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Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 FR 13965, Mar. No. CIII-CV may have up to 5 refills. (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. (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. day supply. endstream endobj 84 0 obj <>stream (5) The total number of refills for that prescription. [36 FR 7799, Apr. You may dispense up to a 90-day supply for drugs that fall under this category. (b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for "detoxification treatment" or "maintenance treatment" must include the identification number issued by the Administrator under 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of 1301.28(e) of this chapter. Attention deficit disorder Panic disorder (g) Central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this section. 1306.23 Partial filling of prescriptions. (4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation. (2) Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. Sec. Under parameters established by the New York State Board of Pharmacy, prescriptions for non-controlled substances may continue to be electronically transmitted to the pharmacy, either: (vii) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription was originally filled. . (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. The retail pharmacy transmitting the prescription information must: (1) Write the words "CENTRAL FILL" on the face of the original paper prescription and record 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. Both transmissions are considered electronic prescribing, therefore it is Section 812 of the Controlled Substances Act ( 21 U.S.C. (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. (a) A prescription for a controlled substance may be issued only by an individual practitioner who is: (1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and. Phar 8.08 Controlled substances in emergency kits for longterm care facilities. CHAPTER 25 CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS GENERAL PROVISIONS 25.1. ( a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 90-day supply required : 090 : The prescription is written for less than a 90-day supply. Controlled Substances in Schedules III-V may always be prescribed by oral prescription under 21 U.S.C. 823(g)); and. "Control" means to regulate or change the placement of a controlled substance or immediate precursor; under the provisions of this act. (c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record. (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. (a) A pharmacist may dispense not more than a 90-day supply of a dangerous drug other than a controlled substance pursuant to a valid prescription that specifies an initial quantity of less than a 90-day supply followed by periodic refills of that amount if all of the following requirements are satisfied: The dispensing for a period not in excess of twenty-one days, of a narcotic ((substances. Smith, or John H. Smith). Texas Medical Board Guidelines for Pain Management (Texas Administrative Code 170.3) Code C 24, 1997, as amended at 75 FR 16308, Mar. (iii) The transferring pharmacy's name, address, DEA registration number, and prescription number for each dispensing. 31, 2010]. Not more than one day's medication may be administered to the person or for the person's use at one time. (2) The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the Act. Only one controlled drug shall appear on a prescription blank. Chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity 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. Quantities Allowable on Controlled Substance Prescriptions 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). Practitioners with questions about official prescriptions or controlled substances may contact the Bureau of Narcotic Enforcement at (866) 811-7957 or online at: narcotic@health.ny.gov. Practitioners with questions about official prescriptions or controlled substances may contact the Bureau of Narcotic Enforcement at (866) 811-7957 or online at: narcotic@health.ny.gov. (3) The practitioner must comply with the requirements for practitioners in part 1311 of this chapter. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. Schedule IV-V Drugs May be written and dispensed for up to a 90 day supply based on directions. 13:35-7.2(h)) Under parameters established by the New York State Board of Pharmacy, prescriptions for non-controlled substances may continue to be electronically transmitted to the pharmacy, either: Both transmissions are considered electronic prescribing, therefore it is (3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application. (c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, That: (1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time; (2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration; (3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. 1306.22 Refilling of prescriptions. 1306.05 Manner of issuance of prescriptions. Code B (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. the last working day of November 2021. Your doctor must send these to us electronically through a certified system. (2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted. The Controlled Substances Act (CSA) places all regulated substances under existing federal law into 1 of 5 schedules. 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. (a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing 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 such prescription or required by law. Instructions for Downloading Viewers and Players. (5) Central fill pharmacies shall not be authorized under this paragraph to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner. 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. (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. (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 (v) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. Yes. pressure is not controlled by any: a . Source: 36 FR 7799, Apr. cannot prescribe or dispense more than a three-day supply of the controlled substance. Sec. Sec. Controlled Substance Update - Practitioners Newsletter December 2006, Health & Safety in the Home, Workplace & Outdoors, Clinical Guidelines, Standards & Quality of Care, All Health Care Professionals & Patient Safety, Opioid Treatment Guidelines and Other Information for Healthcare Professionals and Patients Center for Disease Control and Prevention (CDC), James V. McDonald, M.D., M.P.H., Acting Commissioner, Multisystem Inflammatory Syndrome in Children (MIS-C), Addressing the Opioid Epidemic in New York State, Health Care and Mental Hygiene Worker Bonus Program, Maternal Mortality & Disparate Racial Outcomes, Help Increasing the Text Size in Your Web Browser, from the practitioner's computer to the pharmacy's fax machine; or. (vi) Name of pharmacist who transferred the prescription. 1306.21 Requirement of prescription. Prescriptions. Title 21 CFR, . (e) The specific directions for use of the controlled drug by the patient. (h) An official exempted from registration under 1301.23(a) of this chapter must include on all prescriptions issued by him his branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and his service identification number, in lieu of the registration number of the practitioner required by this section. During the 2018 legislative session, HB 2250 passed, which was intended to certify PAs for 90-day prescription privileges for non-opioid schedule II and III controlled substances. "Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety. (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. Corresponding Responsibility - A Shared Obligation. The controlled substance law and regulations may be viewed online at: www.nyhealth.gov/professionals/narcotic/. (1) the prescriber has specified on the prescription that, due to medical necessity, the pharmacist may not exceed the number of dosage units identified on the prescription; or (2) the prescription drug is a controlled substance, as defined in section 152.01, subdivision 4. 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. (2) Ensure that all information required to be on a prescription pursuant to Section 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information); (3) Maintain the original prescription for a period of two years from the date the prescription was filled; (4) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery. 24, 1971. (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. The controlled substance law and regulations may be viewed online at: www.nyhealth.gov/professionals/narcotic/. (b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: (i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice; (ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; (iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; (iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and. (ii) Original number of refills authorized on original prescription. (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. 3. (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. Sec. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Narcolepsy CHAPTER 315. More information can be found in Title 21 United States Code (USC) Controlled Substances Act. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. (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. (iv) The name of the pharmacist transferring the prescription. Then, choose your prescriber and select "Request a New Prescription," and click "Submit Refills" once you've reviewed your order. (g) A prescription prepared in accordance with 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare 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. Schedule II drugs have recognized medical uses as well as a potential for dependence and abuse. 24, 1971. 1306.27 Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances. Search for your medication and dose with the Check Drug Cost tool. 13:45H-7.5) . The retail pharmacy transmitting the prescription information must: (1) Write the word "CENTRAL FILL" on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal; (2) Ensure that all information required to be on a prescription pursuant to 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information); (3) Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining; (4) Maintain the original prescription for a period of two years from the date the prescription was last refilled; (5) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery. Chapter 69.50 RCW: UNIFORM CONTROLLED SUBSTANCES ACT RCWs > Title 69 > Chapter 69.50 Complete Chapter HTML PDF | RCW Dispositions Chapter 69.50 RCW UNIFORM CONTROLLED SUBSTANCES ACT Sections NOTES: Drug nuisances Injunctions: Chapter 7.43 RCW. All rules governing pharmacies and pharmacy practice are consolidated into the new chapter 246-945 WAC. Sec. This new law encompasses 205 pages and imposes new obligations on practitioners that carry . The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. (N.J.A.C. Must be used as adjunctive treatment with a Division of Alcohol and Substance Abuse (DASA) state-certified intensive outpatient chemical dependency treatment program. The original prescription shall be maintained in accordance with 1304.04(h) of this chapter. (a) The partial filling of a prescription for a controlled 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 he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. [62 FR 13965, Mar. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. RULE 315.3. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so. (b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to 1306.07. (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. [68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005]. Since then many substances have been added, removed, or transferred from one schedule to another. with a presumption that a three-day supply or . If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable. Sec. What We Do (5) The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (b)(4) of this section. A controlled substance prescription issued by a PA must contain the imprinted names of (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). 10. Sec. (e) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law. Sec. (b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter. Section 80.66 - Schedule I substances. It must be verified and signed by each pharmacist who is involved with such dispensing. (b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. Prime Example Hospital 1 Main Street NY, NY 10000 (888) 888-8888 Drug:oxycodone/acetaminophen Strength/Dosage form:2.5mg/325mg tab Sig:Take 1 tab po q6hrs prn pain Qty:360 "three hundred sixty" MDD:4 tabs Days Supply: 90 days Code:D Indication:Pain Codes Required for >30 Day Supply of Controlled Substances Code A - Panic Disorders Code B - Q@|FS752B. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order. The controlled substance law and regulations may be viewed online at: www.nyhealth.gov/professionals/narcotic/. 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. This printout of the day's controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed.