24 Del. Admin. Code §§ 2500-5.0

Current through Register Vol. 27, No. 12, June 1, 2024

Section 2500-5.0 - Dispensing

5.1 The practice of dispensing shall include, but not be limited to the following acts which shall be performed only by a pharmacist, or a pharmacy intern or student participating in an approved College of Pharmacy coordinated, practical experience program under the direct supervision of a pharmacist.

5.1.1 Receive oral prescriptions and reduce them immediately to writing.

5.1.2 Certification of the prescription order - (This involves authenticating the prescription, confirming proper dosage and instructions, and reviewing for incompatibility, etc.)

5.1.3 The pharmacist, intern or student who dispenses the original prescription shall hand-sign or initial the prescription. Initials mechanically or electronically generated are acceptable.

5.1.4 Prior to dispensing a prescription to the patient or agent of the patient the pharmacist must verify that the medication in the container is as labeled. Pharmacies must include a description of their verification process in their policy and procedures manual.

5.1.5 Before dispensing or delivering a new medication to a patient or his or her agent, a pharmacist or pharmacy intern or student participating in an approved College of Pharmacy coordinated practical experience program and working under the direct supervision of the pharmacist, shall conduct a prospective drug review. A prospective drug review may be conducted before refilling a prescription to the extent deemed appropriate. A prospective drug review shall include screening for potential drug therapy problems due to therapeutic duplication, drug-drug interactions, including serious interactions with over-the-counter drugs, drug-disease contraindications, if disease is known, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse or misuse based on available information received by the pharmacist.

5.1.5.1 Effective 6 months after the effective date of this regulation, a pharmacy, a pharmacist, or a pharmacy intern or student participating in an approved College of Pharmacy coordinated, practical experience program under the direct supervision of a pharmacist, shall not deliver, or cause to be delivered, dispensed drugs to a patient's residence where such drugs are intended to be subsequently transported by the patient or patient's agent to a hospital, medical clinic, prescriber's office, or pharmacy for administration and that require special storage, reconstitution or compounding prior to administration. An exception to this subsection may be made for patients with inherited bleeding disorders who may require therapy to prevent or treat bleeding episodes.

5.1.5.2 Effective 6 months after the effective date of this regulation, a patient-specific compounded preparation may not be delivered by a pharmacy to the office of a practitioner or an infusion center for administration unless there is a written contract or agreement between the dispensing pharmacy and the ordering physician or facility determining that this delivery arrangement is in the best interest of that specific patient. The written contract or agreement must describe the procedures for such a delivery system and the responsibilities of each party.

5.1.6 Compounding is the responsibility of the pharmacist. All compounding must be in compliance with FFDCA Section 503A and any regulations promulgated by FDA concerning compounding pertaining to this section. The pharmacist may utilize the assistance of a certified pharmacy technician, or a pharmacy technician who has completed a Board-approved program for sterile compounding, under the direct supervision of a pharmacist if:

5.1.6.1 The formulation is developed by a pharmacist before proceeding with the compounding.

5.1.6.2 The compounding ingredients are checked by the pharmacist before proceeding with the compounding.

5.1.6.3 Every weight and measurement is checked by the pharmacist before proceeding with the compounding.

5.1.6.4 The finished product is checked by the pharmacist before dispensing.

5.1.6.5 A log is maintained showing the identity of the person actually compounding the medication and the identity of the pharmacist who has performed each of the checks indicated above for each step of the procedure. If policies and procedures are in place ensuring adequate checks by the pharmacist per regulation, the requirement for a log will be waived.

5.1.7 Compounded medications for office use.

5.1.7.1 Compounded nonsterile or sterile preparations for human use provided by a Delaware licensed pharmacy without a patient specific prescription.

5.1.7.1.1 Only an FDA-registered outsourcing facility properly licensed in Delaware may distribute to a practitioner for office use human compounded preparations without a patient-specific prescription.

5.1.7.2 Compounded nonsterile or sterile preparations for animal use without a patient specific prescription.

5.1.7.2.1 A Delaware licensed pharmacy may provide a compounded nonsterile or sterile preparation without a patient-specific prescription to a Delaware licensed veterinarian who intends to administer to the animal patient in his or her care or to dispense to the patient's owner or caretaker only if the pharmacy:

5.1.7.2.1.1 Complies with USP 795 or USP 797, or any updated versions, as applicable;

5.1.7.2.1.2 Complies with applicable federal law; and

5.1.7.2.1.3 Labels compounded nonsterile or sterile preparations with:

5.1.7.2.1.3.1 The name and strength of the preparation; or a list of the active ingredients and the strength of the active ingredients in the preparation;

5.1.7.2.1.3.2 An appropriate beyond-use date as determined by the pharmacist in accordance with USP-NF standards for pharmacy compounding;

5.1.7.2.1.3.3 The quantity of the preparation; and

5.1.7.2.1.3.4 The name, address and license number of the pharmacy.

5.1.7.2.2 A Delaware licensed pharmacy may not provide compounded nonsterile or sterile preparations without a patient-specific prescription to Delaware licensed veterinarians:

5.1.7.2.2.1 In an amount greater than 10% of the total amount of non-patient specific compounded preparations sold by the pharmacy in a rolling year; or

5.1.7.2.2.2 If the compounded nonsterile or sterile preparations are copies or close approximations to products approved by the FDA.

5.1.7.3 Compounded nonsterile or sterile preparations for animal use provided by an FDA-registered outsourcing facility properly licensed in Delaware with or without a patient specific prescription.

5.1.7.3.1 An FDA-registered outsourcing facility properly licensed in Delaware may provide compounded nonsterile or sterile preparations:

5.1.7.3.1.1 Pursuant to a patient-specific prescription, or

5.1.7.3.1.2 In response to an order from a Delaware licensed veterinarian that is not for an identified animal patient where the veterinarian intends to administer the prescription to the animal patient in his or her care or to dispense to the animal patient's owner or caretaker.

5.1.7.3.2 Delaware licensed veterinarians must follow federal laws and regulations when administering or dispensing preparations obtained from an outsourcing facility.

5.1.7.3.3 Subsection 5.1.7.2.2.1 does not apply to subsection 5.1.7.3.

5.1.8 Automatic Dispensing Devices. If any automatic counting device is used by a pharmacy, each cell shall have clearly displayed thereon, the date filled, the name of the drug, the batch number, the manufacturer's name, and the expiration date of the particular batch number unless the information is stored electronically and readily retrievable. No drug can be added to the cell until the present supply is depleted unless the drug is of the same lot number and expiration date.

5.1.9 Authorization for renewal of prescriptions. A prescription written for medication which, pursuant to State and Federal law, may be sold, dispensed, or furnished only upon prescription, shall not be renewed without specific authorization of the prescriber. The pharmacist shall in his/her professional judgment refill prescriptions in keeping with the number of doses ordered and the directions for use. Refills beyond 1 year of the date of the original prescription shall not be dispensed without further authorization of the prescriber.

5.1.10 Mandatory Patient Profile Record System

5.1.10.1 A patient profile record system must be maintained at all pharmacies for persons for whom prescriptions are dispensed. The patient profile system shall be devised so as to entitle the immediate retrieval of information necessary to enable the dispensing pharmacist to identify previously dispensed medication at the time a prescription is presented for dispensing.

5.1.10.2 The following information shall be recorded by a pharmacist or designee:

5.1.10.2.1 The family name and first name of the person for whom the medication is intended (the patient);

5.1.10.2.2 The address of the patient and phone number;

5.1.10.2.3 The patient's age, or date of birth, and gender;

5.1.10.2.4 The original date the medication is dispensed pursuant to the receipt of a prescriber's prescription;

5.1.10.2.5 The number or designation identifying the prescription;

5.1.10.2.6 The prescriber's name;

5.1.10.2.7 The name, strength, quantity, directions and refill information of the drug dispensed;

5.1.10.2.8 The initials of the dispensing pharmacist and the date of dispensing medication as a renewal (refill) if said initials and such date are not recorded on the original prescription;

5.1.10.2.9 If the patient refuses to give all or part of the required information, the pharmacist shall so indicate and initial in the appropriate area.

5.1.10.2.10 Pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

5.1.10.3 The pharmacist or pharmacy intern under the direct supervision of a pharmacist shall attempt to ascertain and shall record any allergies and idiosyncrasies of the patient and any chronic disease states and frequently used over-the-counter medication as communicated to the pharmacist by the patient. If the answer is none, this must be indicated on the profile.

5.1.10.4 Upon receipt of a new prescription, a pharmacist, pharmacy intern, or student participating in a College of Pharmacy practical experience program under the direct supervision of a pharmacist must examine the patient's profile record before dispensing the medication to determine the possibility of a harmful drug interaction or reaction. Upon recognizing a potential harmful reaction or interaction, the pharmacist shall take appropriate action to avoid or minimize the problem and shall, if necessary, consult with the prescriber.

5.1.10.5 A patient profile record must be maintained for a period of not less than 1 year from the date of the last entry in the profile record unless it is also used as a dispensing record.

5.1.11 Exchange of Valid Non-Controlled Prescriptions Between Pharmacies

5.1.11.1 Verbal Exchange of Prescriptions - When a pharmacy receives a verbal request for a prescription transfer, it may be honored provided that:

5.1.11.1.1 The request comes from a registered pharmacist or pharmacy intern or student participating in an approved College of Pharmacy coordinated practical experience program under the direct supervision of a pharmacist.

5.1.11.1.2 The copy is immediately reduced to writing and contains the information required on a written prescription as listed in Section 5.0, and includes the first and last name of the pharmacist transmitting the information.

5.1.11.1.3 The prescription used for refills must be clearly identified as a copy.

5.1.11.1.4 The copy shows the date and the file number of the original prescription and indicates the name and address of the pharmacy providing the copy.

5.1.11.1.5 The copy shows the last date of dispensing.

5.1.11.1.6 Only the actual number of refills remaining are indicated.

5.1.11.1.7 A notation indicating a copy was given and refills are no longer valid must be placed on either the original prescription or patient profile. The document used must be the same one used for the recording of refills per the pharmacy's policy.

5.1.11.2 A copy prepared or transmitted that does not meet the requirements of this Regulation is deemed to be an invalid prescription.

5.1.11.3 Written copies of prescriptions are for information only and are not valid for refilling.

5.1.12 Automated Data Processing Systems (ADPS)

5.1.12.1 Profiles. When ADP'S are used to maintain patient profile records, all the requirements of Delaware Pharmacy 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.

5.1.12.2 Prescription (Drug Order) Information. Prescription information (drug order) shall include, but not be limited to:

5.1.12.2.1 Original dispensing date.

5.1.12.2.2 Name and address of patient (patient location if in an institution).

5.1.12.2.3 Name of prescriber.

5.1.12.2.4 Address and phone number of office where prescriber was located at the time prescription was issued.

5.1.12.2.5 DEA number of prescriber in the case of a controlled substance.

5.1.12.2.6 Name, strength, dosage form and quantity, (or Stop Date), and route of administration if other than oral form of drug prescribed.

5.1.12.2.7 Renewals authorized.

5.1.12.2.8 Directions of use for patient.

5.1.12.3 Records of Dispensing. Records of dispensing for original and refill prescriptions are to be made and kept by pharmacies for 3 years. Information must be immediately accessible for a period of not less than 1 year from the date of last entry. Information beyond 1 year but up to 3 years from the date of last entry may be maintained off-line but must be produced no later than 5 days upon request from proper authorities. The information shall include, but not be limited to:

5.1.12.3.1 Quantity dispensed.

5.1.12.3.2 Date of dispensing.

5.1.12.3.3 Serial Number (or equivalent if an institution).

5.1.12.3.4 The identification of the pharmacist responsible for dispensing.

5.1.12.3.5 Record of renewals to date.

5.1.12.3.6 Name and strength of medicine.

5.1.12.3.7 Records kept pursuant to this section may be maintained in an alternative data retention system, such as a direct digital imaging system, provided that: the records maintained in the alternative data retention system contain all of the information required in a manual record; the data processing system is capable of producing a hard copy of the electronic record on the request of the Board, its representative, or any law enforcement agency; and the digital images are recorded and stored only by means of a technology that does not allow subsequent revision or replacement of the images.

5.1.12.4 Record Retrieval (Documentation of Activity). Any such ADPS must provide via CRT display and or hard copy printout a current history of all authorized prescription activity. This information shall include, but not be limited to:

5.1.12.4.1 Serial number of prescription (equivalent if an institution).

5.1.12.4.2 Date of processing.

5.1.12.4.3 Quantity dispensed.

5.1.12.4.4 The identification of the pharmacist responsible for dispensing.

5.1.12.4.5 Medication dispensed.

5.1.12.5 Auxiliary Recordkeeping System. An auxiliary recordkeeping system shall be established for the documentation of renewals if the ADPS is inoperative for any reason. The auxiliary system shall insure that all renewals are authorized by the original prescription and that the maximum number of renewals is not exceeded. When the ADPS is restored to operation, the information regarding prescriptions dispensed and renewed during the inoperative period shall be entered into the automated data processing system.

5.1.12.6 Common Data Base. Two or more pharmacies may establish and use a common data file or base to maintain required or pertinent dispensing information. Pharmacies using such a common file are not required to transfer prescriptions or information for dispensing purposes between or among pharmacies participating in the same common prescription file or data base; provided however, any such common file must contain complete and adequate records of such prescription and renewals dispensed. Where common data base is used, this shall not be considered a transfer under Board Section 5.0 for non-controlled substances.

5.1.12.7 Transfer of Prescriptions via Automated Data Processing (ADP). A pharmacist may transfer a prescription electronically (ADP) for Schedule III, IV, or V controlled substances to another pharmacy for renewal purposes in accordance with Title 21, Code of Federal Regulations Section 1306. A pharmacist may transfer a prescription electronically (ADP) for non-controlled drug for renewal purposes in accordance with current State Regulations.

5.1.12.7.1 Any pharmacy using ADP must comply with all applicable State and Federal regulations.

5.1.12.7.2 A pharmacy shall make arrangements with the supplier of data processing services or materials to assure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason. A pharmacy shall assure continuity in maintenance of records.

5.1.12.7.3 The computer record shall reflect the fact that the prescription order has been transferred, the name of the pharmacy to which it was transferred, the date of transfer, the name of the pharmacist transferring information, and any remaining refill information, if applicable.

5.1.12.7.4 The pharmacist receiving the transferred prescription drug order shall reduce it to writing with the following information:

5.1.12.7.4.1 Write the word "TRANSFER" on the face of the transferred prescription unless the prescription is electronically transferred.

5.1.12.7.4.2 Provide all information required to be on the prescription drug order pursuant to State and Federal laws and regulations.

5.1.12.7.5 To maintain the confidentiality of patient's prescriptions (drug orders) or other pertinent records, there must exist adequate safeguards of security. This shall also pertain to prevent non-user access.

5.1.13 Electronic Transmission of Prescriptions

5.1.13.1 All Prescription Drug Orders communicated by way of Electronic Transmission shall:

5.1.13.1.1 Be transmitted directly to a Pharmacist in a licensed Pharmacy of the patient's choice with no intervening Person having access to the Prescription Drug Order;

5.1.13.1.2 Identify the transmitter's phone number for verbal confirmation, the time and date of transmission, and the identity of the Pharmacy intended to receive the transmission, as well as any other information required by Federal or State law;

5.1.13.1.3 Be transmitted by an authorized Practitioner or his designated agent; and

5.1.13.1.4 Be deemed the original Prescription Drug Order provided it meets the requirements of this subsection.

5.1.13.2 The prescribing Practitioner may authorize his agent to communicate a Prescription Drug Order orally or by way of Electronic Transmission to a Pharmacist in a licensed Pharmacy, provided that the identity of the transmitting agent is included in the order.

5.1.13.3 The Pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the Prescription Drug Order communicated by way of Electronic Transmission consistent with existing Federal or State laws and rules.

5.1.13.4 All electronic equipment for receipt of Prescription Drug Orders communicated by way of Electronic Transmission shall be maintained so as to ensure against unauthorized access.

5.1.13.5 Persons other than those bound by a confidentiality agreement shall not have access to Pharmacy records containing Confidential Information or personally identifiable information concerning the Pharmacy's patients.

5.1.13.6 Controlled substance prescriptions may be electronically transmitted.

5.1.13.7 Facsimile prescriptions must meet the following requirements in addition to the above listed electronic Transmission requirements.

5.1.13.7.1 The prescription order shall include the fax number of the transmitter, the number of transmitted pages, the name, phone number, and fax number of the pharmacy intended to receive the transmission, and a confidentiality statement in bold type stating the electronic transmission should not be seen by unauthorized persons.

5.1.13.7.2 Unless the prescription is written for a schedule II controlled substance, the prescriber should not issue the written prescription to the patient.

5.1.13.7.3 A facsimile transmitted prescription order must be reduced to writing, unless received as a non-fading document, with a notation that the order was received by facsimile.

5.1.13.7.4 The receiving facsimile machine must be in the prescription department to protect patient-pharmacist-authorized prescriber confidentiality and security.

5.1.13.7.5 Both non-controlled and controlled substance prescriptions may be transmitted via facsimile following state and federal requirements. All prescription orders for controlled substances shall be hand-signed by the practitioner.

5.1.14 Return and Disposal of Medications and Supply

5.1.14.1 Except as provided in subsection 5.1.14.2, non-controlled substance prescriptions may not be returned to the pharmacy except for disposal.

5.1.14.2 Products under the direct control of a health care professional which are packaged in manufacturer unit dose or tamper-proof unopened bulk containers, tamper proof seal in tact, including unused multi-dose punch cards, and which have been stored under USPNF (United States Pharmacopeia/National Formulary) conditions, may be redispensed in accordance with expiration dating. The pharmacist must examine the medication prior to re-dispensing for obvious signs of misbranding or adulteration. Partially used products may not be redispensed. Nothing in this regulation precludes the Federal laws and regulations.

5.1.14.3 Dispensed medications returned by the public shall be properly disposed of in accordance with Delaware Controlled Substance laws and regulations and the federal Controlled Substance Act, 21 CFR 1300 to the end. Proposed disposal methods must be authorized by the Delaware Office of Controlled Substances and federal authority.

5.1.15 Centralized Prescription Processing

5.1.15.1 A pharmacy may perform or outsource centralized prescription processing, services provided the parties:

5.1.15.1.1 Have the same owner; or

5.1.15.1.2 Have a written contract outlining the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of said contract in compliance with federal and state laws and regulations; and

5.1.15.1.3 Share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to fill or refill a prescription drug order.

5.1.15.2 The parties performing or contracting for centralized prescription processing services shall maintain a policy and procedures manual and documentation that implementation is occurring in a manner that shall be made available to the Board for review upon request and that includes, but is not limited to, the following:

5.1.15.2.1 A description of how the parties will comply with federal and state laws and regulations;

5.1.15.2.2 The maintenance of appropriate records to identify the responsible pharmacist(s) in each step of the dispensing and counseling processes;

5.1.15.2.3 The maintenance of a mechanism for tracking the prescription drug order during each step in the dispensing process;

5.1.15.2.4 The maintenance of a mechanism to identify on the prescription label all pharmacies involved in dispensing the prescription drug, order;

5.1.15.2.5 The provision of adequate security to protect the confidentiality and integrity of patient information;

5.1.15.2.6 The maintenance of a quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

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.

5.1.15.4 Any pharmacy where prescriptions are processed and/or dispensed via central fill must notify their patents using signage clearly visible to patients in the pharmacy department that part or parts of their prescription may be processed at a location other than where it is dispensed.

5.1.15.5 In addition to a QA program any pharmacy where prescriptions are processed and/or dispensed via central fill must record and track medication errors and potential errors and identify the system breakdown responsible for the errors and potential errors. Such records must be readily available for inspection.

5.2 Patient Counseling

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 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:

5.2.1.1 The name and description of the prescribed drug;

5.2.1.2 The dosage and the dosage form;

5.2.1.3 The method and route of administration;

5.2.1.4 The duration of the prescribed drug therapy;

5.2.1.5 Any special directions and precautions for preparation, administration, and use by the patient that the pharmacist determines are necessary;

5.2.1.6 Common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, how to avoid them, and what actions should be taken if they occur;

5.2.1.7 Patient techniques for self-monitoring of the drug therapy;

5.2.1.8 Proper storage and appropriate disposal methods for unwanted or unused medications;

5.2.1.9 Prescription refill information;

5.2.1.10 The action to be taken in the event of a missed dose; and

5.2.1.11 Current over-the-counter medication use.

5.2.2 This section does not apply to a pharmacist dispensing drugs for inpatient use in a hospital or other institution where the drug is to be administered by a nurse or other appropriate health care provider.

5.2.3 Nothing in this section requires a pharmacist or pharmacy intern or student participating in an approved College of Pharmacy coordinated practical experience program and working under the direct supervision of a pharmacist, to provide patient counseling when a patient refuses the counseling. There must be a record in a uniform place that documents a patient's acceptance or refusal of counseling.

5.2.4 If the dispensed prescription is delivered by an agent of the pharmacy when the pharmacist is not present (i.e. home delivery, pharmacist off duty and non-resident pharmacies), or if an agent is picking up the prescription for the patient, written or printed information shall be included with the prescription. The patient or his/her agent shall be provided with the pharmacist's contact information and informed that the pharmacist will be available for consultation.

5.2.5 Patient counseling may be conducted through telehealth subject to the following requirements:

5.2.5.1 During the telehealth treatment session, the patient shall be located within the borders of the State of Delaware.

5.2.5.2 Informed consent: Before services are provided through telehealth, the pharmacist, or a registered intern or pharmacy student working under the direct supervision of a pharmacist, shall obtain verbal informed consent from the patient, or other appropriate person with authority to make health care treatment decisions for the patient.

5.2.5.3 Confidentiality: The pharmacist, or a registered intern or pharmacy student working under the direct supervision of a pharmacist, shall ensure that their electronic transmission is secure to maintain confidentiality of the patient's medical information as required by the Health Insurance Portability and Accountability Act (HIPAA) and other applicable Federal and State laws.

5.2.5.4 Competence and scope of practice: the pharmacist, or a registered intern or pharmacy student working under the direct supervision of a pharmacist, shall be responsible for determining and documenting that telehealth is an appropriate level of care for the patient; shall comply with the Board's law and rules and regulations and all current standards of care requirements applicable to onsite care; and shall limit the practice of telehealth to the area of competence in which proficiency has been gained through education, training and experience.

Effective Date: October 11, 1996

Effective Date: April 14, 1997 Section 5.4 revised

Effective Date: June 11, 1998

Amended Effective September 11, 1999

24 Del. Admin. Code §§ 2500-5.0

1 DE Reg. 1965 (06/01/98)
3 DE Reg. 431 (09/01/99)
4 DE Reg. 163 (07/01/00)
4 DE Reg. 682 (10/01/00)
9 DE Reg. 85 (07/01/05)
9 DE Reg. 1253 (02/01/06)
13 DE Reg. 506 (10/01/09)
13 DE Reg. 1581 (06/01/10)
15 DE Reg. 99 (07/01/11)
16 DE Reg. 654 (12/01/12)
17 DE Reg. 990 (4/1/2014)
18 DE Reg. 707 (3/1/2015)
19 DE Reg. 860 (3/1/2016)
20 DE Reg. 995 (6/1/2017)
21 DE Reg. 989 (6/1/2018)
26 DE Reg. 768 (3/1/2023)
27 DE Reg. 258 (10/1/2023)
27 DE Reg. 980 (6/1/2024) (Final)