Drug Enforcement Administration, Justice

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					                                Drug Enforcement Administration, Justice                                                            § 1306.11

                                acute withdrawal symptoms when nec-                           (b) An individual practitioner may
                                essary while arrangements are being                        administer or dispense directly a con-
                                made for referral for treatment. Not                       trolled substance listed in Schedule II
                                more than one day’s medication may                         in the course of his professional prac-
                                be administered to the person or for                       tice without a prescription, subject to
                                the person’s use at one time. Such                         § 1306.07.
                                emergency treatment may be carried                            (c) An institutional practitioner may
                                out for not more than three days and                       administer or dispense directly (but
                                may not be renewed or extended.                            not prescribe) a controlled substance
                                  (c) This section is not intended to im-                  listed in Schedule II only pursuant to a
                                pose any limitations on a physician or                     written prescription signed by the pre-
                                authorized hospital staff to administer                    scribing individual practitioner or to
                                or dispense narcotic drugs in a hospital                   an order for medication made by an in-
                                to maintain or detoxify a person as an                     dividual practitioner which is dis-
                                incidental adjunct to medical or sur-                      pensed for immediate administration
                                gical treatment of conditions other                        to the ultimate user.
                                than addiction, or to administer or dis-                      (d) In the case of an emergency situa-
                                pense narcotic drugs to persons with                       tion, as defined by the Secretary in
                                intractable pain in which no relief or                     § 290.10 of this title, a pharmacist may
                                cure is possible or none has been found                    dispense a controlled substance listed
                                after reasonable efforts.                                  in Schedule II upon receiving oral au-
                                  (d) A practitioner may administer or                     thorization of a prescribing individual
                                dispense (including prescribe) any                         practitioner, provided that:
                                Schedule III, IV, or V narcotic drug ap-                      (1) The quantity prescribed and dis-
                                proved by the Food and Drug Adminis-                       pensed is limited to the amount ade-
                                tration specifically for use in mainte-                    quate to treat the patient during the
                                nance or detoxification treatment to a                     emergency period (dispensing beyond
                                narcotic dependent person if the practi-                   the emergency period must be pursuant
                                tioner complies with the requirements                      to a written prescription signed by the
                                of § 1301.28 of this chapter.                              prescribing individual practitioner);
                                                                                              (2) The prescription shall be imme-
                                [39 FR 37986, Oct. 25, 1974, as amended at 70              diately reduced to writing by the phar-
                                FR 36344, June 23, 2005]                                   macist and shall contain all informa-
                                                                                           tion required in § 1306.05, except for the
                                   CONTROLLED SUBSTANCES LISTED IN                         signature of the prescribing individual
                                            SCHEDULE II                                    practitioner;
                                                                                              (3) If the prescribing individual prac-
                                § 1306.11     Requirement of prescription.                 titioner is not known to the phar-
                                   (a) A pharmacist may dispense di-                       macist, he must make a reasonable ef-
                                rectly a controlled substance listed in                    fort to determine that the oral author-
                                Schedule II, which is a prescription                       ization came from a registered indi-
                                drug as determined under the Federal                       vidual practitioner, which may include
                                Food, Drug, and Cosmetic Act, only                         a callback to the prescribing individual
                                pursuant to a written prescription                         practitioner using his phone number as
                                signed by the practitioner, except as                      listed in the telephone directory and/or
                                provided in paragraph (d) of this sec-                     other good faith efforts to insure his
                                tion. A prescription for a Schedule II                     identity; and
                                controlled substance may be trans-                            (4) Within 7 days after authorizing an
                                mitted by the practitioner or the prac-                    emergency oral prescription, the pre-
                                titioner’s agent to a pharmacy via fac-                    scribing individual practitioner shall
                                simile equipment, provided that the                        cause a written prescription for the
                                original written, signed prescription is                   emergency quantity prescribed to be
                                presented to the pharmacist for review                     delivered to the dispensing pharmacist.
                                prior to the actual dispensing of the                      In addition to conforming to the re-
                                controlled substance, except as noted                      quirements of § 1306.05, the prescription
                                in paragraph (e), (f), or (g) of this sec-                 shall have written on its face ‘‘Author-
                                tion. The original prescription shall be                   ization for Emergency Dispensing,’’
                                maintained        in   accordance    with                  and the date of the oral order. The
                                § 1304.04(h) of this chapter.                              written prescription may be delivered


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                                § 1306.12                                                               21 CFR Ch. II (4–1–06 Edition)

                                to the pharmacist in person or by mail,                    the prescription that the patient is a
                                but if delivered by mail it must be                        hospice patient. The facsimile serves as
                                postmarked within the 7 day period.                        the original written prescription for
                                Upon receipt, the dispensing phar-                         purposes of this paragraph (g) and it
                                macist shall attach this prescription to                   shall be maintained in accordance with
                                the oral emergency prescription which                      § 1304.04(h).
                                had earlier been reduced to writing.
                                                                                           [36 FR 7799, Apr. 24, 1971, as amended at 36
                                The pharmacist shall notify the near-                      FR 18733, Sept. 21, 1971. Redesignated at 38
                                est office of the Administration if the                    FR 26609, Sept. 24, 1973 and amended at 53 FR
                                prescribing      individual   practitioner                 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994;
                                fails to deliver a written prescription                    59 FR 30832, June 15, 1994; 62 FR 13964, Mar.
                                to him; failure of the pharmacist to do                    24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410,
                                so shall void the authority conferred                      June 24, 2003]
                                by this paragraph to dispense without
                                a written prescription of a prescribing                    § 1306.12     Refilling prescriptions.
                                individual practitioner.                                     The refilling of a prescription for a
                                   (5) Central fill pharmacies shall not                   controlled substance listed in Schedule
                                be authorized under this paragraph to                      II is prohibited.
                                prepare prescriptions for a controlled
                                substance listed in Schedule II upon re-                   § 1306.13 Partial       filling    of      prescrip-
                                ceiving an oral authorization from a                           tions.
                                retail pharmacist or an individual                            (a) The partial filling of a prescrip-
                                practitioner.                                              tion for a controlled substance listed in
                                   (e) A prescription prepared in accord-                  Schedule II is permissible, if the phar-
                                ance with § 1306.05 written for a Sched-                   macist is unable to supply the full
                                ule II narcotic substance to be com-                       quantity called for in a written or
                                pounded for the direct administration                      emergency oral prescription and he
                                to a patient by parenteral, intra-                         makes a notation of the quantity sup-
                                venous, intramuscular, subcutaneous                        plied on the face of the written pre-
                                or intraspinal infusion may be trans-                      scription (or written record of the
                                mitted by the practitioner or the prac-                    emergency oral prescription). The re-
                                titioner’s agent to the pharmacy by                        maining portion of the prescription
                                facsimile. The facsimile serves as the                     may be filled within 72 hours of the
                                original written prescription for pur-                     first partial filling; however, if the re-
                                poses of this paragraph (e) and it shall                   maining portion is not or cannot be
                                be maintained in accordance with                           filled within the 72-hour period, the
                                § 1304.04(h) of this chapter.                              pharmacist shall so notify the pre-
                                   (f) A prescription prepared in accord-                  scribing individual practitioner. No
                                ance with § 1306.05 written for Schedule                   further quantity may be supplied be-
                                II substance for a resident of a Long                      yond 72 hours without a new prescrip-
                                Term Care Facility may be trans-                           tion.
                                mitted by the practitioner or the prac-                       (b) A prescription for a Schedule II
                                titioner’s agent to the dispensing phar-                   controlled substance written for a pa-
                                macy by facsimile. The facsimile                           tient in a Long Term Care Facility
                                serves as the original written prescrip-                   (LTCF) or for a patient with a medical
                                tion for purposes of this paragraph (f)                    diagnosis documenting a terminal ill-
                                and it shall be maintained in accord-                      ness may be filled in partial quantities
                                ance with § 1304.04(h).                                    to include individual dosage units. If
                                   (g) A prescription prepared in accord-                  there is any question whether a patient
                                ance with § 1306.05 written for a Sched-                   may be classified as having a terminal
                                ule II narcotic substance for a patient                    illness, the pharmacist must contact
                                enrolled in a hospice care program cer-                    the practitioner prior to partially fill-
                                tified and/or paid for by Medicare under                   ing the prescription. Both the phar-
                                Title XVIII or a hospice program which                     macist and the prescribing practitioner
                                is licensed by the state may be trans-                     have a corresponding responsibility to
                                mitted by the practitioner or the prac-                    assure that the controlled substance is
                                titioner’s agent to the dispensing phar-                   for a terminally ill patient. The phar-
                                macy by facsimile. The practitioner or                     macist must record on the prescription
                                the practitioner’s agent will note on                      whether the patient is ‘‘terminally ill’’


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