Which of the following statements is true concerning beyond use dating of compounded non sterile products?

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• (a) Purpose. Pharmacies compounding non-sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. The purpose of this section is to provide standards for the: (1) compounding of non-sterile preparations pursuant to a prescription or medication order for a patient from a practitioner in Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacies; (2) compounding, dispensing, and delivery of a reasonable quantity of a compounded non-sterile preparation in a Class A (Community), Class C (Institutional), and Class E (Non-resident) pharmacy to a practitioner's office for office use by the practitioner; (3) compounding and distribution of compounded non-sterile preparations by a Class A (Community) pharmacy for a Class C (Institutional) pharmacy; and (4) compounding of non-sterile preparations by a Class C (Institutional) pharmacy and the distribution of the compounded preparations to other Class C (Institutional) pharmacies under common ownership. (b) Definitions. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. (1) Beyond-use date--The date or time after which the compounded non-sterile preparation shall not be stored or transported or begin to be administered to a patient. The beyond-use date is determined from the date or time when the preparation was compounded. (2) Cleaning--The process of removing soil (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products. (3) Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation. (4) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device: (A) as the result of a practitioner's prescription drug or medication order, based on the practitioner-patient-pharmacist relationship in the course of professional practice; (B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice; (C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or (D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under §562.154 or Chapter 563 of the Occupations Code. (5) Hot water--The temperature of water from the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees C). (6) Reasonable quantity--An amount of a compounded drug that: (A) does not exceed the amount a practitioner anticipates may be used in the practitioner's office or facility before the beyond use date of the drug; (B) is reasonable considering the intended use of the compounded drug and the nature of the practitioner's practice; and (C) for any practitioner and all practitioners as a whole, is not greater than an amount the pharmacy is capable of compounding in compliance with pharmaceutical standards for identity, strength, quality, and purity of the compounded drug that are consistent with United States Pharmacopoeia guidelines and accreditation practices. (7) Sanitizing--A process for reducing on inanimate surfaces the number of all forms of microbial life including fungi, viruses, and bacteria using an appropriate agent. (8) SOPs--Standard operating procedures. (9) USP/NF--The current edition of the United States Pharmacopeia/National Formulary. (c) Personnel. (1) Pharmacist-in-charge. In addition to the responsibilities for the specific class of pharmacy, the pharmacist-in-charge shall have the responsibility for, at a minimum, the following concerning non-sterile compounding: (A) determining that all personnel involved in non-sterile compounding possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; (B) determining that all personnel involved in non-sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel; (C) assuring that the equipment used in compounding is properly maintained; (D) maintaining an appropriate environment in areas where non-sterile compounding occurs; and (E) assuring that effective quality control procedures are developed and followed. (2) Pharmacists. Special requirements for non-sterile compounding. (A) All pharmacists engaged in compounding shall: (i) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken or supervised; and (ii) obtain continuing education appropriate for the type of compounding done by the pharmacist. (B) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling, and any other materials involved in the compounding process. (C) A pharmacist shall review all compounding records for accuracy and conduct in-process and final checks to ensure that errors have not occurred in the compounding process. (D) A pharmacist is responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process. (3) Pharmacy technicians and pharmacy technician trainees. All pharmacy technicians and pharmacy technician trainees engaged in non-sterile compounding shall: (A) possess the education, training, and proficiency necessary to properly and safely perform compounding duties undertaken; (B) obtain continuing education appropriate for the type of compounding done by the pharmacy technician or pharmacy technician trainee; and (C) perform compounding duties under the direct supervision of and responsible to a pharmacist. (4) Training. (A) All training activities shall be documented and covered by appropriate SOPs as outlined in subsection (d)(8)(A) of this section. (B) All personnel involved in non-sterile compounding shall be well trained and must participate in continuing relevant training programs. (C) Training shall include instruction, experience, and demonstrated proficiency in the following areas: (i) hand hygiene; (ii) garbing; (iii) cleaning and sanitizing; (iv) handling and transporting components and compounded non-sterile preparations; (v) measuring and mixing; (vi) proper use of equipment and devices selected to compound non-sterile preparations; and (vii) documentation of the compounding process (e.g., Master Formulation Records and Compounding Records). (d) Operational Standards. (1) General requirements. (A) Non-sterile drug preparations may be compounded in licensed pharmacies: (i) upon presentation of a practitioner's prescription drug or medication order based on a valid pharmacist/patient/prescriber relationship; (ii) in anticipation of future prescription drug or medication orders based on routine, regularly observed prescribing patterns; or (iii) in reasonable quantities for office use by a practitioner and for use by a veterinarian. (B) Non-sterile compounding in anticipation of future prescription drug or medication orders must be based upon a history of receiving valid prescriptions issued within an established pharmacist/patient/prescriber relationship, provided that in the pharmacist's professional judgment the quantity prepared is stable for the anticipated shelf time. (i) The pharmacist's professional judgment shall be based on the criteria used to determine a beyond-use date outlined in paragraph (5)(C) of this subsection. (ii) Documentation of the criteria used to determine the stability for the anticipated shelf time must be maintained and be available for inspection. (iii) Any preparation compounded in anticipation of future prescription drug or medication orders shall be labeled. Such label shall contain: (I) name and strength of the compounded preparation or list of the active ingredients and strengths; (II) facility's lot number; (III) beyond-use date as determined by the pharmacist using appropriate documented criteria as outlined in paragraph (5)(C) of this subsection; and (IV) quantity or amount in the container. (C) Commercially available products may be compounded for dispensing to individual patients provided the following conditions are met: (i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient's needs; (ii) the pharmacy maintains documentation that the product is not reasonably available due to a drug shortage or unavailability from the manufacturer; and (iii) the prescribing practitioner has requested that the drug be compounded as described in subparagraph (D) of this paragraph. (D) A pharmacy may not compound preparations that are essentially copies of commercially available products (e.g., the preparation is dispensed in a strength that is only slightly different from a commercially available product) unless the prescribing practitioner specifically orders the strength or dosage form and specifies why the patient needs the particular strength or dosage form of the preparation. The prescribing practitioner shall provide documentation of a patient specific medical need and the preparation produces a clinically significant therapeutic response (e.g. the physician requests an alternate product due to hypersensitivity to excipients or preservative in the FDA-approved product, or the physician requests an effective alternate dosage form) or if the drug product is not commercially available. The unavailability of such drug product must be documented prior to compounding. The methodology for documenting unavailability includes maintaining a copy of the wholesaler's notification showing back-ordered, discontinued, or out-of-stock items. This documentation must be available in hard-copy or electronic format for inspection by the board. (E) A pharmacy may enter into an agreement to compound and dispense prescription/medication orders for another pharmacy provided the pharmacy complies with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing). (F) Compounding pharmacies/pharmacists may advertise and promote the fact that they provide non-sterile prescription compounding services, which may include specific drug products and classes of drugs. (G) A pharmacy may not compound veterinary preparations for use in food producing animals except in accordance with federal guidelines. (H) A pharmacist may add flavoring to a prescription at the request of a patient, the patient's agent, or the prescriber. The pharmacist shall label the flavored prescription with a beyond-use-date that shall be no longer than fourteen days if stored in a refrigerator unless otherwise documented. Documentation of beyond-use-dates longer than fourteen days shall be maintained by the pharmacy electronically or manually and made available to agents of the board on request. A pharmacist may not add flavoring to an over-the-counter product at the request of a patient or patient's agent unless the pharmacist obtains a prescription for the over-the-counter product from the patient's practitioner. (2) Library. In addition to the library requirements of the pharmacy's specific license classification, a pharmacy shall maintain a current copy, in hard-copy or electronic format, of Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations. (3) Environment. (A) Pharmacies engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of non-sterile preparations, including the placement of equipment and materials. (B) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation. (C) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition. Supplies necessary for adequate washing shall be accessible in the immediate area of the sink and include: (i) soap or detergent; and (ii) air-driers or single-use towels. (D) If drug products which require special precautions to prevent contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its use for the preparation of other drug products, must be used in order to prevent cross-contamination. (E) Cleaning and sanitizing of surfaces in the non-sterile compounding area(s) shall occur on a regular basis as defined in appropriate SOPs as outlined in paragraph (8)(A) of this subsection. (4) Equipment and Supplies. The pharmacy shall: (A) if the pharmacy engages in compounding non-sterile preparations that require weighing a component of the preparation, have a Class A prescription balance, or analytical balance and weights which shall be calibrated and have the accuracy of the balance verified by the pharmacy at least every 12 months as specified in the pharmacy's SOPs. The pharmacy shall document the calibration and verification; and (B) have equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be: (i) of appropriate design and capacity, and be operated within designed operational limits; (ii) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the desired result; (iii) cleaned and sanitized immediately prior to and after each use; and (iv) routinely inspected, calibrated (if necessary), or checked to ensure proper performance. (5) Labeling. In addition to the labeling requirements of the pharmacy's specific license classification, the label dispensed or distributed pursuant to a prescription drug or medication order shall contain the following. (A) The generic name(s) or the official name(s) of the principal active ingredient(s) of the compounded preparation. (B) A statement that the preparation has been compounded by the pharmacy. (An auxiliary label may be used on the container to meet this requirement). (C) A beyond-use date after which the compounded preparation should not be used. The beyond-use date shall be determined as outlined in Chapter 795 of the USP/NF concerning Pharmacy Compounding Non-Sterile Preparations including the following: (i) The pharmacist shall consider: (I) physical and chemical properties of active ingredients; (II) use of preservatives and/or stabilizing agents; (III) dosage form; (IV) storage containers and conditions; and (V) scientific, laboratory, or reference data from a peer reviewed source and retained in the pharmacy. The reference data should follow the same preparation instructions for combining raw materials and packaged in a container with similar properties. (ii) In the absence of stability information applicable for a specific drug or preparation, the following maximum beyond-use dates are to be used when the compounded preparation is packaged in tight, light-resistant containers and stored at controlled room temperatures. (I) Nonaqueous liquids and solid formulations (Where the manufactured drug product is the source of active ingredient): 25% of the time remaining until the product's expiration date or 6 months, whichever is earlier. (II) Water-containing formulations (Prepared from ingredients in solid form): Not later than 14 days when refrigerated between 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit). (III) All other formulations: Intended duration of therapy or 30 days, whichever is earlier. (iii) Beyond-use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation. (6) Written drug information. Written information about the compounded preparation or its major active ingredient(s) shall be given to the patient at the time of dispensing. A statement which indicates that the preparation was compounded by the pharmacy must be included in this written information. If there is no written information available, the patient should be advised that the drug has been compounded and how to contact a pharmacist, and if appropriate the prescriber, concerning the drug. (7) Drugs, components, and materials used in non-sterile compounding. (A) Drugs used in non-sterile compounding shall be USP/NF grade substances manufactured in an FDA-registered facility. (B) If USP/NF grade substances are not available, or when food, cosmetics, or other substances are or must be used, the substance shall be of a chemical grade in one of the following categories: (i) Chemically Pure (CP); (ii) Analytical Reagent (AR); or (iii) American Chemical Society (ACS); or (iv) Food Chemical Codex; or (C) If a drug, component, or material is not purchased from an FDA-registered facility, the pharmacist shall establish purity and stability by obtaining a Certificate of Analysis from the supplier and the pharmacist shall compare the monograph of drugs in a similar class to the Certificate of Analysis. (D) A manufactured drug product may be a source of active ingredient. Only manufactured drugs from containers labeled with a batch control number and a future expiration date are acceptable as a potential source of active ingredients. When compounding with manufactured drug products, the pharmacist must consider all ingredients present in the drug product relative to the intended use of the compounded preparation. (E) All components shall be stored in properly labeled containers in a clean, dry area, under proper temperatures. (F) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the compounded drug product beyond the desired result. (G) Components, drug product containers, and closures shall be rotated so that the oldest stock is used first. (H) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the compounded drug product. (I) A pharmacy may not compound a preparation that contains ingredients appearing on a federal Food and Drug Administration list of drug products withdrawn or removed from the market for safety reasons. (8) Compounding process. (A) All significant procedures performed in the compounding area shall be covered by written SOPs designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process. At a minimum, SOPs shall be developed for: (i) the facility; (ii) equipment; (iii) personnel; (iv) preparation evaluation; (v) quality assurance; (vi) preparation recall; (vii) packaging; and (viii) storage of compounded preparations. (B) Any compounded preparation with an official monograph in the USP/NF shall be compounded, labeled, and packaged in conformity with the USP/NF monograph for the drug. (C) Any person with an apparent illness or open lesion that may adversely affect the safety or quality of a drug product being compounded shall be excluded from direct contact with components, drug product containers, closures, any materials involved in the compounding process, and drug products until the condition is corrected. (D) Personnel engaged in the compounding of drug preparations shall perform proper hand hygiene prior to engaging in compounding activities. Proper hand hygiene shall be defined in appropriate SOPs as outlined in subparagraph (A) of this paragraph and appropriate for prevention of preparation and facility contamination. (E) Garbing requirements and the frequency of changing garb shall be determined by the pharmacy and documented in appropriate SOPs as outlined in subparagraph (A) of this paragraph. The garbing requirements under the pharmacy's SOPs must be appropriate for the type of compounding performed. (F) At each step of the compounding process, the pharmacist shall ensure that components used in compounding are accurately weighed, measured, or subdivided as appropriate to conform to the formula being prepared. (9) Quality Assurance. (A) Initial formula validation. Prior to routine compounding of a non-sterile preparation, a pharmacy shall conduct an evaluation that shows that the pharmacy is capable of compounding a product that contains the stated amount of active ingredient(s). (B) Finished preparation checks. The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded non-sterile preparations shall be inspected for accuracy of correct identities and amounts of ingredients, packaging, labeling, and expected physical appearance before the non-sterile preparations are dispensed. (10) Quality Control. (A) The pharmacy shall follow established quality control procedures to monitor the quality of compounded drug preparations for uniformity and consistency such as capsule weight variations, adequacy of mixing, clarity, or pH of solutions. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 795, concerning Pharmacy Compounding Non-Sterile Preparations, Chapter 1075, concerning Good Compounding Practices, and Chapter 1160, concerning Pharmaceutical Calculations in Prescription Compounding contained in the current USP/NF. Such procedures shall be documented and be available for inspection. (B) Compounding procedures that are routinely performed, including batch compounding, shall be completed and verified according to written procedures. The act of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing, and compounding techniques were appropriate and accurately performed. (C) Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit weight or volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation. (e) Records. (1) Maintenance of records. Every record required by this section shall be: (A) kept by the pharmacy and be available, for at least two years, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and (B) 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 an electronic format. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act. (2) Compounding records. (A) Compounding pursuant to patient specific prescription drug or medication orders. Compounding records for all compounded preparations shall be maintained by the pharmacy electronically or manually as part of the prescription drug or medication order, formula record, formula book, or compounding log and shall include: (i) the date of preparation; (ii) a complete formula, including methodology and necessary equipment which includes the brand name(s) of the raw materials, or if no brand name, the generic name(s) and name(s) of the manufacturer(s) of the raw materials and the quantities of each; (iii) signature or initials of the pharmacist or pharmacy technician or pharmacy technician trainee performing the compounding; (iv) signature or initials of the pharmacist responsible for supervising pharmacy technicians or pharmacy technician trainees and conducting in-process and final checks of compounded preparations if pharmacy technicians or pharmacy technician trainees perform the compounding function; (v) the quantity in units of finished preparations or amount of raw materials; (vi) the container used and the number of units prepared; (vii) a reference to the location of the following documentation which may be maintained with other records, such as quality control records: (I) the criteria used to determine the beyond-use date; and (II) documentation of performance of quality control procedures. Documentation of the performance of quality control procedures is not required if the compounding process is done pursuant to a patient specific order and involves the mixing of two or more commercially available oral liquids or commercially available preparations when the final product is intended for external use. (B) Compounding records when batch compounding or compounding in anticipation of future prescription drug or medication orders. (i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for preparations prepared in batch. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum: (I) the formula; (II) the components; (III) the compounding directions; (IV) a sample label; (V) evaluation and testing requirements; (VI) specific equipment used during preparation; (VII) storage requirements; (VIII) a reference to the location of the following documentation which may be maintained with other records, such as quality control records: (-a-) the criteria used to determine the beyond-use date; and (-b-) documentation of performance of quality control procedures. (ii) Preparation work sheet. The preparation work sheet for each batch of preparations shall document the following: (I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes; (II) lot number and expiration date of each component; (III) component manufacturer/distributor or suitable identifying number; (IV) container specifications; (V) unique lot or control number assigned to batch; (VI) beyond use date of batch-prepared preparations; (VII) date of preparation; (VIII) name, initials, or electronic signature of the person(s) involved in the preparation; (IX) name, initials, or electronic signature of the responsible pharmacist; (X) finished preparation evaluation and testing specifications, if applicable; and (XI) comparison of actual yield to anticipated or theoretical yield, when appropriate. (f) Office Use Compounding and Distribution of Compounded Preparations to Class C Pharmacies or Veterinarians in Accordance With §563.054 of the Act. (1) General. (A) A pharmacy may dispense and deliver a reasonable quantity of a compounded preparation to a practitioner for office use by the practitioner in accordance with this subsection. (B) A Class A pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations to a Class C pharmacy. (C) A Class C pharmacy is not required to register or be licensed under Chapter 431, Health and Safety Code, to distribute non-sterile compounded preparations that the Class C pharmacy has compounded for other Class C pharmacies under common ownership. (D) To dispense and deliver a compounded preparation under this subsection, a pharmacy must: (i) verify the source of the raw materials to be used in a compounded drug; (ii) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191); (iii) enter into a written agreement with a practitioner for the practitioner's office use of a compounded preparation; (iv) comply with all applicable competency and accrediting standards as determined by the board; and (v) comply with the provisions of this subsection. (2) Written Agreement. A pharmacy that provides non-sterile compounded preparations to practitioners for office use or to another pharmacy shall enter into a written agreement with the practitioner or pharmacy. The written agreement shall: (A) address acceptable standards of practice for a compounding pharmacy and a practitioner and receiving pharmacy that enter into the agreement including a statement that the compounded preparations may only be administered to the patient and may not be dispensed to the patient or sold to any other person or entity except as authorized by §563.054 of the Act; (B) state that the practitioner or receiving pharmacy should include on a separate log or in a patient's chart, medication order, or medication administration record the lot number and beyond-use date of a compounded preparation administered to a patient; and (C) describe the scope of services to be performed by the pharmacy and practitioner or receiving pharmacy, including a statement of the process for: (i) a patient to report an adverse reaction or submit a complaint; and (ii) the pharmacy to recall batches of compounded preparations. (3) Recordkeeping. (A) Maintenance of Records. (i) Records of orders and distribution of non-sterile compounded preparations to a practitioner for office use or to a Class C pharmacy for administration to a patient shall: (I) be kept by the pharmacy and be available, for at least two years from the date of the record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; (II) maintained separately from the records of products dispensed pursuant to a prescription or medication order; and (III) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy or its representative. If the pharmacy maintains the records in an electronic format, the requested records must be provided in an electronic format. Failure to provide the 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. (ii) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided the data processing 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. (B) Orders. The pharmacy shall maintain a record of all non-sterile compounded preparations ordered by a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information: (i) date of the order; (ii) name, address, and phone number of the practitioner who ordered the preparation and, if applicable, the name, address, and phone number of the Class C pharmacy ordering the preparation; and (iii) name, strength, and quantity of the preparation ordered. (C) Distributions. The pharmacy shall maintain a record of all non-sterile compounded preparations distributed pursuant to an order to a practitioner for office use or by a Class C pharmacy for administration to a patient. The record shall include the following information: (i) date the preparation was compounded; (ii) date the preparation was distributed; (iii) name, strength, and quantity in each container of the preparation; (iv) pharmacy's lot number; (v) quantity of containers shipped; and (vi) name, address, and phone number of the practitioner or Class C pharmacy to whom the preparation is distributed. (D) Audit Trail. (i) The pharmacy shall store the order and distribution records of preparations for all non-sterile compounded preparations ordered by and or distributed to a practitioner for office use or by a Class C pharmacy for administration to a patient in such a manner as to be able to provide an audit trail for all orders and distributions of any of the following during a specified time period. (I) any strength and dosage form of a preparation (by either brand or generic name or both); (II) any ingredient; (III) any lot number; (IV) any practitioner; (V) any facility; and (VI) any pharmacy, if applicable. (ii) The audit trail shall contain the following information: (I) date of order and date of the distribution; (II) practitioner's name, address, and name of the Class C pharmacy, if applicable; (III) name, strength, and quantity of the preparation in each container of the preparation; (IV) name and quantity of each active ingredient; (V) quantity of containers distributed; and (VI) pharmacy's lot number; (4) Labeling. The pharmacy shall affix a label to the preparation containing the following information: (A) name, address, and phone number of the compounding pharmacy; (B) the statement: "For Institutional or Office Use Only--Not for Resale"; or if the preparation is distributed to a veterinarian the statement: "Compounded Preparation"; (C) name and strength of the preparation or list of the active ingredients and strengths; (D) pharmacy's lot number; (E) beyond-use date as determined by the pharmacist using appropriate documented criteria; (F) quantity or amount in the container; (G) appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate; and (H) device-specific instructions, where appropriate. (g) Recall Procedures. (1) The pharmacy shall have written procedures for the recall of any compounded non-sterile preparations provided to a patient, to a practitioner for office use, or a pharmacy for administration. Written procedures shall include, but not be limited to, the requirements as specified in paragraph (3) of this subsection. (2) The pharmacy shall immediately initiate a recall of any non-sterile preparation compounded by the pharmacy upon identification of a potential or confirmed harm to a patient. (3) In the event of a recall, the pharmacist-in-charge shall ensure that: (A) each practitioner, facility, and/or pharmacy to which the preparation was distributed is notified, in writing, of the recall; (B) each patient to whom the preparation was dispensed is notified, in writing, of the recall; (C) if the preparation is prepared as a batch, the board is notified of the recall, in writing; (D) if the preparation is distributed for office use, the Texas Department of State Health Services, Drugs and Medical Devices Group, is notified of the recall, in writing; (E) the preparation is quarantined; and (F) the pharmacy keeps a written record of the recall including all actions taken to notify all parties and steps taken to ensure corrective measures. (4) If a pharmacy fails to initiate a recall, the board may require a pharmacy to initiate a recall if there is potential for or confirmed harm to a patient.

Source Note: The provisions of this §291.131 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective March 6, 2008, 33 TexReg 1801; amended to be effective September 9, 2012, 37 TexReg 6917; amended to be effective January 4, 2018, 42 TexReg 7700; amended to be effective August 24, 2022, 47 TexReg 4977

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