10.19.03.08

.08 Controlled Substances Listed in Schedule II.

A. Requirement of Prescription—Schedule II (21 CFR §1306.11).

(1) A pharmacist may dispense directly a controlled dangerous substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as provided in §A(4) of this regulation. Except as noted in §A(5)—(7) of this regulation, a prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy by facsimile equipment, if the original written, signed prescription is presented to the pharmacist for review before the actual dispensing of a controlled substance.

(2) An individual practitioner may administer or dispense directly a controlled dangerous substance listed in Schedule II in the course of the individual practitioner's professional practice without a prescription, subject to Regulation .07 of this chapter.

(3) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

(4) In the case of an emergency situation, as cited in 21 CFR §1306.11(d), a pharmacist may dispense a controlled dangerous substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, if all of the following requirements are met:

(a) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);

(b) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in Regulation .07 of this chapter, except for the signature of the prescribing individual practitioner;

(c) If the prescribing individual practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a call back to the prescribing individual practitioner using the prescribing individual practitioner's telephone number as listed in the telephone directory or other good faith efforts to insure the individual practitioner's identity;

(d) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall have a written prescription for the emergency quantity prescribed delivered to the dispensing pharmacist. In addition to conforming to the requirements of Regulation .07 of this chapter, the prescription shall have written on its face "Authorization for Emergency Dispensing", and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if it is delivered by mail, it shall be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify in writing the Maryland Department of Health if the prescribing individual practitioner fails to deliver a written prescription to the pharmacist; failure of the pharmacist to do so shall void the authority conferred by this section to dispense without a written prescription of a prescribing individual practitioner.

(5) A prescription prepared in accordance with 21 CFR §1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion, may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile equipment. The facsimile received by facsimile equipment serves as the original written prescription for purposes of §A(5) of this regulation and the facsimile received by facsimile equipment shall be maintained in accordance with 21 CFR §1304.04(h).

(6) A prescription prepared in accordance with 21 CFR §1306.05 written for a Schedule II substance for a resident of a long-term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile equipment. The facsimile received by facsimile equipment serves as the original written prescription for purposes of §A(6) of this regulation and the facsimile received by facsimile equipment shall be maintained in accordance with 21 CFR §1304.04(h).

(7) A prescription prepared in accordance with 21 CFR §1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified or paid for by Medicare, or both, under Title XVIII or a hospice program which is licensed by the State, may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile equipment. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The facsimile received by the facsimile equipment serves as the original written prescription for purposes of §A(7) of this regulation and the facsimile received by facsimile equipment shall be maintained in accordance with 21 CFR §1304.04(h).

(8) A prescription for a Schedule II controlled dangerous substance shall be dispensed within 120 days of the date of issue.

B. Refilling of Prescription—Schedule II (21 CFR §1306.12). The refilling of a prescription for a controlled dangerous substance listed in Schedule II is prohibited.

C. Partial Filling of Prescriptions—Schedule II (21 CFR §1306.13).

(1) The partial filling of a prescription for a controlled dangerous substance 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 the pharmacist makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

(2) Long-Term Care Facility or Terminal Illness Patient.

(a) A prescription for a Schedule II controlled dangerous substance, written for a patient in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner before partially filling the prescription.

(b) Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled dangerous substance is for a terminally ill patient.

(c) The pharmacist shall record on the prescription whether the patient is a "terminally ill" or "LTCF" patient.

(d) A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" is considered to have been filled in violation of Criminal Law Article, §§5-101—5-1101, Annotated Code of Maryland.

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

(i) Date of the partial filling;

(ii) Quantity dispensed;

(iii) Remaining quantity authorized to be dispensed; and

(iv) Identification of the dispensing pharmacist.

(f) Before any subsequent partial filling, the pharmacist shall determine if the additional partial filling is necessary. The total quantity of Schedule II controlled dangerous substances dispensed in all partial fillings may not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness are valid for a period not to exceed 60 days from the issue date, unless sooner terminated by the discontinuance of medication.

(g) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit output (display or printout) of the:

(i) Original prescription number;

(ii) Date of issue;

(iii) Identification of prescribing individual practitioner;

(iv) Identification of patient;

(v) Address of the LTCF or address of the hospital or residence of the patient;

(vi) Identification of medication authorized, including dosage, form, strength, and quantity;

(vii) Listing of the partial fillings that have been dispensed under each prescription;

(viii) Information required in §C(2)(a)—(f) of this regulation; and

(ix) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.

(h) Retrieval of partially filled Schedule II prescription information is the same as required by 21 CFR §1306.22(b)(4) and (5) for Schedule III and IV prescription refill information.

D. Labeling of Substances (21 CFR §1306.14).

(1) The pharmacist filling a written or emergency oral prescription for a controlled dangerous substance listed in Schedule II shall affix to the package a label showing the date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in this prescription or required by law. It is further provided that the label of a drug listed in Schedules II, III, IV, and V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland, shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. When the size of the label space requires a reduction in type, the reduction shall be made to a size no smaller than necessary and in no event to a size smaller than six-point type.

(2) The requirements of §D(1) of this regulation, do not apply when a controlled dangerous substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized, provided that:

(a) Not more than a 7-day supply of the controlled dangerous substance listed in Schedule II is dispensed at one time;

(b) The controlled dangerous substance listed in Schedule II is not listed in the possession of the ultimate user before the administration;

(c) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled dangerous substance listed in Schedule II; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

(3) When dispensed to or for a patient, the label of a drug listed in Schedules II, III, IV, or V shall contain a clear and concise warning that it is a crime to transfer the drug to any person other than the patient.

E. Filing of Prescriptions (21 CFR §1306.14). All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirement of Regulation .05.