Tenn. Comp. R. & Regs. 1140-03-.03 - MEDICAL AND PRESCRIPTION ORDERS

(1) To the extent that a medical order contains an order for the compounding, dispensing or administration of a prescription drug or device or related material, the medical order shall be treated as a prescription order. Written medical and prescription orders must be signed by the prescriber. Verbal medical and prescription orders must be immediately reduced to writing (by hand or other means), dated, and initialed by the authorized individual accepting the medical and prescription orders.

(2) Each medical and prescription order when dispensed shall be serially numbered, filed numerically and maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date the medical and prescription order was last dispensed. Institutional pharmacies shall not be required to serially number medical and prescription orders dispensed for administration to inpatients of that institution.

(3) A pharmacist upon initial dispensing of a medical or prescription order shall record on that medical or prescription order: the date such medical or prescription order was dispensed, the pharmacist's initials, and the amount of any product dispensed. If the pharmacist merely initials and dates a medical or prescription order the pharmacist shall be deemed to have dispensed the full face amount of the medical or prescription order.

(4) A pharmacist upon refilling a medical or prescription order shall enter on the back of that medical or prescription order: the date such medical or prescription order was refilled, the pharmacist's initials, and the amount of any product dispensed on such refill. If the pharmacist merely initials and dates the back of the medical or prescription order the pharmacist shall be deemed to have dispensed a refill for the full face amount of the medical or prescription order. As an alternative to recording refill information on the back of medical and prescription orders, an automated data processing system may be used for the storage and retrieval of refill information for medical and prescription orders, subject to the following conditions:

(a) Any such computerized system must provide on-line retrieval (via CRT display or hard-copy printout) of the original medical or prescription order information and the complete refill history of all medical and prescription orders which are currently authorized for refilling. This shall include all the information contained in and required to be entered on each such medical or prescription order. This data must include at least the medical or prescription order serial number; date of issuance of the medical or prescription order; patient's name (and address on controlled substance medical and prescription orders); prescriber's name (and address and DEA registration number on controlled substance medical and prescription orders); product name, strength, dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and identity (name, initials, or identification code) of the dispensing pharmacist for the original dispensing and each refill.

(b) Each individual pharmacist using a computerized system in the refilling of a medical or prescription order shall certify that the information entered into the computer for such a refill is correct by verifying, dating, and signing a hard-copy printout of each day's medical or prescription order refill data, or in lieu of such a printout, by signing a statement in a book or file each day attesting that the refill information entered that day has been reviewed by the pharmacist and is correct as shown. Such documentation shall be separately maintained at the pharmacy practice site for at least two (2) years from the date of the last dispensing.

(c) Any such computerized system shall have the capability of producing a hard-copy printout of any medical or prescription order refill data which the pharmacy practice site is responsible for maintaining under the laws and/or regulations of this state and/or the federal government. (This would, for example, furnish a medical or prescription order-by-medical or prescription order, refill-by-refill audit trail for any specified strength and dosage form of any prescription drug and device, by either brand or generic name or both.) Such a printout must include: the medical or prescription order serial number; patient's name (and address on controlled substance medical and prescription orders); name of prescriber; name, strength, and dosage form of the product; and the date of each refill, quantity dispensed on each refill, and the name or identification code of the dispensing pharmacist. Controlled substance data contained on such a printout must be separated, asterisked, or in some other manner visually identifiable apart from other items appearing on the printout. Any computerized system employed by a pharmacy practice site must, upon the request of an authorized representative of the board, send or provide such a printout to the pharmacy practice site within forty eight (48) hours excluding weekends (Saturdays and Sundays) and legal holidays.

(d) In the event that a pharmacy practice site which utilizes such a computerized system experiences system down-time, the pharmacy practice site must have a written or readily retrievable auxiliary policy and procedure which will be used for documentation of refills of all medical and prescription orders. This auxiliary procedure must ensure that each refill is authorized, and that all appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(e) Each pharmacy practice site and pharmacist using such a computerized system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall apply, unless this initial dispensing data is included on the printout required by subparagraph four (4)(b) of this rule, and is identified as pertaining to the initial dispensing.

(5) A pharmacist may dispense an appropriately authorized refill of a medical or prescription order by referral to a patient profile (medication record) instead of the original medical or prescription order on file at that pharmacy practice site, subject to the following conditions:

(a) The patient profile must contain all the information contained in and required to be entered on the original medical or prescription order, including the complete refill history of that medical or prescription order. This data includes the medical or prescription order serial number; date of issuance of the medical or prescription order; name of patient; name of the prescriber; product name; strength; dosage form, and quantity prescribed; directions for use, and labeling instructions; refill instructions; and the date of dispensing, quantity dispensed, and initials of the dispensing pharmacist for the original dispensing and each refill. Dispensing data must be identified as to whether it pertains to the original dispensing or to a refill.

(b) Controlled substance data contained on the patient profile must be asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the profile.

(c) The patient profile system must contain a complete and accurate record of the refill history of all medical and prescription orders dispensed at the pharmacy practice site. (This record will constitute compliance with the provisions of paragraph four (4) of this rule.)

(d) Each such profile must be maintained so as to be readily retrievable at the pharmacy practice site for at least two (2) years from the date of the last dispensing recorded on the profile.

(e) A pharmacist dispensing a medical or prescription order by referral to a patient profile in so doing certifies as to the accuracy and validity of the information contained on the patient profile.

(f) Each pharmacy practice site and pharmacist using such a patient profile system must comply with the provisions of paragraphs one (1) and two (2) of this rule. In addition, the requirements of paragraph three (3) of this rule shall obtain, unless the patient profile system contains a record of this initial dispensing information for all medical and prescription orders dispensed at the pharmacy practice site.

(6) No pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, shall compound or dispense any medical or prescription order except upon the following conditions:

(a) All medical and prescription orders shall be compounded and dispensed in strict conformity with any directions of the prescriber. Nothing in this rule shall prohibit a pharmacist from substituting a therapeutically equivalent prescription drug or device or related material containing the same active ingredient or ingredients, dosage form and strength;

(b) No medical or prescription order shall be refilled if it contains a statement over the signature of the prescriber that it is not to be refilled, and a medical or prescription order shall not be refilled unless so authorized by the prescriber;

(c) If any medical or prescription order contains a statement that it may be refilled a specified number of times within or during any particular period, such order shall be refilled in strict conformity with such statement; and

(d) If a prescription contains a statement that during any particular time it may be refilled at will, the order shall be refilled in strict conformity to dosage directions, with the exception that it may not be refilled after the expiration of the time specified or one (1) year from the date the order was originally issued or dispensed, whichever comes first.

(e) At a rate, based on the actual number of medical and prescription orders compounded and dispensed per hour or per day, that does not pose a danger to the public health, safety or welfare.

(7) Copies of Medical and Prescription Orders.

(a) Copies of medical and prescription orders issued directly to the patient by the pharmacy practice site where the order was originally compounded and dispensed pursuant to the receipt of the order shall bear on the face thereof, in letters red in color and equal in size to those describing the prescription drug or device or related material, the statement: "Copy for Information Only." Presentation of an informational written copy or label of a dispensing container shall be for information purposes only and have no legal status as a valid medical or prescription order. The recipient pharmacist of such copy or label shall contact the prescriber or transferor pharmacy practice site and obtain all information required by this rule, which is the same as obtaining an original medical or prescription order;

(b) Medical and prescription orders shall be transferred between pharmacy practice sites for the purpose of compounding and dispensing provided that the transferee, upon receiving such order directly from the transferor, records the following:

1. The name, address and original medical or prescription order serial number at the pharmacy practice site from which the order was transferred;

2. The name of the transferor; and

3. All information constituting a medical or prescription order including the following:

(i) Date the order was originally issued and dispensed;

(ii) Original number of refills authorized on the original order;

(iii) Date of last dispensing; and

(iv) Number of valid refills remaining.

(c) The transferee informs the patient that the original medical or prescription order has been canceled at the pharmacy practice site from which it was obtained.

(d) Computerized systems must satisfy all information requirements.

(e) The transfer of schedule III, IV, V, controlled substances are subject to the conditions set forth in 21 C.F.R. 1306.25.

(8) It is permissible for any pharmacy practice site, pharmacist, or pharmacy intern or pharmacy technician under the supervision of a pharmacist, or any other place of business engaged in compounding and dispensing prescription drugs and devices and related materials for human consumption to receive from any patient or other person the return of any portion of an order that has been taken from the premises of the pharmacy practice site or other place of business, only if authorized:

(a) Pursuant to Tennessee Board of Pharmacy rule 1140-04-.10; or

(b) For the purpose of collection for disposal or destruction of any prescription drug; provided that participation in the program shall be voluntary, and such collection and destruction shall be conducted in accordance with the provisions of 21 CFR § 1317.

(9) Medical and prescription orders cannot be accepted, solicited, collected or advertised at any location other than a pharmacy practice site for which a license has been issued by the Board, and such pharmacy practice site shall be actively engaged in compounding and dispensing medical and prescription orders. An entity or other non-licensed site which does not dispense drugs directly to patients may accept, solicit, and collect prescriptions for the purpose of medication therapy management or other consultative services related to drug therapy and patient care.

(10) Medical and prescription orders typed or printed must be signed by the prescriber. Oral medical and prescription orders shall be initialed by the authorized individual accepting the order.

Notes

Tenn. Comp. R. & Regs. 1140-03-.03

Original rule filed February 7, 1983; effective March 9, 1983. Amendment filed November 16, 1992; effective January 8, 1993. Repeal and new rule filed May 11, 1998; effective July 25, 1998. Amendment filed September 15, 2015; effective December 14, 2015. Amendments filed November 22, 2016; effective 2/20/2017.

Authority: T.C.A. §§ 63-10-204, 63-10-304, 63-10-404(4), (11), (14), (19), (26), (29), (30), and (34), 63-10-504(b)(1), 63-10-504(j), 63-10-504(b)(1) and (2), 63-10-204, 63-10-304, and 2015 Acts, Pub. Chap. 40.