| (a) Purpose. The purpose of this section is to provide standards in the conduct, practice activities, and operation of a pharmacy located in a freestanding emergency medical care center that is licensed by the Texas Department of State Health Services or in a freestanding emergency medical care center operated by a hospital that is exempt from registration as provided by §254.052, Health and Safety Code. Class F pharmacies located in a freestanding emergency medical care center shall comply with this section. (b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Occupations Code, as amended. (2) Automated drug dispensing system--An automated device that measures, counts, and/or packages a specified quantity of dosage units for a designated drug product. (3) Board--The Texas State Board of Pharmacy. (4) Consultant pharmacist--A pharmacist retained by a facility on a routine basis to consult with the FEMCC in areas that pertain to the practice of pharmacy. (5) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I - V or Penalty Groups 1 - 4 of the Texas Controlled Substances Act, as amended, or a drug immediate precursor, or other substance included in Schedule I - V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513). (6) Direct copy--Electronic copy or carbonized copy of a medication order including a facsimile (FAX) or digital image. (7) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner. (8) Distribute--The delivery of a prescription drug or device other than by administering or dispensing. (9) Downtime--Period of time during which a data processing system is not operable. (10) Electronic signature--A unique security code or other identifier which specifically identifies the person entering information into a data processing system. A facility which utilizes electronic signatures must: (A) maintain a permanent list of the unique security codes assigned to persons authorized to use the data processing system; and (B) have an ongoing security program which is capable of identifying misuse and/or unauthorized use of electronic signatures. (11) Floor stock--Prescription drugs or devices not labeled for a specific patient and maintained at a nursing station or other FEMCC department (excluding the pharmacy) for the purpose of administration to a patient of the FEMCC. (12) Formulary--List of drugs approved for use in the FEMCC by an appropriate committee of the freestanding emergency medical care center. (13) Freestanding emergency medical care center (FEMCC)--A freestanding facility that is licensed by the Texas Department of State Health Services pursuant to Chapter 254, Health and Safety Code, to provide emergency care to patients. (14) Hard copy--A physical document that is readable without the use of a special device (i.e., data processing system, computer, etc.). (15) Investigational new drug--New drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the federal Food and Drug Administration. (16) Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device. (17) Pharmacist-in-charge--Pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy. (18) Pharmacy--Area or areas in a facility, separate from patient care areas, where drugs are stored, bulk compounded, delivered, compounded, dispensed, and/or distributed to other areas or departments of the FEMCC, or dispensed to an ultimate user or his or her agent. (19) Prescription drug-- (A) A substance for which federal or state law requires a prescription before it may be legally dispensed to the public; (B) A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements: (i) Caution: federal law prohibits dispensing without prescription or "Rx only" or another legend that complies with federal law; or (ii) Caution: federal law restricts this drug to use by or on order of a licensed veterinarian; or (C) A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only. (20) Prescription drug order-- (A) A written order from a practitioner or verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or (B) A written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code. (21) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open. (22) Part-time pharmacist--A pharmacist who works less than full-time. (23) Pharmacy technician--An individual who is registered with the board as a pharmacy technician and whose responsibility in a pharmacy is to provide technical services that do not require professional judgment regarding preparing and distributing drugs and who works under the direct supervision of and is responsible to a pharmacist. (24) Pharmacy technician trainee--An individual who is registered with the board as a pharmacy technician trainee and is authorized to participate in a pharmacy's technician training program. (25) Texas Controlled Substances Act--The Texas Controlled Substances Act, the Health and Safety Code, Chapter 481, as amended. (c) Personnel. (1) Pharmacist-in-charge. (A) General. Each freestanding emergency medical care center shall have one pharmacist-in-charge who is employed or under contract, at least on a consulting or part-time basis, but may be employed on a full-time basis. (B) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following: (i) establishment of specifications for procurement and storage of all materials, including drugs, chemicals, and biologicals; (ii) participation in the development of a formulary for the FEMCC, subject to approval of the appropriate committee of the FEMCC; (iii) distribution of drugs to be administered to patients pursuant to an original or direct copy of the practitioner's medication order; (iv) filling and labeling all containers from which drugs are to be distributed or dispensed; (v) maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and patient care areas, as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the FEMCC; (vi) records of all transactions of the FEMCC pharmacy as may be required by applicable state and federal law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials; (vii) participation in those aspects of the FEMCC's patient care evaluation program which relate to pharmaceutical material utilization and effectiveness; (viii) participation in teaching and/or research programs in the FEMCC; (ix) implementation of the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the FEMCC; (x) effective and efficient messenger and delivery service to connect the FEMCC pharmacy with appropriate areas of the FEMCC on a regular basis throughout the normal workday of the FEMCC; (xi) labeling, storage, and distribution of investigational new drugs, including maintenance of information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions, and symptoms of toxicity of investigational new drugs; (xii) meeting all inspection and other requirements of the Texas Pharmacy Act and this section; and (xiii) maintenance of records in a data processing system such that the data processing system is in compliance with the requirements for a FEMCC. (2) Consultant pharmacist. (A) The consultant pharmacist may be the pharmacist-in-charge. (B) A written contract shall exist between the FEMCC and any consultant pharmacist, and a copy of the written contract shall be made available to the board upon request. (3) Pharmacists. (A) General. (i) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the FEMCC pharmacy competently, safely, and adequately to meet the needs of the patients of the facility. (ii) All pharmacists shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in paragraph (1)(B) of this subsection and in ordering, administering, and accounting for pharmaceutical materials. (iii) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians or pharmacy technician trainees under his or her supervision. (iv) All pharmacists while on duty shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy. (B) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to, the following: (i) receiving and interpreting prescription drug orders and oral medication orders and reducing these orders to writing either manually or electronically; (ii) selection of prescription drugs and/or devices and/or suppliers; and (iii) interpreting patient profiles. (C) Special requirements for compounding. (i) Non-Sterile Preparations. All pharmacists engaged in compounding non-sterile preparations shall meet the training requirements specified in §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations). (ii) Sterile Preparations. All pharmacists engaged in compounding sterile preparations shall meet the training requirements specified in §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations). (4) Pharmacy technicians and pharmacy technician trainees. (A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training). (B) Duties. Duties may include, but need not be limited to, the following functions, under the direct supervision of a pharmacist: (i) prepacking and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check and affixes his or her name, initials, electronic signature to the appropriate quality control records prior to distribution; (ii) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation; (iii) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in §291.131 of this title; (iv) compounding sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees: (I) have completed the training specified in §291.133 of this title; and (II) are supervised by a pharmacist who has completed the sterile preparations training specified in §291.133 of this title, conducts in-process and final checks, and affixes his or her name, initials, or electronic signature to the label or if batch prepared to the appropriate quality control records. (The name, initials, or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.) (v) bulk compounding, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution; (vi) distributing routine orders for stock supplies to patient care areas; Cont'd... |
