HHS 21 CFR PART 1306-2011 PRESCRIPTIONS《处方》.pdf

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1、90 21 CFR Ch. II (4111 Edition) 1305.27 record of the second order and a copy of the statement with the record of the first order and retain them. (c) If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is Not Accepted and return i

2、t to the purchaser. The purchaser must link the returned order to the record of that order and the statement. 1305.27 Preservation of electronic or-ders. (a) A purchaser must, for each order filled, retain the original signed order and all linked records for that order for two years. The purchaser m

3、ust also re-tain all copies of each unaccepted or defective order and each linked state-ment. (b) A supplier must retain each origi-nal order filled and the linked records for two years. (c) If electronic order records are maintained on a central server, the records must be readily retrievable at th

4、e registered location. 1305.28 Canceling and voiding elec-tronic orders. (a) A supplier may void all or part of an electronic order by notifying the purchaser of the voiding. If the entire order is voided, the supplier must make an electronic copy of the order, indi-cate on the copy Void, and return

5、 it to the purchaser. The supplier is not required to retain a record of orders that are not filled. (b) The purchaser must retain an electronic copy of the voided order. (c) To partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided. 13

6、05.29 Reporting to DEA. A supplier must, for each electronic order filled, forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within two busi-ness days. PART 1306PRESCRIPTIONS GENERAL INFORMATION Sec. 1306.01 Scope of part 1306. 1

7、306.02 Definitions. 1306.03 Persons entitled to issue prescrip-tions. 1306.04 Purpose of issue of prescription. 1306.05 Manner of issuance of prescriptions. 1306.06 Persons entitled to fill prescriptions. 1306.07 Administering or dispensing of nar-cotic drugs. 1306.08 Electronic prescriptions. 1306.

8、09 Prescription requirements for online pharmacies. CONTROLLED SUBSTANCES LISTED IN SCHEDULE II 1306.11 Requirement of prescription. 1306.12 Refilling prescriptions; issuance of multiple prescriptions. 1306.13 Partial filling of prescriptions. 1306.14 Labeling of substances and filling of prescripti

9、ons. 1306.15 Provision of prescription informa-tion between retail pharmacies and cen-tral fill pharmacies for prescriptions of Schedule II controlled substances. CONTROLLED SUBSTANCES LISTED IN SCHEDULES III, IV, AND V 1306.21 Requirement of prescription. 1306.22 Refilling of prescriptions. 1306.23

10、 Partial filling of prescriptions. 1306.24 Labeling of substances and filling of prescriptions. 1306.25 Transfer between pharmacies of pre-scription information for Schedules III, IV, and V controlled substances for refill purposes. 1306.26 Dispensing without prescription. 1306.27 Provision of presc

11、ription informa-tion between retail pharmacies and cen-tral fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances. AUTHORITY: 21 U.S.C. 821, 829, 831, 871(b), unless otherwise noted. SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, unless

12、otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. GENERAL INFORMATION 1306.01 Scope of part 1306. Rules governing the issuance, filling and filing of prescriptions pursuant to section 309 of the Act (21 U.S.C. 829) are set forth generally in that section and specifically by the sections

13、of this part. 1306.02 Definitions. Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter. 62 FR 13964, Mar. 24, 1997 VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00100 Fmt 8010 Sfmt 8010 Y:SGML223073.X

14、XX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-91 Drug Enforcement Administration, Justice 1306.05 1306.03 Persons entitled to issue pre-scriptions. (a) A prescription for a controlled substance may be issued

15、 only by an in-dividual practitioner who is: (1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2) Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. (b) A prescription issued

16、by an indi-vidual practitioner may be commu-nicated to a pharmacist by an em-ployee or agent of the individual prac-titioner. 36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, Mar. 24, 1997 1306.04 Purpose of

17、 issue of prescrip-tion. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled sub

18、stances is upon the pre-scribing practitioner, but a cor-responding responsibility rests with the pharmacist who fills the prescrip-tion. An order purporting to be a pre-scription issued not in the usual course of professional treatment or in legiti-mate and authorized research is not a prescription

19、 within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law re-lating to controlled substances. (b) A pres

20、cription may not be issued in order for an individual practitioner to obtain controlled substances for sup-plying the individual practitioner for the purpose of general dispensing to pa-tients. (c) A prescription may not be issued for detoxification treatment or maintenance treatment, unless the pre

21、scription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxifica-tion treatment and the practitioner is in compliance with requirements in 1301.28 of this chapter. 36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 2

22、6609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005 1306.05 Manner of issuance of pre-scriptions. (a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient,

23、the drug name, strength, dosage form, quantity prescribed, di-rections for use, and the name, address and registration number of the practi-tioner. (b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for detoxification treatment or maintenance treat-ment must i

24、nclude the identification number issued by the Administrator under 1301.28(d) of this chapter or a written notice stating that the practi-tioner is acting under the good faith exception of 1301.28(e) of this chapter. (c) Where a prescription is for gamma-hydroxybutyric acid, the prac-titioner shall

25、note on the face of the prescription the medical need of the patient for the prescription. (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions sha

26、ll be written with ink or indelible pencil, type-writer, or printed on a computer print-er and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. (e) Electronic prescriptions shall be created and s

27、igned using an application that meets the requirements of part 1311 of this chapter. (f) A prescription may be prepared by the secretary or agent for the signa-ture of a practitioner, but the pre-scribing practitioner is responsible in case the prescription does not conform in all essential respects

28、 to the law and regulations. A corresponding liability VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00101 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-92 21 CF

29、R Ch. II (4111 Edition) 1306.06 rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations. (g) An individual practitioner ex-empted from registration under 1301.22(c) of this chapter shall in

30、clude on all prescriptions issued by him the registration number of the hospital or other institution and the special inter-nal code number assigned to him by the hospital or other institution as provided in 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required

31、by this sec-tion. Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practi-tioner. (h) An official exempted from reg-istration under 1301.23(a) of this chap-ter must include on all prescriptions issued by him his bra

32、nch of service or agency (e.g., U.S. Army or Public Health Service) and his service identi-fication number, in lieu of the registra-tion number of the practitioner re-quired by this section. The service identification number for a Public Health Service employee is his Social Security identification

33、number. Each paper prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signa-ture of the officer. 75 FR 16307, Mar. 31, 2010 1306.06 Persons entitled to fill pre-scriptions. A prescription for a controlled sub-stance may only be filled by a phar-macis

34、t, acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or registered in-stitutional practitioner. 68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005 1306.07 Administerin

35、g or dispensing of narcotic drugs. (a) A practitioner may administer or dispense directly (but not prescribe) a narcotic drug listed in any schedule to a narcotic dependant person for the purpose of maintenance or detoxifica-tion treatment if the practitioner meets both of the following conditions:

36、(1) The practitioner is separately reg-istered with DEA as a narcotic treat-ment program. (2) The practitioner is in compliance with DEA regulations regarding treat-ment qualifications, security, records, and unsupervised use of the drugs pur-suant to the Act. (b) Nothing in this section shall pro-h

37、ibit a physician who is not specifi-cally registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when nec-essary while arrangements are being made for referral for treatment. Not mo

38、re than one days medication may be administered to the person or for the persons use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended. (c) This section is not intended to im-pose any limitations on a physician or authorized hosp

39、ital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or sur-gical treatment of conditions other than addiction, or to administer or dis-pense narcotic drugs to persons with intractable pain in which no relief or cure i

40、s possible or none has been found after reasonable efforts. (d) A practitioner may administer or dispense (including prescribe) any Schedule III, IV, or V narcotic drug ap-proved by the Food and Drug Adminis-tration specifically for use in mainte-nance or detoxification treatment to a narcotic depen

41、dent person if the practi-tioner complies with the requirements of 1301.28 of this chapter. 39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005 1306.08 Electronic prescriptions. (a) An individual practitioner may sign and transmit electronic prescrip-tions for controlled substances

42、pro-vided the practitioner meets all of the following requirements: (1) The practitioner must comply with all other requirements for issuing VerDate Mar2010 07:57 May 04, 2011 Jkt 223073 PO 00000 Frm 00102 Fmt 8010 Sfmt 8010 Y:SGML223073.XXX 223073erowe on DSK5CLS3C1PROD with CFRProvided by IHSNot f

43、or ResaleNo reproduction or networking permitted without license from IHS-,-,-93 Drug Enforcement Administration, Justice 1306.11 controlled substance prescriptions in this part; (2) The practitioner must use an ap-plication that meets the requirements of part 1311 of this chapter; and (3) The pract

44、itioner must comply with the requirements for practitioners in part 1311 of this chapter. (b) A pharmacy may fill an electroni-cally transmitted prescription for a controlled substance provided the phar-macy complies with all other require-ments for filling controlled substance prescriptions in this

45、 part and with the requirements of part 1311 of this chap-ter. (c) To annotate an electronic pre-scription, a pharmacist must include all of the information that this part re-quires in the prescription record. (d) If the content of any of the infor-mation required under 1306.05 for a controlled subs

46、tance prescription is al-tered during the transmission, the pre-scription is deemed to be invalid and the pharmacy may not dispense the controlled substance. 75 FR 16307, Mar. 31, 2010 1306.09 Prescription requirements for online pharmacies. (a) No controlled substance that is a prescription drug ma

47、y be delivered, distributed, or dispensed by means of the Internet without a valid prescrip-tion. (b) In accordance with the Act, it is unlawful for any person to knowingly or intentionally fill a prescription for a controlled substance that was issued in a manner that constitutes dispensing by mean

48、s of the Internet unless such person is a pharmacist who is acting in the usual course of his professional practice and is acting on behalf of a pharmacy whose registration has been modified under sections 1301.13 and 1301.19 of this chapter to authorize it to operate as an online pharmacy. (c) Any

49、online pharmacy that partici-pates in the transfer between phar-macies of prescription information must do so in accordance with the re-quirements of 1306.15 and 1306.25 of this part. 74 FR 15624, Apr. 6, 2009 CONTROLLED SUBSTANCES LISTED IN SCHEDULE II 1306.11 Requirement of prescription. (a) A pharmacist may dispense di-rectly a controlled substance listed in Schedule II that is a prescription drug as