1. (a) Issue of prescriptions or orders.

   1. (1)

      1. (A) “Prescription” means an order for medication that is dispensed to or for an ultimate user but does not include an order for medication that is dispensed for immediate administration to the ultimate user.
      2. (B) For example, an order to dispense a medication to a resident or patient for immediate administration in a licensed facility is not a prescription.
      3. (C) However, the recordkeeping requirements of 20 CAR § 203-107 do apply to such orders.

   2. (2) A prescription or an order for controlled substances may be issued only by an individual practitioner who:

      1. (A) Is legally authorized to prescribe or order controlled substances in the State of Arkansas; and
      2. (B) Holds a current Drug Enforcement Administration registration.

   3. (3)

      1. (A) In settings where non-Drug Enforcement Administration-registered nurse practitioners, advanced practice nurses, and physician’s assistants are employed, a Drug Enforcement Administration-registered licensed practitioner must determine the need for a controlled substance to be issued to a patient.
      2. (B) Only the Drug Enforcement Administration-registered licensed practitioner may then communicate the order to the pharmacist, either by written, oral, fax, or electronic prescription, if issued in compliance with federal law and regulations.
      3. (C) No standing orders or protocol for controlled substances shall be valid.

2. (b) Purpose of issue.

   1. (1)

      1. (A) A prescription, in order to be effective, must be issued for legitimate medical purposes.
      2. (B) The responsibility for the proper prescribing and dispensing of controlled substances is upon the practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.
   2. (2) An order purporting to be a prescription issued to an addict or habitual user of controlled substances, not in the course of professional treatment but for the purpose of providing the user with controlled substances sufficient to keep him or her comfortable by maintaining his or her customary use, is not a prescription within the meaning and interest of Arkansas Code § 20-64-206, and the person knowingly dispensing such an order, as well as the person knowingly issuing it, shall be subject to penalties by Arkansas Code § 20-64-220.

   3. (3)

      1. (A) All prescriptions for controlled substances shall: (i) Be dated as of, and signed on, the day when issued; and

         1. (ii) Bear the:
3. (a) (a) Full name and address of the patient;

4. (b) (b) Drug name;

   1. (c) (c) Strength;

      1. (d) (d) Dosage form;
5. (e) (e) Quantity prescribed;
6. (f) (f) Directions for use; and

7. (g) (g) Name, address, and registration number of the individual prescribing practitioner.

   1. (B) A practitioner shall sign a prescription in the same manner as he or she would sign a check or legal document.

      1. (C) When an oral order is not permitted, prescriptions shall be:

         1. (i) Written with ink, indelible pencil, or typewriter; and
         2. (ii) Manually signed by the practitioner.
      2. (D) The prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential aspects to the law and rules.
      3. (E) A corresponding liability rests upon the pharmacist who dispenses a prescription not prepared in the form prescribed in this part.

   2. (4)

      1. (A) An intern, resident, foreign-trained physician, or physician on the staff of a Veterans’ Administration facility exempted from registration under 21 C.F.R. § 1301.24(c) shall include on all prescriptions issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in lieu of the registration number of the practitioner as required by this section.
      2. (B) Each written prescription shall have the name of the practitioner stamped, typed, or printed on it as well as the signature in ink of the practitioner.

      3. (C) In lieu of the registration number of the practitioner required by this section, all prescriptions issued shall include the branch of service or agency and service identification number.

         1. (c) Refilling of prescriptions.
   3. (1) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.

   4. (2)

      1. (A) No prescription for a controlled substance listed in Schedules III, IV, or V shall be:

         1. (i) Dispensed or refilled more than six (6) months after the date on which the prescription was issued; and
         2. (ii) Authorized to be refilled more than five (5) times.
      2. (B) Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document.
      3. (C) If entered on another document, such as a medication record, the document shall be uniformly maintained and readily retrievable.

      4. (D) The following information shall be retrievable by the prescription number, consisting of the:

         1. (i) Name and dosage form of the controlled substance;
         2. (ii) Date dispensed or refilled;
         3. (iii) Quantity dispensed;
         4. (iv) Initials of the dispensing pharmacist for each refill; and
         5. (v) Total number of refills for that prescription.
      5. (E) If the pharmacist merely initials and dates the back of the prescription it shall be deemed that the full face amount of the prescription has been dispensed.

      6. (F) The prescribing practitioner may authorize additional refills of Schedules III, IV, or V controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:

         1. (i) The total quantity authorized, including the amount of the original prescription, does not exceed five (5) refills nor extend beyond six (6) months from the date of issue of the original prescription;
         2. (ii) The pharmacist obtaining the oral authorization records on the reverse of the original prescription the:
8. (a) (a) Date;

9. (b) (b) Quantity of refill;

   1. (c) (c) Number of additional refills authorized; and

      1. (d) (d) Initials the prescription showing who received the authorization from the prescribing practitioner who issued the original prescription;

         1. (iii) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and
         2. (iv) The prescribing practitioner shall execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.

   2. (3) As an alternative to the procedures provided by subdivision (c)(2) of this section, an electronic data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V subject to the following conditions:

      1. (A)

         1. (i) Any such proposed electronic data processing system shall provide online retrieval (electronic record of hard-copy printout) of original prescription order information.
         2. (ii) This shall include, but is not limited to, data such as the:
10. (a) (a) Original prescription number;

11. (b) (b) Date of issuance of the original prescription order by the practitioner;

    1. (c) (c) Full name and address of the patient;

       1. (d) (d) Name, address, and Drug Enforcement Administration registration number of the practitioner;
12. (e) (e) Name, strength, dosage form, and quantity of the controlled substance prescribed, and quantity dispensed if different from the quantity prescribed; and

13. (f) (f) Total number of refills authorized by the prescribing practitioner;

    1. (B)

       1. (i) Any such electronic data processing system must also provide online retrieval (electronic record of hard-copy printout) of the current refill history for Schedules III, IV, or V controlled substance prescription orders, those authorized for refill during the past six (6) months.

          1. (ii) This refill history shall include but is not limited to the:
14. (a) (a) Name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or the name or initials of the dispensing pharmacist for each refill; and

15. (b) (b) Total number of refills dispensed to date for the prescription order;

    1. (C)

       1. (i) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedules III, IV, or V controlled substance is correct shall be provided by the individual pharmacist who makes use of the system.

          1. (ii) If such a system provides a hard-copy printout of controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order.
          2. (iii) The individual pharmacist shall verify that the data indicated is correct and then sign this document in the same manner in which he or she would sign a check or legal document, for example, J. H. Smith or John H. Smith.
          3. (iv) This document shall be maintained in a separate file at the pharmacy for a period of two (2) years from the dispensing date.
          4. (v) This printout of the day’s controlled substance prescription order refill data shall be provided to each pharmacy using such an electronic data processing system within seventy-two (72) hours of the date on which the refill was dispensed.
          5. (vi) It shall be verified and signed by each pharmacist who is involved with such dispensing.
          6. (vii) All required information shall be:
16. (a) (a) Entered on the records of all prescription orders dispensed at the pharmacy including nonrefillable prescriptions; and

17. (b) (b) Maintained for a period of no less than two (2) years.

    1. (viii) In lieu of such a printout, the pharmacy shall maintain a bound log book or separate file in which each individual pharmacist involved in such dispensing shall sign a statement, in the manner previously described, each day attesting to the fact that the refill information entered into the computer that day:
18. (a) (a) Has been reviewed by him or her; and

19. (b) (b) Is correct as shown.

    1. (ix) Such a book or file shall be maintained at the pharmacy employing such a system for a period of two (2) years after the date of dispensing the appropriately authorized refill;

       1. (D)

          1. (i) Any such electronic data processing system shall have the capability of generating a printout of any refill data that the user pharmacy is responsible for maintaining under this part.
          2. (ii) For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance by brand, generic name, or both.
          3. (iii) Such a printout shall include the:
20. (a) (a) Name of the prescribing practitioner;

21. (b) (b) Name and address of the patient;

    1. (c) (c) Quantity dispensed on each refill;

       1. (d) (d) Date of dispensing for each refill;
22. (e) (e) Name or identification code of the dispensing pharmacist; and

23. (f) (f) Number of the original prescription order.

    1. (iv) In any electronic data processing system employed by a user pharmacy the central recordkeeping location shall be capable of sending the printout to the pharmacy within forty-eight (48) hours, and if the agent or investigator requests a copy of such printout from the user pharmacy, it shall, if requested to do so by the agent or investigator, verify the printout transmittal capability of its system by documentation, for example, postmark;

       1. (E)

          1. (i) In the event a pharmacy that employs such an electronic data processing system experiences downtime, the pharmacy shall have an approved auxiliary procedure that will be used for documentation of refills of Schedules III, IV, and V controlled substance prescription orders.
          2. (ii) This auxiliary procedure shall ensure that:
24. (a) (a) Refills are authorized by the original prescription order;

25. (b) (b) The maximum number of refills has not been exceeded; and

    1. (c) (c) All the appropriate data is retained for online data entry as soon as the computer system is available for use again; and

       1. (F) When filing refill information for original prescription orders for Schedules III, IV, or V controlled substances, a pharmacy may use only one (1) of the two (2) systems described in this section.

          1. (d) Partial dispensing of prescriptions.

    2. (1) The partial dispensing of a prescription for a controlled substance listed in Schedules III, IV, or V is permissible provided that:

       1. (A) Each partial dispensing is recorded in the same manner as the refilling;
       2. (B) The total quantity dispensed in all partial dispensings does not exceed the total quantity prescribed; and
       3. (C) No dispensing occurs six (6) months after the date on which the prescription was issued.

    3. (2)

       1. (A) The partial dispensing of a prescription for controlled substances listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of a written prescription, or written record of the emergency oral prescription, on the first partial dispensing.
       2. (B) However, if the remaining portion is not or cannot be dispensed within a seventy-two-hour period, the pharmacist shall so notify the prescribing individual practitioner.
       3. (C) No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

    4. (3)

       1. (A) A prescription for a Schedule II controlled substance written for a patient in an LTCF or for a patient with a medical diagnosis documenting a terminal illness may be dispensed in partial quantities to include individual dosage units.
       2. (B) If there is any question as to whether a patient may be classified as having a terminal illness, the pharmacist may contact the practitioner prior to partially dispensing the prescription.
       3. (C) Both the pharmacist and the prescribing practitioner have a corresponding responsibility to ensure that the controlled substance is for a terminally ill patient.
       4. (D) The pharmacist shall record on the prescription whether the patient is “terminally ill” or an “LTCF patient”.
       5. (E) Prior to any subsequent partial dispensing, the pharmacist shall determine the necessity of additional medication.

       6. (F) For each partial dispensing, the dispensing pharmacist shall record on the back of the prescription, or on another appropriate record, uniformly maintained and readily retrievable, the:

          1. (i) Date of the partial dispensing;
          2. (ii) Quantity dispensed;
          3. (iii) Remaining quantity authorized to be dispensed; and
          4. (iv) Identification of the dispensing pharmacist.
       7. (G) The total quantity of Schedule II controlled substances dispensed in all partial dispensings shall not exceed the total quantity prescribed.
       8. (H) Schedule II prescriptions for patients in an LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by discontinuance of medication.

    5. (4) Information pertaining to current Schedule II prescriptions for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if the system has the capability to permit:

       1. (A) Output, display or print, of the:

          1. (i) Original prescription number;
          2. (ii) Date of issue;
          3. (iii) Identification of prescribing individual practitioner;
          4. (iv) Identification of patient;
          5. (v) Address of the LTCF or address of the hospital or residence of the patient;
          6. (vi) Identification of medication authorized, to include dosage, form, strength, and quantity;
          7. (vii) Listing of the partial dispensings that have been dispensed under each prescription; and
          8. (viii) Information required in this section;
       2. (B) Immediate, real-time updating of the prescription record each time a partial dispensing of the prescription is concluded; and
       3. (C) Retrieval of partially dispensed Schedule II prescription information is the same as required for Schedules III, IV, and V prescription refill information.
    6. (5) The authority to dispense Schedule II prescriptions for partial quantities does not apply to other classes of patients such as a patient with severe intractable pain who is not diagnosed as terminal.

26. (e) Telephone or oral prescriptions.

    1. (1)

       1. (A) In the case of an emergency situation, as defined by this part, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner provided that the quantity prescribed and dispensed is limited to the amount adequate to treat that patient during the emergency period, but never more than seventy-two (72) hours.
       2. (B) Dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner.

       3. (C) For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the List of Controlled Substances, 5 CAR pt. 22, “emergency situation” means those situations in which the prescribing practitioner determines that:

          1. (i) Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;
          2. (ii) No appropriate alternative treatment is available, which includes the administration of a medication that is not a Schedule II medication; and
          3. (iii) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the dispensing pharmacist prior to the dispensing.

    2. (2)

       1. (A) The prescription shall be immediately reduced to writing by the pharmacist.
       2. (B) Within seven (7) days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist.
       3. (C) Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription that had earlier been reduced to writing.
       4. (D) The pharmacist must notify the nearest Drug Enforcement Administration if the prescribing individual practitioner fails to deliver a written prescription to him or her.

    3. (3)

       1. (A) A pharmacist may dispense a controlled substance listed in Schedules III, IV, or V pursuant to an oral prescription:

          1. (i) Made by an individual practitioner; or
          2. (ii) Communicated by an employee or agent of the individual practitioner to a pharmacist.
       2. (B) The pharmacist shall promptly either enter the prescription into the pharmacy’s electronic prescription system or reduce it to writing.
       3. (C) The prescription shall include all the information required in the case of a written prescription except for the written signature of the individual practitioner.

27. (f) Prescription transfers.

    1. (1)

       1. (A) The transfer of original prescription information for a controlled substance listed in Schedules III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only.
       2. (B) However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.
       3. (C) Transfers are subject to the following requirements.

       4. (D) The transfer is communicable directly between two (2) licensed pharmacists and the transferring pharmacist records the following information:

          1. (i) Write the word “VOID” on the face of the invalidated prescriptions;
          2. (ii) Record on the reverse side of the invalidated prescription the:
28. (a) (a) Name, address, and Drug Enforcement Administration registration number of the pharmacy to which it was transferred; and

29. (b) (b) Name of the pharmacist receiving the prescribing information; and

    1. (iii) Record the date of the transfer and the name of the pharmacist transferring the information.

    2. (2) The pharmacist receiving the transferred prescription information shall electronically record or reduce to writing the following:

       1. (A) Write the word “TRANSFER” on the face of the transferred prescription;

       2. (B) Provide all information required to be on a prescription pursuant to federal law (21 C.F.R. § 1306.05) and include:

          1. (i) Date of issuance of original prescription;
          2. (ii) Original number of refills authorized on original prescription;
          3. (iii) Date of original dispensing;
          4. (iv) Number of valid refills remaining and date and location of previous refills;
          5. (v) Pharmacy’s name, address, Drug Enforcement Administration registration number, and original prescription number from which the prescription information was transferred; and
          6. (vi) Name of pharmacist who transferred the prescription; and
       3. (C) The original and transferred prescription shall be maintained for a period of two (2) years from the date of last refill.

30. (g) Facsimile.

    1. (1)

       1. (A) A prescription for a Schedule II controlled substance may be transmitted by the prescribing practitioner to a pharmacy via facsimile equipment provided the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in subdivision (g)(2), subdivision (g)(3), or subdivision (g)(4) of this section.
       2. (B) The original prescription shall be maintained in accordance with this part.

    2. (2)

       1. (A) A prescription prepared in accordance with this part written for a Schedule II narcotic substance to be compounded for direct administration to a patient by parenteral, intravenous, subcutaneous, or intraspinal infusion may be transmitted by the prescribing practitioner to the home infusion pharmacy by facsimile.

       2. (B) The facsimile:

          1. (i) Serves as the original written prescription for purposes of this paragraph; and
          2. (ii) Shall be maintained in accordance with this part.

    3. (3)

       1. (A) A prescription prepared in accordance with this part written for a Schedule II substance for a resident of an LTCF may be transmitted by the prescribing individual practitioner to the dispensing pharmacy by facsimile.

       2. (B) The facsimile:

          1. (i) Serves as the original written prescription for purposes of this paragraph; and
          2. (ii) Shall be maintained in accordance with this part.

    4. (4)

       1. (A) A prescription written for a Schedule II substance for a home hospice patient may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile.
       2. (B) It must be noted on the prescription that this is a hospice patient.
       3. (C) The facsimile serves as the original written prescription.

    5. (5) A pharmacist may dispense directly a controlled substance listed in Schedules III, IV, or V that is a prescription drug only pursuant to:

       1. (A) A written prescription signed by a prescribing individual practitioner;
       2. (B) A facsimile of a written signed prescription transmitted by the prescribing practitioner to the pharmacy; or
       3. (C) An oral prescription made by a prescribing individual practitioner and promptly either entered into the pharmacy’s electronic prescription system or reduced to writing by the pharmacist, including all information required by this part except for the signature of the prescribing practitioner.

    6. (6) An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedules III, IV, or V only pursuant to:

       1. (A) A written prescription signed by a prescribing individual practitioner;
       2. (B) A facsimile of a written prescription or order for medication transmitted directly by the prescribing practitioner to the pharmacist;
       3. (C) An oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist, including all information required by this part except for the signature of the individual practitioner; or
       4. (D) An order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.

Codification Notes: “LTCF” means long-term care facility.