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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsDecember 2017

Regulatory Flexibility Act Form

Authenticated PDF Version

24 DE Admin. Code 2500
Pursuant to 24 Del.C. §2506(a)(1), the Delaware Board of Pharmacy has proposed revisions to its rules and regulations.
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. Patient counseling may be provided through telehealth.
"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.
"Telehealth" means the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation. Telehealth may be used for patient counseling only.
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.
1.4.2 Hardship ‑ Hardship exemptions may be granted by the Board of Pharmacy upon receipt of evidence that the individual was unable to complete the requirements due to circumstances beyond his control.
1.4.3 Criteria for Hardship Exemption as Recommended by the Board of Pharmacy: Persons who are newly licensed after the registration period begins, must complete continuing education units proportional to the total number of continuing education units required for the biennial licensure renewal. (1.25 hours/per month).
1.6.4 Sanctions for Unjustified Noncompliance. The minimum penalty for the first finding of unjustified noncompliance shall be a $250.00 monetary penalty. However, the Board may impose any of the additional penalties specified in 24 Del.C. §2516. The minimum penalty for the second finding of unjustified noncompliance shall be a $500 monetary penalty. However, the Board may recommend to the Board imposing any of the additional penalties specified in 24 Del.C. §2516.
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. While a pharmacist may renew his or her license within 60 days immediately following expiration of the license, all CE requirements must be met by the renewal deadline, which is September 30 of even years.
1.91.10 Pharmacy Licenses. Pharmacy licenses shall include retail, hospital, nuclear and specialty institutional pharmacy licenses.
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: The copy is immediately reduced to writing and contains the information required on a written prescription as listed in Regulation Section 5.0, and includes the first and last name of the pharmacist transmitting the information. Profiles. When ADP'S are used to maintain patient profile records, all the requirements of Delaware Pharmacy Regulation Section 5.0 must be met. In addition, there must be readily retrievable records that identify the responsible pharmacist(s) for each step in the dispensing and counseling processes; and a mechanism for tracking the prescription drug order during each step in the dispensing process and to identify all pharmacies involved in the dispensing of the and/or processing of the medication. The system must be adequately secured in order to protect the confidentiality and integrity of patient information. DEA number of prescriber in the case of a controlled substance. Name, strength, dosage form and quantity, (or Stop Date), and route of administration if other than oral form of drug prescribed and diagnosis. Renewals authorized. Directions of use for patient. Except as provided in Regulation subsection, non-controlled substance prescriptions may not be returned to the pharmacy except for disposal. 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.
5.2.1 Prior to dispensing a prescriptive medication to a new patient, a new medication to an existing patient or a medication that has had a change in the dose, strength, route of administration or directions for use, a pharmacist, or a registered intern or pharmacy student working under the direct supervision of a pharmacist, shall provide verbal counseling to the patient on pertinent medication information. The counseling may be provided verbally or electronically, whichever method the patient prefers. The counseling may include, but not be limited to the following:
“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.
8.0 Requirements for Obtaining a Permit to Distribute Drugs on a Wholesale Basis as a Wholesaler, Manufacturer, Outsourcing Facility or Third-Party Logistics Provider
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 Section 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 a wholesaler, manufacturer, outsourcing facility or third-party logistics provider, whether corporations, companies, associations, firms, partnerships, societies and joint-stock companies, but does not include individuals.
"Key personnel" includes, but is not limited to: the most senior individual or individuals responsible for facility operations, purchasing, and inventory control and the individual or individuals they report to and the pharmacists-in-charge; if the applicant is a corporation and not publicly traded on a major stock exchange, key personnel also includes: key company officers, key management, principals and key owners.
"Manufacturer" means a person engaged in the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from a substance of natural origin or independently by a chemical or biological synthesis. The term includes packaging or repackaging a substance or labeling or relabeling a container and promoting and marketing the drug or device and preparing and promoting a commercially available product from a bulk compound for resale by a person, including a pharmacy or practitioner. The term does not include compounding.
"Outsourcing facility" means a facility that is located within the United States of America at one address that is engaged in the compounding of sterile drugs and nonsterile drugs; has registered as an outsourcing facility with the federal Food and Drug Administration under Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b); and is doing business within or into Delaware.
"Third-party logistics provider" means an entity that provides or coordinates warehousing or other logistics services for a dangerous drug or dangerous device in intrastate or interstate commerce on behalf of a manufacturer, wholesaler, or dispenser of the dangerous drug or dangerous device, but does not take ownershi.p of the dangerous drug or dangerous device, nor have responsibility to direct its sale or disposition
"Wholesaler" 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. “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. “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.
8.2 Permit Requirements. Wholesale distributors Wholesalers, manufacturers, outsourcing facilities and third-party logistics providers that operate within this state, whether or not the wholesale distributor is physically located within this state, must first be granted a permit by the Board.
8.2.1 Wholesale distributors The applicant for a permit shall provide information required by a Board-approved application, including but not limited to: All trade or business names used by the permittee, e.g. “doing business as” or “formerly known as.” Trade or business names cannot be identical to the name used by another, unrelated wholesale distributor entity permitted to purchase drugs in the state; Name of the owner or owners and operator or operators and the pharmacist-in-charge of the permittee applicant (if not the same entity), including: Assurance that a copy of the wholesale distributor’s applicant’s written policies and procedures, required by Regulation subsection 8.6, will be available at the distributor’s on-site for review prior to licensure and thereafter for inspection; A list of all disciplinary actions by state and federal agencies against the wholesale distributor applicant, as well as any actions against principals, owners, directors, or officers and pharmacists, including the pharmacist-in-charge; A copy of the deed or lease for the property on which the wholesale distributor’s establishment is located. If leased, the lease must be for an original term of not less than one (1) calendar year.
8.2.2 Changes in any information required by Regulation subsection 8.2.1 shall be submitted to the Board within 30 days after such change.
8.2.3 Wholesale distributors An applicant shall submit an application fee to be determined by the Division of Professional Regulation.
8.2.4 Wholesale distribution Applicant facilities must undergo an inspection by the Board or its authorized agent prior to initial licensure and periodically thereafter in accordance with a schedule to be determined by the Board.
8.2.5 Wholesale distributors After receipt of a permit, the permittee must publicly display or have readily available all permits and the most recent inspection report administered by the Board.
8.2.6 All out-of-state wholesale distributors permittees must comply with all rules, regulations, and laws of the state in which they are physically located and of all states in which they hold permits, including this state.
8.3.1 Any findings by the Board that the key personnel of the applicant has violated or been disciplined by a regulatory agency in any state violating Federal, State, or local laws relating to drug distribution;
8.3.2 Any criminal convictions of the key personnel of the applicant under Federal, State, or local laws deemed substantially related to the practice of pharmacy as set forth in Section 17.0; The Board shall consider the results of a criminal and financial background check of the key personnel of the applicant to determine if an applicant or others associated with the ownership, management, or operations of the wholesale distributor have committed criminal acts that would constitute grounds for denial of licensure whether such individuals have been convicted of a crime substantially related to the practice of pharmacy as set forth in Section 17.0. The background check shall include all key personnel involved in the operations of the wholesale distributor applicant. Key personnel includes, but is not limited to: the most senior individual or individuals responsible for facility operations, purchasing, and inventory control and the individual or individuals he or they report to; if the applicant is a corporation and not publicly traded on a major stock exchange, key personnel also includes: key company officers, key management, principals, and key owners. The background check will be conducted in compliance with any applicable federal, state, or local laws. The background check will be conducted at the applicant's expense and will be sufficient to include all states of residence since the individuals have been adults. Manufacturers shall be exempt from criminal and financial background checks.
8.4 Personnel. As a condition for receiving and retaining a wholesale drug distributor permit, the permittee shall:
8.4.1 Require each individual employed in any drug wholesale distribution activity employee to have any combination of education, training, and experience sufficient for that individual to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety, and security will at all times be maintained as required by law;
8.4.2 Maintain records evidencing that each employee has been trained in accordance with the policy and procedure manual approved required by Regulation subsection 8.6. These records shall be kept for two (2) years from the date of separation of the employee from the company. Records on all current employees shall be available at any time for inspection;
8.4.3 Designate a registered agent in this state for service of process. Any permitted wholesale distributor permittee that does not so designate a registered agent shall be deemed to have designated the Secretary of State of Delaware to be its true and lawful attorney, upon whom may be served all legal processes in any action or proceeding against such permitted wholesale distributor permittee growing out of or arising from its activities in this state. A copy of any such service of process shall be mailed to the wholesale distributor permittee by the Board via certified mail, return receipt requested, postage prepaid, at the address the permitted wholesale distributor permittee has designated on its application for permit in Delaware. If a wholesale distributor an entity is not permitted in Delaware, service on the Secretary of State only shall be sufficient service; and
8.4.4 Ensure that all key personnel have at least an associate’s degree from an accredited institution of higher education acceptable to the Board or a minimum of two (2) years of verifiable full-time managerial or supervisory experience acceptable to the Board in a licensed pharmacy or wholesale distributor related business where the individual’s responsibilities included, but were not limited to, recordkeeping, storage, and shipment of drugs. Key personnel includes, but is not limited to: the most senior individual or individuals responsible for facility operations, purchasing, and inventory control and the individual or individuals he or they report to; if the applicant is a corporation and not publicly traded on a major stock exchange, key personnel also includes: key company officers, key management, principals, and key owners.
8.5.2 Wholesale distributors Wholesalers, manufacturers, outsourcing facilities and third-party logistics providers shall:
8.5.3 Wholesale distributors Permittees involved in the distribution of controlled substances shall be duly registered with Drug Enforcement Administration (DEA) and the appropriate state agency and in compliance with all applicable laws and rules for the storage, handling, transport, shipment, and distribution of controlled substances.
8.6 Written Policies and Procedures. Wholesale distributors Permittees shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, transport, shipping, and distribution of drugs. Wholesale distributors Permittees shall also establish, maintain, and adhere to written policies and procedures for: identifying, recording, and reporting losses or thefts; for correcting all errors and inaccuracies in inventories; and implementing and maintaining a continuous quality improvement system. Wholesale distributors shall include in their wWritten policies and procedures shall include the following:
8.6.2 A procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of a strike, fire, flood, other natural disaster, or other situations of local, state, or national emergency.
8.7 Salvaging and Reprocessing. Wholesale distributors Permittees shall be subject to the provisions of any applicable Federal, State, or local laws or rules that relate to drug product salvaging or reprocessing.
8.8.5 May possess and maintain, in good working order, technology and equipment that allows the wholesale distributor to authenticate, track, and trace drugs. The technology and equipment shall satisfy standards set by the Board and shall only be used to conduct tracking, tracing, and authentication of drugs. Wholesale distributors Permittees shall employ, train, and document the training of personnel in the proper use of such technology and equipment. Polices Policies and procedures shall specify the duties to be performed by pharmacy personnel.
10.1.1 The Board requires aAll individuals and entities licensed by the Delaware Board of Pharmacy engaged in compounding to shall adhere to and comply with both the current edition of the United States Pharmacopeia Chapters 795 (USP 795) and 797 (USP 797) and this Regulation, as applicable to their specific practice setting. Chapters 795 and 797 shall be reviewed and followed by compounders prior to non-sterile or sterile pharmaceutical compounding. The purpose of this Regulation is to provide all compounders with the requirements for good compounding practices for the preparation of non-sterile and sterile compounded formulations for dispensing and/or administration to humans and animals. Compounding is an integral part of pharmacy practice and is essential to the provision of healthcare. These regulations apply to non-sterile and sterile compounding of medications that are prepared for a specific patient and that are prescribed or ordered subject to a valid practitioner order or practitioner-patient relationship. The Delaware licensee engaged in compounding is responsible for ensuring compliance the requirements of Section 10.0 and any updates published by USP. By December 1, 2019, all licensees engaged in compounding shall either be in compliance with USP 800, or shall submit a plan for coming into compliance to be reviewed and approved by the Board.
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 “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.
“Radiopharmaceuticals” are radioactive drugs as defined by the FDA.
“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. Pharmacists successfully completing the above education and practical training shall notify the Board. The Board will record the successful training in Board database systems. The pharmacist's license shall include the notation that such licensee has completed the training for the administration of injectable medications, biologicals and adult immunizations. A minimum of two hours (0.2 C.E.U.) of the thirty hour requirement for continuing education for licensed pharmacists, every licensure period, must be dedicated to this area of practice. To be relieved of this requirement, the licensee must notify the Board, in writing, that he or she is no longer administering injectable medications, biological and adult immunizations.
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.
15.6.3 Hospital/Institution. Unit based or centralized dispensing requires the same level of supervision required in Regulation subsection 9.2.3 which states: pharmacy technicians may be utilized in assisting the pharmacist. These persons must be supervised by a registered pharmacist who is present within the hospital and is responsible for the activities of those persons”.
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 Section 16.0, shall have the following meaning, unless the context clearly indicates otherwise:
Authorized agent” is as defined in regulation subsection 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 subsection 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.
17.2.17 Theft. Felony. 11 Del.C. §841.
17.2.18 Forgery. 11 Del.C. §861.
"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. The pharmacist-in-charge is responsible for ensuring proper training of all pharmacy technicians. The actual training may be delegated to a pharmacist or other trained pharmacy technicians. The permit holder shall ensure that pharmacy technicians successfully complete a training program. Once training has commenced, the technician in training may work in the pharmacy under the direct supervision of a pharmacist. For the purposes of this subsection, "direct supervision" means that a pharmacist is present in the pharmacy at all times.
19.1.2 Certified pharmacy technicians must be at least 18 years of age, and successfully pass the PTCB Exam or other national technician certification exam approved by the Board of Pharmacy. Only certified pharmacy technicians or those individuals approved pursuant to Regulations subsection may assist the pharmacist by reconstituting oral solutions and contacting the prescriber or their agent to obtain refill authorization or other patient or prescription information of a non-clinical nature, or assisting the pharmacist with compounding.
Last Updated: December 31 1969 19:00:00.
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