The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. (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. Contact: Bobbi Dresser, Program Analyst, (for general information). Read a description of the Office of the Director Administrative Management Branch. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). (b) Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. Silver Spring, MD 20993-0002, U.S. Food & Drug Administration Unique Device Identification: Direct Marking of Devices Final GuidancePresentationPrintable SlidesTranscript, 7. Global Unique Device Identification Database (GUDID) Account Request: Preparation and ProcessPresentationPrintable SlidesTranscript, 3. Office of Device Evaluation (f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005; 85 FR 69167, Nov. 2, 2020]. Assistant Director for Committee Management and Planning. [36 FR 7799, Apr. (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. Email: OCE@fda.hhs.gov. (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. (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. 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. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with 1304.04(h). (vi) Name of pharmacist who transferred the prescription. 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes. Center for Devices and Radiological Health (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. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. (3) For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to 1306.21(a), the pharmacist receiving the transferred prescription information must write the word "transfer" on the face of the transferred prescription and reduce to writing all information required to be on a prescription pursuant to 1306.05 and include: (i) Date of issuance of original prescription. The .gov means its official.Federal government websites often end in .gov or .mil. For more information see www.imdrf.org. [36 FR 18733, Sept. 21, 1971. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. Deputy Division Director. Controlled Substances Listed in Schedule II. 10903 New Hampshire Avenue 1306.13 Partial filling of prescriptions. Digital Imaging and Communications in Medicine (DICOM) is the standard for the communication and management of medical imaging information and related data. (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. Training and Continuing Education, Recalls, Market Withdrawals and Safety Alerts, How to submit a Small Business Certification Request, Unique Device Identification (UDI) System, 510(k) Third Party Review Program (for Third Party Review Organizations), Workshop Page with Presentation in Segments, Workshop Page with Presentation inSegments. (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. Go to Staff Directory home Browse Staff by Office Office of the Director Administrative Management Branch Select staff are listed in alphabetical order by last name. [36 FR 7799, Apr. Who We Are. 24, 1971; 36 FR 13386, July 21, 1971, unless otherwise noted. | Note: For HHS OIG personnel inquiries, please proceed to https://oig.hhs.gov/ WO62-3214 Sec. If you encounter a viewing error, we suggest you try another browser. (e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. (c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record. Gaithersburg, MD 20877. The .gov means it's official. 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 paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. (3) Retrieval of partially filled Schedule II prescription information is the same as required by 1306.22(b) (4) and (5) for Schedule III and IV prescription refill information. (g) An individual practitioner exempted from registration under 1301.22(c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal 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 by this section. Someone asked me for staff emails just a few days ago, and I looked the person up, got their email, but also provided the main directory link. (4) The initials of the dispensing pharmacist for each refill. It must be verified and signed by each pharmacist who is involved with such dispensing. Center for Devices and Radiological Health For more specific information including emails and phone numbers seethe CDRH Management Directory by Organization. Food, Drug & Cosmetic Act - Laws and amendments giving the U.S. Food and Drug Administration regulatory authority over food, drugs, cosmetics, medical devices, biologics, animal drugs and feed, radiation-emitting products, and tobacco Part D, Chapter D-B, (Food and Drug Administration), the Statement of Organization, Functions and Delegations of Authority for the Department of Health and Human Services ( 35 FR 3685, February 25, 1970, 60 FR 56606, November 9, 1995, 64 FR 36361, July 6, 1999, 72 FR 50112, August 30, 2007, 74 FR 41713, August 18, 2009, 76 FR 45270, July 28 . Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order. 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. (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. Silver Spring, MD 20993-0002, U.S. Food & Drug Administration (v) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription information was transferred. Before sharing sensitive information, make sure you're on a federal government site. (h) When filing refill information for electronic prescriptions, a pharmacy must use an application that meets the requirements of part 1311 of this chapter. (ii) Original number of refills authorized on original prescription. 12720 Twinbrook Parkway. CDRH encourages the medical device industry to consider engaging with patients in the design and conduct of clinical investigations. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 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. (a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. 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. 31, 2010]. Drug Databases NDC National Drug Code Directory The National Drug Code (NDC) Directory is updated daily. 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. 823(g)); and. . 10903 New Hampshire Avenue (b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. 821, 823, 829, 829a, 831, 871(b) unless otherwise noted. The site is secure. Office of Management Operations united states food and drug administration. 24, 1971. 827), the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, shall maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of, under this paragraph (f), including the persons to whom the controlled substances were delivered and such other information as may be required under this chapter. (d) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal. 24, 1997]. (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. For at least 15 years, there's been an HHS Online Directory of all staff (HHS, CMS, FDA, etc), providing name, agency, department, phone, and email. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. (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. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 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. Recognized Consensus Standards. (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. operate to bind FDA or the public. Sec. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, Mar. 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. 24, 1997; 75 FR 16308, Mar. To make corrections, see the HHS directory contact list. (2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted. In the fall of 2018, the U.S. Food & Drug Administration's (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization in years to initiate the Total Product Life Cycle (TPLC) approach across the institution (read more here).Fast forward to May 1, 2019the date that the CDRH declared that it had fully implemented the new TPLC organizational . (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). Sec. (iii) The transferring pharmacy's name, address, DEA registration number, and prescription number for each dispensing. Silver Spring, MD 20993-0002, U.S. Food & Drug Administration 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. For network communications, a set of protocols to be followed by devices claiming conformance to the Standard. Sec. The syntax and semantics of Commands and . Instructions for Downloading Viewers and Players. 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. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. Office of the Center Director (a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. The information on this page is current as of Jun 07, 2023. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13966, Mar. 1306.14 Labeling of substances and filling of prescriptions. according to the FDA-recognized consensus standard, ES 60601-1. For general questions about medical devices regulation . the central fill pharmacy's DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section. (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. - Usability was documented by referring to IEC 60601-1-6. The FDA is currently developing draft guidance for public comment to help industry and FDA staff understand how the 21st Century Cures Act affects FDA's oversight of medical device software. This information is current as of July 7, 2023, Assistant Director for Employee Engagement and (2) Either registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter. 1306.11 Requirement of prescription. 802) or part 1300 of this chapter. Sec. U.S. Food & Drug Administration corporate office is located in 10903 New Hampshire Ave Rm 5129, Silver Spring, Maryland, 20993, United States and has 17,168 employees. (d) A practitioner may administer or dispense (including prescribe) any Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to a narcotic dependent person if the practitioner complies with the requirements of 1301.28 of this chapter. (c) Any online pharmacy that participates in the transfer between pharmacies of prescription information must do so in accordance with the requirements of 1306.15 and 1306.25 of this part. private, common or contract carrier). Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner. (b) Nothing in this section shall prohibit a physician who is not specifically 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 necessary while arrangements are being made for referral for treatment. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, The information on this page is current as of. (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. (3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription. Sec. 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Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill. Digital Communication Media Staff. (e) The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met: (1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription. 829) are set forth generally in that section and specifically by the sections of this part. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. Before sharing sensitive information, make sure you're on a federal government site. 301-796-2452. Device Advice is CDRH's premier text-based resource for comprehensive regulatory education that explains medical device laws, regulations, guidances, and policies, across the entire product life cycle. 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. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." 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fda cdrh staff directory
