Chapter C_Part1 PDF Notes on Texas Health and Safety Code

CHAPTER C Notes CHAPTER 483 TEXAS HEALTH and SAFETY CODE Texas Dangerous Drug Act (TDDA) (Administered and Enforced by TSBP) and Related Texas Laws and Rules Section 483.001 Definitions and Practice Issues A. Dangerous Drug j Any drug or device that is unsafe for selfmedication and is not included in \ Schedules I through V or Penalty Groups I through IV of Chapter 481 (Texas j Controlled Substances Act). The term includes a device or a drug that bears or is | required to bear the legend: 1. "Caution: Federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law. 2. "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." B. Designated Agent 1. A licensed nurse, physician assistant, pharmacist, or other individual des j ignated by a practitioner to communicate prescription drug orders to a pharmacist; 2. A licensed nurse, physician assistant, or pharmacist employed in a healthcare facility to whom the practitioner communicates a prescription drug order; A registered nurse or physician assistant authorized by a practitioner to carry out (or sign) a prescription drug order for dangerous drugs under the Medical Practice Act; or 3. 4. A person who is a licensed vocational nurse or has an education equivalent to or greater than that required for a licensed vocational nurse who is des ignated by the practitioner to communicate prescriptions for an advanced practice registered nurse or physician assistant authorized by the practi tioner to sign prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code). Note: B.4. is included here for clarity although it is actually found in Section 483.022(f). C. Pharmacy A facility at which prescription drug or medication orders are received, pro cessed, or dispensed under this chapter, Chapter 481, and the Texas Pharmacy Act. The term does not include a narcotic drug treatment program that is regu lated by Chapter 466, Health and Safety Code. D. Practice of Pharmacy 1. Provision of those acts or services necessary to provide pharmaceutical care. 2. Interpretation and evaluation of prescription drug orders or medication orders. 3. Participation in drug and device selection as authorized by law, drug admin istration, drug regimen review, or drug or drugrelated research. 4. Provision of patient counseling. 5. Responsibility for: a. Dispensing of prescription drug orders or distribution of medication orders in the patient's best interest; b. Compounding and labeling of drugs and devices, except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged prescription drugs and devices; Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes c. Proper and safe storage of drugs and devices; or d. Maintenance of proper records for drugs and devices. 6. Performance of a specific act of drug therapy management for a patient dele gated to a pharmacist by a written protocol from a physician licensed undei the Texas Medical Practice Act. E. Practitioner A person licensed: 1. By the Texas Medical Board, State Board of Dental Examiners, Texas Depart ment of Licensing and Regulation as a podiatrist, Texas Optometry Board, or State Board of Veterinary Medical Examiners to prescribe and administer dangerous drugs; 2. By another state in a health field in which, under the laws of this state, a licensee may legally prescribe dangerous drugs; 3. In Canada or Mexico in a health field in which, under the laws of this state, a licensee may legally prescribe dangerous drugs; and Note: Prescriptions from Canadian and Mexican practitioners can be legally filled only if the pharmacist has the original written prescription. E 4. An advanced practice registered nurse or physician assistant to whom a phy sician has delegated the authority to prescribe or order a drug or device. Prescription An order from a practitioner or an agent of the practitioner designated in writ ing as authorized to communicate prescriptions or an order from an advanced practice registered nurse or physician's assistant to a pharmacist for a dangerous drug to be dispensed that states: 1. The date of the order's issue; 2. The name and address of the patient; 3. If the drug is prescribed for an animal, the species of such animal; 4. The name and quantity of the drug prescribed; 5. The directions for use of the drug; 6. The intended use of the drug unless the practitioner determines the furnish ing of this information is not in the best interest of the patient; 7. The name, address, and telephone number of the practitioner at the practi tioner s usual place of business, legibly printed or stamped; and 8. The name, address, and telephone number of the advanced practice regis tered nurse or physician assistant, legibly printed or stamped, if signed by an advanced practice registered nurse or physician assistant. G. Scope of Practice of a Practitioner A physician (D.O. or M.D.) may legally prescribe a drug to treat any disease or illness. Although a pharmacist should exercise caution, it is legal to fill a pre scription written outside of a physician's specialty such as a hypertension med ic a ion written by an orthopedic surgeon or an oncologist. However, dentists, P diatrists, and veterinarians may only prescribe drugs used within their scope 1 nr« t' °rfeXamplf' 3 veterinarian cannot prescribe drugs for humans, and p escription from a dentist for birth control pills would not likely be a valid prescription. Likewise, prescriptive authority for optometrists is limited to drugs o reat conditions of the eye and is subject to other restrictions. (See Indepen dent Prescriptive Authority of Therapeutic Optometrists and Optometric Glau coma Specialists in this chapter.) H. SelfPrescribing Texas law does not specifically prohibit a physician from prescribing a danger ous drug or a controlled substance for himself or herself or for family mem ph^'ickmsfVer' 2 ^ I Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Pr°VideS Ae foI1°winS §uidance t0 1. It may be appropriate to undertake selftreatment or treatment of immedi ate family members in emergency situations. In addition, while physicians should not serve as primary or regular care providers for immediate family members, there are situations in which routine care is acceptable for short term, minor problems. There are significant risks for physicians who write prescriptions for controlled substances for themselves or immediate fam ily members. Physicians should always document any treatment provided to avoid legal sanctions by the Texas Medical Board (TMB). 2. Texas Medical Board Rule 190.8(1)(M) states that inappropriate prescribing of dangerous drugs or controlled substances to oneself, family members, or others in which there is a close personal relationship is a violation of the Medical Practice Act. The rule states that (1) prescribing or administering dangerous drugs or controlled substances without taking an adequate his tory, performing a proper physical examination, and creating and main taining adequate records and (2) prescribing controlled substances in the absence of immediate need (no more than 72 hours) constitute inappropriate prescribing. I. Prescriptions may only be issued to a patient. Prescriptions may not be written "For Office Use." If a practitioner wishes to obtain drugs for office use, he or she may order the drugs from a wholesaler, a manufacturer, or a pharmacy and must use appropriate forms for ordering controlled substances (an invoice or DKA Form 222). J. What happens to existing refills on a prescription if the prescriber dies? While there are no specific rules on this topic, it has been discussed by the Texas Med ical Board and the Texas State Board of Pharmacy. Both have agreed that it is acceptable for the pharmacist to provide a 30day supply to the patient and inform him or her to find a new doctor. However, DEA has not given an opinion on this, so pharmacists should use professional judgment if it is for a controlled substance. If there are no refills remaining on the prescription, it may be best to use the existing emergency refills rules. Documentation of these procedures by the pharmacist is crucial. Section 483.002 Rules The Texas State Board of Pharmacy may adopt rules to administer and enforce this chapter. Section 483.003 Department of State Health Services Hearings Regarding Certain Drugs A. The Texas Department of State Health Services may hold public hearings to determine if a dangerous drug is being abused. B. Upon the Texas Department of State Health Services finding that a drug is being abused, dispensing of such drug may be limited to prescriptions issued by prac titioners licensed in Texas or another U.S. state or territory (i.e., prescriptions from Canadian or Mexican practitioners cannot be dispensed). Section 483.004 Commissioner of State Health Services Emergency Authority Relating to Dangerous Drugs. If the Commissioner of State Health Services determines an immediate danger to public health exists as a result of dangerous drug prescriptions issued by practitioners in Canada or Mexico, emer gency authority may be used to limit prescriptions to practitioners in Texas or other states of the United States. Section 483.021 Determination by Pharmacist on Request to Dispense Certain Drugs A. A pharmacist who is requested to dispense a dangerous drug under a prescrip tion issued by a practitioner shall determine in the exercise of the pharma cists professional judgment that the prescription is a valid prescription. A phar macist may not dispense a dangerous drug if the pharmacist knows or should Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes have known that the prescription was issued without a relationship. valid patientphysician Note: This is similar to the corresponding responsibility for pharmacists for con trolled substances. B. Therapeutic Optometrist A pharmacist who is requested to dispense a dangerous drug prescription issued by a therapeutic optometrist shall determine in the exercise of the phar macist's professional judgment whether the prescription is for a dangerous drug that a therapeutic optometrist is authorized to prescribe under the Texas Optometry Act. Section 483.022 Practitioner's Designation of Agent; Practitioner's Responsibilities A. A practitioner shall provide in writing the name of each designated agent. B. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. C. The practitioner shall provide a pharmacist with a copy of the practitioner's writ ten authorization for a designated agent on the pharmacist's request. D. A practitioner remains personally responsible for the actions of a designated agent who communicates a prescription to a pharmacist. E. This section does not relieve a practitioner from complying with the require ments of Subchapter A, Chapter 562, Occupations Code (relating to generic substitution). F. A practitioner may designate a person licensed as a licensed vocational nurse or has an education equivalent to or greater than a licensed vocational nurse to communicate prescriptions of an advanced practice registered nurse or physi cian's assistant. Section 483.023 Retention of Prescriptions Pharmacies must retain prescriptions for two years from the initial dispensing or the last date of refilling. Section 483.024 Records of a Drug Acquisition or Disposal The following persons shall maintain a record of each acquisition and each disposal of a dangerous drug for two years after the date of the acquisition or disposal: A. Pharmacies B. Practitioners C. Persons obtaining drugs for lawful research, teaching, or testing but not for resale D. Hospitals E. Manufacturers and wholesalers Section 483.025 Inspections and Inventories A person required to keep records of dangerous drugs shall: A. Provide records for inspection and copying. B. Allow the inventorying of drugs. Section 483.041 Possession of Dangerous Drugs A. A person commits an offense if the person possesses a dangerous drug unless the person obtains the drug from a pharmacist acting in the manner described by Section 483.042A.1. below or from a practitioner as described bv Section 483.042A.2. below. Note: This means the dangerous drug must be delivered by a pharmacist pursu ant to a valid prescription and be appropriately labeled or, in limited situations, delivered by a practitioner. Delivery by a practitioner should only meet a patient's immediate needs (72hour supply) or in rural areas where under specific circum stances physicians can dispense dangerous drugs. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore B. Except as provided by this chapter, a person commits an offense if the person possesses a dangerous drug for the purpose of selling the drug. C. The following or their agents or employees may possess drugs if acting in the usual course of business or practice or in the performance of official duties 1. A pharmacy licensed by the Board (not pharmacist unless acting as an agent of the pharmacy). 2. A practitioner: M.D., D.O., D.D.S., Podiatrist, Veterinarian, or Optometrist 3. A person who obtains a dangerous drug for lawful research, teaching, or testing but not for resale. 4. A hospital that obtains a dangerous drug for lawful administration by a practitioner. 5. An officer or employee of federal, state, or local government. 6. A manufacturer or wholesaler licensed by the Commissioner of Health under Chapter 431 (Texas Food, Drug, and Cosmetic Act). 7. A carrier or warehouseman. 8. A Home and Community Support Services Agency (HCSSA) licensed under Chapter 142. 9. A midwife who obtains oxygen or a dangerous drug for administration to a mother or newborn. 10. A salvage broker or operator. 11. A certified laser hair removal professional who possesses and uses a laser or pulsed light device. D. Offense: Illegal possession of dangerous drugs is a Class A misdemeanor. Section 483.042 Delivery (Sale) or Offer to Deliver a Drug A. It is unlawful for anyone to deliver a dangerous drug unless: 1. Delivered by a pharmacist pursuant to: a. A prescription issued by a practitioner; b. A prescription issued by an advanced practice registered nurse (APRN) or physician assistant (PA) in compliance with the Medical Practice Act; or c. An original written prescription issued by a practitioner described in Section 483.001(12)(C) (i.e., a practitioner in Mexico or Canada). 2. Delivered by: a. A practitioner in the course of practice or b. An advanced practice registered nurse (APRN) or physician assistant (PA) in the course of practice and pursuant to the Medical Practice Act. B. Labeling of Container 1. A pharmacist must attach a label to the immediate container. The label must contain the following information: a. Name and address of the pharmacy; b. Date dispensed; c. Prescription number; d. Name of the practitioner who prescribed the drug; e. Name of the patient and, if for an animal, the species of the animal; and f. Directions for the use of the drug. 2. A practitioner, advanced practice registered nurse, or physician assistant that delivers a drug in the course of practice pursuant to the Medical Prac tice Act must attach a label to the immediate container. The label must con tain the following information: a. Name and address of the practitioner who prescribed the drug; b. Date dispensed; c. Name of the patient and, if for an animal, the species of the animal; d. Name of the practitioner who prescribed the drug; and e. Name, strength, and directions for the use of the drug. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes C. Subsection A. above does not apply to the delivery or offer to deliver a dangerous drug to a person listed in Section 483.041(C) for use in the usual course of busi ness or practice or the performance of official duties by the person (e.g., phar macy, practitioner, TSBP, etc.). D. The labeling provisions of B. do not apply to a dangerous drug prescribed or dis pensed for administration to a patient who is institutionalized. E. The offense of an illegal delivery (sale) is a state jail felony. Section 483.043 Manufacture of a Dangerous Drug A. It is unlawful to manufacture a dangerous drug unless so authorized. B. An offense is a state jail felony. Section 483.045 Forging or Altering Prescriptions A. It is unlawful to: 1. Forge a prescription or increase the prescribed quantity of a prescription (without a physician's authorization). Note: A pharmacist may increase the quantity of most dangerous drug pre scriptions as permitted under the Texas Pharmacy Act Section 562.0545. (See Chapter D in this book.) 2. 3. Issue a prescription with a forged signature. Possess or obtain or attempt to obtain dangerous drugs: a. By a forged, fictitious, or altered prescription or b. By a fictitious or fraudulent telephone call. B. The offense is a: 1. Class B misdemeanor or 2. Class A misdemeanor if the defendant has been previously convicted for a dangerous drug offense. Section 483.046 Failure to Retain a Prescription A. A pharmacist commits an offense if the pharmacist delivers a dangerous drug under a prescription and fails to retain the prescription. B. The offense is a Class B misdemeanor or a Class A misdemeanor if previously convicted. Section 483.047 Refilling a Prescription Without Authorization (Emergency Refills) See Chapter G for detailed rules on emergency refills. Section 483.048 Unauthorized Communication of Prescription A. It is unlawful for a practitioner's agent to telephonically communicate a pre scription unless the agent is designated as such in writing. B. The offense is a: 1. Class B misdemeanor or 2. Class A misdemeanor if previously convicted. Section 483.049 Failure to Maintain Records A. A person commits an offense if the person is required to maintain a record under Section 483.023 (Retention of Prescription Records) or Section 483.024 (Records of Drug Acquisition or Disposal) and the person fails to maintain the record in the manner required by those sections. B. The offense is a: 1. Class B misdemeanor or 2. Class A misdemeanor if previously convicted. Section 483.050 Refusal to Permit Inspection A. A person commits an offense if the person is required to permit an inspection under Section 483.025 and fails to permit the inspection. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore B. The offense is a: 1. Class B misdemeanor or 2. Class A misdemeanor if previously convicted. Notes Section 483.073 Search Warrant A peace officer may obtain a warrant to search for illegally possessed dangerous drugs. Section 483.074 Seizure and Destruction Dangerous drugs that are illegally manufactured, sold, or possessed may be seized and destroyed. SUBCHAPTER E. Opioid Antagonists Note: Sections 483.101483.106 below permit a physician to prescribe and a pharmacist to dispense an opioid antagonist pursuant to a prescription or a standing order to a person at risk of experiencing an opioidrelated drug overdose or to a family member, friend, or other person in a position to assist a person at risk of an opioidrelated drug overdose. It also pro vides protection from civil and criminal liability and disciplinary action to prescribers or pharmacists who choose to prescribe/dispense or not to prescribe/dispense such drugs. Section 483.101 Definitions A. Emergency services personnel includes firefighters, emergency medical ser vices personnel as defined by Section 773.003, emergency room personnel, and other individuals who in the course and scope of employment or as a volun teer provide services for the benefit of the general public during emergency situations. B. "Opioid antagonist" means any drug that binds to opioid receptors and blocks or otherwise inhibits the effects of opioids acting on those receptors. j C. "Opioidrelated drug overdose" means a condition evidenced by symptoms such ; as extreme physical illness, decreased level of consciousness, constriction of" ! the pupils, respiratory depression, or coma that a layperson would reasonably believe to be the result of the consumption or use of an opioid. D. "Prescriber" means a person authorized by law to prescribe an opioid antagonist. Section 483.102 Prescription for an Opioid Antagonist; Standing Order From a Prescriber A. A prescriber may directly or by standing order prescribe an opioid antagonist to: 1. A person at risk of experiencing an opioidrelated drug overdose or 2. A family member, friend, or other person in a position to assist a person described by A. 1. above. B. A prescription issued under this section is considered as issued for a legitimate medical purpose in the usual course of professional practice. C. A prescriber who acting in good faith with reasonable care prescribes or does not prescribe an opioid antagonist is not subject to any criminal or civil liability or any professional disciplinary action for: 1. Prescribing or failing to prescribe the opioid antagonist or 2. If the prescriber chooses to prescribe an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist. i Note: A pharmacy must have a standing order with a physician to dispense an opioid antagonist such as naloxone without an individual prescription. Many chain pharma cies have standing orders that cover all their pharmacies in the state. The Texas Phar macy Association also has a standing order that members can access after complet ing training. A prescription for an opioid antagonist issued by a pharmacist under a standing order is considered a valid prescription. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore C.7 Notes Section 483.103 Dispensing of an Opioid Antagonist by a Pharmacist A. A pharmacist may dispense an opioid antagonist under a valid prescription to: 1. A person at risk of experiencing an opioidrelated drug overdose or 2. A family member, friend, or other person in a position to assist a person described by A.l. above. B. A prescription filled under this section is considered as filled for a legitimate medical purpose in the usual course of professional practice. C. A pharmacist who acting in good faith and with reasonable care dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for: 1. Dispensing or failing to dispense the opioid antagonist or 2. If the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist. 'j. Board of Pharmacy Rule 295.14 Dispensing of Opioid Antagonist by a Pharmacist (a) Purpose. The purpose of this section is to provide standards for pharmacists engaged in the dispensing of opioid antagonists as authorized in Chapter 483, Health and Safety Code. (b) Definitions. (1) Opioid antagonist—Any drug that binds to opioid receptors and blocks or otherwise inhibits the effects of opioids acting on those receptors. (2) Opioidrelated drug overdose—A condition evidenced by symptoms such as extreme physical illness, decreased level of consciousness, constriction of the pupils, respiratory depression, or coma that a layperson would reason ably believe to be the result of the consumption or use of an opioid. (3) Prescriber A person authorized by law to prescribe an opioid antagonist. (c) Dispensing. (1) A pharmacist may dispense an opioid antagonist under a valid prescription including a prescription issued by a standing order to: (A) A person at risk of experiencing an opioidrelated drug overdose or (B) A family member, friend, or other person in a position to assist a person described by (A) above. (2) A prescription dispensed under this section is considered as dispensed for a legitimate medical purpose in the usual course of professional practice. (3) A pharmacist who acting in good faith and with reasonable care dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for: (A) Dispensing or failing to dispense the opioid antagonist or (B) If the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist. Section 483.104 Distribution of Opioid Antagonist; Standing Order A person or organization acting under a standing order issued by a prescriber may store an opioid antagonist and may distribute an opioid antagonist provided the person or organization does not request or receive compensation for storage or & distribution. Section 483.105 Possession of Opioid Antagonist Any person may possess an opioid antagonist regardless of whether the person holds a prescription for the opioid antagonist. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Section 483.106 Administration of Opioid Antagonist A. A person who acting in good faith and with reasonable care administers or does not administer an opioid antagonist to another person whom the person believes is suffering an opioidrelated drug overdose is not subject to criminal prosecu tion, sanction under any professional licensing statute, or civil liability for an act or omission resulting from the administration of or failure to administer the opioid antagonist. B. Emergency services personnel are authorized to administer an opioid antagonist to a person who appears to be suffering an opioidrelated drug overdose as clini cally indicated. Prescriptive Authority for Advanced Practice Registered Nurses and Physician Assistants I. General A. Texas law allows Advanced Practice Registered Nurses (APRNs) and Physician Assistants (PAs) to prescribe under what is essentially "dependent" prescriptive authority. Although they are recognized as practitioners, they must be work ing under the supervision of a physician under rules developed by the Board of Nursing and the Texas Medical Board. B. The term Advanced Practice Registered Nurse includes a nurse practitioner, a nursemidwife, a nurse anesthetist, and a clinical nurse specialist. The term is synonymous with "advanced nurse practitioner." C. Prescribing by APRNs and PAs includes prescribing or ordering nonprescription drugs, dangerous drugs or devices, and controlled substances subject to the lim itations described below including the issuing of a prescription drug order or a medication order. D. Prescriptive Authority Agreement or Facility Protocol ' 1. A physician may delegate to an APRN or PA acting under adequate physi cian supervision the act of prescribing or ordering a drug or device as autho rized in a prescriptive authority agreement between the physician and the APRN or PA. A prescriptive authority agreement must identify the practice locations and types or categories of drugs or devices that may be prescribed or the types or categories of drugs or devices that may not be prescribed. For detailed requirements on prescriptive authority agreements, see Texas Occupations Code Sections 157.0512, 157.0513, and 157.0514 and Texas Medi cal Board rules. 2. The Texas Medical Board shall maintain and make available to the public a 1 searchable online list of physicians, APRNs, and PAs with whom each physi cian, APRN, or PA has entered into a prescriptive authority agreement. 3. In a hospital or longterm care facility, prescriptive authority may be del egated to APRNs and PAs through a protocol rather than a prescriptive : authority agreement. However, free standing clinics or other medical prac tices that are owned or operated by or associated with a hospital or long. term care facility that are not physically located within the hospital or long term care facility are not considered facilitybased practices. Prescriptive authority agreements are required in these settings. E. Prescribing Controlled Substances 1. The APRN or PA must be registered with the DEA. 2. APRNs and PAs must follow these requirements and conditions for pre | scribing Schedule III, IV, and V controlled substances. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore C.9 Notes a. Section 157.0511(b) of the Texas Medical Practices Act states that fo Schedule III, IV, and V controlled substances prescribed by an APRN o PA, the prescription including a refill of the prescription may not exceec a 90day supply. b. Although it states "a refill," both the Texas State Board of Pharmacy anc the Texas Medical Board have agreed that a prescription for a Schedule IIIV controlled substance from an APRN or PA can have more than one refill, but the prescription and any refills are only valid for 90 days. A controlled substance prescription from an APRN or PA is limited to a 90day supply and expires after 90 days. After that, a new prescription would be required. c. Refills of Schedule III, IV, or V prescriptions may be authorized after consultation with the delegating physician, and the consultation is noted in the patient's chart. d. For controlled substance prescriptions for a child fewer than two years of age, the APRN or PA must consult with the delegating physician, and the consultation must be noted in the patient's chart. e. A physician may also delegate to a PA who provides boardcertified obstetrical services or a certified nurse midwife (CNM) the adminis tering or providing of controlled substances to a patient during intra partum and immediate postpartum care. Schedule II Prescriptions a. Most APRNs and PAs cannot prescribe Schedule II controlled substances. b. One exception to this rule is a physician may delegate to an APRN or PA the authority to prescribe or order a Schedule II controlled substance in a hospitalbased practice (not a nursing home or clinic that is not part of the hospital) in accordance with policies approved by the hospital's medical staff to a patient who has been admitted to the hospital for an intended length of stay of 24 hours or greater. Other exceptions are to a patient receiving services in the emergency department of the hospi tal or as part of a plan of care for the treatment of a person who has exe cuted a written certification of a terminal illness, has elected to receive hospice care, and is receiving hospice treatment from a qualified hospic nee provider. Mandated Information to be Provided on Each Prescription Issued by an APRN or PA A. B. C. D. E. F. G. Patient's name and address; Date issued; Name, strength, and quantity of drug prescribed; Directions for use; Intended use of the drug if appropriate; Number of refills permitted; and Name, address, and telephone number of the APRN or PA signing the pre scription as well as the name, address, and telephone number of the delegating & physician. Note: The signature of the physician is not required. H. If the prescription is for a controlled substance, the DEA number of the APRN or PA and the DEA number of the delegating physician must be on the prescription. Supervision A. Except as provided in B. below, the combined number of APRNs and PAs with whom a physician may enter into a prescriptive authority agreement may not exceed seven APRNs and PAs or their fulltime equivalents..10 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore B. The limitation in A. above does not apply to a prescriptive authority agreement if it is exercised in: 1. A practice serving a medically underserved population or 2. A facilitybased practice in a hospital or longterm care facility. (This does not apply to a freestanding clinic, center, or practice of the facility.) C. A physician must provide continuous supervision of the prescribing or order ing of a drug or device, but the constant physical presence of the physician is not required. Notes IV. OutofState APRNs and PAs A. Dangerous Drugs Prescriptions for dangerous drugs from outofstate APRNs or PAs can be filled in Texas. However, the APRN or PA must have prescriptive authority for these drugs in his or her own state. B. Controlled Substances—Prescriptions for controlled substances from outof state APRNs or PAs are not valid prescriptions and cannot be filled in Texas. Independent Prescriptive Authority of Therapeutic Optometrists and Optometric Glaucoma Specialists I. Introduction A. There are three separate types of licenses for Texas optometrists, each with dif ferent prescribing authority. The three types are: (1) Optometrists, (2) Therapeu tic Optometrists, and (3) Optometric Glaucoma Specialists. B. Optometrists may administer drugs to diagnose defects of vision and disease but do not have any prescriptive authority other than for contact lenses and pre scription eyeglasses. They can be identified by their license number because it does not contain the letters "T" or "TG." II. Therapeutic Optometrists A. Therapeutic Optometrists may administer or prescribe drugs to treat the eye and adnexa (tissue surrounding the eye) but may not prescribe oral or parenteral drugs to treat glaucoma. B Therapeutic Optometrists may prescribe topical ocular pharmaceutical agents and dangerous drugs to diagnose or treat diseases of the eye and adnexa but may not prescribe more than one 3day supply of any controlled substance in Sched ules III, IV, or V. \ ! j j Note: This implies they may not prescribe controlled substances in Schedule II. C D Therapeutic Optometrists can be identified by the letter "T" in their license. Most licensed optometrists are therapeutic optometrists. Therapeutic Optometrists must be registered with DEA to prescribe and admin ister controlled substances. i Optometric Glaucoma Specialists A. Optometric Glaucoma Specialists are Therapeutic Optometrists who may also treat glaucoma. They have all of the privileges of a Therapeutic Optometrist but may also administer and prescribe oral or parenteral drugs to treat glaucoma. B. Optometric Glaucoma Specialists can be identified by the letters "TG" in their license. C. The law to allow Optometric Glaucoma Specialists to prescribe medication to treat glaucoma contains a number of restrictions and requirements. (See Texas Occupations Code Section 351.3581for more information.) D. Optometric Glaucoma Specialists must be registered with DEA to prescribe and administer controlled substances. Copyright © 2022 Fred S. Brinkiey, Jr., and Gary G. Cacciatore C.11 Notes IV. OutofState Prescriptions From Optometrists If a Texas pharmacy receives a prescription from an outofstate optometrist, the pr£ scription can be filled if the drug is one that may be prescribed by a Texas license' Therapeutic Optometrist. Although some states may allow other drugs to be pre scribed by optometrists, a Texas pharmacy may only dispense a drug that is allowe* to be prescribed by an optometrist licensed in Texas. As with any outofstate pre scription, the pharmacist must first determine if the optometrist is authorized t< prescribe the drug in his or her home state. V. Cocaine Eye Drops for Diagnostic Purposes A. Therapeutic Optometrists and Optometric Glaucoma Specialists can administer (but not prescribe or dispense) cocaine eye drops not greater than a 10% solution in prepackaged liquid form for diagnostic purposes. B Therapeutic Optometrists and Optometric Glaucoma Specialists must have a controlled substance registration certificate from DEA to possess and adminis ter cocaine eye drops. C Pharmacist's Information A pharmacist may only distribute cocaine to Therapeutic Optometrists or Optometric Glaucoma Specialists pursuant to a DEA Form 222. 2. A pharmacist may not distribute a controlled substance (other than a 10% solution of cocaine in prepackaged liquid form) to a Therapeutic Optometrist. 3. The 10% cocaine solution may not be compounded. Texas Health and Safety Code Chapter 488 OvertheCounter Sales of Dextromethorphan Note: This law prohibits overthecounter sales of products containing dextromethorphan to customers under 18 years of age. Section 488.001 Definitions A. In this chapter: 1. Dextromethorphan means any compound, mixture, or preparation con taining any detectable amount of that substance, including its salts, optical isomers, and salts of optical isomers. 2. "Sale" includes a conveyance, exchange, barter, or trade. B. A term that is used in this chapter but is not defined by A. above has the mean ing assigned by Section 481.002 if the term is defined in that section. Section 488.002 Inapplicability A. This chapter does not apply to the sale of any product dispensed or delivered by a pharmacist according to a prescription issued by a practitioner for a valid med ical purpose within the scope of the practitioner's practice as authorized by the practitioner s license issued under Title 3, Occupations Code. B. This chapter does not require a business establishment to: 1. Keep specific records of transactions covered by this chapter or 2. Store dextromethorphan in a specific location in a business establishment or otherwise restrict the availability of dextromethorphan to customers. Section 488.003 Distribution to Minors Prohibited; Prerequisite to Sale A. A business establishment may not dispense, distribute, or sell dextromethor phan to a customer under 18 years of age. B. Before dispensing distributing, or selling dextromethorphan over the counter a business establishment must require the customer obtaining the drug to dis play a drivers 1,cense or other form of identification containing the customer s Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore photograph and indicating that the customer is 18 years of age or older unless from the customer's outward appearance the person making the sale may rea sonably presume the customer to be 27 years of age or older. Notes Section 488.004 Violation; Civil Penalty A. A county or district attorney shall issue a warning to a business establishment for a first violation of this chapter. B. After receiving a warning for the first violation under A. above, a business estab lishment is liable to the state for a civil penalty of: 1. $150 for the second violation and 2. $250 for each subsequent violation. C. It is a defense in an action brought under this section that the person to whom the dextromethorphan was dispensed, distributed, or sold presented to the busi ness establishment apparently valid proof of identification. D. A proof of identification satisfies the requirements of C. above if it contains a physical description and photograph consistent with the person's appearance, purports to establish that the person is 18 years of age or older, and was issued by a governmental agency. The proof of identification may include a driver s license issued by this state or another state, a passport, or an identification card issued by a state or the federal government. E. It is a defense in an action brought under this section that the business establish ment made a good faith effort to comply with this section. Section 488.005 Prohibited Local Regulation A. A political subdivision of this state may not adopt or enforce an ordinance, order, rule, regulation, or policy that governs the sale, distribution, or possession of dextromethorphan. B. An ordinance, order, rule, regulation, or policy described by A. above is void and unenforceable. ! ! j I | Possession and Administration of Certain Dangerous Drugs by Home and Community Support Services Agencies A. The Health and Safety Code authorizes Home and Community Support Services Agencies (HCSSA) and its employees who are registered nurses or licensed voca tional nurses under physician's standing orders to purchase, store, or transport for the purpose of administering to: 1. Their home health or hospice patients: a. Sterile water for injection and irrigation and b. Sterile saline for injection and irrigation. 2. The agency's employees, home health or hospice patients, or patient's family members: a. Hepatitis B vaccine; b. Influenza vaccine; and c. Tuberculin purified protein derivative for tuberculosis testing. B. Possession An HCSSA and its employees who are registered nurses or licensed vocational nurses may purchase, store, or transport for the purpose of administering: 1. The following items in a sealed portable container of a size determined by the dispensing pharmacist: a. 1,000 ml of 0.9% sodium chloride intravenous infusion; b. 1,000 ml of 5% dextrose in water for injection; or c. Sterile saline. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore C.13 Notes 2. Not more than 5 dosage units of: a. Heparin sodium lock flush—10 units/ml or 100 units/ml; b. Epinephrine HC1 solution 1:1,000; c. Diphenhydramine HC150mg/ml; d. Methylprednisolone 125mg/2ml; e. Naloxone lmg/ml in a 2ml vial; f. Promethazine 25mg/ml; Glucagon injection lmg/ml; h. Furosemide lOmg/ml; i. Lidocaine 2.5% and prilocaine 2.5% in a 5 gram tube; or j Lidocaine HC1 solution 1% in a 2ml vial. C. Sealed Container An HCSSA and its authorized employees may purchase, store, or transport the drugs in a sealed container only if the agency has established policies to ensure that: 1. The container is handled properly with respect to storage, transportation, and temperature stability; 2. A drug is removed from the container only on a physician's order; 3. Administration of any drug in the container is performed in accordance with a specific treatment protocol; and 4. The agency maintains a written record of the dates/times the container is in the possession of a RN or LVN. D. Administering in a Patient's Home An HCSSA or its authorized employees who administer drugs listed under A. above may administer the drugs only in the patient's residence under a physi cian's orders with the provision of emergency treatment or the adjustment of: 1. Parenteral drug therapy; 2. Vaccine or tuberculin administration; and 3. If the drug is administered pursuant to a physician's order, the physician shall promptly send a signed copy of the order to the agency, and the agency shall: a. No later than 24 hours after receipt of the order reduce the order to writ ten form and send a copy to the dispensing pharmacy and b. No later than 20 days after receipt of the order send a copy of the order as signed by and received from the physician to the dispensing pharmacy. E. A pharmacist that dispenses a sealed portable container under this section shall ensure that the container: 1. Is designed to allow access to the contents of the container only if a tamper proof seal is broken; 2. Bears a label that lists the drugs in the container and provides notice of the container's expiration date, which is the earlier of: a. The date that is six months after the date on which the container is dis pensed or b. The earliest expiration date of any drug in the container; and 3. Remains in the pharmacy or under the control of a pharmacist, RN, or LVN. F. If an HCSSA or an authorized employee purchases, stores, or transports a sealed container, the agency shall deliver the container to the dispensing pharmacy for verification of drug quality, quantity, integrity, and the expiration dates no later than the earlier of: 1. The 7th day after the date on which the seal on the container is broken or 2. The date for which notice is provided on the container label. G. A pharmacy that dispenses a sealed portable container shall take reasonable pre cautionary measures to ensure that the HCSSA receiving the container complies 14 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore with F. above. On receipt of a container under F„ the pharmacy shall perform an inventory of the drugs used from the container and shall restock and reseal the container before delivering the container to the agency for reuse. Notes Texas Food, Drug, and Cosmetic Act (Chapter 431, Health and Safety Code, Title 6, Subtitle A) Subchapter M Drug Donation Program (Administered by the Texas Department of State Health Services) The Texas Food, Drug, and Cosmetic Act allows a charitable drug donor to donate unused prescription drugs to a charitable medical clinic, and the clinic can accept, dis pense, or administer the donated drugs. A summary of the law follows. A. Definitions 1. Charitable drug donor means: a. A licensed convalescent or nursing home; b. A licensed hospice; c. A hospital; d. A physician; e. A pharmacy; or f. A pharmaceutical seller or manufacturer. Note: A seller or manufacturer may not donate drugs except pursuant to a qualified patient assistance program that donates drugs to a charitable medi cal clinic. 2. Charitable medical clinic means a clinic that: a. Provides medical care without charge or for a substantially reduced charge; b. Complies with the insurance requirements of Chapter 84, Civil Practice and Remedies Code; c. Is exempt from federal income tax; and d. Is operated exclusively for the promotion of social welfare by being pri marily engaged in promoting the common good and general welfare of the people in a community. B. A charitable drug donor must use appropriate safeguards established by the Texas Department of State Health Services (TDSHS) to ensure that the drugs are not compromised or illegally diverted while being stored or transported to the charitable medical clinic. C. A charitable medical clinic may not accept the drugs unless: 1. It certifies that the drugs have been properly stored while in possession of the donor; 2. The donor provides the clinic with a verifiable address and telephone num ber; and 3. The person transferring possession of the drugs presents photographic identification. D. The donated drugs must be: 1. Prescription drugs but may not be controlled substances; 2. Approved by FDA and individually packaged or packaged in unitdose packaging; 3. Oral or parenteral medication in sealed singledose containers approved by FDA; 4. Topical or inhalant drugs in sealed unitofuse containers approved by FDA; or Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore : j I ' ! C.15 E. F. G. H. 5. Parenteral medication in a sealed multipledose container approved by FD> from which no doses have been withdrawn. The donated drugs may not be the subject of a mandatory or voluntary recall. The charitable medical clinic may dispense or administer the donated drugs only 1. Before the expiration date of the drug and 2. After a licensed pharmacist has determined that the drugs are of an accept able integrity. The law also establishes a limitation on liability for charitable drug donors, char itable medical clinics, and their employees if they comply with the terms of th< law and rules. TDSHS adopted the following Rule 229.22 to implement these provisions. TOSHS RULE 229.22 Donation of Drugs to Charitable Medical Clinics A charitable medical clinic may receive a drug donated by a charitable drug donor for dispensing to a patient of the charitable medical clinic provided that the following requirements are met. (1) The charitable drug donor must be licensed with TDSHS as a wholesale drug distributor. Manufacturers who participate in a patient assistance program and physicians who donate samples will not be required to be licensed with the department. (2) The donated drugs must be dangerous drugs as defined in Health and Safety Code Chapter 483 entitled "Texas Dangerous Drug Act." (3) Donated drugs may not be controlled substances as defined in Health and Safety Code Chapter 481 entitled "Texas Controlled Substances Act." (4) All donated drugs must be approved by the Food and Drug Administration (FDA) and intended for human use. (5) Donation of drug samples must comply with Title 21, Code of Federal Regula tions (CFR), 203.39. (6) Previously dispensed drugs shall not be donated. (7) The charitable drug donor must verify that the requesting charity is legitimate. (A) Verification shall include copies of documents proving the charitable med ical clinic s status as exempt from federal income tax and the address, tele phone number, and name of the contact person at the charitable medical clinic. (B) Documentation of verification must be retained by the charitable drug donor for three years. (8) A drug donated by a charitable drug donor shall be received by a charitable medical clinic in the manufacturer's unopened original tamperevident pack aging with its labeling intact. (9) Delivery of a donated drug to a recipient charitable medical clinic shall be com pleted by an authorized agent or employee of the recipient charitable medical clinic or by the charitable drug donor. All deliveries shall be made in person. The authorized agent or employee shall present his or her official state identifi cation to the recipient upon delivery. (10) The recipient charitable medical clinic shall prepare at the time of collection or delivery of drugs a complete and accurate donation record. A copy of this record shall be retained by the recipient charitable medical clinic for at least three years and contain the following information: (A) A signed written statement from the charitable drug donor that the drugs have been properly stored in accordance with the manufacturer's instructions; Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore (B) A verifiable name, address, and telephone number of the charitable drug 8 donor; (C) The manufacturer, brand name, quantity, and lot or control number of the drugs donated; (D) The date of the donation; and (E) A copy of the official state identification of the authorized agent or employee of the charitable drug donor. (11) A donated drug shall not be dispensed to a patient until it has been examined by a registered pharmacist at the recipient charitable medical clinic to confirm that the donation record accurately describes the drug delivered and to confirm in his or her professional judgment that no drug is adulterated or misbranded for any reason including, but not limited to, the following: (A) The drug is out of date; (B) The labeling has become mutilated, obscured, or detached from the drug packaging; (C) The drug shows evidence of having been stored or shipped under condi tions that might adversely affect its stability, integrity, or effectiveness; (D) The drug has been recalled or is no longer marketed; or (E) The drug is otherwise possibly contaminated, deteriorated, or adulterated. (12) Documentation of the examination of the drug and the drug donation record by the registered pharmacist shall be retained by the charitable medical clinic for three years after the date of examination. (13) The recipient charitable medical clinic shall dispose of any drug found to be adulterated/misbranded by destroying it. The charitable medical clinic shall retain complete records of the disposition of all destroyed drugs for three years from the date of destruction. (14) Each recipient charitable medical clinic shall conduct at least annually an inventory of drug stocks and shall prepare a report reconciling the results of each inventory with the most recent prior inventory. Drug inventory discrep ancies and reconciliation problems shall be investigated by the charitable med ical clinic and outcomes documented. All reports of reconciliation, investiga tion, and outcome shall be retained by the charitable medical clinic for three years. (15) All charitable drug donors shall comply with the existing statutory standards contained in the Texas Health and Safety Code Chapter 431 and the require ments of 229.253 of this title (relating to Minimum Standards for Licensing) for "Licensing of Wholesale Distributors of Drugs," which includes "Good Manu facturing Practices." (16) A charitable medical clinic shall immediately notify the Drugs and Medical Devices Division using the tollfree telephone number 8888396676 when it becomes aware of a significant loss or theft of drugs. A copy of the inven tory reconciliation, investigation, and outcome report shall be forwarded to the Drugs and Medical Devices Division, 1100 West 49th Street, Austin, Texas 78756 within five days of the telephone notification. (17) A charitable drug donor shall promptly notify in writing a charitable medi cal clinic to which donations have been made if the donor becomes aware of a recall or other situation pertaining to the safety and efficacy of the previously donated drugs. Documentation of this notice shall be retained for three years after the date of notification. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore , j 1 ! 1 j ! > ! j I j j j j C.17 Texas Food, Drug, and Cosmetic Act (Chapter 442, Health and Safety Code, Title 6, Subtitle A) Donation of Prescription Drugs A. This new chapter passed by the Texas Legislature requires the Executive Com missioner of the Texas Department of State Health Services to adopt standards and procedures for: 1. Accepting, storing, labeling, and dispensing donated prescription drugs and 2. Inspecting donated prescription drugs to determine whether the drugs are safe and suitable for redistribution (Section 442.052). B. Donors may donate unused prescription drugs to participating providers who may be healthcare facilities, pharmacies, or pharmacists who are employees of a facility or pharmacy that elects to participate in the collection and redistribution of donated prescription drugs (Section 442.001 and Section 442.051). C. Participating providers may dispense donated prescription drugs to a recipient in accordance with rules to be developed. A recipient is a person who voluntarily receives donated prescription drugs under the chapter (Section 442.001 and Sec tion 442.051). D. Donated prescription drugs may be accepted or dispensed only if the drug is in its original, unopened, sealed, and tamperevident unitdose packaging. A donated prescription drug may not be accepted or dispensed under the Act if the drug is a controlled substance, is adulterated or misbranded, is not stored in compliance with the product s labeling, or the FDA requires the drug to have a risk evaluation and mitigation strategy (REMS) (Section 442.053). E. Before being dispensed to a recipient, a prescription drug donated under the chapter must be inspected by the participating provider to determine if the drug is adulterated or misbranded and whether the drug has been stored in compli ance with the requirements of the drug's label (Section 442.054). F. I he Act provides a limitation of liability from criminal, administrative, and civil liability for donors, participating providers, and drug manufacturers (Section 442.057). Note: See TDSHS website for additional information. Medical Gases (Oxygen) Any pharmacy involved in the manufacturing or filling of medical gases for patient use is required to be licensed with the Texas Department of State Health Services (TDSHS) and the FDA as a drug manufacturer and must comply with CGMPs. However, a hospital pharmacy that fills and provides oxygen for inpatient use would not have to be licensed as a manufacturer. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore TSBP Quick Reference Guide—Prescriptions forl»):lil.Mj.llH»IJIMiiipj m*i t That May Be Dispensed in Texas S. Prescriptio \ (Rx Drug Orde N. Forma \&Refi Electronic (Electronic Data File) Rx1 Written (Paper) Rx Facsimile (Faxed) Rx1 Oral (Verbal/ Telephonic) Rx1 May be refilled if authorization is received orally Remaining refills may be transferred between Texas pharmacies Remaining refills may be transferred from outofstate pharmacy to Texas pharmacy Yes Yes Manual signature or electronic replica of manual signature printed on secured paper required Yes Yes Yes Yes Yes PrescriberType;\ Texas Physician, Dentist, Veterinarian or Podiatrist Yes Delegating physi cian information required Yes Manual signature or electronic replica of the manual signature printed on secured paper Delegating physi cian information required Yes Delegating physi cian information required Yes RPh practices at federally qualified health center PhysicianDelegated (FQHC), hospital, Texas Pharmacist hospitalbased Performing Drug clinic, or aca Therapy Manage demic healthcare ment (DTM) institution Delegating physi cian information required Yes Signature required RPh practices at a FQHC, hospital, hospitalbased clinic, or academic healthcare institution Delegating physi cian information required Yes Signature required RPh practices at a FQHC, hospital, hospitalbased clinic, or academic healthcare institution Delegating physi cian information required Authorized Texas Advanced Practice Registered Nurse (APRN) or Physician Assistant (PA) Texas Therapeutic Optometrist (T) (Topical & Oral Drugs for Health Conditions of the Eye, Excluding Glaucoma)2 Texas Therapeutic Optometrist Optometric Glaucoma Specialist (TG) (Topical & Oral Drugs for Health Conditions of the Eye)2 OutofState3 Physician, Dentist, Veterinarian, or Podiatrist OutofState3 Nurse Practitioner or Physician Assistant (Supervising Physi cian Required) Canadian or Mexican Physician, Dentist, Veterinarian, or Podiatrist Yes Delegating physi cian information required No (Note: DTM RPh may orally commu nicate new Rx as designated agent of the prescribing DTMdelegating physician) Yes No (Note: DTM RPh may orally communicate new Rx as designated agent of the prescribing DTM delegating physician) Yes Delegating physician information required Yes For TX APRN/PA Rx recognized by other state Delegating physaaen information required Yes Ye. For TX DTM RPhsigned Rx recognized by other slate Delegating phystaan information required Yes License # plus "T" designation Yes Manual signature or electronic replica of the manual signature printed on secured paper License # plus "T" designation Yes License # plus "TG" designation Yes Manual signature or electronic replica of the manual signature printed on secured paper License # plus "TG" designation Yes License # plus "TG" designation Yes License # plus "TG" designation Yes Yes Licensed plus TG* designation Yes Yes Manual signature or electronic replica of the manual signature printed on secured paper Yes Yes Yes Yes Yes Yes Delegating physi cian information required Yes Yes Yes No No Only refills authorized on original written Rx may be dispensed Yes Only refiBs authorized on ongmal written Rx may be transferred Yes Delegating physi cian information required No Yes Manual signature or electronic replica of the manual signature printed on secured paper Delegating physi cian information required Yes Manual signature or electronic eplica of the manual signature printed on secured paper Yes Yes License # plus "T" designation Yes License # plus "T" designation Yes Yes License plusr designation For TX Therapeutic Optometrist R recognized by other slate License p*u* T designation Yes Yes Delegating physi cian information required No For TX Optomet he Glaucoma Specialist Rx recognized by other state License » phis *TQ* designation Yes Only reMs authorized on en ongeiel wrdten (paper) Rx may be transferred Name of designated agent required on electronic, faxed, and oral Rxs, if applicable. Statement indicating Rx has been "fa*e:: rec f«" >» Therapeutic Optometrists (T) may prescribe topical or oral medications to treat the eye but must obtain (TG) certification tc .ea: j.... — i Includes United States (excluding TX) and U.S. Territories (Puerto Rico, U.S. Virgin Islands, American Samoa. Guam. Northern Va aa s a :.) Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore C.19 TSBP Quick Reference Guide—Prescriptions for Controlled Substances in Schedules III, IV, & V That May Be Dispensed in Texas Prescription (Rx) Drug Order Format Electronic Prescriptions for Controlled Substances (EPCS) Rx'4 Consistent with EPCS Exemptions and Other Requirements Listed in TCSA 481.07555 Written (Paper) Rx5 Facsimile (Faxed) Rx46 Yes Manual signature Yes Facsimile of a manually signed written (paper) Rx Yes Manual signature For a period not to exceed 90 days Delegating physi cian information & DEA# required Yes Facsimile of a manually signed written (paper) Rx For a period not to exceed 90 days Delegating physi cian information & DEA# required Oral (Verbal or Telephonic) Rx45 Prescriber Type: Texas Physician. Dentist. Vetennarian. or Podiatrist Yes For a period not to exceed 90 days Delegating physi cian information & DEA# required Authorized Texas Advanced Practice Registered Nurse (APRN) or Physician Assistant (PA) Texas Therapeutic Optometrtst Optometnc Glaucoma Specialist (TG) (Topical ft Oral Drugs for Health Conditions of the Yes Delegating physi cian information & DEA# Limited to one 3day supply of any drug in Schedule III, IV. or V (No Refills) License # plus "T* designation Yes Limited to one 3day supply of any drug in Schedule III. IV. or V (No Refills) License # plus "T" designation Manual signature Yes Limited to one 3day supply of any drug in Schedule III, IV, or V (No Refills) License # plus "T" designation Facsimile of a manually signed written (paper) Rx Yes Limited to one 3day supply of any drug in Schedule III, IV, or V (No Refills) License # plus "T" designation Yes Limited to one 3day supply of any drug in Schedule III. IV. or V (No Refills) License U plus "TG" designation Yes Limited to one 3day supply of any drug in Schedule III. IV. or V (No Refills) License # plus *TG" designation Manual signature Yes Limited to one 3day supply of any drug in Schedule III, IV, or V (No Refills) License # plus "TG" designation Facsimile of a manually signed written (paper) Rx Yes Limited to one 3day supply of any drug in Schedule III, IV, or V (No Refills) License # plus "TG" designation Yes Texes Therapeutic Optometrist (T) (Topical ft Oral Rx Drugs for Health Conditions of the Eye. Excluding Glaucoma)4 Yes Manual signature or electronic replica of the manual signature printed on secured paper OutofState' Physician. Dentist. Vetennerten. or Podiatrist Remaining refills may be transferred between Texas pharmacies Remaining refills may be transferred from outofstate pharmacy to Texas pharmacy Yes On a onetime basis6 No (Note: DTM RPh mayoralty commu nicate new Rx as designated agent of the prescribing DTMdelegating physician) Physician Delegated Texas Pharmacist Performing Drug Therapy Manage ment (DTM) May be refilled if authorization is received orally Yes Facsimile of a manually signed written (paper) Rx Yes On a onetime basis6 No (Note: DTM RPh may orally communicate new Rx as designated agent of the prescribing DTM delegating physician) Yes On a onetime basis6 OutofState' Nurse Practitioner or Physician Assistant Canadian or Mexican Practitioner ">* ' ies«; i r,.,.d 0n EPCS fnxed and oral Rxs if an'niirahi Qt I f'. American Samoa, Guam, Northern Mariana Islands). ,he T,*as and Fadarai s® ^ C.20 ^ °n"ne dalabaM ma" lra"s,0 «™*i™m refills permitted by law and presenter's authorization. Copyright O 2022 Fred S. Brinkley. Jr., and Gary G. Cacciatore Yes On a onetime basis6 TSBP Quick Reference Guide—Prescriptions That May Be Dispensed in Texas N. \ \ Prescription (Rx Drug Order N. Format \&Refil Electronic Prescriptions for Controlled Substances (EPCS) Rx13 lTTmpiii Consistent with EPCS Exemptions and Other Requirements Listed in TCSA 481.0755 & Federal CSA4 Written (Paper) Rx4 Facsimile (Faxed) Rx34 PrescriberTyperN Texas Physician, Dentist, Veterinarian, or Podiatrist Yes Yes Manual signature written on a TSBP "Official Form" Oral ("Emergency Situation" Verbal & Telephonic) Rx345 Remaining refills may be transferred between Texas pharmacies Remaining refills may be transferred from outofstate pharmacy to Texas pharmacy No (Refill or transfer not allowed for Cll) No (Reft! or transfer not allowed lor Cll) No (Refill not allowed for Cll) No (Refill or transfer not allowed for Cll) No (Refttor transfernol allowed lor Cll) May be refilled if authorization is received orally Yes Facsimile of a manually signed Yes written (paper) Rx Only for "emer No written on a TSBP gency situations" (Refill not "Official Form" in accordance with allowed for Cll) Only in 3 situa 21 CFR §1306.11(d) tions described in 21 CFR §1306.11(e), (f), (g) Yes Facsimile of a manually signed Yes written (paper) Rx Only for "emer written on a TSBP gency situations" "Official Form" in accordance Only in 3 situa with 21 CFR tions described §1306.11(d) in 21 CFR Delegating physi §1306.11(e), (f), (g) cian information Delegating physi & DEA# required cian information Only in specific & DEA# required situations8 Only in specific 6 situations Yes Delegating physi cian information & DEA# required Only in specific situations6 Yes Manual signature Written on a TSBP "Official Form" Delegating physi cian information & DEA# required Only in specific situations6 Texas Pharmacist Performing Drug Therapy Manage ment (DTM) No No No No No No No Texas Therapeutic Optometrist (T) No No No No No No No Texas Therapeutic Optometrist Optometric Glaucoma Specialist (TG) No No No No No No No Authorized Texas Advanced Practice Registered Nurse (APRN) or Physician Assistant (PA) OutofState2 Physician, Dentist, Veterinarian, or Podiatrist No Unless pharmacy has plan approved by TSBP No Unless pharmacy has plan approved by TSBP: Manual signature required No Unless pharmacy has plan approved by TSBP: Facsimile of a manually signed written (paper) Rx Only in 3 situa tions described in 21 CFR §1306.11(e), (f), (g) No Unless pharmacy has plan approved by TSBP: Only for "emer gency situations" in accordance with 21 CFR §1306.11(d) No (Refill not allowed for Cll) No (Refill or transfer not allowed for Cll) No (ReM or transfernol allowed lor Cll) OutofState2 Nurse Practitioner or Physician Assistant No No No No No No No Canadian or Mexican Practitioner No No No No No No No 'EPCS prescribing and pharmacy applications must meet the requirements of Title 21 Code of Federal Regulations (CFR) Chapter n Part \3V United States (excluding TX) and U.S. Territories (Puerto Rico, U.S. Virgin Islands, American Samoa, Guam, Northern War.a i sia of designated agent required on EPCS, faxed, and oral Rxs, if applicable. Statement indicating Rx has been "faxed" required ' '.!: «>'. 4 A pharmacist who receives a controlled substance prescription in a manner other than electronically is not required to verify t.at : ; res : a the requirements for electronic transmission. A pharmacist may dispense a controlled substance pursuant to an otherwise vain: .11. 'eK communicated prescription consistent with the requirements in the Texas and Federal Controlled Substances Acts 5ln an "emergency situation," the practitioner may issue an oral prescription. Otherwise, a written prescription must be used if exem; te : f: 6 In accordance with the requirements of the Texas Medical Practice Act, authorized Texas APRNs/PAs may issue a Schedule n prescr p: A terminally ill patient who is receiving hospice treatment from a qualified hospice provider; or A patient hospitalized for 24 hours or greater, provided that the Cll Rx is filled at the inhospital pharmacy; or A patient receiving emergency services in the hospital's emergency department, provided that the Cll Rx is filled at the inhosp ;H 1/1 CD N C ^ CD O J3 j2 co 0 > "T 8 0 E « g c E p 0 0 O P. c o. © E ® o Y Q: > o /N VC 0 CL CO 0 O V S. > Q CO E > CO c © l_ I? '8 113 O 0 0 "D O. "K E.2 = c o "D CO E 'E 0 © Q "8 C 0 O O) (0 "O o © 0 C > 0 5 o ® 0 o 5 S CD Q) O CO 0 N V O CO 3 CD 0 >> © CM CZ c Q g CD £ o \ t i ? © 8.£ g !r ® ® c ? c > 0 o.'5 © 3 O) 3 C 0 | 3 CO > 3 i_ © 0 1 ° f 5 i ° P or ® o © Q u_i © o.2 © ° £ o to Ol 0 0 Q_ § O "O O " 8 : « CL "D C o Q ©roc CD 0 j: 0 c 0 C =) ZD > > CO 8 CO Q. 0 CD CL CD = >. o.. 0 t 0) 0 0 CO Q. 0 0 0 o "D ® 0 C CD © 31 © 2o > SD ® 0 8 0 S5 > CO o g o 0 0 > CL h lz CO « ) D O) T: E tz U> ro Co tz 8 o £ >, ® E 8i. 5 ® © O) E © Q 0 CO c © a. © CO c © a co ** co o re E L. re JZ a. re o 'E JZ u £ >* u re E oa 2 C c re o c 0 £ >> 8 ® re 0 12 5g a. i— >« « CO to git O C 1s lift I 2 >* a. © > E O a c Z= o u J: re re — © E E c > ^ = 2 — re re i x x 8 a a J CL Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacc / D.19 Notes Section 554.053 Rulemaking; Pharmacy Technician and Pharmacy Technician Trainee A. The Board shall establish rules for the use and duties of a pharmacy technician and pharmacy technician trainee in a pharmacy licensed by the Board. A phar macy technician and pharmacy technician trainee shall be responsible to and must be directly supervised by a pharmacist. B. The Board may not adopt a rule establishing a ratio of pharmacists to pharmacy technicians and pharmacy technician trainees in a Class C pharmacy or limiting the number of pharmacy technicians or pharmacy technician trainees that may be used in a Class C pharmacy. C. The Board may determine and issue standards for the recognition and approval of a training program for pharmacy technicians and maintain a list of training programs that meet those standards. Section 554.054 Rules Restricting Advertising or Competitive Bidding A. The Board may not adopt rules restricting advertising or competitive bidding by a person regulated by the Board except to prohibit false, misleading, or deceptive practices by that person. B. The Board may not adopt a rule to prohibit false, misleading, or deceptive prac tices by a person regulated by the Board if the rule: 1. Restricts the use of any medium for advertising; 2. Restricts the person's personal appearance or use of the person's voice in an 3. 4. advertisement; Relates to the size or duration of an advertisement used by the person; or Restricts the use of a trade name in advertising by the person. Section 554.055 Rulemaking: Electronic Media The Board shall adopt rules regarding the sale and delivery of drugs by use of elec tronic media including the Internet. Chapter 557 Pharmacist Interns Section 557.001 Pharmacist Intern Registration A person must register with the Board before beginning a Boardapproved intern ship in this state. Section 557.002 Application for Registration An application for the registration as a pharmacist intern must be on a form pre scribed by the Board. Section 557.003 Duration of Registration A person's registration as a pharmacist intern remains in effect as long as the person meets the qualifications for an internship specified by Board rule. Section 557.004 Limitations on Registration A. The Board may: 1. Refuse to issue a registration to an applicant or 2. Restrict, suspend, or revoke a pharmacist intern registration for a violation of this Act. B. The Board may take disciplinary action against an applicant for a pharmacist intern registration or the holder of a current or expired pharmacist intern reg istration in the same manner as against an applicant for a license or a license holder by imposing a sanction authorized under Section 565.001 if the Board finds that the applicant or registration holder has engaged in conduct described by Section 565.001 of the Act. Note: See Chapter Ffor disciplinary action. D.20 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Chapter 558 License to Practice Pharmacy Notes SUBCHAPTER A. License (Pharmacists) Section 558.001 License Required A. A person may not practice pharmacy unless the person holds a license to prac tice pharmacy under this Act. B. A person may not: 1. Impersonate a pharmacist or 2. Use the title "Registered Pharmacist" or "R.Ph." or words of similar intent unless the person is licensed to practice pharmacy in this state. C. A person may not dispense or distribute prescription drugs unless the person: 1. Is a pharmacist or 2. Is otherwise authorized by this Act to dispense or distribute prescription drugs. Section 558.002 Unauthorized Acquisition of a License A person may not: 1. Impersonate before the Board an applicant applying for a license under this Act or 2. Acquire, with the intent to fraudulently acquire the license, a license in a manner other than provided by this Act. Board of Pharmacy Rule 281.12 Criminal History Evaluation Letter A. A person, who is enrolled or planning to enroll in an educational program that prepares the person for a license as a pharmacist or a registration as a pharmacy technician or trainee, or planning to take an examination required for such a license or registration, and who has reason to believe that he or she may be inel igible due to a conviction or deferred adjudication for a felony or misdemeanor offense, may request a criminal history evaluation letter regarding his or her eli gibility for a license or registration. B. The person must submit an application for the criminal history evaluation letter on a form provided by the Board which includes: 1. A statement indicating the reasons and basis for potential ineligibility, including each criminal offense for which the person was arrested, charged, convicted, or received deferred adjudication; 2. All legal documents related to the reasons and basis for potential ineligibility including, but not limited to, police reports, indictments, orders of deferred adjudication, judgments, probation records, and evidence of completion of probation, if applicable; 3. All requirements necessary for the Board to access the criminal history rec ord information including submitting fingerprint information and paying the required fees; and 4. A nonrefundable fee of $150 for processing the application. C. The application is considered complete when all documents and other inhu mation supporting the potential reasons and basis for potential ineligibility have been received by the Board. If such documentation is not recei\ed within 120 days of the initial receipt of the application, the application is considered to be expired and must be refiled along with the appropriate fees. D. The Board shall conduct an investigation of the application and the person s eli gibility for a license or registration. E. The person or the Board may amend the application to include additional grounds for potential ineligibility at any time before a final determination is made. Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore D.21 F A determination of eligibility will be made by the Board or its designees. Notifi cation of the determination will be provided to the person in writing. 1 If no grounds for ineligibility are identified, the notification shall address the determination regarding each ground of potential ineligibility. 2. If grounds for ineligibility exist, the notification shall set out each basis for potential ineligibility and the corresponding determination. G. The Board shall mail the determination of eligibility no later than the 90th day after the complete application, as required by B. and C. above, has been received by the Board. H. The determination of eligibility shall be made based on the law in effect on the date of the receipt of a complete application. I. In the discretion of the Board, any information the person fails to disclose on the application or any information determined to be inaccurate or incomplete shall invalidate the determination of eligibility on the basis of the information. J. The administrative rules regarding disciplinary guidelines and regarding con siderations and sanctions for criminal conduct apply in determining eligibility. K. If a person submits an application for a license or registration at the same time or within 90 days after the receipt of a complete application for a criminal his tory evaluation letter, the Board will process only the application for a license or registration and will not issue a separate determination of eligibility. SUBCHAPTER B. Licensing by Examination (Pharmacists) Section 558.051 Qualifications for a License by Examination A. To qualify for a license to practice pharmacy, an applicant for licensing by exam ination must submit to the Board: 1. A license fee set by the Board and 2. A completed application on a form prescribed by the Board with satisfactory sworn evidence that the applicant: a. Is at least 18 years old; b. Has completed a minimum of a 1,000hour internship or other pro gram that has been approved by the Board or has demonstrated, to the Board's satisfaction, experience in the practice of pharmacy that meets or exceeds the Board's minimum internship requirements; Note: The Act (law) requires 1,000 hours minimum. However, Board rules now require the same number of hours that are required by ACPE. This requirement is currently 300 hours of Introductory Pharmacy Practice Experience (IPPE) and 1440 hours of Advanced Pharmacy Practice Expe rience (APPE). c. Has graduated and received a professional practice degree, as defined by Board rule, from an accredited pharmacy degree program approved by the Board; d. Has passed the examinations required by the Board (NAPLEX and Texas MPJE); and e. Has not had a pharmacist license granted by another state restricted, suspended, revoked, or surrendered for any reason. B. Each applicant must obtain practical experience in the practice of pharmacy concurrent with college attendance or after college graduation or both under conditions the Board determines. Section 558.052 Content, Preparation, and Validation of Examination A. The Board shall determine the content and subject matter of a licensing examination. B. The examination shall be prepared to measure the competence of the applicant to practice pharmacy. D.22 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore C. The Board may employ and cooperate with an organization or consultant in pre paring an appropriate examination. D. A written examination prepared or offered by the Board, including a standardized national examination, must be validated by an independent testing professional. Board of Pharmacy Rule 283.7 Examination Requirements A. Prior to taking the required examinations, the applicant shall meet minimum educational and age requirements and may be required to meet all require ments necessary for the Board to access the criminal history record information, including submitting fingerprint information and being responsible for all asso ciated costs. B. Applicant must pass NAPLEX which includes the following subject areas: 1. Chemistry; 2. Mathematics; 3. Pharmacy; 4. Pharmacology; and 5. Practice of pharmacy. C. To pass NAPLEX, the applicant must score 75 on a scaled score. NABP uses a mathematicallybased weighted scoring model to calculate an ability measure for each NAPLEX examinee. The ability measures are transformed to a report ing scaled score that ranges from 0 to 150. Scaled scores do not represent a per centage or the raw number of correct answers. If the applicant fails, he or she may retake the exam four additional times for a total of five exams. Prior to any subsequent retakes, the applicant must comply with Rule 283.11 (Exam Retake Requirements). D. To pass the Texas MPJE, the applicant must score 75 on a scaled score. NABP uses a mathematicallybased weighted scoring model to calculate an ability measure for each MPJE candidate. These ability measures are transformed to a reporting scale that ranges from 0 to 100. Scaled scores do not represent a per centage or the raw number of correct answers. If the applicant fails, he or she may retake the exam four additional times for a total of five exams. Prior to any subsequent retakes, the applicant must comply with Rule 283.11 (Exam Retake Requirements). E. NAPLEX and Texas MPJE exams are scored separately and can be retaken inde pendently. A passing grade on an examination may be used for the purpose ot licensure for a period of two years from the date of passing the examination. F. A person who has failed the NAPLEX or Texas MPJE five times must present documentation of additional training before he or she can retake the exam as required by Board Rule 283.11 (Examination Retake Requirements). G. Score Transfer Program. Note: The Score Transfer Program allows a person to take the NAPLEX one time and have the score count toward licensure by examination in more than one state. (See NABP NAPLEX Registration Bulletin.) Each applicant for licensure by examination using NAPLEX scores transferred from another state to Texas shall meet the following requirements tor licensure in addition to the requirements above. 1. The applicant shall request NABP to transfer NAPLEX scores to TSBP. Such a request shall be in accordance with NABP policy. 2. The applicant shall pay the fee set out in Board Rule 283.9 (Fee Requirements for Licensure by Examination and Reciprocity). 3. The applicant must pass the Texas Pharmacy Jurisprudence Examination (MPJE). Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes H. The NAPLEX and Texas MPJE shall be administered in compliance with the Americans with Disability Act of 1990 and in accordance with NABP policy. I. The Board, in accordance with NABP policy, shall provide reasonable accommo dations for an applicant diagnosed as having dyslexia as defined in 51.970, Texas Education Code. The applicant shall provide: 1. Written documentation from a licensed physician which indicates that the applicant has been diagnosed as having dyslexia and 2. A written request outlining the reasonable accommodations requested. Section 558.053 Grading of the Examination A. The Board may employ and cooperate with an organization or consultant in grading the examination. B. The Board shall determine whether an applicant has passed the examination. The Board has sole discretion and responsibility for that determination. Section 558.054 Frequency of Offering Examinations The Board shall give the examination at least two times during each state fiscal year. Section 558.055 Failure to Pass; Reexamination A. An applicant who on the applicant's first attempt fails the examination may take the examination four additional times. B. Before an applicant who has failed the examination five times is allowed to retake the examination, the applicant must provide documentation from a col lege of pharmacy that the applicant has successfully completed additional col lege course work in each examination area that the applicant failed. C. If requested in writing by a person who fails the examination, the Board shall fur nish the person with an analysis of the person's performance on the examination. Board of Pharmacy Rule 283.11 Examination Retake Requirements A. Licensing by Examination. If an applicant fails to make a passing grade (75) on the NAPLEX and/or the Texas MPJE, the applicant may retake the exam(s) four additional times for a total of five exam administrations. Prior to any subsequent retakes for the exam(s), the applicant must: 1. Complete course work in the subject areas recommended by the Board; 2. Submit documentation to the Board which specifies that the applicant has successfully completed the course work specified; and 3. Comply with the requirements of Board Rule 283.7 (Examination Requirements). B. Licensing by Reciprocity. It an applicant fails to make a passing grade (75) on the Texas MPJE, the appli cant may retake the exam four additional times for a total of five exam adminis trations. Prior to any subsequent retakes for the exam, the applicant must: 1. Complete course work in the subject areas recommended by the Board; 2. Submit documentation to the Board which specifies that the applicant has successfully completed the course work specified; and 3. Comply with the requirements of Board Rule 283.8 (Reciprocity Requirements). C. Course Work. Course work consists of one or more standard courses or selfpaced work offered in a college of pharmacy's academic program. Section 558.056 Notification T"he Board must notify each person taking an examination of the results of the exam ination no later than 30 days after the date the Board receives the results. D.24 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Section 558.057 Internship or Other Program to Qualify for Examination A. In this section, "preceptor" means a pharmacist licensed in this state to practice pharmacy or another healthcare professional who meets the preceptor require ments specified by rule and who is recognized by the Board to supervise and be responsible for the activities and functions of a pharmacist intern in an intern ship program. B. The Board shall: 1. 2. Establish standards for an internship or other program necessary to qualify an applicant for the licensing examination and Determine the qualifications necessary for a preceptor used in the program. Board of Pharmacy Rule 283.2 Internship—Definitions Note: There are three types of pharmacist interns—student interns, resident interns, and extended interns. The following words and terms shall have the following meanings unless the context clearly indicates otherwise. 1. ACPE—Accreditation Council for Pharmacy Education. 2. Applicant—An individual having applied for licensure to act as a pharmacist in Texas. 3. Approved Continuing Education—Continuing education (C.E.) which meets the requirements of Board Rule 295.8 (Continuing Education Requirements). 4. Board—The Texas State Board of Pharmacy; all members, divisions, depart ments, sections, and employees thereof. 5. College/School of pharmacy—A college/school of pharmacy that has a profes sional degree program approved by the Board and accredited by: a. ACPE or b. The Canadian Council for Accreditation of Pharmacy Programs for 1993 2004 graduates. 6. Competency—A demonstrated state of preparedness for the realities of profes sional pharmacy practice. 7. Direct supervision—A pharmacist preceptor or healthcare professional precep tor who is physically present and onsite at the licensed location of the pharmacy where the pharmacist intern is performing pharmacist intern duties. 8. Didactic—Systematic classroom instruction. 9. Extended intern—An intern registered with the Board who has: a. Applied to the Board for licensure by examination and has successfully passed the NAPLEX and Texas MPJE but lacks the required number of hours of internship for licensure; or b. Applied to the Board to take the NAPLEX and Texas MPJE within six calen dar months after graduation and has: (1) Graduated and received a professional degree from a college/school ot pharmacy and (2) Completed all of the requirements for graduation and for receipt of a professional degree from a college/school of pharmacy, the professional degree program of which has been accredited by ACPE and approved by the Board; or c. Applied to take the NAPLEX and Texas MPJE within six calendar months after obtaining full certification from the Foreign Pharmacy Graduate Equivalency Commission; or d. Applied to the Board for reissuance of a pharmacist license which has been expired for more than two years but less than ten years and has successful!) Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes passed the Texas MPJE but lacks the required number of hours of internship or continuing education required for licensure; or e. Been ordered by the Board to complete an internship. 10. Foreign pharmacy graduate—An individual whose pharmacy degree was con ferred by a pharmacy school whose professional degree program has not been accredited by ACPE and approved by the Board. An individual whose pharmacy degree was conferred by a pharmacy school that was accredited by the Canadian Council for Accreditation of Pharmacy Programs between 1993 and 2004 is not considered a foreign pharmacy graduate. 11. FPGEC—The Foreign Pharmacy Graduate Equivalency Commission. 12. Healthcare professional—An individual licensed as a physician, dentist, podi atrist, veterinarian, advanced practice registered nurse, or physician assistant in Texas or another state or a pharmacist in a state other than Texas but not licensed in Texas. 13. Healthcare professional preceptor—A healthcare professional serving as an instructor for a Texas college/schoolbased internship program which is recog nized by a Texas college/school of pharmacy to supervise and be responsible for the activities and functions of a student intern in the internship program. 14. Internship—A practical experience program approved by the Board. 15. MPJE—Multistate Pharmacy Jurisprudence Examination. 16. NABP—The National Association of Boards of Pharmacy. 17. NAPLEX—The North American Pharmacy Licensing Examination or its prede cessor, National Association of Boards of Pharmacy Licensing Examination. 18. Pharmaceutical care—The provision of drug therapy and other pharmaceutical services defined in the rules of the Board and intended to assist in the care, pre vention of a disease, elimination or reduction of a patient's symptoms, or arrest ing or slowing of a disease process. 19. Pharmacist intern—A student intern, a resident intern, or an extended intern who is participating in a Boardapproved internship program. 20. Pharmacist preceptor—A pharmacist licensed in Texas to practice pharmacy who meets requirements under Board rules and is recognized by the Board to supervise and be responsible for the activities and functions of a pharmacist intern in an internship program. 21. Preceptor—A pharmacist preceptor or a healthcare professional preceptor. 22. Professional degree—A bachelor of science degree in pharmacy (B.S.) or a doc torate of pharmacy (Pharm.D.). 23. Resident intern—An individual who is registered with the Board and: a. Has graduated from a college/school of pharmacy and b. Is completing a residency program accredited by the American Society of HealthSystem Pharmacists in the state of Texas. 24. State—One of the 50 states in the United States of America, the District of Columbia, Puerto Rico, American Samoa, Guam, Northern Mariana Islands, and U.S. Virgin Islands. 25. Student intern—An individual registered with the Board who is enrolled in the professional sequence of a college/school of pharmacy and is participating in a Boardapproved internship program. 26. Texas Pharmacy Jurisprudence Examination—A licensing exam developed or approved by the Board which evaluates an applicant's knowledge of the drug and pharmacy requirements to practice pharmacy legally in the state of Texas. D.26 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Notes Board of Pharmacy Rule 283.3 Educational and Age Requirements An applicant for licensure as a pharmacist must be at least 18 years of age and meet one of the following: 1. Has graduated and received a professional degree (B.S. or Pharm.D.) from a college of pharmacy or 2. Has graduated from a foreign college of pharmacy and obtained full certifi cation from the FPGEC. Board of Pharmacy Rule 283.4 Internship Requirements A. Goals and Objectives of Internship. 1. The goal of internship is for the pharmacist intern to attain the knowledge, skills, and abilities to safely, efficiently, and effectively provide pharmacist delivered patient care to a diverse patient population and practice pharmacy under the laws and rules of the state of Texas. 2. The following competency objectives are necessary to accomplish the goal of internship in A.l. above: a. Provides drug products. The pharmacist intern shall demonstrate competence in determining the appropriateness of prescription drug orders and medication orders; evaluating and selecting products; and assuring the accuracy of the product/prescription dispensing process. b. Communicates with patients and/or patients' agents about prescription drugs. The pharmacist intern shall demonstrate the competence in interview ing and counseling patients and/or the patients' agents on drug usage, dosage, packaging, routes of administration, intended drug use, and storage; discussing drug cautions, adverse effects, and patient condi tions; explaining policies on fees and services; relating to patients in a professional manner; and interacting to confirm patient understanding. c. Communicates with patients and/or patients' agents about nonprescrip tion products, devices, dietary supplements, diet, nutrition, traditional nondrug therapies, complementary and alternative therapies, and diag nostic aids. The pharmacist intern shall demonstrate competence in interviewing and counseling patients and/or patients' agents on conditions, intended drug use, and adverse effects; assisting in and recommending drug selection; triaging and assessing the need for treatment referral, includ ing referral for a patient seeking pharmacistguided selfcare; providing information on medical/surgical devices and home diagnostic products; and providing poison control treatment information and referral. d. Communicates with healthcare professionals and patients and/or patients' e. agents. The pharmacist intern shall demonstrate competence in obtaining and providing accurate and concise information in a professional manner and using appropriate oral, written, and nonverbal language. Practices as a member of the patient's interdisciplinary healthcare team. The pharmacist intern shall demonstrate competence in collaborat ing with physicians, other healthcare professionals, and patients and or patients' agents to formulate a therapeutic plan; demonstrate competence Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore I D.27 in establishing and interpreting databases; identify drugrelated prob lems and recommend appropriate pharmacotherapy specific to patient needs; monitor and evaluate patient outcomes; and devise followup Notes f. plans. Maintains professional ethical standards. The pharmacist intern is required to comply with laws and rules per taining to pharmacy practice; to apply professional judgment; to exhibit reliability and credibility in dealing with others; to deal professionally and ethically with colleagues and patients; to demonstrate sensitivity and empathy for patients/caregivers; and to maintain confidentiality. g. Compounding. The pharmacist intern shall demonstrate competence in using acceptable professional procedures; selecting appropriate equipment and contain ers; appropriately preparing compound nonsterile and sterile prepara tions; and documenting calculations and procedures. Pharmacist interns engaged in compounding nonsterile preparations shall meet the train ing requirements for pharmacists specified in Board Rule 291.131 (Phar macies Compounding Nonsterile Preparations). Pharmacist interns engaged in compounding sterile preparations shall meet the training requirements for pharmacists specified in Board Rule 291.133 (Pharma cies Compounding Sterile Preparations). h. Retrieves and evaluates drug information. The pharmacist intern shall demonstrate competence in retrieving, evaluating, managing, and using the best available clinical and scien tific publications for answering a drugrelated request in a timely fash ion and assessing, evaluating, and applying evidencebased information to promote optimal health care. The pharmacist intern shall perform investigations on relevant topics to promote inquiry and problem solv ing with dissemination of findings to the healthcare community and/or the public. i. Manages general pharmacy operations. The pharmacist intern shall develop a general understanding of plan ning, personnel and fiscal management, leadership skills, and policy development. The pharmacist intern shall have an understanding of drug security, drug storage, control procedures, the regulatory requirements associated with these procedures, and maintaining quality assurance and performance improvement. The pharmacist intern shall observe and document discrepancies and irregularities, keep accurate records, and document actions. The pharmacist intern shall attend meetings requir ing pharmacy representation. j. Participates in public health, community service, or professional activities. The pharmacist intern shall develop basic knowledge and skills needed to become an effective healthcare educator and a responsible participant in civic and professional organizations. k. Demonstrates scientific inquiry. The pharmacist intern shall develop skills to expand and/or refine knowl edge in the areas of pharmaceutical and medical sciences or pharmaceu tical services. These skills and knowledge may include data analysis of scientific, clinical, sociological, and/or economic impacts of pharmaceu ticals (including investigational drugs), pharmaceutical care, and patient behaviors, with dissemination of findings to the scientific community and/or the public. D.28 Copyright © 2022 Fred S. Brinkley, Jr., and Gary G. Cacciatore Hours Requirement. 1. The Board requires the same number of hours of internship required by ACPE for licensure (300 hours of Introductory Pharmacy Practice Expe rience (IPPE) and 1440 hours of Advanced Pharmacy Practice Experience (APPE)) which may be obtained through the following methods: a. In a Boardapproved student internship as specified in C. below; or b. In a Boardapproved, extended internship program as specified in D. below; and/or c. Graduation from a college/school of pharmacy after luly 1, 2007. Persons graduating from such programs shall be credited the required hours or the number of hours actually obtained and reported by the college; and/or d. Through internship hours approved and certified to the Board by another state board of pharmacy. 2. Pharmacist interns participating in an internship may be credited no more than 50 hours per week of internship experience. 3. Internship hours may be used for the purpose of licensure for no longer than two years from the date the internship is completed. College/SchoolBased Internship Programs. 1. Internship Experience Acquired by Student Interns. a. An individual may be designated a student intern provided he or she meets all of the following requirements: (1) Submits an application to the Board with required information; (2) Is enrolled in the professional sequence of a college/school of phar macy that has a professional degree program accredited by ACPE and approved by the Board; and (3) Has met all requirements necessary for the Board to access the criminal history record information, including submitting finger print information and being responsible for all associated costs. b. The terms of the student internship shall be as follows: (1) The student internship shall be gained concurrent with college attendance which may include: (a) Partial semester breaks such as spring breaks; (b) Between semester breaks; and (c) Whole semester breaks provided the student intern attended the college/school in the immediate preceding semester and is scheduled with the college/school to attend in the immediate subsequent semester. (2) The student internship shall be obtained in pharmacies licensed by the Board, federal government pharmacies, or in a Boardapproved program. (3) The student internship shall be in the presence of and under the super vision of a healthcare professional preceptor or a pharmacist

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