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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsDecember 2013

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24 DE Admin. Code 2500
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.
The first public hearing was held on May 15, 2013, with deliberations conducted on June 19, 2013. As the result of deliberations, the Board decided to make substantive revisions to the proposed amendments originally published in the Delaware Register of Regulations on April 1, 2013, Volume 16, Issue 10. Specifically, the Board proposed to strike the language “only to patients that are self-medicating” in Rule 6.4.
The proposed changes to the rules and regulations were published in the Register of Regulations, Volume 17, Issue 2, on August 1, 2013, and the rescheduled hearing was noticed in the Register of Regulations, Volume 17, Issue 3, on September 1, 2013. Notice of the October 16, 2013 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 October 31, 2013, 15 days following the public hearing. The Board deliberated on the proposed revisions at its regularly scheduled meeting on November 20, 2013.
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 proposed revisions provide greater public protection by enhancing the rules pertaining to “Customized Patient Medication Packages.” The revisions will also ensure the provision of quality care to the public by permitting registered interns and pharmacy students to administer injectable medications under the direct supervision of a licensed pharmacist. The Board concludes that adoption of the rules and regulations as amended is in the best interest of the public.
The Board hereby adopts the proposed amendments to the rules and regulations to be effective 10 days following final publication of this Order in the Register of Regulations.
The text of the revised rules and regulations remains as published in the Register of Regulations, Volume 17, Issue 2 on August 1, 2013.
IT IS SO ORDERED this 20th day of November 2013 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. Reconstitution of oral solutions is not considered compounding.
"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 the offer to discuss the patient's prescription made by the pharmacist or the pharmacist's designee in a face-to-face communication with the patient or his agent, unless in the professional judgment of the pharmacist it is deemed impracticable and in such instances, it would be permissible for the offer to counsel to be made through alternative means.
"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:
5.1.15.3 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.
6.4 All biologicals, vaccines, drugs, chemicals, preparations and compounds must be packaged, labeled, stored and preserved in compliance with USP/NF and all other State and Federal standards. A pharmacist may, with the permission of the patient or the patient's agent, provide a “Customized Patient Medication Package” only to patients that are self‑medicating. The containers shall meet all of the requirements of the USP/NF standard entitled, "Customized Patient Medication Package." Packaging of controlled substances in a “Customized Patient Medication Package” is prohibited.
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.
“Admixture” A solution for parenteral administration to which one or more additional drugs have been added.
“Antineoplastic Agent” A drug used to treat various forms of cancer.
“Aseptic Technique” A procedure for compounding sterile preparations designed to minimize/prevent contamination during the compounding procedure.
“Class 100" A classification of an airflow unit capable of producing an environment containing no more than 100 airborne particles of a size 0.5 micron and larger per cubic foot (3.5 particles/liter) of air.
“Enteral Nutrition” The administration into the gastro‑intestinal tract of calories, nitrogen, and/or other nutrients to achieve tissue synthesis and anabolism for patients requiring medically prescribed, defined formula, liquid diets.
“HEPA” (High‑efficiency particulate air) Filter ‑ A filter that provides a minimum‑efficiency of 99.97% in removal of particles 0.3 micron or larger from the effluent air.
“Laminar Airflow” An entire body of air moving with uniform velocity along parallel flow lines.
“Parenteral” A sterile preparation intended for injection and used in the diagnosis, cure, mitigation, or treatment of disease or modification of physiological functions in human beings, but not including blood or blood products or as otherwise defined in the current United States Pharmacopeia.
“Sterile Pharmaceutical” A dosage form free from living microorganisms.
“Total Parenteral Nutrition” The intravenous administration of calories, nitrogen, and other to achieve tissue synthesis and anabolism.
“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.
“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.
14.0 Administration of Injectable Medications, Biologicals and Adult Immunizations
14.1.1 In order to administer injectable medications, biologicals, and adult immunizations a licensed pharmacist, a registered intern or a pharmacy student shall provide proof that the following requirements have been satisfied: complete a Board approved academic and practical curriculum and maintain a current Cardio-Pulmonary Resuscitation (CPR) certificate acceptable to the Board of Pharmacy.
14.1.1.1 The satisfactory completion of an An approved academic and practical curriculum approved by the Board of Pharmacy which includes, but is not limited to, disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events, and related topics.
14.1.1.2 A current Cardio‑Pulmonary Resuscitation (CPR) certificate acceptable to the Board of Pharmacy. Pharmacists successfully completing the above education and practical training shall notify the Board. The Board will record the successful training in Board database systems.
14.1.2 A registered licensed pharmacist, registered intern or pharmacy student may only administer injections consistent with public health and safety and in a competent manner consistent with the academic curriculum and training completed.
14.1.3 Continued competency shall be maintained. A minimum of two hours (0.2 C.E.U.) of the thirty hour requirement for continuing education, every licensure period, must be dedicated to this area of practice and available for Board inspection.
14.1.4 Documentation of the satisfactory completion of the proper academic and practical training requirements shall be listed in a policy and procedures manual available for inspection by the Board of Pharmacy. Maintaining such a policy and procedures manual shall be the responsibility of each registered pharmacist administering injections documentation shall be the responsibility of the pharmacist-in-charge.
14.2.1 The pharmacist-in-charge must maintain a manual with policies consistent with OSHA (Occupational Exposure to Bloodborne Pathogens) and procedures for dealing with acute adverse events.
14.2.2 Prescriptions and/or physician‑approved written protocols will be maintained and available for inspection by the Board of Pharmacy. The administration of injectable medications, biologicals and adult immunizations by registered interns and pharmacy students must be directly supervised by a licensed pharmacist who is approved for injectable administration.
14.2.3 The pharmacist, registered intern, or pharmacy student, before administering an injectable medication, biological, or immunization, must counsel the patient and/or the patient’s representative about contraindications and inform them in writing in specific and readily understood terms about the risks and benefits. A signed copy of the patient’s consent shall be filed and available for inspection by the Board of Pharmacy.
14.2.4 The pharmacist, registered intern, or pharmacy student must document all injections made and have such documentation available for inspection by the Board of Pharmacy. Documentation shall include:
14.2.4.4 The name of the prescribing practitioner and the pharmacist, registered intern or pharmacy student administering the dose.
14.2.5 The pharmacist, registered intern or pharmacy student must document fully and report all clinically significant adverse events to the primary‑care provider and to the Vaccine Adverse Event Reporting System (VAERS) when appropriate.
14.2.6 The pharmacist, registered intern or pharmacy student shall provide documentation to each person receiving immunizations and when appropriate to the Immunization Section of the Department of Health and Social Services so the names of those individuals can be added to the Vaccination Registry shall report to the Immunization Vaccination Registry.
14.3 Classes and Indications of Approved Medications. Classes of medications shall include injectable medications, immunizations, and biologicals contained in the list of Approved Drug Products with Therapeutic Equivalence Evaluations or drugs under clinical study when administered in accordance with indications approved by the Food & Drug Administration. Administration of medications includes injectable medications, biologicals and adult immunizations pursuant to a valid prescription or approved protocol approved by a physician duly licensed in this State.
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. §777
"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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