Header:
TEXAS ADMINISTRATIVE CODE
TITLE 22. EXAMINING BOARDS
PART 15. TEXAS STATE BOARD OF PHARMACY
CHAPTER 291. PHARMACIES
SUBCHAPTER D. INSTITUTIONAL PHARMACY (CLASS C)
Date:
08/31/2009
Document:
§ 291.76. Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center
(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 ambulatory surgical center that is licensed by the Texas Department of State Health Services. Class C pharmacies located in a freestanding ambulatory surgical center shall comply with this section, in lieu of §§ 291.71 - 291.75 of this title (relating to Purpose; Definitions; Personnel; Operational Standards; and Records).
(b) Definitions. The following words and terms, when used in these sections, 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) Ambulatory surgical center (ASC)--A freestanding facility that is licensed by the Texas Department of State Health Services to provide surgical services to patients who do not require overnight hospital care.
(3) Automated drug dispensing system--An automated device that measures, counts, and/or packages a specified quantity of dosage units for a designated drug product.
(4) Board--The Texas State Board of Pharmacy.
(5) Consultant pharmacist--A pharmacist retained by a facility on a routine basis to consult with the ASC in areas that pertain to the practice of pharmacy.
(6) 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).
(7) Direct copy--Electronic copy or carbonized copy of a medication order including a facsimile (FAX) or digital image.
(8) 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.
(9) Distribute--The delivery of a prescription drug or device other than by administering or dispensing.
(10) Downtime--Period of time during which a data processing system is not operable.
(11) 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.
(12) Floor stock--Prescription drugs or devices not labeled for a specific patient and maintained at a nursing station or other ASC department (excluding the pharmacy) for the purpose of administration to a patient of the ASC.
(13) Formulary--List of drugs approved for use in the ASC by an appropriate committee of the ambulatory surgical center.
(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 ASC, 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 ambulatory surgical 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 ASC, subject to approval of the appropriate committee of the ASC; (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 ASC; (vi) records of all transactions of the ASC 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 ASC's patient care evaluation program which relate to pharmaceutical material utilization and effectiveness; (viii) participation in teaching and/or research programs in the ASC; (ix) implementation of the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the ASC; (x) effective and efficient messenger and delivery service to connect the ASC pharmacy with appropriate areas of the ASC on a regular basis throughout the normal workday of the ASC; (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 subsection; and (xiii) maintenance of records in a data processing system such that the data processing system is in compliance with the requirements for a Class C (institutional) pharmacy located in a freestanding ASC.
(2) Consultant pharmacist.
(A) The consultant pharmacist may be the pharmacist-in-charge.
(B) A written contract shall exist between the ASC 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 ASC 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; (vii) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in subsection (d)(6)(E) and (F) of this section; (viii) maintaining inventories of drug supplies; (ix) maintaining pharmacy records; and (x) loading bulk unlabeled drugs into an automated drug dispensing system provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials or electronic signature to the appropriate quality control records.
(C) Procedures. (i) Pharmacy technicians and pharmacy technician trainees shall handle medication orders in accordance with standard written procedures and guidelines. (ii) Pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as pharmacy technicians or pharmacy technician trainees working in a Class A pharmacy.
(D) Special requirements for compounding. (i) Non-Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding non-sterile preparations shall meet the training requirements specified in § 291.131 of this title. (ii) Sterile Preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding sterile preparations shall meet the training requirements specified in § 291.133 of this title.
(5) Owner. The owner of an ASC pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
(A) establishment of policies for procurement of prescription drugs and devices and other products dispensed from the ASC pharmacy;
(B) establishment and maintenance of effective controls against the theft or diversion of prescription drugs;
(C) if the pharmacy uses an automated pharmacy dispensing system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(D) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(E) establishment of policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
(6) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows:
(A) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee a registered pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board.
(B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
(C) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.
(D) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.
(d) Operational standards.
(1) Licensing requirements.
(A) An ASC pharmacy shall register annually with the board on a pharmacy license application provided by the board, following the procedures specified in § 291.1 of this title (relating to Pharmacy License Application).
(B) If the ASC pharmacy is owned or operated by a pharmacy management or consulting firm, the following conditions apply. (i) The pharmacy license application shall list the pharmacy management or consulting firm as the owner or operator. (ii) The pharmacy management or consulting firm shall obtain DEA and DPS controlled substances registrations that are issued in the name of the firm, unless the following occur:
(I) the pharmacy 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 pharmacy management or consulting firm maintains dual responsibility for the controlled substances.
(C) An ASC 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).
(D) An ASC pharmacy which changes location and/or name shall notify the board of the change within 10 days and file for an amended license as specified in § 291.3 of this title.
(E) An ASC 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.
(F) An ASC 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.
(G) A fee as specified in § 291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance and renewal of a license and the issuance of an amended license.
(H) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
(I) An ASC pharmacy, licensed under the Act, § 560.051(a)(3), concerning institutional pharmacy (Class C), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, § 560.051(a)(1), concerning community pharmacy (Class A), or the Act, § 560.051(a)(2), concerning nuclear pharmacy (Class B), is not required to secure a license for the other type of pharmacy; provided, however, such license 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), or § 291.51 of this title (relating to Purpose), § 291.52 of this title (relating to Definitions), § 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 applicable to the operation of the pharmacy.
(J) An ASC pharmacy engaged in the compounding of non-sterile preparations shall comply with the provisions of § 291.131 of this title.
(K) An ASC pharmacy engaged in the compounding of sterile preparations shall comply with the provisions of § 291.133 of this title.
(L) An ASC 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).
(M) An ASC 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 Centralized Prescription Drug or Medication Order Processing) and/or § 291.125 of this title (relating to Centralized Prescription Dispensing).
(2) Environment.
(A) General requirements. (i) Each ambulatory surgical center shall have a designated work area separate from patient areas, and which shall have space adequate for the size and scope of pharmaceutical services and shall have adequate space and security for the storage of drugs. (ii) The ASC pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.
(B) Special requirements. (i) The ASC pharmacy shall have locked storage for Schedule II controlled substances and other controlled drugs requiring additional security. (ii) The ASC pharmacy shall have a designated area for the storage of poisons and externals separate from drug storage areas.
(C) Security. (i) Only authorized personnel may have access to storage areas for prescription drugs and/or devices. (ii) All storage areas for prescription drugs and/or devices shall be locked by key or combination, so as to prevent access by unauthorized personnel. (iii) The pharmacist-in-charge shall consult with ASC personnel with respect to security of the drug storage areas, including provisions for adequate safeguards against theft or diversion of prescription drugs and/or devices.
(3) Equipment and supplies. Ambulatory surgical centers supplying drugs for postoperative use shall have the following equipment and supplies:
(A) data processing system including a printer or comparable equipment;
(B) adequate supply of child-resistant, moisture-proof, and light-proof containers; and
(C) adequate supply of prescription labels and other applicable identification labels;
(4) 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:
(A) current copies of the following: (i) Texas Pharmacy Act and rules; (ii) Texas Dangerous Drug Act and rules; (iii) Texas Controlled Substances Act and rules; (iv) Federal Controlled Substances Act and rules or official publication describing the requirements of the Federal Controlled Substances Act and rules;
(B) at least one current or updated reference from each of the following categories: (i) 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 information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken; (ii) General information. 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;
(C) a current or updated reference on injectable drug products, such as Handbook of Injectable Drugs;
(D) basic antidote information and the telephone number of the nearest regional poison control center;
(E) if the pharmacy compounds sterile preparations, specialty references appropriate for the scope of services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic drugs, a reference text on the preparation of cytotoxic drugs, such as Procedures for Handling Cytotoxic Drugs; and
(F) metric-apothecary weight and measure conversion charts.
(5) Drugs.
(A) Procurement, preparation, and storage. (i) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff of the facility, relative to such responsibility. (ii) The pharmacist-in-charge shall have the responsibility for determining specifications of all drugs procured by the facility. (iii) ASC pharmacies may not sell, purchase, trade, or possess prescription drug samples, unless the pharmacy meets the requirements as specified in § 291.16 of this title (relating to Samples). (iv) All drugs shall be stored at the proper temperatures, as defined in the USP/NF and in § 291.15 of this title (relating to Storage of Drugs.) (v) Any drug bearing an expiration date may not be dispensed or distributed beyond the expiration date of the drug. (vi) Outdated drugs shall be removed from dispensing stock and shall be quarantined together until such drugs are disposed of.
(B) Formulary. (i) A formulary may be developed by an appropriate committee of the ambulatory surgical center. (ii) The pharmacist-in-charge or consultant pharmacist shall be a full voting member of any committee which involves pharmaceutical services.
(C) Prepackaging of drugs and loading of bulk unlabeled drugs into automated drug dispensing system. (i) Prepackaging of drugs.
(I) Drugs may be prepackaged in quantities suitable for internal distribution only 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:
(-a-) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(-b-) facility's lot number;
(-c-) expiration date; and
(-d-) quantity of the drug, if quantity is greater than one.
(III) Records of prepackaging shall be maintained to show:
(-a-) the name of the drug, strength, and dosage form;
(-b-) facility's lot number;
(-c-) manufacturer or distributor;
(-d-) manufacturer's lot number;
(-e-) expiration date;
(-f-) quantity per prepackaged unit;
(-g-) number of prepackaged units;
(-h-) date packaged;
(-i-) name, initials, or electronic signature of the prepacker; and
(-j-) signature or electronic signature of the responsible pharmacist.
(IV) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist. (ii) Loading bulk unlabeled drugs into automated drug dispensing systems.
(I) Automated drug dispensing systems may be loaded with bulk unlabeled drugs only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.
(II) The label of an automated drug dispensing system 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 distributor.
(III) Records of loading bulk unlabeled drugs into an automated drug dispensing system shall be maintained to show:
(-a-) name of the drug, strength, and dosage form;
(-b-) manufacturer or distributor;
(-c-) manufacturer's lot number;
(-d-) expiration date;
(-e-) date of loading;
(-f-) name, initials, or electronic signature of the person loading the automated drug dispensing system; and
(-g-) signature or electronic signature of the responsible pharmacist.
(IV) The automated drug dispensing system shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in subclause (III) of this clause.
(6) Medication orders.
(A) Drugs may be administered to patients in ASCs only on the order of a practitioner. No change in the order for drugs may be made without the approval of a practitioner.
(B) Drugs may be distributed only pursuant to the original or a direct copy of the practitioner's medication order.
(C) Pharmacy technicians and pharmacy technician trainees may not receive oral medication orders.
(D) ASC 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.
(E) In ASCs 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 sufficient quantities for immediate therapeutic needs of a patient may be removed from the ASC 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 devices. The record shall contain the following information:
(I) name of the patient;
(II) name of device or drug, strength, and dosage form;
(III) dose prescribed;
(IV) quantity taken;
(V) time and date; and
(VI) signature or electronic signature of person making withdrawal. (iv) The original or direct copy of the medication order may substitute for such record, provided the medication order meets all the requirements of clause (iii) of this subparagraph. (v) The pharmacist shall verify the withdrawal as soon as practical, but in no event more than 72 hours from the time of such withdrawal.
(F) In ASCs with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the ASC 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 ASC 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 devices; the record shall meet the same requirements as specified in subparagraph (E)(iii) of this paragraph. (iv) The pharmacist shall verify each distribution after a reasonable interval, but in no event may such interval exceed seven days.
(7) Floor stock. In facilities using a floor stock method of drug distribution, the following is applicable for removing drugs or devices in the absence of a pharmacist.
(A) Prescription drugs and devices may be removed from the pharmacy only in the original manufacturer's container 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 or electronic signature of person making the withdrawal.
(D) A pharmacist shall verify the withdrawal according to the following schedule. (i) In facilities with a full-time pharmacist, the withdrawal shall be verified as soon as practical, but in no event more than 72 hours from the time of such withdrawal. (ii) In facilities with a part-time or consultant pharmacist, the withdrawal shall be verified after a reasonable interval, but in no event may such interval exceed seven days.
(8) Policies and procedures. Written policies and procedures for a drug distribution system, appropriate for the ambulatory surgical center, shall be developed and implemented by the pharmacist-in-charge with the advice of the appropriate committee. The written policies and procedures for the drug distribution system shall include, but not be limited to, procedures regarding the following:
(A) controlled substances;
(B) investigational drugs;
(C) prepackaging and manufacturing;
(D) medication errors;
(E) orders of physician or other practitioner;
(F) floor stocks;
(G) adverse drug reactions;
(H) drugs brought into the facility by the patient;
(I) self-administration;
(J) emergency drug tray;
(K) formulary, if applicable;
(L) drug storage areas;
(M) drug samples;
(N) drug product defect reports;
(O) drug recalls;
(P) outdated drugs;
(Q) preparation and distribution of IV admixtures;
(R) procedures for supplying drugs for postoperative use, if applicable;
(S) use of automated drug dispensing systems; and
(T) use of data processing systems.
(9) Drugs supplied for postoperative use. Drugs supplied to patients for postoperative use shall be supplied according to the following procedures.
(A) Drugs may only be supplied to patients who have been admitted to the ambulatory surgical center.
(B) Drugs may only be supplied in accordance with the system of control and accountability established for drugs supplied from the ambulatory surgical center; such system shall be developed and supervised by the pharmacist-in-charge or staff pharmacist designated by the pharmacist-in-charge.
(C) Only drugs listed on the approved postoperative drug list may be supplied; such list shall be developed by the pharmacist-in-charge and the medical staff and shall consist of drugs of the nature and type to meet the immediate postoperative needs of the ambulatory surgical center patient.
(D) Drugs 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 pharmacy, provided, however that topicals and ophthalmics in original manufacturer's containers may be supplied in a quantity exceeding a 72-hour supply.
(E) At the time of delivery of the drug, the practitioner shall complete the label, such that the prescription container bears a label with at least the following information: (i) date supplied; (ii) name of practitioner; (iii) name of patient; (iv) directions for use; (v) brand name and strength of the drug; or if no brand name, then the generic name of the drug dispensed, strength, and the name of the manufacturer or distributor of the drug; and (vi) unique identification number.
(F) After the drug has been labeled by the practitioner, the practitioner or a licensed nurse under the supervision of the practitioner shall give the appropriately labeled, prepackaged medication to the patient.
(G) A perpetual record of drugs which are supplied from the ASC shall be maintained which includes: (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 drug; or if no brand name, then the generic name of the drug dispensed, strength, and the name of the manufacturer or distributor of the drug; and (vii) unique identification number.
(H) The pharmacist-in-charge, or a pharmacist designated by the pharmacist-in-charge, shall review the records at least once every seven days.
(e) Records.
(1) Maintenance of records.
(A) Every inventory or other record required to be kept under the provisions of this section (relating to Institutional Pharmacy (Class C)) shall be: (i) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative, and other authorized local, state, or federal law enforcement agencies; and (ii) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this subsection, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
(B) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
(C) Records of controlled substances listed in Schedules III - V shall be maintained separately or readily retrievable from all other records of the pharmacy. For purposes of this subsection, readily retrievable means that the controlled substances shall be asterisked, red-lined, or in some other manner readily identifiable apart from all other items appearing on the record.
(D) Records, except when specifically required to be maintained in original or hard-copy form, may be maintained in an alternative data retention system, such as a data processing or direct imaging system, e.g., microfilm or microfiche, provided: (i) the records in the alternative data retention system contain all of the information required on the manual record; and (ii) the alternative data retention system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
(2) Outpatient records.
(A) Only a registered pharmacist may receive, certify, and receive prescription drug orders.
(B) Outpatient records shall be maintained as provided in § 291.34 and § 291.35 of this title contained in Community Pharmacy (Class A).
(C) Outpatient prescriptions, including, but not limited to, discharge prescriptions, that are written by the practitioner, must be written on a form which meets the requirements of the Act, § 562.006. Medication order forms or copies thereof do not meet the requirements for outpatient forms.
(D) Controlled substances listed in Schedule II must be written on an electronic prescription form in accordance with the Texas Controlled Substances Act, § 481.075, and rules promulgated pursuant to the Texas Controlled Substances Act, unless exempted by the Texas Controlled Substances Rules, 37 TAC § 13.74. Outpatient prescriptions for Schedule II controlled substances that are exempted from the official prescription requirement must be manually signed by the practitioner.
(3) Patient records.
(A) Each original medication order or set of orders issued together shall bear the following information: (i) patient name; (ii) drug name, strength, and dosage form; (iii) directions for use; (iv) date; and (v) signature or electronic signature of the practitioner or that of his or her authorized agent, defined as a licensed nurse employee or consultant/full or part-time pharmacist of the ASC.
(B) Original medication orders shall be maintained with the medication administration record in the medical records of the patient.
(C) Controlled substances records shall be maintained as follows. (i) All records for controlled substances shall be maintained in a readily retrievable manner. (ii) Controlled substances records shall be maintained in a manner to establish receipt and distribution of all controlled substances.
(D) Records of controlled substances listed in Schedule II shall be maintained as follows. (i) Records of controlled substances listed in Schedule II shall be maintained separately from records of controlled substances in Schedules III, IV, and V, and all other records. (ii) An ASC pharmacy shall maintain a perpetual inventory of any controlled substance listed in Schedule II. (iii) Distribution records for Schedule II - V controlled substances floor stock shall include the following information:
(I) patient's name;
(II) practitioner who ordered drug;
(III) name of drug, dosage form, and strength;
(IV) time and date of administration to patient and quantity administered;
(V) signature or electronic signature of individual administering controlled substance;
(VI) returns to the pharmacy; and
(VII) waste (waste is required to be witnessed and cosigned, manually or electronically, by another individual).
(E) Floor stock records shall be maintained as follows. (i) Distribution records for Schedules III - V controlled substances floor stock shall include the following information:
(I) patient's name;
(II) practitioner who ordered controlled substance;
(III) name of controlled substance, dosage form, and strength;
(IV) time and date of administration to patient;
(V) quantity administered;
(VI) signature or electronic signature of individual administering drug;
(VII) returns to the pharmacy; and
(VIII) waste (waste is required to be witnessed and cosigned, manually or electronically, by another individual). (ii) The record required by clause (i) of this subparagraph shall be maintained separately from patient records. (iii) A pharmacist shall review distribution records with medication orders on a periodic basis to verify proper usage of drugs, not to exceed 30 days between such reviews.
(F) General requirements for records maintained in a data processing system are as follows. (i) If an ASC pharmacy's data processing system is not in compliance with the board's requirements, the pharmacy must maintain a manual recordkeeping system. (ii) Requirements for backup systems. The facility shall maintain a backup copy of information stored in the data processing system using disk, tape, or other electronic backup system and update this backup copy on a regular basis to assure that data is not lost due to system failure. (iii) Change or discontinuance of a data processing system.
(I) Records of distribution and return for all controlled substances, nalbuphine (Nubain), and carisoprodol (Soma). A pharmacy that changes or discontinues use of a data processing system must:
(-a-) transfer the records to the new data processing system; or
(-b-) purge the records to a printout which contains the same information as required on the audit trail printout as specified in subparagraph (G)(ii) of this paragraph. The information on this printout shall be sorted and printed by drug name and list all distributions/returns chronologically.
(II) Other records. A pharmacy that changes or discontinues use of a data processing system must:
(-a-) transfer the records to the new data processing system; or
(-b-) purge the records to a printout which contains all of the information required on the original document.
(III) Maintenance of purged records. Information purged from a data processing system must be maintained by the pharmacy for two years from the date of initial entry into the data processing system. (iv) Loss of data. The pharmacist-in-charge shall report to the board in writing any significant loss of information from the data processing system within 10 days of discovery of the loss.
(G) Data processing system maintenance of records for the distribution and return of all controlled substances, nalbuphine (Nubain), or carisoprodol (Soma) to the pharmacy. (i) Each time a controlled substance, nalbuphine (Nubain), or carisoprodol (Soma) is distributed from or returned to the pharmacy, a record of such distribution or return shall be entered into the data processing system. (ii) The data processing system shall have the capacity to produce a hard-copy printout of an audit trail of drug distribution and return for any strength and dosage form of a drug (by either brand or generic name or both) during a specified time period. This printout shall contain the following information:
(I) patient's name and room number or patient's facility identification number;
(II) prescribing or attending practitioner's name;
(III) name, strength, and dosage form of the drug product actually distributed;
(IV) total quantity distributed from and returned to the pharmacy;
(V) if not immediately retrievable via electronic image, the following shall also be included on the printout:
(-a-) prescribing or attending practitioner's address; and
(-b-) practitioner's DEA registration number, if the medication order is for a controlled substance. (iii) An audit trail printout for each strength and dosage form of these drugs distributed during the preceding month shall be produced at least monthly and shall be maintained in a separate file at the facility. The information on this printout shall be sorted by drug name and list all distributions/returns for that drug chronologically. (iv) The pharmacy may elect not to produce the monthly audit trail printout if the data processing system has a workable (electronic) data retention system which can produce an audit trail of drug distribution and returns for the preceding two years. The audit trail required in this clause shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy, or other authorized local, state, or federal law enforcement or regulatory agencies.
(H) Failure to maintain records. Failure to provide records set out in this subsection, either on site or within 72 hours for whatever reason, constitutes prima facie evidence of failure to keep and maintain records.
(I) Data processing system downtime. In the event that an ASC pharmacy which uses a data processing system experiences system downtime, the pharmacy must have an auxiliary procedure which will ensure that all data is retained for on-line data entry as soon as the system is available for use again.
(4) Distribution of controlled substances to another registrant. A pharmacy may distribute controlled substances to a practitioner, another pharmacy, or other registrant, without being registered to distribute, under the following conditions.
(A) The registrant to whom the controlled substance is to be distributed is registered under the Controlled Substances Act to dispense that controlled substance.
(B) The total number of dosage units of controlled substances distributed by a pharmacy may not exceed 5.0% of all controlled substances dispensed by the pharmacy during the 12-month period in which the pharmacy is registered; if at any time it does exceed 5.0%, the pharmacy is required to obtain an additional registration to distribute controlled substances.
(C) If the distribution is for a Schedule III, IV, or V controlled substance, a record shall be maintained which indicates: (i) the actual date of distribution; (ii) the name, strength, and quantity of controlled substances distributed; (iii) the name, address, and DEA registration number of the distributing pharmacy; and (iv) the name, address, and DEA registration number of the pharmacy, practitioner, or other registrant to whom the controlled substances are distributed.
(D) If the distribution is for a Schedule I or II controlled substance, the following is applicable. (i) The pharmacy, practitioner, or other registrant who is receiving the controlled substances shall issue Copy 1 and Copy 2 of a DEA order form (DEA 222C) to the distributing pharmacy. (ii) The distributing pharmacy shall:
(I) complete the area on the DEA order form (DEA 222C) titled "To Be Filled in by Supplier";
(II) maintain Copy 1 of the DEA order form (DEA 222C) at the pharmacy for two years; and
(III) forward Copy 2 of the DEA order form (DEA 222C) to the divisional office of the Drug Enforcement Administration.
(5) Other records. Other records to be maintained by the pharmacy include:
(A) a permanent log of the initials or identification codes which will identify each pharmacist by name. The initials or identification code shall be unique to ensure that each pharmacist can be identified, i.e., identical initials or identification codes cannot be used;
(B) Copy 3 of DEA order form (DEA 222C), which has been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents;
(C) a hard copy of the power of attorney to sign DEA 222C order forms (if applicable);
(D) suppliers' invoices of dangerous drugs and controlled substances; a pharmacist shall verify that the controlled drugs listed on the invoices were actually received by clearly recording his/her initials and the actual date of receipt of the controlled substances;
(E) supplier's credit memos for controlled substances and dangerous drugs;
(F) a hard copy of inventories required by § 291.17 of this title (relating to Inventory Requirements) except that a perpetual inventory of controlled substances listed in Schedule II may be kept in a data processing system if the data processing system is capable of producing a hard copy of the perpetual inventory on-site;
(G) hard-copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;
(H) a hard-copy Schedule V nonprescription register book;
(I) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and
(J) a hard copy of any notification required by the Texas Pharmacy Act or these rules, including, but not limited to, the following: (i) reports of theft or significant loss of controlled substances to DEA, DPS, and the board; (ii) notification of a change in pharmacist-in-charge of a pharmacy; and (iii) reports of a fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in the diagnosis or treatment of injury, illness, and disease.
(6) Permission to maintain central records. Any pharmacy that uses a centralized recordkeeping system for invoices and financial data shall comply with the following procedures.
(A) Controlled substance records. Invoices and financial data for controlled substances may be maintained at a central location provided the following conditions are met. (i) Prior to the initiation of central recordkeeping, the pharmacy submits written notification by registered or certified mail to the divisional director of the Drug Enforcement Administration as required by the Code of Federal Regulations, Title 21, § 1304(a), and submits a copy of this written notification to the Texas State Board of Pharmacy. Unless the registrant is informed by the divisional director of the Drug Enforcement Administration that permission to keep central records is denied, the pharmacy may maintain central records commencing 14 days after receipt of notification by the divisional director. (ii) The pharmacy maintains a copy of the notification required in this subparagraph. (iii) The records to be maintained at the central record location shall not include executed DEA order forms, prescription drug orders, or controlled substance inventories, which shall be maintained at the pharmacy.
(B) Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.
(C) Access to records. If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the pharmacy shall provide access to such equipment with the records.
(D) Delivery of records. The pharmacy agrees to deliver all or any part of such records to the pharmacy location within two business days of written request of a board agent or any other authorized official.
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