Schedule II drugs have recognized medical uses as well as a potential for dependence and abuse. CONTROLLED SUBSTANCES. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (e.g., postmark). (c) 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 that is dispensed for immediate administration to the ultimate user. (f) Notwithstanding the definition of dispense under section 102(10) of the Act (21 U.S.C 802(10)), a pharmacy may deliver a controlled substance to a practitioner, pursuant to a prescription that meets the requirements under 1306.04 for the purpose of administering the controlled substance by the practitioner if: (1) The controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location, listed on the practitioner's certificate of registration; (2) The controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2)(G)(iii) of the Act (21 U.S.C. from the practitioner's computer to the pharmacy's computer. The quantity of Schedule III, IV or V controlled substances prescribed or dispensed at any one time shall be limited to a ninety-day supply and shall be prescribed and dispensed in compliance with the general provisions of sections 195.005 to 195.425. . 31, 2010], Controlled Substances Listed in Schedules III, IV, and V. (a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. (c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule III, IV, or V only pursuant to a paper prescription signed by an individual practitioner, a facsimile of a paper prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in 1306.05 except for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to 1306.07. That mechanism involves the use of condition codes, as delineated in section 80.67 (d)(1) of the Rules . [36 FR 7799, Apr. (6) Notwithstanding any exceptions under section 307 of the Act (21 U.S.C. Sec. . Schedule IV-V Drugs May be written and dispensed for up to a 90 day supply based on directions. 13:45H-7.5) . 24, 1997, as amended at 68 FR 37411, June 24, 2003]. H]o0+e|ILc4UhfPk],W'{CO ggBX@\~# (b) (1) An individual practitioner may issue multiple prescriptions authorizing the patient. (g) Central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this section. (c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription. Licensed Nurse Practitioners (NPs) who are registered with the Drug Enforcement Administration (DEA) are authorized to prescribe schedule II, III, IV, and V controlled substances. This placement is based upon the substance's medical use, potential for abuse, and safety or dependence liability. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). Not more than one day's medication may be administered to the person or for the person's use at one time. (d) The strength of the controlled drug prescribed. Electronic Code of Federal Regulations (eCFR). (b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973. The drug's intended duration, as defined by the prescriber, or the estimated number of days a prescription will last, based on the number of days a given prescription should last if taken according to the instructions. 31, 2010]. (1) A physician may delegate the prescription of controlled substances listed in schedules 2 to 5 to a registered nurse who holds a specialty certification under section 17210 of the code, MCL 333.17210, with the exception of a nurse anesthetist, if the delegating physician establishes a written authorization that contains all of the following 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 relating to controlled substances. The original prescription shall be maintained in accordance with 1304.04(h) of this chapter. 90-day supply required : 090 : The prescription is written for less than a 90-day supply. Section 80.63 - Prescribing. (a) When used for the treatment of acute pain, prescriptions for opiates or narcotic pain relievers listed in Schedules II through IV in section 152.02 shall not exceed a seven-day supply for an adult and shall not exceed a five-day supply for a minor under 18 years of age. (ii) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record. 90-day supply. 1306.11 Requirement of prescription. It prohibits dispensing or selling more than a 90-day supply of the drug, as determined according to the prescription's instructions for use . (v) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. the patient to receive up to a 90-day supply of a Schedule II CDS over those multiple prescriptions.6 Can a Schedule III-V prescription be refilled? (Ill. Admin. Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. Chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data are retained for online data entry as soon as the computer system is available for use again. (a) Schedule II Prescriptions. Ohio. When prescribing more than a 30-day supply of a controlled substance to treat one of the above conditions, a practitioner must write on the face of the prescription either the condition or the Code designating the condition. with a presumption that a three-day supply or . The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that: (a) Each partial filling is recorded in the same manner as a refilling, (b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and. . Prescriptions for controlled substances are limited to a 30-day supply. "Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety. (5) The total number of refills for that prescription. 31, 2010]. (iv) Number of valid refills remaining and date(s) and locations of previous refill(s). The controlled substance law and regulations may be viewed online at: www.nyhealth.gov/professionals/narcotic/. 823(g)); and. Narcolepsy May be refilled up to 5 times in 6 months. . Sec. Prescriptions. If such an application provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. When prescribing more than a 30-day supply of a controlled substance to treat one of the above conditions, a practitioner must write on the face of the prescription either the condition or the Code designating the condition. 802) or part 1300 of this chapter. (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. (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 detoxification treatment if the practitioner meets both of the following conditions: (1) The practitioner is separately registered with DEA as a narcotic treatment program. The Official Prescription Program and Electronic Prescribing (CSA) lists substances which were controlled in 1970 when the CSA was enacted. (2) A CRNP may prescribe a Schedule III or IV controlled substance for up to a 90 day supply as identified in the collaborative agreement. A corresponding liability 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. Both transmissions are considered electronic prescribing, therefore it is Subd. 453.440 Prescriptions: Contents; additions and changes. If it has a code on it, you may dispense up to a 90 day supply with 1 refill: Code A: Panic Disorders, Code B: ADHD, Code C: Seizure/convulsive disorders, Code D: Pain, Code E: Narcolepsy. Such prescription issued by a qualifying practitioner shall not be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients. For electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record. Sec. (2) The transferring pharmacist must do the following: (i) Write the word "VOID" on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record. (vi) Name of pharmacist who transferred the prescription. (b) The central fill pharmacy receiving the transmitted prescription must: (1) Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription; (2) Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling of the prescription; (3) Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. Search for your medication and dose with the Check Drug Cost tool. (225 ILCS 65/65-40 (a)). 31, 2010]. Controlled Substance Prescribing by Nurse Practitioners and Physician's Assistants An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. Note: If you need help accessing information in different file formats, see CHAPTER 25 CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS GENERAL PROVISIONS 25.1. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13966, Mar. Prescriptions for controlled substances are limited to a 30-day supply. (d) If the content of any of the information required under 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance. Narcolepsy Code D Emergency refill of schedule III-V control substances extended to a 30-day supply; a pharmacist may dispense a one-time emergency refill of a 90-day supply for a non-controlled medication Electronic entry. day, nor does it allow pharmacists to fill prescriptions written more than 30 days prior to presentation. (c) 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: (1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription and the information required in 1306.13(b). (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 means 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. (2) Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. However, a practitioner may prescribe up to a three-month supply of a controlled substance, including human chorionic gonadotropin (hcg), or up to a six-month supply of an anabolic steroid for treatment of the following conditions: When prescribing more than a 30-day supply of a controlled substance to treat one of the above conditions, a practitioner must write on the face of the prescription either the condition or the Code designating the condition. 24, 1997]. The dispensing for a period not in excess of twenty-one days, of a narcotic ((substances. (b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, IV, or V in the course of his/her professional practice without a prescription, subject to 1306.07. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, June 24, 2003; 75 FR 16307, Mar. amended Oct. 26, 1972, P.L.1048, No.263) "Controlled substance" means a drug, substance, or immediate precursor included in schedules I through V of this act. Unfortunately, the final language that was passed in HB 2250 ( attached ) is being interpreted to restrict the prescribing of schedule II and III controlled . 1306.26 Dispensing without prescription. (e) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law. (e) A prescription prepared in accordance with 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. (1) A physician may delegate the prescription of controlled substances listed in schedules 2 to 5 to a registered nurse who holds a specialty certification under section 17210 of the code, MCL 333.17210, 823(g)(2)(G)(iii)); and, (i) The practitioner who issued the prescription is a qualifying practitioner as defined in section 303(g) of the Act (21 U.S.C. (a) A person knowingly and unlawfully manufacturing or cultivating a regulated drug shall be imprisoned not more than 20 years or fined not more than $1,000,000.00, or both. endstream endobj 84 0 obj <>stream (a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. (2) Any such proposed computerized application must also provide online retrieval (via computer monitor or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months). (d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed. A CDS prescription must be presented for filling no more than 30 days after the date on which it was written, regardless of the schedule. (4) For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data: (ii) The number of refills remaining and the date(s) and locations of previous refills. (a) The Legislature finds that every competent adult has the fundamental right of self-determination regarding decisions pertaining to his or her own health, including the right to refuse an opioid drug listed as a Schedule II controlled substance in s. 893.03 or 21 U.S.C. 1306.22 Refilling of prescriptions. 1306.13 Partial filling of prescriptions. (c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized: Provided, That: (1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time; (2) The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration; (3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V; and. Rule 111. Title 21 CFR, . Must be used as adjunctive treatment with a Division of Alcohol and Substance Abuse (DASA) state-certified intensive outpatient chemical dependency treatment program. CIII-CV may have up to 5 refills. 453.420 Dispensing of schedule II controlled substance in emergency. 1306.03 Persons entitled to issue prescriptions. (2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription. The controlled substance law and regulations may be viewed online at: www.nyhealth.gov/professionals/narcotic/. (g) When filing refill information for original paper, fax, or oral prescription orders for Schedule III or IV controlled substances, a pharmacy may use only one of the two applications described in paragraphs (a) through (e) or (f) of this section. (f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law. Controlled Substance Prescribing by Nurse Practitioners and Physician's Assistants Prescription Code B Practitioners are required to review a patient's controlled substance prescription history and opioid antidote administration history, pursuant to Section 44-130-60 or 44-130-80, before issuing a prescription for a Schedule II controlled substance in accordance with Section 44-53-1645 (A). Smith, or John H. Smith). . longterm care facilities which are not registered with the DEA shall meet all of the following requirements regarding emergency kits containing controlled substances: (1)The source of supply must be a DEA registered hospital, pharmacy or practitioner. (v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law. Code B 1306.04 Purpose of issue of prescription. Sec. No later than the close of business on the next business day after dispensing a controlled substance . At least 45 hours of graduate level pharmacology and annual completion of 5 hours 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 has been reviewed by him and is correct as shown. sodium: 041 Diagnosis of alcohol dependency. May a prescriber issue more than one controlled substance on a single prescription blank? (2) Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription; Authority: 21 U.S.C. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. This is of course a significant change from the prior law regarding the . A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. A prescription for a controlled substance may only be filled by a pharmacist, 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 institutional practitioner. 24, 1997]. Section 80.64 - Who may issue. (a) An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements: (1) The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part; (2) The practitioner must use an application that meets the requirements of part 1311 of this chapter; and. CHAPTER 25 CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS GENERAL PROVISIONS 25.1. 1306.07 Administering or dispensing of narcotic drugs. 24, 1997, as amended at 75 FR 16308, Mar. Contact the NC Department of Health & Human Services, Drug Control Unit at (919) 733-1765 for disposal or destruction of controlled substance medications in: - Hospitals. A mechanism already exists, however, for practitioners in N.Y. State to provide patients with a 90-day supply of a controlled substance. Licensed Physician's Assistants (PAs) who are registered with DEA may prescribe schedule III, IV, and V controlled substances if authorized by a supervising physician. [68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005]. Prescriptions become void unless dispensed within 180 days of original date written. Section 80.67 - Schedule II and certain other substances. . The following words and terms when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: ActThe Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. 780-101 780-144). 1306.06 Persons entitled to fill prescriptions. (ii) The controlled substance is to be administered by injection or implantation; (3) The pharmacy and the practitioner are authorized to conduct such activities specified in this paragraph (f) under the law of the State in which such activities take place; (4) The prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients; (5) The controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and.