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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMarch 2016

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24 DE Admin. Code 2500
After due notice in the Delaware Register of Regulations and two Delaware newspapers, a public hearing was held on October 21, 2015 at a scheduled meeting of the Delaware Board of Pharmacy ("Board") to receive comments regarding the Board's proposed revisions to its rules and regulations. Specifically, the Board proposed amendments to Regulation 5.1.7.1 which concerns office use of compounded products.
The proposed changes to Regulation 5.1.7.1 were published in the Delaware Register of Regulations, Volume 19, Issue 4, on October 1, 2015. Notice of the October 21, 2015 hearing was published in the News Journal (Exhibit 1) and the Delaware State News. Exhibit 2. Pursuant to 29 Del.C. §10118(a), the date to receive final written comments was November 5, 2015, 15 days following the public hearing. The Board deliberated on the proposed revisions at its regularly scheduled meeting on November 18, 2015.
Board Exhibit 1: News Journal Affidavit of Publication.
Board Exhibit 2: Delaware State News Affidavit of Publication.
Pursuant to 24 Del.C. §2506(a)(1), the Board has the statutory authority to promulgate rules and regulations.
The text of the revised rules and regulations remains as published in the Register of Regulations, Volume 19, Issue 4 on October 1, 2015.
IT IS SO ORDERED this 20th day of January, 2016 by the Delaware Board of Pharmacy.
Words and terms defined in Delaware Code Title 1, Section 302 and Title 24, Section 2502 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within these regulations, shall have the following meaning unless the context clearly indicates otherwise or an alternate definition has been given:
"Automated Data Processing System (ADPS)" means a system utilizing computer software and hardware for the purposes of recordkeeping.
"Cell" means any container that holds the medication for automatic dispensing.
"Central Prescription Processing" means the processing by a pharmacy of a request from another pharmacy to fill or refill a prescription drug order or to perform processing functions such as dispensing, DUR, claims adjudication, refill authorizations, and therapeutic interventions.
"Common Database" means a file or database created by an ADPS that enables authorized users to have common access to this file regardless of physical location.
"Compounding" means the art of the extemporaneous preparation and manipulation of drugs as a result of a practitioner's prescription order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice, including the preparation of drugs in anticipation of drug orders based on routine, regularly observed prescribing patterns.
"Computer" means a programmable electronic device, capable of multifunctions including but not limited to storage, retrieval and processing of information.
"Controlled Substance" means those drug items regulated by Federal (CSA of 1970) and/or State Controlled (dangerous) Substances Act.
"CRT" means a Cathode Ray Tube used to impose visual information on a screen.
"Delivery" means the transfer of a dispensed prescription to the ultimate user (patient) or his/her agent.
"Dispensing" means to furnish or deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner; including the preparation, packaging, labeling or compounding necessary to prepare the drug for that delivery.
"Downtime" means that period of time when a computer is not operable.
"Facsimile (FAX) Prescription" means a facsimile prescription is an order which is transmitted by an electronic device over telephone lines which sends an exact copy image to the receiver (pharmacy).
"New Medication" means a medication not previously dispensed by the pharmacy for the ultimate user.
"Patient Counseling" means an oral communication process between a pharmacist, or a registered intern or a pharmacy student working under the direct supervision of a pharmacist, and a patient, in which the pharmacist obtains information from the patient and the patient’s pharmacy records, assesses that information and provides the patient with professional advice regarding the safe and effective use of the prescription drug for the purpose of assuring therapeutic appropriateness.
"Pertinent Patient Medication Information" means information which increases the patient's ability to minimize the risks and enhance the benefits of drug use. The type of information the pharmacist should consider is contained in the latest edition of USP DI "Advice for the Patient."
"Prescriber" means a practitioner authorized to prescribe and acting within the scope of this authorization.
"Prescription" or "Prescription drug order" means the lawful written or verbal order of a practitioner for a drug, but does not include an order for medication which is dispensed for immediate administration to the ultimate user, (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)
"Printout" means a hard copy produced by computer that is readable without the aid of any special device.
"Reduced to Writing" means the preparation of a paper document containing all the information required for a written prescription including the State requirement for drug product selection;
"Regulatory Agency" means any Federal or State agency charged with enforcement of pharmacy or drug laws and regulations.
"Stop Date" means a date established by an appropriate authority which indicates when medication will no longer be administered or dispensed in the absence of a specific time period directed by the prescriber.
1.3.1 In accordance with the requirements of 24 Del.C. §2515, all Pharmacist applicants, with the exception of reciprocity (licensure transfer) applicants, are required to complete a minimum of 1500 hours of Board approved practical experience under the supervision of a licensed pharmacist before being licensed. A minimum of 1000 hours shall be obtained in the community or hospital settings. The remaining 500 hours may be obtained in other recognized fields of practice, e.g.: Industrial Pharmacist, Drug Information Pharmacist, Military Pharmacist, Mail Order Pharmacist, HMO Pharmacist, Consultant Pharmacist (Nursing Home, Infusion, Medicaid DUR, Etc.), Home Health Care Pharmacist (may include Durable Medical Equipment, etc.), Nuclear Pharmacist, Compliance Pharmacist, Government Pharmacist, Clinical Pharmacist, Contracted Pharmacy Services. If the applicant has not completed the required 1500 hours in another state, he or she will be required to register as an intern in Delaware to complete the required hours.
1.3.2 An applicant for registration as an intern must submit an “Application for Registration of Internship” after entering the first professional year of college of pharmacy. This application must include an “Affidavit of Class Standing” form and an “Affidavit of Preceptor” form. If the applicant is a graduate of a foreign pharmacy school, he/she must produce evidence that he/she has passed an equivalency examination by the Board.
1.8 Late Renewal - If a pharmacist license or pharmacy permit expire for failure to renew before the deadline, the license or permit may be renewed at any time within the 60 days immediately following expiration upon application and payment of the renewal fee and a late fee. In accordance with 24 Del.C. §§2507 and 2526, it is unlawful for a licensee or permittee to practice or operate while their license or permit is expired. All late pharmacist license renewals will be audited for compliance with the CE renewal requirement.
2.1 Conduct that may merit discipline pursuant to 24 Del.C. §2518(a) includes but is not limited to the following act(s):
3.6 Security. When the pharmacist is not physically present and the operation is open for business, the pharmacy department shall be physically or electronically secured from floor to ceiling. The partitioned off section required by 24 Del.C. §2533 must be five feet high measured from the floor. A conspicuous sign with letters not less than three inches in height, reading "PRESCRIPTION LABORATORY TEMPORARILY CLOSED, NO PROFESSIONAL SERVICES RENDERED," or words of similar import, must be posted in the front section of the operation or in front of the prescription area, room or partitioned off section where it can be seen by the public.
4.2.3 A public notice must be posted in a highly visible place within the prescription department at least 5 days prior to the temporary closing of a pharmacy (24 Del.C. §2528(B)) and also on a window visible to the public from outside the store. The notice must state:
5.1.7.1 On the order of a practitioner, Non-patient specific compounded products may not be sold to the practitioner for use in his or her office to administer to individual patients, but not for resale unless authorized by Federal authority.
5.1.15.3 In addition to the requirements of 24 Del.C. §2536, all drugs dispensed to a patient that have been filled via a centralized prescription processing system shall bear a label containing an identifiable code that provides a complete audit trail of the dispensing of the drug and pharmaceutical care activities.
“Central Nervous System” Central nervous system stimulants are drugs which increase the activity of some portion of the brain or spinal cord. Drugs which act upon the cerebral cortex and subcortical structures including the thalamus (e.g. methylphenidate, etc.) increase motor activity and enhance mental alertness; those which act upon the sensory areas in the brain (e.g. caffeine and its various combinations) increase alertness, brighten spirits and combat mental fatigue; those which act directly or reflexly on the medulla (e.g. nikethamide, pentylenetetrazol and picrotoxin) stimulate the respiratory center; those which act on the spinal cord (e.g. nux vomica and strychnine) facilitate and exaggerate spinal reflexes.
6.3 Anyone who repacks and labels drugs in convenient quantities for their own subsequent use must maintain a log on the premises showing the date prepacked, the quantity prepacked, the control number, expiration date and name and strength of the drug. Prepacking must be done under the supervision of a registered pharmacist or any other person authorized to dispense under 24 Del.C. §2513. Each container must have a label containing the name of the drug, its strength, the manufacturer's control number, the expiration date if applicable, the name of the manufacturer, or the name and strength of the drug and a conference code number which would enable the control number, manufacturer and expiration date to be retrieved from the log. Nothing in this regulation precludes the Federal laws and regulations.
7.6 Labeling ‑ A medication dispensed must be labeled in compliance with 24 Del.C. §2536 and other applicable State and Federal Statutes and Regulations.
8.1 Definitions. Words and terms defined in Title 24, Chapter 25 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within Regulation 8.0, shall have the following meaning unless the context clearly indicates otherwise:
“Authorized agent” means a pharmacist who is trained and qualified to inspect against the Board’s standards and has been designated by the Board to conduct inspections on its behalf.
“Entity” means corporations, companies, associations, firms, partnerships, societies and joint-stock companies, but does not include individuals.
8.1.1.1 “Common control,” as used in 24 Del.C. §2502(t)(3), means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise.
8.1.1.2 “Emergency medical distributions,” as provided for by 24 Del.C. §2502(t)(4), may include, but is not limited to: transfers of a drug between a wholesale distributor and pharmacy to alleviate a temporary shortage of the drug arising from delays in or interruption of distribution schedules arranged in the ordinary course of business; or transfers of drugs by a licensed pharmacy or limited services permit holder to another licensed pharmacy or limited services permit holder. In all cases, transfers conducted pursuant to emergency medical reasons may be reviewed by the Board. Such transfers shall not exceed 5.0% of the total drug sales revenue of either the transferor or transferee pharmacy during any 12 consecutive month period.
Active ingredients means chemicals, substances, or other components of articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or animals or for use as nutritional supplements.
Added substances means the ingredients necessary to prepare the drug product but are not intended or expected to cause human pharmacological response if administered alone in the amount or concentration contained in a single dose of the compounded preparation. The term “added substances” is used synonymously with the terms “inactive ingredients,” “excipients,” and “pharmaceutical ingredients.”
Beyond-use date” (“BUD”) means the date after which a compounded preparation should not to be used as determined from the date the preparation is compounded. For sterile compounding, see subsection 10.4.
Component” means any ingredient used in the compounding of a drug preparation, including any active ingredient or added substance that is used in its preparation.
Compounder” means an individual or entity licensed by the Delaware Board of Pharmacy and engaged in the performance of compounding pursuant to a prescription or medication order by a licensed prescriber.
Compounding” means the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes, but is not limited to, the following:
CSPs” means Compounded Sterile Preparations.
Hazardous drugs” means any drug in studies of animals or humans that have been classified as carcinogenic, toxic to development or reproduction, or toxic to organs.
Manufacturing” means any compounding activity that is not pursuant to a valid prescription or an order to prepare for administration and for an individual patient. Manufacturing is the production, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction of the drug from substances of natural origin or by means of chemical or biological synthesis. Manufacturing may also include any packaging or repackaging of the substance(s) or labeling or relabeling of containers for resale by pharmacies, practitioners, or other persons. Any person engaged in manufacturing must be licensed in accordance with 24 Del.C. §2541.
Preparation” means a compounded drug dosage form or dietary supplement or a device to which a compounder has introduced a drug. This term will be used to describe compounded formulations.
Product” means manufactured pharmaceutical dosage forms.
Vehicle” means a component for internal or external use that is used as a carrier or diluent in which liquids, semisolids, or solids are dissolved or suspended. Examples include, but are not limited to, water, syrups, elixirs, oleaginous liquids, solid and semisolid carriers, and proprietary products.
Ante-Area” means an ISO Class 8 (see table 1) or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate-generating activities are performed.
Aseptic Processing” means a mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and the package; and the transfer of the product into the container and its closure under at least ISO Class 5 conditions.
Beyond-Use-Date (BUD)” means the date or time after which a CSP shall not be used, stored, or transported. The date is determined from the date or time the preparation is compounded.
Biological Safety Cabinet (BSC)” means a ventilated cabinet providing downward high-efficiency particulate air (HEPA) filtered airflow for CSPs, personnel, product, and environmental protection.
Buffer Area” means an area where the primary engineering control (PEC) is physically located and where preparation and staging of components used to compound CSPs is done.
Clean Room” means a room in which the concentration of airborne particles is controlled to meet a specific class.
Compounding Aseptic Containment Isolator (CACI)” means an aseptic isolator designed to provide worker protection from drug exposure during compounding.
Compounding Aseptic Isolator (CAI)” means an isolator designed to maintain an aseptic environment for compounding pharmaceutical ingredients or preparations.
Critical Site” means a location that includes any component or fluid pathway surfaces or openings at risk of contamination. (e.g., vial septa, open vials, injection ports, beakers, ampuls, needle hubs, syringe tips)
Disinfectant” means an agent applied to inanimate objects that destroys disease-causing pathogens or other harmful micro-organisms.
Media-Fill Test” means a test used to qualify aseptic technique of compounding personnel.
Multiple-Dose Container” means a multiple-unit container for preservative-containing preparations intended for parenteral administration only. The beyond-use date for an open or entered container containing preservatives is 28 days unless otherwise specified by the manufacturer.
Primary Engineering Control (PEC)” means a device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs. (Laminar Air Flow Workbenches, Biological Safety Cabinet, Compounding Aseptic Isolators, Compounding Aseptic Containment Isolators).
Single-Use Container” means a single-unit container for preparations intended for parenteral administration intended for single-use only.
Segregated Compounding Area” means a designated space, demarcated area or room, that is restricted to preparing low-risk level CSPs with a BUD of 12 hours or less. Such area shall contain a device that provides an ISO Class 5 air quality and shall be void of activities and materials that are extraneous to sterile compounding.
Sterilization by Filtration” means a passage of a solution through a sterilizing grade membrane.
Terminal Sterilization” means the application of a lethal process (e.g. autoclaving) to sealed containers for the purpose of achieving sterility.
“Authentication of Product History” means, but is not limited to, identifying the purchase sources, and any handling of any Component of a radiopharmaceutical.
“Internal Test Assessment” means, but is not limited to, conducting those tests of quality assurance necessary to ensure the integrity of the product.
“Nuclear Pharmacy” means a Pharmacy providing radiopharmaceutical services or, as provided in Section 3.0
“Qualified Nuclear Pharmacist” means a currently licensed Pharmacist in the State of Delaware, who is certified as a Nuclear Pharmacist by a certification Board recognized by the Delaware Board of Pharmacy, or who meets the following standards set by the Delaware Board of Pharmacy:
Completed a minimum of 200 contact hours of instruction in nuclear Pharmacy and the safe handling and the use of radioactive materials from a program approved by the NRC or the Office of Radiation Control (ORC), with emphasis in the following areas: radiation physics and instrumentation; radiation protection; mathematics of radioactivity; radiation biology; and radiopharmaceutical chemistry.
“Radiopharmaceutical Quality Assurance” means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.
“Radiopharmaceutical Service” means, but is not limited to, the procurement, storage, handling preparation, labeling, quality assurance testing, dispensing, delivery, recordkeeping, and disposal of radiopharmaceuticals and other drugs.
“Radiopharmaceuticals” are radioactive drugs as defined by the FDA.
15.2.1 "Automated Pharmacy Systems" include, but are not limited to, mechanical systems that perform operations or activities, other than compounding or administration, relative to storage, packaging, dispensing, or distribution of medications, and which collect, control, and maintain all transaction information.
16.1 Definitions – Words and terms defined in Title 24, Section 2502 of the Delaware Code are applicable to these regulations. The following additional words and terms, when used within regulation 16.0, shall have the following meaning, unless the context clearly indicates otherwise:
Authorized agent” is as defined in regulation 8.1.
Automated delivery device” or “device” means a mechanical device used exclusively for the storage and delivery to patients of prescriptions that have been processed and verified by a licensed pharmacist.
Delivery” is defined in regulation 5.1.
17.1.1 “Conviction” means a verdict of guilty entered by a judge or jury, or a plea of guilty or a plea of nolo contendere or other similar plea such as a “Robinson” or “Alford” plea unless the individual has been discharged under 11 Del.C. §4218 (probation before judgment) or under 10 Del.C. §1024 (domestic violence diversion program) or under 16 Del.C. §4764 (first offenders controlled substances diversion program).
17.2.5 Theft. 11 Del.C. §841.
17.2.6 Forgery. 11 Del.C. §861.
17.2.31 Bestiality. 11 Del.C. §775
"Medical gas" means those gases and liquid oxygen intended for human consumption as per the standards of the U.S.P.
"Medical gas dispenser" A person or entity who sells medical gases directly to a patient in Delaware.
"Medical gas distributor" A person or entity who is licensed to distribute medical gases to another facility that is authorized to possess medical gases.
"Order" means an order issued by a licensed practitioner legally authorized to order medicinal gases.
18.2.1 Any person that dispenses medical gas directly to patients by sale shall register with the Board of Pharmacy pursuant to 24 Del.C. §2523. Applications for registration under this Regulation shall be on a form supplied by the Board and accompanied by a fee determined by the Board. The registration shall be renewed bi-biennially as determined by the Board.
Last Updated: December 31 1969 19:00:00.
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