Header:
TEXAS ADMINISTRATIVE CODE
TITLE 22. EXAMINING BOARDS
PART 15. TEXAS STATE BOARD OF PHARMACY
CHAPTER 291. PHARMACIES
SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)
Date:
08/31/2009
Document:
§ 291.34. Records
(a) Maintenance of records.
(1) Every inventory or other record required to be kept under 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 Requirements), contained in Community Pharmacy (Class A) shall be:
(A) 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 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 a mutually agreeable electronic format if specifically requested by the board or its representative. 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) Records of controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy.
(3) Records of controlled substances, other than prescription drug orders, 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.
(4) 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 system or direct imaging system provided:
(A) the records maintained in the alternative system contain all of the information required on the manual record; and
(B) 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) Prescriptions.
(1) Professional responsibility.
(A) Pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order they dispense. If the pharmacist questions the accuracy or authenticity of a prescription drug order, he/she shall verify the order with the practitioner prior to dispensing.
(B) Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist may not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship.
(C) Subparagraph (B) of this paragraph does not prohibit a pharmacist from dispensing a prescription when a valid patient-practitioner relationship is not present in an emergency situation (e.g. a practitioner taking calls for the patient's regular practitioner).
(2) Written prescription drug orders.
(A) Practitioner's signature. (i) Except as noted in clause (ii) of this subparagraph, written prescription drug orders shall be:
(I) manually signed by the practitioner; or
(II) electronically signed by the practitioner using a system which electronically replicates the practitioner's manual signature on the written prescription, provided:
(-a-) that security features of the system require the practitioner to authorize each use; and
(-b-) the prescription is printed on paper that is designed to prevent unauthorized copying of a completed prescription and to prevent the erasure or modification of information written on the prescription by the prescribing practitioner. (For example, the paper contains security provisions against copying that results in some indication on the copy that it is a copy and therefore render the prescription null and void.) (ii) Prescription drug orders for Schedule II controlled substances shall be issued on an official prescription form as required by the Texas Controlled Substances Act, § 481.075, and be manually signed by the practitioner. (iii) A practitioner may sign a prescription drug order in the same manner as he would sign a check or legal document, e.g. J.H. Smith or John H. Smith. (iv) Rubber stamped or otherwise reproduced signatures may not be used except as authorized in clause (i) of this subparagraph. (v) The prescription drug order may not be signed by a practitioner's agent but may be prepared by an agent for the signature of a practitioner. However, the prescribing practitioner is responsible in case the prescription drug order does not conform in all essential respects to the law and regulations.
(B) Prescription drug orders written by practitioners in another state. (i) Dangerous drug prescription orders. A pharmacist may dispense a prescription drug order for dangerous drugs issued by practitioners in a state other than Texas in the same manner as prescription drug orders for dangerous drugs issued by practitioners in Texas are dispensed. (ii) Controlled substance prescription drug orders.
(I) A pharmacist may dispense prescription drug order for controlled substances in Schedule II issued by a practitioner in another state provided:
(-a-) the prescription is filled in compliance with a written plan approved by the Director of the Texas Department of Public Safety in consultation with the Board, which provides the manner in which the dispensing pharmacy may fill a prescription for a Schedule II controlled substance;
(-b-) the prescription drug order is an original written prescription issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration (DEA) registration number, and who may legally prescribe Schedule II controlled substances in such other state; and
(-c-) the prescription drug order is not dispensed after the end of the seventh day after the date on which the prescription is issued.
(II) A pharmacist may dispense prescription drug orders for controlled substances in Schedule III, IV, or V issued by a physician, dentist, veterinarian, or podiatrist in another state provided:
(-a-) the prescription drug order is a written, oral, or telephonically or electronically communicated prescription, as allowed by the DEA issued by a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal DEA registration number, and who may legally prescribe Schedule III, IV, or V controlled substances in such other state;
(-b-) the prescription drug order is not dispensed or refilled more than six months from the initial date of issuance and may not be refilled more than five times; and
(-c-) if there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, a new prescription drug order is obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.
(C) Prescription drug orders written by practitioners in the United Mexican States or the Dominion of Canada. (i) Controlled substance prescription drug orders. A pharmacist may not dispense a prescription drug order for a Schedule II, III, IV, or V controlled substance issued by a practitioner in the Dominion of Canada or the United Mexican States. (ii) Dangerous drug prescription drug orders. A pharmacist may dispense a dangerous drug prescription issued by a person licensed in the Dominion of Canada or the United Mexican States as a physician, dentist, veterinarian, or podiatrist provided:
(I) the prescription drug order is an original written prescription; and
(II) if there are no refill instructions on the original written prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original written prescription drug order have been dispensed, a new written prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of dangerous drugs.
(D) Prescription drug orders carried out or signed by an advanced practice nurse, physician assistant, or pharmacist. (i) A pharmacist may dispense a prescription drug order which is:
(I) carried out or signed by an advanced practice nurse or physician assistant provided the advanced practice nurse or physician assistant is practicing in accordance with Subtitle B, Chapter 157, Occupations Code, and
(II) for a dangerous drug and signed by a pharmacist under delegated authority of a physician as specified in Subtitle B, Chapter 157, Occupations Code. (ii) Each practitioner shall designate in writing the name of each advanced practice nurse or physician assistant authorized to carry out or sign a prescription drug order pursuant to Subtitle B, Chapter 157, Occupations Code. A list of the advanced practice nurses or physician assistants designated by the practitioner must be maintained in the practitioner's usual place of business. On request by a pharmacist, a practitioner shall furnish the pharmacist with a copy of the written authorization for a specific advanced practice nurse or physician assistant.
(E) Prescription drug orders for Schedule II controlled substances. No Schedule II controlled substance may be dispensed without a written prescription drug order of a practitioner on an official prescription form as required by the Texas Controlled Substances Act, § 481.075.
(3) Verbal prescription drug orders.
(A) A verbal prescription drug order from a practitioner or a practitioner's designated agent may only be received by a pharmacist or a pharmacist-intern under the direct supervision of a pharmacist.
(B) A practitioner shall designate in writing the name of each agent authorized by the practitioner to communicate prescriptions verbally for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.
(C) A pharmacist may not dispense a verbal prescription drug order for a dangerous drug or a controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.
(4) Electronic prescription drug orders. For the purpose of this subsection, prescription drug orders shall be considered the same as verbal prescription drug orders.
(A) An electronic prescription drug order may be transmitted by a practitioner or a practitioner's designated agent: (i) directly to a pharmacy; or (ii) through the use of a data communication device provided:
(I) the confidential prescription information is not altered during transmission; and
(II) confidential patient information is not accessed or maintained by the operator of the data communication device other than for legal purposes under federal and state law.
(B) A practitioner shall designate in writing the name of each agent authorized by the practitioner to electronically transmit prescriptions for the practitioner. The practitioner shall maintain at the practitioner's usual place of business a list of the designated agents. The practitioner shall provide a pharmacist with a copy of the practitioner's written authorization for a specific agent on the pharmacist's request.
(C) A pharmacist may not dispense an electronic prescription drug order for a: (i) Schedule II controlled substance, except as authorized for faxed prescriptions in § 481.074, Health and Safety Code; or (ii) dangerous drug or controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.
(5) Original prescription drug order records.
(A) Original prescriptions may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order including clarifications to the order given to the pharmacist by the practitioner or the practitioner's agent and recorded on the prescription.
(B) Original prescriptions shall be maintained by the pharmacy in numerical order and remain legible for a period of two years from the date of filling or the date of the last refill dispensed.
(C) If an original prescription drug order is changed, such prescription order shall be invalid and of no further force and effect; if additional drugs are to be dispensed, a new prescription drug order with a new and separate number is required.
(D) Original prescriptions shall be maintained in three separate files as follows: (i) prescriptions for controlled substances listed in Schedule II; (ii) prescriptions for controlled substances listed in Schedules III - V; and (iii) prescriptions for dangerous drugs and nonprescription drugs.
(E) Original prescription records other than prescriptions for Schedule II controlled substances may be stored on microfilm, microfiche, or other system which is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable: (i) the record of refills recorded on the original prescription must also be stored in this system; (ii) the original prescription records must be maintained in numerical order and separated in three files as specified in subparagraph (D) of this paragraph; and (iii) the pharmacy must provide immediate access to equipment necessary to render the records easily readable.
(6) Prescription drug order information.
(A) All original prescriptions shall bear: (i) name of the patient, or if such drug is for an animal, the species of such animal and the name of the owner; (ii) address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records; (iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner; (iv) name and strength of the drug prescribed; (v) quantity prescribed; (vi) directions for use; (vii) intended use for the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient; and (viii) date of issuance.
(B) All original electronic prescription drug orders shall bear: (i) name of the patient, if such drug is for an animal, the species of such animal, and the name of the owner; (ii) address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records; (iii) name, and if for a controlled substance, the address and DEA registration number of the practitioner; (iv) name and strength of the drug prescribed; (v) quantity prescribed; (vi) directions for use; (vii) indications for use, unless the practitioner determines the furnishing of this information is not in the best interest of the patient; (viii) date of issuance; (ix) if a faxed prescription, a statement which indicates that the prescription has been faxed (e.g., Faxed to); (x) telephone number of the prescribing practitioner; (xi) date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription; and (xii) if transmitted by a designated agent, the full name of the designated agent.
(C) All original written prescriptions carried out or signed by an advanced practice nurse or physician assistant in accordance with Subtitle B, Chapter 157, Occupations Code, shall bear: (i) name and address of the patient; (ii) name, address, telephone number, and if the prescription is for a controlled substance, the DEA number of the supervising practitioner; (iii) name, identification number, original signature and if the prescription is for a controlled substance, the DEA number of the advanced practice nurse or physician assistant; (iv) address and telephone number of the clinic at which the prescription drug order was carried out or signed; (v) name, strength, and quantity of the drug; (vi) directions for use; (vii) indications for use, if appropriate; (viii) date of issuance; and (ix) number of refills authorized.
(D) At the time of dispensing, a pharmacist is responsible for documenting the following information on either the original hard-copy prescription or in the pharmacy's data processing system: (i) unique identification number of the prescription drug order; (ii) initials or identification code of the dispensing pharmacist; (iii) effective January 1, 2009, initials or identification code of the pharmacy technician or pharmacy technician trainee performing data entry of the prescription, if applicable; (iv) quantity dispensed, if different from the quantity prescribed; (v) date of dispensing, if different from the date of issuance; (vi) brand name or manufacturer of the drug product actually dispensed, if the drug was prescribed by generic name or if a drug product other than the one prescribed was dispensed pursuant to the provisions of the Act, Chapters 562 and 563; and (vii) effective June 1, 2010, for each new prescription the initials or identification code of the pharmacist responsible for providing counseling.
(7) Refills.
(A) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order.
(B) If there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner shall be obtained prior to dispensing any refills.
(C) Refills of prescription drug orders for dangerous drugs or nonprescription drugs. (i) Prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after one year from the date of issuance of the original prescription drug order. (ii) If one year has expired from the date of issuance of an original prescription drug order for a dangerous drug or nonprescription drug, authorization shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of the drug.
(D) Refills of prescription drug orders for Schedules III - V controlled substances. (i) Prescription drug orders for Schedules III - V controlled substances may not be refilled more than five times or after six months from the date of issuance of the original prescription drug order, whichever occurs first. (ii) If a prescription drug order for a Schedule III, IV, or V controlled substance has been refilled a total of five times or if six months have expired from the date of issuance of the original prescription drug order, whichever occurs first, a new and separate prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.
(E) If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided: (i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (ii) the quantity of prescription drug dispensed does not exceed a 72-hour supply; (iii) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; (iv) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time; (v) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; (vi) the pharmacist affixes a label to the dispensing container as specified in § 291.33(c)(7) of this title; and (vii) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;
(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph.
(F) If a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided: (i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (ii) the quantity of prescription drug dispensed does not exceed a 30-day supply; (iii) the governor has declared a state of disaster; (iv) the board, through the executive director, has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs; (v) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; (vi) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time; (vii) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection; (viii) the pharmacist affixes a label to the dispensing container as specified in § 291.33(c)(7) of this title; and (ix) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:
(I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy which contains the essential information;
(II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;
(III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and
(IV) the pharmacist complies with the requirements of clauses (ii) - (viii) of this subparagraph.
(c) Patient medication records.
(1) A patient medication record system shall be maintained by the pharmacy for patients to whom prescription drug orders are dispensed.
(2) The patient medication record system shall provide for the immediate retrieval of information for the previous 12 months which is necessary for the dispensing pharmacist to conduct a prospective drug regimen review at the time a prescription drug order is presented for dispensing.
(3) The pharmacist-in-charge shall assure that a reasonable effort is made to obtain and record in the patient medication record at least the following information:
(A) full name of the patient for whom the drug is prescribed;
(B) address and telephone number of the patient;
(C) patient's age or date of birth;
(D) patient's gender;
(E) any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs currently being used by the patient which may relate to prospective drug regimen review;
(F) pharmacist's comments relevant to the individual's drug therapy, including any other information unique to the specific patient or drug; and
(G) a list of all prescription drug orders dispensed (new and refill) to the patient by the pharmacy during the last two years. Such list shall contain the following information: (i) date dispensed; (ii) name, strength, and quantity of the drug dispensed; (iii) prescribing practitioner's name; (iv) unique identification number of the prescription; and (v) name or initials of the dispensing pharmacists.
(4) A patient medication record shall be maintained in the pharmacy for two years. If patient medication records are maintained in a data processing system, all of the information specified in this subsection shall be maintained in a retrievable form for two years and information for the previous 12 months shall be maintained on-line. Effective January 1, 2009, a patient medication record must contain documentation of any modification, change, or manipulation to a patient profile.
(5) Nothing in this paragraph shall be construed as requiring a pharmacist to obtain, record, and maintain patient information other than prescription drug order information when a patient or patient's agent refuses to provide the necessary information for such patient medication records.
(d) Prescription drug order records maintained in a manual system.
(1) Original prescriptions shall be maintained in three files as specified in subsection (b)(5)(C) of this section.
(2) Refills.
(A) Each time a prescription drug order is refilled, a record of such refill shall be made: (i) on the back of the prescription by recording the date of dispensing, the written initials or identification code of the dispensing pharmacist, effective January 1, 2009, the initials or identification code of the pharmacy technician or pharmacy technician trainee preparing the prescription label, if applicable, and the amount dispensed. (If the pharmacist merely initials and dates the back of the prescription drug order, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription drug order); or (ii) on another appropriate, uniformly maintained, readily retrievable record, such as medication records, which indicates by patient name the following information:
(I) unique identification number of the prescription;
(II) name and strength of the drug dispensed;
(III) date of each dispensing;
(IV) quantity dispensed at each dispensing;
(V) initials or identification code of the dispensing pharmacist;
(VI) effective January 1, 2009, initials or identification code of the pharmacy technician or pharmacy technician trainee preparing the prescription label, if applicable; and
(VII) total number of refills for the prescription.
(B) If refill records are maintained in accordance with subparagraph (A)(ii) of this paragraph, refill records for controlled substances in Schedules III - V shall be maintained separately from refill records of dangerous drugs and nonprescription drugs.
(3) Authorization of refills. Practitioner authorization for additional refills of a prescription drug order shall be noted on the original prescription, in addition to the documentation of dispensing the refill.
(4) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements:
(A) the transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis;
(B) the transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills;
(C) the transfer is communicated directly between pharmacists and/or pharmacist interns;
(D) both the original and the transferred prescription drug order are maintained for a period of two years from the date of last refill;
(E) the pharmacist or pharmacist intern transferring the prescription drug order information shall: (i) write the word "void" on the face of the invalidated prescription drug order; and (ii) record on the reverse of the invalidated prescription drug order the following information:
(I) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription drug order is transferred;
(II) the name of the pharmacist or pharmacist intern receiving the prescription drug order information;
(III) the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and
(IV) the date of the transfer;
(F) the pharmacist or pharmacist intern receiving the transferred prescription drug order information shall: (i) write the word "transfer" on the face of the transferred prescription drug order; and (ii) record on the transferred prescription drug order the following information:
(I) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(II) original prescription number and the number of refills authorized on the original prescription drug order;
(III) number of valid refills remaining and the date of last refill, if applicable;
(IV) name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription information is transferred; and
(V) name of the pharmacist or pharmacist intern transferring the prescription drug order information.
(5) A pharmacist or pharmacist intern may not refuse to transfer original prescription information to another pharmacist or pharmacist intern who is acting on behalf of a patient and who is making a request for this information as specified in paragraph (4) of this subsection.
(6) Effective January 1, 2009, each time a modification, change, or manipulation is made to a record of dispensing, documentation of such change shall be recorded on the back of the prescription or on another appropriate, uniformly maintained, readily retrievable record, such as medication records. The documentation of any modification, change, or manipulation to a record of dispensing shall include the identification of the individual responsible for the alteration.
(e) Prescription drug order records maintained in a data processing system.
(1) General requirements for records maintained in a data processing system.
(A) Compliance with data processing system requirements. If a Class A (community) pharmacy's data processing system is not in compliance with this subsection, the pharmacy must maintain a manual recordkeeping system as specified in subsection (d) of this section.
(B) Original prescriptions. Original prescriptions shall be maintained in three files as specified in subsection (b)(5)(C) of this section.
(C) Requirements for backup systems. (i) The pharmacy 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, at least monthly, to assure that data is not lost due to system failure. (ii) Data processing systems shall have a workable (electronic) data retention system which can produce an audit trail of drug usage for the preceding two years as specified in paragraph (2)(G) of this subsection.
(D) Change or discontinuance of a data processing system. (i) Records of dispensing. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records of dispensing to the new data processing system; or
(II) purge the records of dispensing to a printout which contains the same information required on the daily printout as specified in paragraph (2)(B) of this subsection. The information on this hard-copy printout shall be sorted and printed by prescription number and list each dispensing for this prescription chronologically. (ii) Other records. A pharmacy that changes or discontinues use of a data processing system must:
(I) transfer the records to the new data processing system; or
(II) 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.
(E) 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.
(2) Records of dispensing.
(A) Each time a prescription drug order is filled or refilled, a record of such dispensing shall be entered into the data processing system.
(B) Effective January 1, 2009, each time a modification, change or manipulation is made to a record of dispensing, documentation of such change shall be recorded in the data processing system. The documentation of any modification, change, or manipulation to a record of dispensing shall include the identification of the individual responsible for the alteration. Should the data processing system not be able to record a modification, change, or manipulation to a record of dispensing, the information should be clearly documented on the hardcopy prescription.
(C) The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. This hard-copy printout shall contain the following information: (i) unique identification number of the prescription; (ii) date of dispensing; (iii) patient name; (iv) prescribing practitioner's name; (v) name and strength of the drug product actually dispensed; if generic name, the brand name or manufacturer of drug dispensed; (vi) quantity dispensed; (vii) initials or an identification code of the dispensing pharmacist; (viii) effective January 1, 2009, initials or an identification code of the pharmacy technician or pharmacy technician trainee performing data entry of the prescription, if applicable; (ix) if not immediately retrievable via CRT display, the following shall also be included on the hard-copy printout:
(I) patient's address;
(II) prescribing practitioner's address;
(III) practitioner's DEA registration number, if the prescription drug order is for a controlled substance;
(IV) quantity prescribed, if different from the quantity dispensed;
(V) date of issuance of the prescription drug order, if different from the date of dispensing; and
(VI) total number of refills dispensed to date for that prescription drug order; and (x) effective January 1, 2009, any changes made to a record of dispensing.
(D) The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy. Records of controlled substances shall be readily retrievable from records of noncontrolled substances.
(E) Each individual pharmacist who dispenses or refills a prescription drug order shall verify that the data indicated on the daily hard-copy printout is correct, by dating and signing such document in the same manner as signing a check or legal document (e.g., J.H. Smith, or John H. Smith) within seven days from the date of dispensing.
(F) In lieu of the printout described in subparagraph (C) of this paragraph, the pharmacy shall maintain a log book in which each individual pharmacist using the data processing system shall sign a statement each day, attesting to the fact that the information entered into the data processing system that day has been reviewed by him or her and is correct as entered. Such log book shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing; provided, however, that the data processing system can produce the hard-copy printout on demand by an authorized agent of the Texas State Board of Pharmacy. If no printer is available on site, the hard-copy printout shall be available within 72 hours with a certification by the individual providing the printout, which states that the printout is true and correct as of the date of entry and such information has not been altered, amended, or modified.
(G) The pharmacist-in-charge is responsible for the proper maintenance of such records and responsible that such data processing system can produce the records outlined in this section and that such system is in compliance with this subsection.
(H) The data processing system shall be capable of producing a hard-copy printout of an audit trail for all dispensings (original and refill) of any specified strength and dosage form of a drug (by either brand or generic name or both) during a specified time period. (i) Such audit trail shall contain all of the information required on the daily printout as set out in subparagraph (C) of this paragraph. (ii) The audit trail required in this subparagraph shall be supplied by the pharmacy within 72 hours, if requested by an authorized agent of the Texas State Board of Pharmacy.
(I) 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.
(J) The data processing system shall provide on-line retrieval (via CRT display or hard-copy printout) of the information set out in subparagraph (C) of this paragraph of: (i) the original controlled substance prescription drug orders currently authorized for refilling; and (ii) the current refill history for Schedules III, IV, and V controlled substances for the immediately preceding six-month period.
(K) In the event that a pharmacy which uses a data processing system experiences system downtime, the following is applicable: (i) an auxiliary procedure shall ensure that refills are authorized by the original prescription drug order and that the maximum number of refills has not been exceeded or authorization from the prescribing practitioner shall be obtained prior to dispensing a refill; and (ii) all of the appropriate data shall be retained for on-line data entry as soon as the system is available for use again.
(3) Authorization of refills. Practitioner authorization for additional refills of a prescription drug order shall be noted as follows:
(A) on the hard-copy prescription drug order;
(B) on the daily hard-copy printout; or
(C) via the CRT display.
(4) Transfer of prescription drug order information. For the purpose of refill or initial dispensing, the transfer of original prescription drug order information is permissible between pharmacies, subject to the following requirements.
(A) The transfer of original prescription drug order information for controlled substances listed in Schedule III, IV, or V is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(B) The transfer of original prescription drug order information for dangerous drugs is permissible between pharmacies without limitation up to the number of originally authorized refills.
(C) The transfer is communicated directly between pharmacists and/or pharmacist interns orally by telephone or via facsimile or as authorized in paragraph (5) of this subsection. A transfer completed as authorized in paragraph (5) of this subsection may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(D) Both the original and the transferred prescription drug orders are maintained for a period of two years from the date of last refill.
(E) The pharmacist or pharmacist intern transferring the prescription drug order information shall: (i) write the word "void" on the face of the invalidated prescription drug order; and (ii) record on the reverse of the invalidated prescription drug order the following information:
(I) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred;
(II) the name of the pharmacist or pharmacist intern receiving the prescription drug order information;
(III) the name of the pharmacist or pharmacist intern transferring the prescription drug order information; and
(IV) the date of the transfer.
(F) The pharmacist or pharmacist intern receiving the transferred prescription drug order information shall: (i) write the word "transfer" on the face of the transferred prescription drug order; and (ii) record on the transferred prescription drug order the following information:
(I) original date of issuance and date of dispensing or receipt, if different from date of issuance;
(II) original prescription number and the number of refills authorized on the original prescription drug order;
(III) number of valid refills remaining and the date of last refill, if applicable;
(IV) name, address, and if a controlled substance, the DEA registration number of the pharmacy from which such prescription drug order information is transferred; and
(V) name of the pharmacist or pharmacist intern transferring the prescription drug order information.
(G) Prescription drug orders may not be transferred by non-electronic means during periods of downtime except on consultation with and authorization by a prescribing practitioner; provided however, during downtime, a hard copy of a prescription drug order may be made available for informational purposes only, to the patient, a pharmacist or pharmacist intern, and the prescription may be read to a pharmacist or pharmacist intern by telephone.
(H) The original prescription drug order shall be invalidated in the data processing system for purposes of filling or refilling, but shall be maintained in the data processing system for refill history purposes.
(I) If the data processing system has the capacity to store all the information required in subparagraphs (E) and (F) of this paragraph, the pharmacist is not required to record this information on the original or transferred prescription drug order.
(J) The data processing system shall have a mechanism to prohibit the transfer or refilling of controlled substance prescription drug orders which have been previously transferred.
(5) Electronic transfer of prescription drug order information between pharmacies. Pharmacies electronically accessing the same prescription drug order records may electronically transfer prescription information if the following requirements are met.
(A) The original prescription is voided and the following information is documented in the records of the transferring pharmacy: (i) the name, address, and if a controlled substance, the DEA registration number of the pharmacy to which such prescription is transferred; (ii) the name of the pharmacist or pharmacist intern receiving the prescription drug order information; and (iii) the date of the transfer.
(B) Pharmacies not owned by the same person may electronically access the same prescription drug order records, provided the owner or chief executive officer of each pharmacy signs an agreement allowing access to such prescription drug order records.
(C) An electronic transfer between pharmacies may be initiated by a pharmacy technician or pharmacy technician trainee acting under the direct supervision of a pharmacist.
(6) A pharmacist or pharmacist intern may not refuse to transfer original prescription information to another pharmacist or pharmacist intern who is acting on behalf of a patient and who is making a request for this information as specified in paragraphs (4) and (5) of this subsection.
(f) Limitation to one type of recordkeeping system. When filing prescription drug order information a pharmacy may use only one of the two systems described in subsection (d) or (e) of this section.
(g) 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.
(1) The registrant to whom the controlled substance is to be distributed is registered under the Controlled Substances Act to dispense that controlled substance.
(2) The total number of dosage units of controlled substances distributed by a pharmacy may not exceed 5.0% of all controlled substances dispensed and distributed 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.
(3) If the distribution is for a Schedule III, IV, or V controlled substance, a record shall be maintained which indicates:
(A) the actual date of distribution;
(B) the name, strength, and quantity of controlled substances distributed;
(C) the name, address, and DEA registration number of the distributing pharmacy; and
(D) the name, address, and DEA registration number of the pharmacy, practitioner, or other registrant to whom the controlled substances are distributed.
(4) If the distribution is for a Schedule I or II controlled substance, the following is applicable.
(A) 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.
(B) 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.
(h) Other records. Other records to be maintained by a pharmacy:
(1) a permanent log of the initials or identification codes which will identify each dispensing 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 shall not be used);
(2) 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;
(3) a hard copy of the power of attorney to sign DEA 222C order forms (if applicable);
(4) 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;
(5) suppliers' credit memos for controlled substances and dangerous drugs;
(6) a hard copy of inventories required by § 291.17 of this title (relating to Inventory Requirements);
(7) hard-copy reports of surrender or destruction of controlled substances and/or dangerous drugs to an appropriate state or federal agency;
(8) a hard copy of the Schedule V nonprescription register book;
(9) records of distribution of controlled substances and/or dangerous drugs to other pharmacies, practitioners, or registrants; and
(10) a hard copy of any notification required by the Texas Pharmacy Act or the sections in this chapter, including, but not limited to, the following:
(A) reports of theft or significant loss of controlled substances to DEA, Department of Public Safety, and the board;
(B) notifications of a change in pharmacist-in-charge of a pharmacy; and
(C) 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.
(i) Permission to maintain central records. Any pharmacy that uses a centralized recordkeeping system for invoices and financial data shall comply with the following procedures.
(1) Controlled substance records. Invoices and financial data for controlled substances may be maintained at a central location provided the following conditions are met.
(A) 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 Title 21, Code of Federal Regulations, § 1304.04(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.
(B) The pharmacy maintains a copy of the notification required in subparagraph (A) of this paragraph.
(C) 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.
(2) Dangerous drug records. Invoices and financial data for dangerous drugs may be maintained at a central location.
(3) 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.
(4) 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.
(j) Ownership of pharmacy records. For the purposes of these sections, a pharmacy licensed under the Act is the only entity which may legally own and maintain prescription drug records.
|