Chapter 1: Overview of Texas Pharmacy Law 1 Contact Hour (Mandatory)

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Chapter 1: Overview of Texas Pharmacy Law 1 Contact Hour (Mandatory) By: Katie Blair, PharmD, RPh Author Disclosure: Katie Blair and Elite Professional Education, LLC do not have any actual or potential conflicts of interest in relation to this lesson. Universal Activity Number (UAN): 0761-9999-18-195-H03-T Activity Type: Knowledge-based Initial Release Date: April 30, 2018 Expiration Date: April 30, 2020 Target Audience: Pharmacy Technicians in a community-based setting. To Obtain Credit: A minimum test score of 70 percent is needed to obtain a credit. Please submit your answers either by mail, fax, or online at PharmacyTech.EliteCMEcom Learning objectives Summarize the details of the Texas Pharmacy Act and how these legislative efforts are important to pharmacists within the State of Texas. Discuss how these rules and laws are applicable to pharmacy professionals within their every day practices. Summarize the specifications within the recently updated Texas Administrative Code s Chapter 315, Controlled Substances. Introduction The Texas Administrative Code states that the fundamental purpose of continuing education is to maintain and enhance the professional competency of pharmacists licensed to practice in Texas, for the protection of the health and welfare of the citizens of Texas. According to the Texas State Board of Pharmacy, the pharmacists must obtain and report proof of the completion of 30 contact hours of approved continuing education during the previous license period to renew an active pharmacist license. One (1) of these hours must be related to Texas pharmacy laws or rules. This course is designed to satisfy the mandatory one hour Texas laws and rules that are required for license renewal. It is important to occasionally review these laws and rules as a new legislative session begins in the first part of January each year; 2017 marked the The Texas State Board of Pharmacy overview The board is the governing body for pharmacy affairs in the state of Texas, and is responsible for issuing licenses for pharmacists, interns, technicians, pharmacies, drug wholesalers, and drug manufacturers. The board s mission and philosophy is to promote, preserve and protect the public health, safety and welfare by fostering the provision of quality pharmaceutical care to the citizens of Texas through the regulation of the practice of pharmacy, the operation of pharmacies and distribution of prescription drugs in the public interest. The board will assume a leadership role in regulating the practice of pharmacy and act in accordance with the highest standards of ethics, accountability, efficiency, effectiveness, and openness. The Texas State Board of Pharmacy consists of eleven (11) members who are appointed by the governor with the advice and consent of the senate, without regard to the race, color, disability, sex, religion, age or national origin of the appointee. Seven of these members are pharmacists, one member is a pharmacy technician, and three members represent the public. To qualify to be considered as the member of the board, the pharmacists must be primarily employed in a Class A (Community) and /or Class C (Institutional) pharmacy. In addition, this potential appointee must be: A resident of the state of Texas; have had a Texas pharmacist license for the five years preceding the appointment; be in good standing to practice pharmacy within the state of Texas; and be practicing pharmacy within the state of Texas. The pharmacy technician board member must, Page 1 Questions regarding statements of credit and other customer service issues should be directed to 1-888-666-9053. This lesson is $10.00. Educational Review Systems is accredited by the Accreditation Council of Pharmacy Education (ACPE) as a provider of continuing pharmaceutical education. This program is approved for 1 hour (0.1 CEU) of continuing pharmacy education credit. Proof of participation will be posted to your NABP CPE profile within 4 to 6 weeks to participants who have successfully completed the post-test. Participants must participate in the entire presentation and complete the course evaluation to receive continuing pharmacy education credit. Explain the unique specifications that pertain to prescription that are for Schedule II-V drugs. Explain the unique specifications when receiving a prescription electronically. Summarize some recently adopted rules and amendments that pertain to the roles of a pharmacy professional within the state of Texas. 85th Texas Legislative Session. Multiple organizations and associations are actively seeking legislation of applicable laws that reflect the rapid adaptations and changes of the pharmacy industry, as well as the growing challenges faced by pharmacy professionals. These entities are active during these legislative sessions to voice concerns, support legislation, as well as address both patient and pharmacist rights. This course provides information about the Texas State Board of Pharmacy. In addition, it presents Chapter 315, Controlled Substances, of the Texas Administrative Code, Title 22; Part 15, which was effective September 1, 2016. Chapter 315 pertains to the prescribing, dispensing, as well as the pharmacy responsibilities legislated with controlled substances, and directly pertains to the pharmacy professional. at the time of the appointment be a resident of the state of Texas, have been registered as a pharmacy technician for the state of Texas and must be acting as a pharmacy technician within the state. The public member is not eligible if either the public member or his/her spouse is: Registered, certified, or licensed by an occupational regulatory agency in the field of health care. Employed by or participates in the management of a business entity or other organization regulated by or receiving funds from the board. Owns or controls, directly or indirectly, more than 10 percent interest in a business entity or other organization regulated by or receiving funds for the board. Uses or receives a substantial amount of tangible goods, services, or funds from the board, other than compensation or reimbursement authorized by law for board membership, attendance or expenses. Members of the board are appointed for staggered six-year terms, with either three or four members terms, as applicable, expiring every other year at midnight on the last day of the state fiscal year in the last year of the members term. The board meets at least once every four months to transact board business, but may meet at other times at the call of the board s president, or two-thirds of the board s members. The Texas Administrative Code has been implemented in order to obtain a just, fair and equitable determination of any matter within the jurisdiction of the board, and to ensure that these determinations are obtained with great expedition and with the least expense as possible

to the parties and to the state of Texas. The provisions of the TAC, therefore, will be given a liberal construction. All actions that are taken by the board will be in accordance with the Act, the Government Code, the Occupations Code, the Board s rules and any other applicable laws or rules. Texas Administrative Code, Title 22; Part 15, Texas State Board of Pharmacy; Chapter 315, Controlled Substances The following Chapter of the Texas Administrative Code was effective September 1, 2016. 315.1. Definitions effective September 1, 2016 TCSA: The Texas Controlled Substances Act (Texas Health and Safety Code, Chapter 481). Advanced practice registered nurse: A registered nurse licensed by the Texas Board of Nursing to practice as an advanced practice registered nurse on the basis of completion of an advanced educational program. The term includes a nurse practitioner, nurse midwife, nurse anesthetist, clinical nurse specialist. The term is synonymous with advanced nurse practitioner and advanced practice nurse. Drug Enforcement Administration (DEA): The Federal Drug Enforcement Administration. Electronic transmission: The transmission of information in electronic form, such as computer, electronic device to computer, e-mail, or the transmission of the exact visual image of a document by way of electronic media. Emergency situation: A situation described in the Code of Federal Regulations, Title 21, 1306.11(d). Individual practitioner: A physician, dentist, veterinarian, optometrist, podiatrist, or other individual licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice, but does not include a pharmacy. Institutional practitioner: A hospital or other person (other than an individual practitioner) licensed, registered, or otherwise permitted to dispense a controlled substance in the course of professional practice, but does not include a pharmacy. Locum tenen: An individual practitioner who practices in a temporary position in this state and licensed by the appropriate Texas state licensing board. Long-term-care facility (LTCF): An establishment licensed as such by the Texas Department of Aging and Disability Services. NDC #: A National Drug Code number. Physician assistant: An individual licensed as such by the Texas Physician Assistant Board. Record: A notification, order form, statement, invoice, prescription, inventory information, or other document for the acquisition or disposal of a controlled substance, precursor, or apparatus in any manner by a registrant or permit holder under a record keeping or inventory requirement of federal law, the TCSA, or this chapter. Reportable prescription: A prescription for a controlled substance: Listed in Schedule II through V; and Not excluded from this chapter by a rule adopted under the TCSA 481-.0761(b). Temporary controlled substances registration (TCSR): A controlled substances registration issued to a locum tenen or a health practitioner for a period of time not to exceed 90 days. 315.2 Official Prescription Form Section 315.2 pertains to how official prescription forms are obtained by practitioners who are registered by the DEA to prescribe Schedule II controlled substances. The board is the sole source for official prescription forms; however, those forms issued prior to September 1, 2016 by the Department of Public Safety are still valid. Other restrictions apply, however, and the full subsection should be reviewed at: texreg.sos.state.tx.us 315.3 Prescriptions Schedule II Prescriptions Written prescriptions for a Schedule II controlled substance should be written on an official Texas prescription form, or through an electronic prescription that meets all requirements of the TECSA (except for situations of advanced practice registered nurses or physician s assistants, which is discussed below). This subsection applies to a prescription issued in an emergency situation. The prescription (for any quantity) for a Schedule II controlled substance must be legibly filled out. The practitioner may issue multiple written prescriptions authorizing a patient to receive up to a 90-day supply if each prescription issued for a legitimate medical purpose, the practitioner provides written instructions on each prescription (other than the first prescription that is to be dispensed within 21 days of issuance, indicating the earliest date on which a pharmacy may dispense each prescription), and the practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse. Schedule III-V Prescriptions A practitioner may use prescription forms and order forms through individual sources. The practitioner may issue, or allow to be issued by person under the practitioner s direction or supervision, a Schedule III through V controlled substance on a prescription form for a valid medical purpose and in the course of medical practice. These prescriptions may be refilled up to five times within six months after date of issuance. A practitioner is permitted to issue an to dispense an electronic controlled substance prescription only in accordance with the requirements of the Code of Federal Regulations, Title 21, Part 1311. Controlled substance prescriptions may not be post-dated. APRNs or PAs may only use the official prescription forms issued with their name, address, phone number and DEA number, and the delegating physician s name and DEA number. The official prescription order form must be signed by the requesting advanced practice registered nurse or physician assistant and by the designating physician. Rule 315.4 Exceptions to use of Form Rule 315.4 covers exceptions to the use of the official form provided by the board that is used in prescribing controlled substances, as well as dispensing instructions for these exceptions. Exceptions include admittance to hospitals or prescriptions through other sorts of facilities, such as emergency rooms, clinics, dental schools, veterinary medical schools, therapeutic optometrists (in compliance with the Texas Optometry Act, and rules adopted by the Texas Optometry Board under the authority of that Act), correctional facilities and institutions that house animals (zoos, wildlife parks, wildlife management programs, state or federal research facilities, etc.). Other restrictions apply, however, and the full subsection should be reviewed at: texreg.sos.state.tx.us Rule 315.5 Pharmacy Responsibility Generally Upon receipt of a properly completed prescription form, a dispensing pharmacist must: Ensure that the date of the prescription presented is not later than 21 days after the date of issuance, if the prescription is for a Schedule II controlled substance. Ensure that each prescription is neither dispensed prior to the earliest date intended by the practitioner nor dispensed beyond 21 days from the earliest date, if multiple prescriptions are issued by the prescribing practitioner, allowing up to a 90-day supply of Schedule II controlled substances. Record the date dispensed and the pharmacy prescription number. Indicate whether the pharmacy dispensed to the patient a quantity less than the quantity prescribed. Record the following information (if issued on an official prescription form) if the information is different from the prescribing practitioner s information: The brand name or, if non, the generic name of the controlled substance dispensed; the strength, quantity and dosage form of the Schedule II controlled substance used to prepare the mixture or compound. The prescription presented for dispensing is void and a new prescription is required if the prescription is for a Schedule II controlled substance, 21 days after issuance, or 21 days after any earliest dispense date, or the prescription is for a Schedule III, IV, or V Page 2

controlled substance more than six months after issuance or has been dispensed five times during the six months after issuance. Rule 315.6 Pharmacy Responsibility Electronic Reporting Within seven days after the date a controlled substance prescription is dispensed, a pharmacy must electronically submit to the board the following data elements from all dispensed controlled substance prescriptions: The prescribing practitioner s DEA registration number, including the prescriber s identifying suffix of the authorizing hospital or other institution s DEA number, when applicable. The official prescription form control number if dispensed from a written official prescription form, unless the prescription is electronic and meets the requirements of Code of Federal Regulations, Title 21, Part 1311. The board s designated placeholder entered into the control number field if the prescription is electronic. The patient s name, age, date of birth and address, including city, state, and zip code; or such information on the animal s owner if the prescription is for veterinarian services. The date the prescription was issued and dispensed. The NDC# of the controlled substance dispensed. The quantity of controlled substance dispensed. The pharmacy s prescription number. The pharmacy s DEA registration number. Rule 315.7 Pharmacy Responsibility Oral, Telephonic, or Emergency Prescription If a pharmacy dispenses a controlled substance pursuant to an orally or telephonically communicated prescription from a practitioner or the practitioner s designated agent, the prescription must be promptly reduced to writing, including the information required by law for a standard prescription and by law (and this subchapter for an official prescription if issued for a Schedule II controlled substance in an emergency situation. After dispensing a Schedule II controlled substance pursuant to an orally or telephonically communicated prescription, the dispensing pharmacy must: Maintain the written record created under subsection (a) of this section. Note the emergency nature of the prescription. Upon receipt from the practitioner, attach the original official prescription to the orally or telephonically communicated prescription. Retain both documents in the pharmacy records. A pharmacy that dispenses Schedule III, IV, or V controlled substances pursuant to an orally or telephonically communicated prescription must inform the prescribing practitioner in the event of an emergency refill of the prescription. Furthermore, all records under this section must be maintained for two years from the date the substance was dispensed. Rule 315.8 Pharmacy Responsibility Modification of Prescription The pharmacy is responsible for documenting the following information regarding a modified prescription: 1. Date the change or adding of information was authorized. 2. Information that was authorized to be added or changed. 3. Name of the prescribing practitioner granting the authorization. 4. Initials or identification code of the pharmacist. Rule 315.9 Pharmacy Responsibility Out-of-State Practitioner A Schedule II controlled substance prescription issued by a practitioner in another state not on the board s official prescription form may be dispensed if: 1. The practitioner is authorized by the other state to prescribe the substance. 2. The pharmacy has a plan approved by and on file with the board allowing the activity. 3. The pharmacy processes and submits the prescription according to the reporting requirements approved in the plan. The pharmacy may dispense a prescription for a Schedule III through V controlled substance issued by a practitioner in another state if the practitioner is authorized by the other state to prescribe the substance. Page 3 Rule 315.10 Return of Unused Official Prescription Form The unused official prescription form is invalid and the practitioner or another person acting on behalf of the practitioner must return the unused form to the board with an appropriate explanation not later than 30th day after the date: The practitioner s license to practice, DEA number is canceled, revoked, suspended, denied, or surrendered or amended to exclude the handling of all Schedule II controlled substances. The practitioner is deceased. An individual who is an institutional practitioner must return an unused official prescription form to the administrator of the hospital or other training institution upon completion or termination of the individual s training at the hospital or institution. The administrator must return an unused official prescription form to the board not later than the 30th day after the date the individual completes or terminates all training programs. Furthermore, no individual may continue to use an official prescription form issued under an institutional practitioner s DEA number or similar number after the individual has been property and individually licensed as a practitioner by the appropriate state health regulatory agency. Rule 315.11 Release of Prescription Data A person listed under 481.076(a) of the TCSA must show proper need for the information when requesting the release of prescription data. The showing of proper need is ongoing. A pharmacist may delegate access to prescription data to a pharmacy technician as defined by Texas Occupations Code, 551.003, employed at the pharmacy and acting under the direction of the pharmacist. A practitioner may delegate access to prescription data to an employee or other agent of the practitioner at the direction of the practitioner. Rule 315.12 Schedule III through V Prescription Forms A practitioner, as defined in the TCSA, 581.002(39)(A),(C) and (D) may use prescription forms ordered through individual sources or through an electronic prescription that includes the controlled substances registration number issued by the board and meets all requirements of the TCSA. If a written prescription form is to be used to prescribe a controlled substance the dispensing practitioner must be registered with the DEA under both state and federal law to prescribed controlled substances. Rule 315.13 Official Prescription Form Accountability: A practitioner who obtains from the board an official prescription form is accountable for each numbered form. Prohibited acts: A practitioner may not: Allow another practitioner to use the individual practitioner s official prescription form. Pre-sign an official prescription blank. Post date an official prescription. Leave an official prescription blank in a location where the practitioner should reasonably believe another could steal or misuse a prescription. While not in immediate use, a practitioner may not maintain or store the book at a location so the book is easily accessible for theft or other misuse. A practitioner must account for each voided official prescription form by sending the voided form to the board. Types of forms: Forms may be single or multiple copy forms as provided by the board. Faxed forms: Faxed official prescription forms will be accounted for as in the TCSA, 481.074(0). Rule 315.14 Official Prescription Report lost forms no later than the close of business on the day of discovery. A practitioner must report a lost or stolen official prescription form to: The local police department or sheriff s office in an effective manner. The board. A recovery report must be filed no later than close of business on the day of recovery of an official prescription form previously reported lost or stolen. A practitioner must, before using the recovered form, notify: The local law enforcement agency to which the matter was originally reported. The board.

Replacement/lost form: Not later than the close of business on the day that an official prescription is replaced or reported lost, with or without a replacement. The prescribing practitioner, or designated agent, must report to the board the following: Recently adopted rules The following rules were recently adopted by the Texas Legislature: It is grounds for discipline of a pharmacist or pharmacy technician if the individual exhibits abusive, intimidating, or threatening behavior toward a board member or employee during the performance of a member s or employee s lawful duties (effective December 6, 2015). It is grounds for discipline of a pharmacy license if the owner, managing officer(s), or other pharmacy employee(s) exhibit abusive, intimidating, or threatening behavior toward a board member or employee during the performance of a member s or employee s lawful duties (effective March 10, 2016). Recent amendments S.B. 460 amends the Pharmacy Act to allow the board to inspect financial records relating to the operation of a pharmacy only in the course of an investigation of a specific complaint. It also now requires a pharmacy to file an application to change location at least 30-days prior to the move (effective September 1, 2015). S.B. 460 also eliminates the Generic Substitution Sign and modifies the requirement for the Complaint Notification to allow electronic posting, as well as specifies that a pharmacy license may not be renewed if it has expired for 91 days or more (effective September 1, 2015). S.B. 460 amends the Pharmacy Act for Class E Pharmacies to: Allow the board to discipline the pharmacy if it has been disciplined in their state. Prohibit a person from owning the pharmacy if their R.Ph. license was revoked, suspended, restricted, surrendered in another state. Require the pharmacy to have a Texas licensed pharmacist serve as the PIC for the Texas license. H.B. 751 (effective September 1, 2015) allows the substitution of interchangeable biological products, specifically biological products rated equivalent by the FDA (Orange Book and the Purple Book). Conclusion This Texas Laws and Rules update included the recently updated Chapter 315 of the Texas Administrative Code, Controlled Substances. In this chapter, specific guidelines are indicated about prescribing The patient name, address, date of birth or age. All drug information. Official prescription form control number. A pharmacist-in-charge (PIC) of a Class A Pharmacy may not also be the PIC of a Class B Pharmacy or a Class C Pharmacy in a hospital with 101 beds or more (effective December 6, 2015). Before preparing an immunization/vaccine and between each patient contact, the pharmacist must: 1.) Cleanse their hands with an alcohol-based waterless antiseptic hand rub; or 2.) Wash their hands with soap and water. If gloves are worn, pharmacists must change gloves between patients (effective December 6, 2015). The transfer of original prescription information must be completed within four business hours of the request (effective June 12, 2016). H.B. 751 also specifies that not later than the 3rd business day after dispensing the pharmacist must communicate to the prescribing doctor the name of the product provided and the manufacturer or NDC number. In addition, the bill outlines several methods to notify the prescriber. Notification is NOT required if: There is no interchangeable biological product approved by the FDA; or a refill is not changed from the product dispensed on the prior dispensing. The notification section of the bill expires on 9/1/2019. H.B. 1550 (effective September 1, 2015) amends the Pharmacy Act to allow a pharmacist to administer epinephrine, using an auto-injector, to a patient in an emergency situation, as well as specify that the pharmacist may not receive remuneration for the administration of the epinephrine but may seek reimbursement for the cost of the epinephrine auto-injector. H.B. 1550 also specifies that a pharmacist who administers epinephrine through an auto-injector device is not liable for civil damages if the pharmacist acts in good faith and complies with Board rules. Schedule II-V drugs within the state of Texas. Also discussed were recent amendments and recently adopted rules. Page 4

1. To qualify to be considered as a pharmacist member of the Texas State Board of Pharmacy, applicants must what? a. Be primarily employed in a Class A (Community) or Class C (Institutional) pharmacy (or both). b. Be a resident of Texas. c. Have had a Texas pharmacist license for five years preceding the appointment. d. All of the above. 2. The transmission of information in electronic form, such as computer, electronic device to computer, e-mail, or the transmission of the exact visual image of a document by way of electronic media is referred to as. a. An original prescription. b. An electronic transmission. c. An emergency prescription. d. Locum tenen. 3. Which of the following is NOT an accurate part of the pharmacist s responsibility upon receiving a properly completed prescription form? a. Recording the date dispensed and the pharmacy prescription number. b. Indicating whether the pharmacy dispensed to the patient a quantity less than the quantity prescribed. c. Recording the brand name (or generic name), the strength, quantity and dosage form of the Schedule II controlled substance used to prepare the mixture or compound. d. Ensuring that the date of the prescription presented is not later than 30 days after the date of issuance, if the prescription is for a Schedule II controlled substance. 4. When a prescription of a controlled substance is received electronically, how many days does a pharmacy have to submit the prescriber s DEA registration number, the patient s name, age, date of birth, address, the date of the prescription s issuance and dispensing, the NDC# of the controlled substance and the quantity of the controlled substance dispensed, to the board? a. Five days. b. Twenty-four hours. c. Seven days. d. Three days. 5. Under certain conditions, it is acceptable that a practitioner would post date an official prescription. a. True. b. False. 6. Before preparing an immunization/vaccine and between each patient contact, a pharmacist must: a. Cleanse his/her hands with an alcohol-based waterless antiseptic hand rub. b. Wash his/her hands with soap, if alcohol-based waterless antiseptic hand rub is not available. c. Change gloves, if gloves are worn. d. All of these are applicable, depending on the situation. OVERVIEW OF TEXAS PHARMACY LAW Final Examination Questions Select the best answer for questions 1 through 10 and mark your answers online at 7. The transfer of original prescription information must be completed within how long of the request? a. Twenty-four hours. b. Two days. c. Four business hours. d. Four business days. 8. According to the Pharmacy Act, the board is allowed to inspect financial records relating to the operation of a pharmacy when? a. Whenever the board feels like it. b. Never. c. Only in the course of an investigation of a specific complaint. d. Every quarter. 9. The Pharmacy Act was amended recently to allow for a pharmacist to administer epinephrine, using an auto injector, to a patient in an emergency situation. What other statements are true regarding this amendment? a. The pharmacist may not receive remuneration for the administration for the administration of the epinephrine. b. The pharmacist may seek reimbursement for the cost of the epinephrine auto injector. c. The pharmacist who administers epinephrine through an autoinjector is not liable for civil damages if the pharmacist has acted in good faith and complies with Board rules. d. All of these are true. 10. A pharmacy license that has been expired for how many days may not be renewed? a. Sixty days. b. Ninety days. c. Ninety-one days (or more). d. Thirty days. RPTTX01TLE18 Page 5