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TEXAS ADMINISTRATIVE CODE
TITLE 22. EXAMINING BOARDS
PART 15. TEXAS STATE BOARD OF PHARMACY
CHAPTER 291. PHARMACIES
SUBCHAPTER D. INSTITUTIONAL PHARMACY (CLASS C)
Date:
03/17/2014
Document:
§ 291.74. Operational Standards
(a) Licensing requirements.
(1) A Class C pharmacy shall register annually or biennially with the board on a pharmacy license application pro-vided by the board, following the procedures specified in § 291.1 of this title (relating to Pharmacy License Applica-tion).
(2) If the institutional pharmacy is owned or operated by a hospital management or consulting firm, the following conditions apply.
(A) The pharmacy license application shall list the hospital management or consulting firm as the owner or oper-ator.
(B) The hospital management or consulting firm shall obtain DEA and DPS controlled substance registrations that are issued in their name, unless the following occurs: (i) the hospital management or consulting firm and the facility cosign a contractual pharmacy service agreement which assigns overall responsibility for controlled substances to the facility; and (ii) such hospital pharmacy management or consulting firm maintains dual responsibility for the controlled substances.
(3) A Class C pharmacy which changes ownership shall notify the board within 10 days of the change of ownership and apply for a new and separate license as specified in § 291.3 of this title (relating to Required Notifications).
(4) A Class C pharmacy which changes location and/or name shall notify the board within 10 days of the change and file for an amended license as specified in § 291.3 of this title.
(5) A Class C pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within 10 days of the change following the procedures in § 291.3 of this title.
(6) A Class C pharmacy shall notify the board in writing within 10 days of closing, following the procedures in § 291.5 of this title (relating to Closing a Pharmacy).
(7) A fee as specified in § 291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.
(8) A separate license is required for each principal place of business and only one pharmacy license may be is-sued to a specific location.
(9) A Class C pharmacy, licensed under the Act, § 560.051(a)(3), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, § 560.051(a)(1) (Community Pharmacy (Class A)) or the Act, § 560.051(a)(2) (Nuclear Pharmacy (Class B)), is not required to secure a license for the such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of § 291.31 of this title (relating to Definitions), § 291.32 of this title (relating to Personnel), § 291.33 of this title (relating to Operational Standards), § 291.34 of this title (relating to Records), and § 291.35 of this title (relating to Official Prescription Records), contained in Community Pharmacy (Class A), or § 291.51 of this title (relating to Purpose), § 291.52 of this title (relating to Defi-nitions), § 291.53 of this title (relating to Personnel), § 291.54 of this title (relating to Operational Standards), and § 291.55 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such sections are ap-plicable to the operation of the pharmacy.
(10) A Class C pharmacy engaged in the compounding of non-sterile preparations shall comply with the provisions of § 291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations).
(11) Prior to August 31, 2014, a Class C pharmacy engaged in the compounding of sterile preparations shall comply with the provisions of § 291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).
(12) Effective August 31, 2014, a Class C pharmacy shall not compound sterile preparations unless the pharmacy has applied for and obtained a Class C-S pharmacy.
(13) A Class C pharmacy engaged in the provision of remote pharmacy services, including storage and dispensing of prescription drugs, shall comply with the provisions of § 291.121 of this title (relating to Remote Pharmacy Services).
(14) A Class C pharmacy engaged in centralized prescription dispensing and/or prescription drug or medication order processing shall comply with the provisions of § 291.123 of this title (relating to Central Prescription Drug or Medication Order Processing) and/or § 291.125 of this title (relating to Centralized Prescription Dispensing).
(15) A Class C pharmacy with an ongoing clinical pharmacy program that proposes to allow a pharmacy technician to verify the accuracy of work performed by another pharmacy technician relating to the filling of floor stock and unit dose distribution systems for a patient admitted to the hospital if the patient's orders have previously been reviewed and approved by a pharmacist shall make application to the board as follows.
(A) The pharmacist-in-charge must submit an application on a form provided by the board, containing the following information: (i) name, address, and pharmacy license number; (ii) name and license number of the pharma-cist-in-charge; (iii) name and registration numbers of the pharmacy technicians; (iv) anticipated date the pharmacy plans to begin allowing a pharmacy technician to verify the accuracy of work performed by another pharmacy techni-cian; (v) documentation that the pharmacy has an ongoing clinical pharmacy program; and (vi) any other information specified on the application.
(B) The pharmacy may not allow a pharmacy technician to check the work of another pharmacy technician until the board has reviewed and approved the application and issued an amended license to the pharmacy.
(C) Every two years, in connection with the application for renewal of the pharmacy license, the pharmacy shall provide updated documentation that the pharmacy continues to have an ongoing clinical pharmacy program as speci-fied in subparagraph (A)(v) of this paragraph.
(16) A rural hospital that wishes to allow a pharmacy technician to perform the duties specified in § 291.73(e)(2)(D) of this title (relating to Personnel), shall make application to the board as follows.
(A) Prior to allowing a pharmacy technician to perform the duties specified in § 291.73(e)(2)(D) of this title, the pharmacist-in-charge must submit an application on a form provided by the board, containing the following infor-mation: (i) name, address, and pharmacy license number; (ii) name and license number of the pharmacist-in-charge; (iii) name and registration number of the pharmacy technicians; (iv) proposed date the pharmacy wishes to start al-lowing pharmacy technicians to perform the duties specified in § 291.73(e)(2)(D) of this title; (v) documentation that the hospital is a rural hospital with 75 or fewer beds and that the rural hospital is either:
(I) located in a county with a population of 50,000 or less as defined by the United States Census Bureau in the most recent U.S. census; or
(II) designated by the Centers for Medicare and Medicaid Services as a critical access hospital, rural referral cen-ter, or sole community hospital; and (vi) any other information specified on the application.
(B) A rural hospital may not allow a pharmacy technician to perform the duties specified in § 291.73(e)(2)(D) of this title until the board has reviewed and approved the application and issued an amended license to the pharmacy.
(C) Every two years in conjunction with the application for renewal of the pharmacy license, the pharma-cist-in-charge shall update the application for pharmacy technicians to perform the duties specified in § 291.73(e)(2)(D) of this title.
(b) Environment.
(1) General requirements.
(A) The institutional pharmacy shall have adequate space necessary for the storage, compounding, labeling, dis-pensing, and sterile preparation of drugs prepared in the pharmacy, and additional space, depending on the size and scope of pharmaceutical services.
(B) The institutional pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equip-ment shall be clean and in good operating condition.
(C) A sink with hot and cold running water exclusive of restroom facilities shall be available to all pharmacy per-sonnel and shall be maintained in a sanitary condition at all times.
(D) The institutional pharmacy shall be properly lighted and ventilated.
(E) The temperature of the institutional pharmacy shall be maintained within a range compatible with the proper storage of drugs. The temperature of the refrigerator and/or freezer shall be maintained within a range compatible with the proper storage of drugs.
(F) If the institutional pharmacy has flammable materials, the pharmacy shall have a designated area for the storage of flammable materials. Such area shall meet the requirements set by local and state fire laws.
(G) The institutional pharmacy shall store antiseptics, other drugs for external use, and disinfectants separately from internal and injectable medications.
(2) Security requirements.
(A) The institutional pharmacy shall be enclosed and capable of being locked by key, combination or other me-chanical or electronic means, so as to prohibit access by unauthorized individuals. Only individuals authorized by the pharmacist-in-charge shall enter the pharmacy.
(B) Each pharmacist on duty shall be responsible for the security of the institutional pharmacy, including provisions for adequate safeguards against theft or diversion of dangerous drugs, controlled substances, and records for such drugs.
(C) The institutional pharmacy shall have locked storage for Schedule II controlled substances and other drugs re-quiring additional security.
(c) Equipment and supplies. Institutional pharmacies distributing medication orders shall have the following equipment:
(1) data processing system including a printer or comparable equipment; and
(2) refrigerator and/or freezer and a system or device (e.g., thermometer) to monitor the temperature to ensure that proper storage requirements are met.
(d) Library. A reference library shall be maintained that includes the following in hard-copy or electronic format and that pharmacy personnel shall be capable of accessing at all times:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and rules;
(C) Texas Controlled Substances Act and regulations; and
(D) Federal Controlled Substances Act and regulations (or official publication describing the requirements of the Federal Controlled Substances Act and regulations);
(2) at least one current or updated reference from each of the following categories:
(A) drug interactions. A reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including infor-mation needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;
(B) a general information reference text, such as: (i) Facts and Comparisons with current supplements; (ii) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider); (iii) AHFS Drug Information with current supplements; (iv) Remington's Pharmaceutical Sciences; or (v) Clinical Pharmacology;
(3) a current or updated reference on injectable drug products, such as Handbook of Injectable Drugs;
(4) basic antidote information and the telephone number of the nearest regional poison control center;
(5) metric-apothecary weight and measure conversion charts.
(e) Absence of a pharmacist.
(1) Medication orders.
(A) In facilities with a full-time pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacy is closed, the following is applicable. (i) Prescription drugs and devices only in suf-ficient quantities for immediate therapeutic needs may be removed from the institutional pharmacy. (ii) Only a des-ignated licensed nurse or practitioner may remove such drugs and devices. (iii) A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices. The record shall contain the following infor-mation:
(I) name of patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity taken;
(V) time and date; and
(VI) signature (first initial and last name or full signature) or electronic signature of person making withdrawal. (iv) The original or direct copy of the medication order may substitute for such record, providing the medication order meets all the requirements of clause (iii) of this subparagraph. (v) The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section as soon as practical, but in no event more than 72 hours from the time of such withdrawal.
(B) In facilities with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacist is not on duty, or when the pharmacy is closed, the following is applicable. (i) Prescription drugs and devices only in sufficient quantities for therapeutic needs may be removed from the institutional pharmacy. (ii) Only a designated licensed nurse or practitioner may remove such drugs and devices. (iii) A record shall be made at the time of withdrawal by the authorized person removing the drugs and de-vices; the record shall meet the same requirements as specified in subparagraph (A)(iii) and (iv) of this paragraph. (iv) The pharmacist shall verify the withdrawal of drugs from the pharmacy and perform a drug regimen review as specified in subsection (g)(1)(B) of this section after a reasonable interval, but in no event may such interval exceed seven days.
(2) Floor stock. In facilities using a floor stock method of drug distribution, the following is applicable.
(A) Prescription drugs and devices may be removed from the pharmacy only in the original manufacturer's con-tainer or prepackaged container.
(B) Only a designated licensed nurse or practitioner may remove such drugs and devices.
(C) A record shall be made at the time of withdrawal by the authorized person removing the drug or device; the record shall contain the following information: (i) name of the drug, strength, and dosage form; (ii) quantity removed; (iii) location of floor stock; (iv) date and time; and (v) signature (first initial and last name or full signature) or electronic signature of person making the withdrawal.
(D) The pharmacist shall verify the withdrawal of drugs from the pharmacy after a reasonable interval, but in no event may such interval exceed seven days.
(3) Rural hospitals. In rural hospitals when a pharmacy technician performs the duties listed in § 291.73(e)(2)(D) of this title, the following is applicable:
(A) the pharmacy technician shall make a record of all drugs distributed from the pharmacy. The record shall be maintained in the pharmacy for two years and contain the following information: (i) name of patient or location where floor stock is distributed; (ii) name of device or drug, strength, and dosage form; (iii) dose prescribed or ordered; (iv) quantity distributed; (v) time and date of the distribution; and (vi) signature (first initial and last name or full signature) or electronic signature of nurse or practitioner that verified the actions of the pharmacy technician.
(B) The original or direct copy of the medication order may substitute for the record specified in subparagraph (A) of this paragraph, provided the medication order meets all the requirements of subparagraph (A) of this paragraph.
(C) The pharmacist shall: (i) verify and document the verification of all distributions made from the pharmacy in the absence of a pharmacist as soon as practical, but in no event more than seven (7) days from the time of such dis-tribution; (ii) perform a drug regimen review for all medication orders as specified in subsection (g)(1)(B) of this section as soon as practical, but in no event more than seven (7) days from the time of such distribution and document such verification including any discrepancies noted by the pharmacist; (iii) review any discrepancy noted by the pharmacist with the pharmacy technician(s) and make any change in procedures or processes necessary to prevent future problems; and (iv) report any adverse events that have a potential for harm to a patient to the appropriate committee of the hospital that reviews adverse events.
(f) Drugs.
(1) Procurement, preparation and storage.
(A) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may re-ceive input from other appropriate staff of the facility, relative to such responsibility.
(B) The pharmacist-in-charge shall have the responsibility for determining specifications of all drugs procured by the facility.
(C) Institutional pharmacies may not sell, purchase, trade or possess prescription drug samples, unless the phar-macy meets the requirements as specified in § 291.16 of this title (relating to Samples).
(D) All drugs shall be stored at the proper temperatures, as defined in the USP/NF and in § 291.15 of this title (re-lating to Storage of Drugs).
(E) Any drug bearing an expiration date may not be distributed beyond the expiration date of the drug.
(F) Outdated and other unusable drugs shall be removed from stock and shall be quarantined together until such drugs are disposed of properly.
(2) Formulary.
(A) A formulary shall be developed by the facility committee performing the pharmacy and therapeutics function for the facility. For the purpose of this section, a formulary is a compilation of pharmaceuticals that reflects the current clinical judgment of a facility's medical staff.
(B) The pharmacist-in-charge or pharmacist designated by the pharmacist-in-charge shall be a full voting member of the committee performing the pharmacy and therapeutics function for the facility, when such committee is per-forming the pharmacy and therapeutics function.
(C) A practitioner may grant approval for pharmacists at the facility to interchange, in accordance with the facility's formulary, for the prescribed drugs on the practitioner's medication orders provided: (i) the pharmacy and thera-peutics committee has developed a formulary; (ii) the formulary has been approved by the medical staff committee of the facility; (iii) there is a reasonable method for the practitioner to override any interchange; and (iv) the practitioner authorizes pharmacists in the facility to interchange on his/her medication orders in accordance with the facility's formulary through his/her written agreement to abide by the policies and procedures of the medical staff and facility.
(3) Prepackaging of drugs.
(A) Distribution within a facility. (i) Drugs may be prepackaged in quantities suitable for internal distribution by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist. (ii) The label of a prepackaged unit shall indicate:
(I) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available literature; and
(IV) quantity of the drug, if the quantity is greater than one. (iii) Records of prepackaging shall be maintained to show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the prepacker; and
(X) name, initials, or electronic signature of the responsible pharmacist. (iv) Stock packages, prepackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(B) Distribution to other Class C (Institutional) pharmacies under common ownership. (i) Drugs may be pre-packaged in quantities suitable for distribution to other Class C (Institutional) pharmacies under common ownership by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist. (ii) The label of a prepackaged unit shall indicate:
(I) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(II) facility's unique lot number;
(III) expiration date based on currently available literature;
(IV) quantity of the drug, if the quantity is greater than one; and
(V) name of the facility responsible for prepackaging the drug. (iii) Records of prepackaging shall be maintained to show:
(I) name of the drug, strength, and dosage form;
(II) facility's unique lot number;
(III) manufacturer or distributor;
(IV) manufacturer's lot number;
(V) expiration date;
(VI) quantity per prepackaged unit;
(VII) number of prepackaged units;
(VIII) date packaged;
(IX) name, initials, or electronic signature of the prepacker;
(X) name, initials, or electronic signature of the responsible pharmacist; and
(XI) name of the facility receiving the prepackaged drug. (iv) Stock packages, prepackaged units, and control records shall be quarantined together until checked/released by the pharmacist. (v) The pharmacy shall have written procedure for the recall of any drug prepackaged for another Class C Pharmacy under common ownership. The recall procedures shall require:
(I) notification to the pharmacy to which the prepackaged drug was distributed;
(II) quarantine of the product if there is a suspicion of harm to a patient;
(III) a mandatory recall if there is confirmed or probable harm to a patient; and
(IV) notification to the board if a mandatory recall is instituted.
(4) Sterile preparations prepared in a location other than the pharmacy. A distinctive supplementary label shall be affixed to the container of any admixture. The label shall bear at a minimum:
(A) patient's name and location, if not immediately administered;
(B) name and amount of drug(s) added;
(C) name of the basic solution;
(D) name or identifying code of person who prepared admixture; and
(E) expiration date of solution.
(5) Distribution.
(A) Medication orders. (i) Drugs may be given to patients in facilities only on the order of a practitioner. No change in the order for drugs may be made without the approval of a practitioner except as authorized by the practi-tioner in compliance with paragraph (2)(C) of this subsection. (ii) Drugs may be distributed only from the original or a direct copy of the practitioner's medication order. (iii) Pharmacy technicians and pharmacy technician trainees may not receive verbal medication orders. (iv) Institutional pharmacies shall be exempt from the labeling provisions and patient notification requirements of § 562.006 and § 562.009 of the Act, as respects drugs distributed pursuant to medication orders.
(B) Procedures. (i) Written policies and procedures for a drug distribution system (best suited for the particular institutional pharmacy) shall be developed and implemented by the pharmacist-in-charge, with the advice of the committee performing the pharmacy and therapeutics function for the facility. (ii) The written policies and proce-dures for the drug distribution system shall include, but not be limited to, procedures regarding the following:
(I) pharmaceutical care services;
(II) handling, storage and disposal of cytotoxic drugs and waste;
(III) disposal of unusable drugs and supplies;
(IV) security;
(V) equipment;
(VI) sanitation;
(VII) reference materials;
(VIII) drug selection and procurement;
(IX) drug storage;
(X) controlled substances;
(XI) investigational drugs, including the obtaining of protocols from the principal investigator;
(XII) prepackaging and manufacturing;
(XIII) stop orders;
(XIV) reporting of medication errors, adverse drug reactions/events, and drug product defects;
(XV) physician orders;
(XVI) floor stocks;
(XVII) drugs brought into the facility;
(XVIII) furlough medications;
(XIX) self-administration;
(XX) emergency drug supply;
(XXI) formulary;
(XXII) monthly inspections of nursing stations and other areas where drugs are stored, distributed, administered or dispensed;
(XXIII) control of drug samples;
(XXIV) outdated and other unusable drugs;
(XXV) routine distribution of patient medication;
(XXVI) preparation and distribution of sterile preparations;
(XXVII) handling of medication orders when a pharmacist is not on duty;
(XXVIII) use of automated compounding or counting devices;
(XXIX) use of data processing and direct imaging systems;
(XXX) drug administration to include infusion devices and drug delivery systems;
(XXXI) drug labeling;
(XXXII) recordkeeping;
(XXXIII) quality assurance/quality control;
(XXXIV) duties and education and training of professional and nonprofessional staff;
(XXXV) procedures for a pharmacy technician to verify the accuracy of work performed by another pharmacy technician, if applicable;
(XXXVI) operation of the pharmacy when a pharmacist in not on-site; and
(XXXVII) emergency preparedness plan, to include continuity of patient therapy and public safety.
(6) Discharge Prescriptions. Discharge prescriptions must be dispensed and labeled in accordance with § 291.33 of this title (relating to Operational Standards) except that certain medications packaged in unit-of-use containers, such as metered-dose inhalers, insulin pens, topical creams or ointments, or ophthalmic or otic preparation that are ad-ministered to the patient during the time the patient was a patient in the hospital, may be provided to the patient upon discharge provided the pharmacy receives a discharge order and the product bears a label containing the following information:
(A) name of the patient;
(B) name and strength of the medication;
(C) name of the prescribing or attending practitioner;
(D) directions for use;
(E) duration of therapy (if applicable); and
(F) name and telephone number of the pharmacy.
(g) Pharmaceutical care services.
(1) The pharmacist-in-charge shall assure that at least the following pharmaceutical care services are provided to patients of the facility.
(A) Drug utilization review. A systematic ongoing process of drug utilization review shall be developed in conjunc-tion with the medical staff to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy.
(B) Drug regimen review. (i) For the purpose of promoting therapeutic appropriateness, a pharmacist shall evaluate medication orders and patient medication records for:
(I) known allergies;
(II) rational therapy--contraindications;
(III) reasonable dose and route of administration;
(IV) reasonable directions for use;
(V) duplication of therapy;
(VI) drug-drug interactions;
(VII) drug-food interactions;
(VIII) drug-disease interactions;
(IX) adverse drug reactions;
(X) proper utilization, including overutilization or underutilization; and
(XI) clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen. (ii) The drug regimen review shall be conducted on a prospective basis when a pharmacist is on duty, except for an emergency or-der, and on a retrospective basis as specified in subsection (e)(1) of this section when a pharmacist is not on duty. (iii) Any questions regarding the order must be resolved with the prescriber and a written notation of these discussions made and maintained. (iv) The drug regimen review may be conducted by remotely accessing the pharmacy's electronic data base from outside the pharmacy by an individual Texas licensed pharmacist employee of the pharmacy, provided the pharmacy establishes controls to protect the privacy of the patient and the security of confidential records.
(C) Education. The pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff of the facility shall develop policies that assure that: (i) the patient and/or patient's caregiver receives information regarding drugs and their safe and appropriate use; and (ii) health care providers are provided with patient specific drug information.
(D) Patient monitoring. The pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff of the facility shall develop policies to ensure that the patient's response to drug therapy is monitored and conveyed to the appropriate health care provider.
(2) Other pharmaceutical care services which may be provided by pharmacists in the facility include, but are not limited to, the following:
(A) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act;
(B) administering immunizations and vaccinations under written protocol of a physician;
(C) managing patient compliance programs;
(D) providing preventative health care services; and
(E) providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern.
(h) Emergency rooms.
(1) During the times a pharmacist is on duty in the facility any prescription drugs supplied to an outpatient, in-cluding emergency department patients, may only be dispensed by a pharmacist.
(2) When a pharmacist is not on duty in the facility, the following is applicable for supplying prescription drugs to be taken home by the patient for self-administration from the emergency room. If the patient has been admitted to the emergency room and assessed by a practitioner at the hospital, the following procedures shall be observed in supplying prescription drugs from the emergency room.
(A) Dangerous drugs and/or controlled substances may only be supplied in accordance with the system of control and accountability for dangerous drugs and/or controlled substances administered or supplied from the emergency room; such system shall be developed and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.
(B) Only dangerous drugs and/or controlled substances listed on the emergency room drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the facility's emergency department committee (or like group or person responsible for policy in that department) and shall consist of dangerous drugs and/or controlled substances of the nature and type to meet the immediate needs of emergency room patients.
(C) Dangerous drugs and/or controlled substances may only be supplied in prepackaged quantities not to exceed a 72-hour supply in suitable containers and appropriately prelabeled (including necessary auxiliary labels) by the institu-tional pharmacy.
(D) At the time of delivery of the dangerous drugs and/or controlled substances, the practitioner or licensed nurse under the supervision of a practitioner shall appropriately complete the label with at least the following information: (i) name, address, and phone number of the facility; (ii) date supplied; (iii) name of practitioner; (iv) name of patient; (v) directions for use; (vi) brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance; (vii) quantity supplied; and (viii) unique identification number.
(E) The practitioner, or a licensed nurse under the supervision of the practitioner, shall give the appropriately la-beled, prepackaged drug to the patient and explain the correct use of the drug.
(F) A perpetual record of dangerous drugs and/or controlled substances supplied from the emergency room shall be maintained in the emergency room. Such record shall include the following: (i) date supplied; (ii) practitioner's name; (iii) patient's name; (iv) brand name and strength of the dangerous drug or controlled substance; or if no brand name, then the generic name, strength, and the name of the manufacturer or distributor of the dangerous drug or controlled substance; (v) quantity supplied; and (vi) unique identification number.
(G) The pharmacist-in-charge, or staff pharmacist designated by the pharmacist-in-charge, shall verify the cor-rectness of this record at least once every seven days.
(i) Radiology departments.
(1) During the times a pharmacist is on duty, any prescription drugs dispensed to an outpatient, including radiology department patients, may only be dispensed by a pharmacist.
(2) When a pharmacist is not on duty, the following procedures shall be observed in supplying prescription drugs from the radiology department.
(A) Prescription drugs may only be supplied to patients who have been scheduled for an x-ray examination at the facility.
(B) Prescription drugs may only be supplied in accordance with the system of control and accountability for pre-scription drugs administered or supplied from the radiology department and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.
(C) Only prescription drugs listed on the radiology drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the facility's radiology committee (or like group or persons responsible for policy in that de-partment) and shall consist of drugs for the preparation of a patient for a radiological procedure.
(D) Prescription drugs may only be supplied in prepackaged quantities in suitable containers and prelabeled by the institutional pharmacy with the following information: (i) name and address of the facility; (ii) directions for use; (iii) name and strength of the prescription drug--if generic name, the name of the manufacturer or distributor of the prescription drug; (iv) quantity; (v) facility's lot number and expiration date; and (vi) appropriate ancillary label(s).
(E) At the time of delivery of the prescription drug, the practitioner or practitioner's agent shall complete the label with the following information: (i) date supplied; (ii) name of physician; (iii) name of patient; and (iv) unique identifica-tion number.
(F) The practitioner or practitioner's agent shall give the appropriately labeled, prepackaged prescription drug to the patient.
(G) A perpetual record of prescription drugs supplied from the radiology department shall be maintained in the radiology department. Such records shall include the following: (i) date supplied; (ii) practitioner's name; (iii) patient's name; (iv) brand name and strength of the prescription drug; or if no brand name, then the generic name, strength, dosage form, and the name of the manufacturer or distributor of the prescription drug; (v) quantity supplied; and (vi) unique identification number.
(H) The pharmacist-in-charge, or a pharmacist designated by the pharmacist-in-charge, shall verify the correctness of this record at least once every seven days.
(j) Automated devices and systems.
(1) Automated compounding or counting devices. If a pharmacy uses automated compounding or counting devic-es:
(A) the pharmacy shall have a method to calibrate and verify the accuracy of the automated compounding or counting device and document the calibration and verification on a routine basis;
(B) the devices may be loaded with unlabeled drugs only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist;
(C) the label of an automated compounding or counting device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distrib-utor;
(D) records of loading unlabeled drugs into an automated compounding or counting device shall be maintained to show: (i) name of the drug, strength, and dosage form; (ii) manufacturer or distributor; (iii) manufacturer's lot number; (iv) expiration date; (v) date of loading; (vi) name, initials, or electronic signature of the person loading the automated compounding or counting device; and (vii) signature or electronic signature of the responsible pharmacist; and
(E) the automated compounding or counting device shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature to the record specified in subparagraph (D) of this paragraph.
(2) Automated medication supply systems.
(A) Authority to use automated medication supply systems. A pharmacy may use an automated medication supply system to fill medication orders provided that: (i) the pharmacist-in-charge is responsible for the supervision of the operation of the system; (ii) the automated medication supply system has been tested by the pharmacy and found to dispense accurately. The pharmacy shall make the results of such testing available to the Board upon request; and (iii) the pharmacy will make the automated medication supply system available for inspection by the board for the purpose of validating the accuracy of the system.
(B) Quality assurance program. A pharmacy which uses an automated medication supply system to fill medication orders shall operate according to a written program for quality assurance of the automated medication supply system which: (i) requires continuous monitoring of the automated medication supply system; and (ii) establishes mechanisms and procedures to test the accuracy of the automated medication supply system at least every six months and whenever any upgrade or change is made to the system and documents each such activity.
(C) Policies and procedures of operation. (i) When an automated medication supply system is used to store or distribute medications for administration pursuant to medication orders, it shall be operated according to written pol-icies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated medication supply system and shall describe policies and procedures that:
(I) include a description of the policies and procedures of operation;
(II) provide for a pharmacist's review and approval of each original or new medication order prior to withdrawal from the automated medication supply system:
(-a-) before the order is filled when a pharmacist is on duty except for an emergency order;
(-b-) retrospectively within 72 hours in a facility with a full-time pharmacist when a pharmacist is not on duty at the time the order is made; or
(-c-) retrospectively within 7 days in a facility with a part-time or consultant pharmacist when a pharmacist is not on duty at the time the order is made;
(III) provide for access to the automated medication supply system for stocking and retrieval of medications which is limited to licensed healthcare professionals, pharmacy technicians, or pharmacy technician trainees acting under the supervision of a pharmacist;
(IV) provide that a pharmacist is responsible for the accuracy of the restocking of the system. The actual restocking may be performed by a pharmacy technician or pharmacy technician trainee;
(V) provide for an accountability record to be maintained which documents all transactions relative to stocking and removing medications from the automated medication supply system;
(VI) require a prospective or retrospective drug regimen review is conducted as specified in subsection (g) of this section; and
(VII) establish and make provisions for documentation of a preventative maintenance program for the automated medication supply system. (ii) A pharmacy which uses an automated medication supply system to fill medication orders shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(D) Automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department (e.g., Pyxis). A pharmacy technician or pharmacy technician trainee may restock an auto-mated medication supply system located outside of the pharmacy department with prescription drugs provided: (i) prior to distribution of the prescription drugs a pharmacist verifies that the prescription drugs pulled to stock the au-tomated supply system match the list of prescription drugs generated by the automated medication supply system except as specified in § 291.73(e)(2)(C)(ii) of this title; or (ii) all of the following occur:
(I) the prescription drugs to restock the system are labeled and verified with a machine readable product identifi-er, such as a barcode;
(II) either:
(-a-) the drugs are in tamper evident product packaging, packaged by an FDA registered repackager or manufac-ture, that is shipped to the pharmacy; or
(-b-) if any manipulation of the product occurs in the pharmacy prior to restocking, such as repackaging or ex-temporaneous compounding, the product must be checked by a pharmacist; and
(III) quality assurance audits are conducted according to established policies and procedures to ensure accuracy of the process.
(E) Recovery Plan. A pharmacy which uses an automated medication supply system to store or distribute medica-tions for administration pursuant to medication orders shall maintain a written plan for recovery from a disaster or any other situation which interrupts the ability of the automated medication supply system to provide services necessary for the operation of the pharmacy. The written plan for recovery shall include: (i) planning and preparation for maintaining pharmacy services when an automated medication supply system is experiencing downtime; (ii) proce-dures for response when an automated medication supply system is experiencing downtime; (iii) procedures for the maintenance and testing of the written plan for recovery; and (iv) procedures for notification of the Board and other appropriate agencies whenever an automated medication supply system experiences downtime for more than two days of operation or a period of time which significantly limits the pharmacy's ability to provide pharmacy services.
(3) Verification of medication orders prepared by the pharmacy department through the use of an automated medication supply system. A pharmacist must check drugs prepared pursuant to medication orders to ensure that the drug is prepared for distribution accurately as prescribed. This paragraph does not apply to automated medication supply systems used for storage and recordkeeping of medications located outside of the pharmacy department.
(A) This check shall be considered accomplished if: (i) a check of the final product is conducted by a pharmacist after the automated system has completed preparation of the medication order and prior to delivery to the patient; or (ii) the following checks are conducted by a pharmacist:
(I) if the automated medication supply system contains unlabeled stock drugs, a pharmacist verifies that those drugs have been accurately stocked; and
(II) a pharmacist checks the accuracy of the data entry of each original or new medication order entered into the automated medication supply system before the order is filled.
(B) If the final check is accomplished as specified in subparagraph (A)(ii) of this paragraph, the following additional requirements must be met. (i) The medication order preparation process must be fully automated from the time the pharmacist releases the medication order to the automated system until a completed medication order, ready for delivery to the patient, is produced. (ii) The pharmacy has conducted initial testing and has a continuous quality as-surance program which documents that the automated medication supply system dispenses accurately as specified in paragraph (2)(A) and (B) of this subsection. (iii) The automated medication supply system documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subpar-agraph (A)(ii) of this paragraph; and
(II) the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy techni-cian or pharmacy technician trainee who performs any other portion of the medication order preparation process. (iv) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated medication supply system at least every month rather than every six months as specified in paragraph (2)(B) of this subsection.
(4) Automated checking device.
(A) For the purpose of this subsection, an automated checking device is a fully automated device which confirms, after a drug is prepared for distribution but prior to delivery to the patient, that the correct drug and strength has been labeled with the correct label for the correct patient.
(B) The final check of a drug prepared pursuant to a medication order shall be considered accomplished using an automated checking device provided: (i) a check of the final product is conducted by a pharmacist prior to delivery to the patient or the following checks are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is checked by a pharmacist who verifies that the drug is labeled and packaged accurately; and
(II) a pharmacist checks the accuracy of each original or new medication order. (ii) the medication order is pre-pared, labeled, and made ready for delivery to the patient in compliance with Class C (Institutional) Pharmacy rules; and (iii) prior to delivery to the patient:
(I) the automated checking device confirms that the correct drug and strength has been labeled with the correct label for the correct patient; and
(II) a pharmacist performs all other duties required to ensure that the medication order has been prepared safely and accurately as prescribed.
(C) If the final check is accomplished as specified in subparagraph (B) of this paragraph, the following additional requirements must be met. (i) The pharmacy has conducted initial testing of the automated checking device and has a continuous quality assurance program which documents that the automated checking device accurately confirms that the correct drug and strength has been labeled with the correct label for the correct patient. (ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subpar-agraph (B)(i) of this paragraph; and
(II) the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs any other portion of the medication order preparation process. (iii) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated checking device at least monthly.
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