delaware board of pharmacy regulations

Del. For a complete copy of the Delaware Medical Marijuana Act, contact the DPH Office of Medical Marijuana, or Laws, c. 368, § 13; 68 Del. (a) The Board shall hold regularly scheduled business meetings at least 6 times in a calendar year, and at other times as the President of the Board considers necessary, and at the request of a majority of the Board members. Delaware law also . Laws, c. 167, § 1; 79 Del. Fiscal year: The fiscal year is the accounting period for the government. In addition, the present (outgoing) and prospective (incoming) PICs must inventory all medications covered under 16 Del. Laws, c. 452, § 2; 65 Del. Laws, c. 167, § 1; 79 Del. Registration requirements, exemptions, inspections o §4739. Del. NOTICE: The Delaware Code appearing on this site is prepared by the Delaware Code Revisors and the editorial staff of LexisNexis in cooperation with the Division of Research of Legislative Council of the General Assembly, and is considered an official version of the State of Delaware statutory code. By a charitable organization described in § 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 68 Del. (c) The Board shall submit a written report to the Governor within 3 months after the conclusion of each fiscal year and shall make the report available to anyone requesting a copy. If you do not already have an e-mail address, you can obtain a free e-mail address through: gmail.com, yahoo.com, aol.com, hotmail.com or ymail.com 1.3. Answer: Section 11.6 of the Board’s Rules and Regulations delineates the duties and responsibilities of a consultant pharmacist and provider pharmacy. (26) “Prescription drug” or “legend drug” means a drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients, subject to § 503(b) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. Section 1.5 explains CE programs. (17) “Originating site” means a site in Delaware at which a patient is located at the time health-care services are provided to him or her by means of telemedicine or telehealth, unless the term is otherwise defined with respect to the provision in which it is used; provided, however, notwithstanding any other provision of law, insurers and providers may agree to alternative siting arrangements deemed appropriate by the parties. The Office is the official repository for all administrative regulations for the State of Delaware. The Office of Controlled Substance (OCS) recommends that the incoming and outgoing PICs take the inventory at the same time, either at the start or the close of the business day. (a) The Board shall issue a license to each applicant who meets the requirements of this chapter for licensure to practice pharmacy and who pays the fee established under § 2511 of this title. location of the sink, all doors, storage room, approved Schedule II controlled substance safe or cabinet, and the method of securing the prescription department from floor to ceiling when the pharmacy department is closed and the remainder of the store is open, type of alarm system and name, address and phone number of alarm provider. Elected Officials The transfer of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage; c. The dispensing of a drug pursuant to a prescription; or. All. C. 1953, § 2502; 59 Del. Laws, c. 262, § 42; 76 Del. One of these requirements is that a new PIC who has never been a PIC in Delaware must appear before the Board for an interview. • Delaware Code. (17) “Originating site” means a site in Delaware or outside of Delaware if the patient is a Delaware resident at which a patient is located at the time health-care services are provided to him or her by means of telemedicine or telehealth, unless the term is otherwise defined with respect to the provision in which it is used; provided, however, notwithstanding any other provision of law, insurers and providers may agree to alternative siting arrangements deemed appropriate by the parties. (b) A license to practice pharmacy must be renewed biennially, in a manner determined by the Division. (c) Except as provided in subsection (d) of this section, each Board member serves a term of 3 years, and may succeed himself or herself for 1 additional term; provided, however, that where a member was initially appointed to fill a vacancy, the member may succeed himself or herself for only 1 additional full term. (b) The Board of Pharmacy shall promulgate regulations specifically identifying those crimes, which are substantially related to the practice of pharmacy. The e-mail will provide a link to the Newsletter. (i) A member who is absent without adequate reason for 3 consecutive regular business meetings or who fails to attend at least 1/2 of all regular business meetings during any calendar year is guilty of neglect of duty. DOVER (Dec. 17, 2020) – The Delaware Division of Public Health (DPH) announced it has set up a Vaccine Call Center for members of the public who have specific questions about the COVID-19 vaccine. The consultant pharmacist must notify the Board in writing within ten days of starting as a consultant in Delaware. C. §2512, Issuance and Renewal of License, and Pharmacy Regulations 1.3 and 1.4. (27) “Prescription drug order” or “prescription” means the lawful written or verbal order of a practitioner for a drug. Please go to the URL for RELIAS 1.2. Among hospitals or other health care entities which are under common control; (38) “Wholesale distributor” means a person engaged in the wholesale distribution of drugs, including, but not limited to, a manufacturer’s or distributor’s warehouse, a chain drug warehouse or wholesale drug warehouse, an independent wholesale drug trader, and a pharmacy that engages in the wholesale distribution of drugs. Laws, c. 318, § 2; 68 Del. Every CNA learner is required to have an e-mail address to access RELIAS learning. The Executive Secretary shall maintain copies of the recorded minutes. (18) “Over-the-counter product” or “OTC” means a substance which may be sold without a prescription and which is packaged for use by the consumer and labeled in accordance with the requirements of state and federal statutes and regulations. At any hearing where evidence is presented, a record from which a verbatim transcript can be prepared must be made. To request an interview, send the Board a written request at least 10 days prior to the next meet- ing. Laws, c. 412, § 1; 74 Del. Three members are public members, 1 from each county. What are a consultant pharmacist’s responsibilities? Pharmacy Rules; Rule 17 Appendix A; Rule 17 Appendix B; Rule 17 Appendix C See Delaware Code Title 24 Sec. Executive Secretary: means the executive secretary of the Delaware State Board of Pharmacy who shall be a pharmacist. Answer: The Delaware-licensed pharmacist-in-charge (PIC) (or, if the PIC is deceased, another designated Delaware-licensed pharmacist) is responsible for carrying out the closing procedure. (d) A majority of the members of the Board constitutes a quorum for the purpose of transacting business; however, no disciplinary action may be taken without the affirmative vote of at least 5 members. d. A substance intended for use as a component of any substance specified in paragraph (8)a., b. or c. of this section. (11) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication with that title containing a list of prescription drugs by generic name. Pharmacist-in-Charge Self-Inspection Report: • within 30 days of your first being designated as PIC, and • by February 1 of each year while you continue as the PIC. (20) “Pharmacist” or “licensee” means an individual licensed by the State pursuant to this chapter to engage in the practice of pharmacy. The Delaware State Board of Pharmacy News is published by the Delaware State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation, Inc, to promote compliance of pharmacy and drug law. (34) “Telemedicine” means a form of telehealth which is the delivery of clinical health-care services by means of real time 2-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health-care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a licensee practicing within his or her scope of practice as would be practiced in-person with a patient and with other restrictions as defined in regulation. Del. Pending Regulations; Approved Regulations; Withdrawn Rulemakings (11) “Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations” means the publication with that title containing a list of prescription drugs by generic name. Laws, c. 186, § 1; 71 Del. (f) The Governor shall suspend or remove a member of the Board for the member’s misfeasance, nonfeasance, malfeasance, misconduct, incompetency, or neglect of duty. Laws, c. 140, § 8; Code 1915, § 857; Code 1935, § 937; 45 Del. Delaware.gov. Laws, c. 206, § 1; 76 Del. The Delaware Board of Pharmacy shall prescribe the minimum of such professional and technical equipment which a pharmacy shall at all times possess. (1) “Biological product” means a biological product as defined in § 351 of the Public Health Service Act (42 U.S.C. (5) “Dispense” means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful prescription of a practitioner. Laws, c. 238, § 1; 80 Del. Laws, c. 103, § 1; Code 1935, §§ 938, 941, 948, 956; 43 Del. Pharmacy Laws & Regulations; Pharmacy Law Changes for 2020 (PDF) Legal Status of Products Containing Cannabidiol (CBD) – Updated 1/24/2019 Original Document (PDF), Accessible Version (PDF) Regulations. Members must be appointed so that the terms of no more than 3 members expire in any 1 year. • The business registers with the Board of Pharmacy (24Del. We are experiencing an unusually high call volume. One of the physicians shall serve as chairperson of the Council. A public member must be accessible to inquiries, comments, and suggestions from the general public. C. 1953, §§ 2501, 2505; 53 Del. DPH will also receive an additional 3,900 doses of the Pfizer vaccine next week; an additional 6,825 doses of Pfizer will be reserved as part of the federal pharmacy program for vaccinating long-term care residents and staff in the coming weeks, bringing the total of Delaware’s Pfizer allotment for the week of Dec. 21, 2020, to 10,725 doses. h. Administration of injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol approved by a physician duly licensed in the State under subchapter III of Chapter 17 of this title. In meeting this objective, the Board shall develop and maintain a registry of drug outlets engaged in the manufacture, production, sale, and distribution of drugs, medications, and such other materials as may be used in the diagnosis and prevention of illness and disease and in the treatment of injury, and shall monitor the outlets to insure safe practices. If the branded product is not AB-rated, interchanging generic products is not permitted. In addition, the PIC of a Delaware-licensed community pharmacy must complete a Pharmacist-in-Charge Self-Inspection Report: When the PIC of a Delaware pharmacy leaves his/her position, notify the Board office using the Report of Pharmacist-in-Charge Change form within 10 days (Section 3.1.2.6). 24 . (34) “Telemedicine” means a form of telehealth which is the delivery of clinical health-care services by means of real time 2-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health-care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management and self-management of a patient’s health care by a licensee practicing within his or her scope of practice as would be practiced in-person with a patient and with other restrictions as defined in regulation which may not require the use of technology permitting visual communication. Del. Pharmacy license number, Controlled Substance registration number and Drug Enforcement Administration registration number, name of the PIC responsible for the closing. From the home page, businesses, professional licensees and the general public can reach our online services to search for information on a licensee, renew a professional license, change contact information or file a complaint. The aisle behind the counter must be at least 30 inches wide and kept clear of obstruction. It also includes: a. See Section 5.1.14.2 of the Rules and Regulations. Privacy Policy After due notice in the Register of Regulations and two Delaware newspapers, a public hearing was held on October 16, 2013 at a scheduled meeting of the Delaware Board of Pharmacy (“the Board”) to receive comments regarding the Board’s proposed revisions to its rules and regulations. (a) The Delaware State Board of Pharmacy shall administer and enforce this chapter. Laws, c. 206, § 1; 70 Del. A substance recognized as a drug in the Official United States Pharmacopoeia/National Formulary; b. https://dpr.delaware.gov/ and click . Generic substitution means a drug that is the same active ingredient, equivalent in strength to the strength written on the prescription and which is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the “Orange Book.”. Forward a copy of this inventory to the attention of OCS in the Division of Professional Regulation. If the CE provider is neither an approved American Council on Pharmaceutical Education (ACPE) provider nor Board-approved provider, you may submit a Service Request for CE Provider Approval in DELPROS online portal for CE approval. Delaware Marketplace Board of Pharmacy. Search the ... Delaware Administrative Code ••• Title 24 - Regulated Professions and Occupations. A person who is subpoenaed may be required to testify in any and all matters within the jurisdiction of the Board. The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of the Foundation or the Board unless expressly so stated. (28) “Reference product” means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. A pharmacy must have a Delaware Pharmacy permit, Delaware controlled subst ance registration and federal DEA permit before storing and /or dispensing controlled substances in Delaware. Gross Receipts Tax Laws, c. 90, § 3; 46 Del. No user may claim detrimental reliance thereon. As an applicant to the Medical Marijuana Program you are responsible for reading this act and following the stipulations within it. Do I need to reapply for a new license if there is a controlling interest change in ownership of a pharmacy? Please read the important COVID-19 information from the Division of Professional Regulation More Info. for Controlled Substances o §4701. The distribution of drugs within a healthcare group-purchasing organization; b. The primary objective of the Delaware professional licensing boards and commissions is to protect the general public from unsafe practices including those which tend reduce competition or fix prices. Individual programs must meet the criteria for CE provider approval. (e) An act or vote on Board business by a person appointed to the Board in violation of this section is invalid. (32) “Substitution” or “substitute” means pharmacist’s selection of prescriber authorized generic or therapeutically equivalent prescription medications or, in the case of biologicals, pharmacist selection of an interchangeable biological product in place of the prescribed product. for Pharmacy – 24 . It also licenses pharmacies (both in Delaware and elsewhere), pharmaceutical manufacturers and distributors, medical gas dispensers and retail businesses that sell non-controlled prescription drugs for veterinary use. Laws, c. 140, §§ 7, 10; Code 1915, §§ 856, 859; 36 Del. (c) The Executive Secretary, who is an ex officio member of the Board without a vote, is responsible for the performance of the regular administrative functions of the Board and other duties as the Board may direct. The pharmacist-in-charge or applicant must submit the floor plans before any construction and at least 15 days before the next scheduled Board of Pharmacy meeting. Transparency (15) “Manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription. For more questions, see Controlled Substances FAQ’s. by February 1 of each year while you continue as the PIC. The integration will be via Appriss Health’s PMP Gateway solution. date and time that the inventory was completed. Each term of office expires on the date specified in the appointment; however, a Board member whose appointment has expired remains eligible to participate in Board proceedings unless or until replaced by the Governor. Definitions o §4732. If the consultant pharmacist has not previously served in that position in Delaware, he/she must appear before the Board for an interview within ninety days of assuming the position. Mandatory Duty to Report Child Abuse . (29) “State” means the State of Delaware. Laws, c. 206, § 1; 70 Del. What do I need to do for continuing education? C. §2522 on labeling and 24 Del. An officer may not serve for more than 3 consecutive terms in the same office. Delaware Topics The PIC of a Delaware-licensed hospital pharmacy must complete this . Help Center (j) Each member of the Board shall be reimbursed for all expenses involved in each meeting, including travel, and in addition shall receive compensation per meeting attended in an amount determined by the Division in accordance with Del. (a) The Board of Pharmacy has the authority to: (1) Promulgate rules and regulations in accordance with the procedures specified in the Administrative Procedures Act [Chapter 101 of Title 29]; (2) Designate the application form to be used by all applicants and to process all applications pursuant to this chapter; (3) Designate the national standardized examinations in pharmacy and jurisprudence as approved by the National Association of Boards of Pharmacy, or its successor, to be taken by a person applying for a license to practice pharmacy; (4) Evaluate the credentials of each person applying for a license to practice pharmacy in order to determine whether the person meets the qualifications set forth in this chapter; (5) Grant a license to and renew the license of each person who qualifies for a license to practice pharmacy; and grant or renew a license with restrictions, if appropriate, as a reasonable accommodation to an applicant with a disability; (6) Establish by regulation continuing education standards required for license renewal; (7) Evaluate certified records, including criminal history records, to determine whether an applicant for licensure who previously has been licensed, certified, or registered in another jurisdiction to practice pharmacy has engaged in any act or offense that would be grounds for disciplinary action under this chapter and whether there are disciplinary proceedings or unresolved complaints pending against the applicant for such acts or offenses; (9) Refer all complaints from licensees and the public concerning persons licensed under this chapter, or concerning the practices of the Board or the profession, to the Division for investigation pursuant to § 8735 of Title 29 and assign a member of the Board to assist the Division in an advisory capacity with the investigation for the technical aspects of the complaint; (10) Issue subpoenas to require the attendance of persons and the production of books and papers for the purpose of conducting investigations preliminary to hearings and for the purpose of eliciting testimony at hearings. The Division of Public Health (DPH), authorized by 16 Del.C.Ch.49A - Delaware’s Medical Marijuana Act, regulates the state’s Medical Marijuana Program (MMP). d. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug: 1. Delaware State Code (e) Minutes of all meetings must be recorded. To meet these objectives, each board/commission 1. develops standards for professional competency 2. promulgates rules and regulations 3. adjudicates complaints and, when necessary, imposes disciplinar… Laws, c. 318, § 1; 60 Del. A Board member may appeal to the Superior Court a suspension or removal initiated pursuant to this subsection. A member subject to a disciplinary hearing must be disqualified from Board business until the charge is adjudicated or the matter is otherwise concluded. 24 Del. Laws, c. 378, § 1; 67 Del. Wholesale distribution does not include: a. This unofficial online version of regulations is the most current version available. Requirements for . C. §2523 (6)), and • All such sales are authorized by a written order from a licensed veterinarian and the veterinarian’s written order includes all information required for a written prescription. C. §1731A For information on filing a report, go to the Division’s website at . If you are unable to reach us by phone, submit your inquiry via email at customerservice.dpr@delaware.gov.Please read the important COVID-19 information from the Division of Professional Regulation More Info The renewal notice the Delaware State Board of Pharmacy sends you will explain how to file an online renewal application. (19) “Person” means a natural person or an entity. This chapter must be liberally construed to carry out these objectives. Effective 10/22/2020 a Security Code is no longer required for registration. The sections of Delaware law that explain your duties are . (23) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order. Exception: You may accept and redispense unused, unexpired products under certain conditions. Laws, c. 167, § 1; 77 Del. (d) A person who has never served on the Board may be appointed to the Board for 2 consecutive terms; but that person is thereafter ineligible to serve for 2 consecutive appointments. Participation in therapeutic drug selection, substitution of therapeutically equivalent drug products; c. Advising practitioners and other health-care professionals, as well as patients, regarding the total scope of drug therapy, so as to deliver the best care possible; e. Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health-care practitioner; screening results to be reported only if outside normal limits; f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed; g. 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