerning the practice of pharmacy may be filed with the Board and lists the Board's name, mailing address, Internet site address, telephone number, and a toll­free number for filing complaints or b. Provide with each dispensed prescription a written notification in type size no smaller than 10­point Times Roman which states: "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 toll­free telephone number for fil­ ing complaints)." 2. If prescriptions are delivered to patients at their residence or another des­ ignated location, the pharmacy shall provide with each dispensed prescrip­ tion written notification in type size no smaller than 10­point Times Roman which states: "Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at: (list the mailing address, Inter­ net site address, telephone number of the Board, and a toll­free telephone number for filing complaints)." If multiple prescriptions are delivered to the same location, only one notice is required. 3. The provisions of this paragraph do not apply to prescriptions for patients where drugs are administered to patients by a person required to do so by the laws of the state (e.g., nursing homes). B. A pharmacy that maintains a generally accessible site on the Internet and that is located in Texas or sells or distributes prescription drugs through this site to res­ idents 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: 1. Information on the ownership of the pharmacy to include at a minimum the: a. Owner's name or, if the owner is a partnership or corporation, the part­ nership or corporation's name and the name of the chief operating officer; b. Owner's address; c. Owner's telephone number; and d. Year the owner began operating pharmacies in the United States. Copyright © 2022 Fred S. Brinkley, Jr