Current through Register Vol. XLI, No. 24, June 14, 2024
Section 15-2-8 - Prescriptions8.1. Rules governing the issuance, filling and filing of prescriptions for controlled substances are set forth generally in W. Va. Code § 60A-3-308 and West Virginia Code of State Rules § 15-1-21.8.3. Persons entitled to issue prescriptions. 8.3.1. A prescription for a controlled substance may be issued only by an individual practitioner who is authorized to prescribe controlled substances in the jurisdiction in which he or she practices, and is strictly limited to the schedule, class or specific substance which he or she is authorized by that jurisdiction to prescribe.8.3.2. A prescription issued by an individual practitioner except for Schedule II controlled substance, may be communicated to a pharmacist by an employee or agent of the individual practitioner.8.4. Purpose of issue of prescription.8.4.1. To be effective, an individual practitioner shall issue a prescription for a controlled substance for a legitimate medical purpose in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Uniform Controlled Substances Act and the person knowingly filling such a purported prescription, as well as the person issuing it, are subject to the penalties provided for violations of the provisions of law relating to controlled substances.8.4.2. An individual practitioner shall not issue a prescription in order for the individual practitioner to obtain controlled substances for the purpose of general dispensing to patients. A pharmacy may provide controlled substances to a practitioner for office use, but must do so by providing appropriate documentation through the use of an invoice or other federally required documentation or forms.8.4.3. A practitioner shall not issue a prescription for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs, except in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.8.5. Manner of issuance of prescriptions. 8.5.1. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, and the name, address and registration number of the practitioner. If the prescription is transmitted by e-prescribing, the signature may be an electronic signature. All paper prescriptions, including, but not limited to traditional paper prescription blanks, computer generated prescriptions that are printed out or faxed, and prescriptions received by the pharmacy as a fax prescription regardless of the method of transmission by the prescriber, must contain the prescriber's manual signature; an electronic signature, an electronic reproduction of the signature, signature stamp, or other form of signature is not a valid signature for a paper prescription. A practitioner may sign a prescription in the same manner as he or she would sign a check or legal document, for example, J.H. Smith or John H. Smith. Where an oral order is not authorized, prescriptions shall be written, typed, or computer-generated and printed with ink, and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and legislative rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed in this rule, Provided that: a pharmacist may make changes to a prescription order written for a controlled substance in accordance with the following:8.5.1.a. the pharmacist may add or change the patient's address upon verification;8.5.1.b. the pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner.8.5.1.c. such consultations and corresponding changes should be noted by the pharmacist on the prescription; and8.5.1.d. the pharmacist is never authorized to make changes to the patient's name, controlled substance prescribed, except for generic substitution authorized by state law or the prescriber's signature.8.6. Form of controlled substance prescription.8.6.1. Each controlled substance prescription shall be written on a separate blank and no non-controlled substance can be ordered on a blank with a controlled substance. This rule does not apply to prescriptions written for patients of an institutional facility as defined by West Virginia Code of State Rules § 15-1-2.1.21, 15 CSR 1. No more than one controlled substance may be written per prescription blank. A controlled substance prescription issued by a practitioner located outside the state of West Virginia that does not comply with this section may be accepted by the pharmacist if it is issued pursuant to the laws in the state in which the practitioner resides.8.6.2. If a pharmacist receives a prescription with more than one controlled substance on the blank or a non-controlled substance on a blank with a controlled substance, then the pharmacist shall refuse to fill the prescription. If the pharmacist in his or her professional judgment determines the immediate necessity for the patient to receive his or her medication, then the prescriptions may be dispensed and the pharmacist shall document in a log the prescription numbers and drugs dispensed. This log shall be kept in the pharmacy and be available for inspection. The pharmacist shall contact the prescriber as soon as possible to inform them that the prescription was not written according this rule. If the pharmacist continues to receive prescriptions from the same practitioner that do not comply with this rule, then the pharmacist shall inform the Board.8.6.3. Every controlled substance prescription shall have the name of the practitioner stamped, typed, or printed legibly on the face of the prescription, as well as the signature of the practitioner. Institutional prescription blanks shall include the DEA number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution, in lieu of the individual DEA number of the practitioner. If multiple practitioners are listed on a prescription blank, then the specific name of the prescriber shall be clearly distinguished upon the prescription. If a pharmacist receives a prescription that does not comply with this subsection, then the pharmacist shall refuse to fill the prescription. If the pharmacist in his or her professional judgment determines the immediate necessity for the patient to receive his or her medication, then the prescriptions may be dispensed and the pharmacist shall document in a log the date, patient name, practitioner name, prescription numbers, and drugs dispensed. This log shall be kept in the pharmacy and be available for inspection. The pharmacist shall contact the prescriber as soon as possible to inform them that the prescription was not written according to this rule. If the pharmacist continues to receive prescriptions from the same practitioner that do not comply with this rule, then the pharmacist shall inform the Board.8.7. Persons entitled to fill prescriptions. 8.7.1. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his or her professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner, for example, a hospital, nursing home, home for the aged, clinic, orphanage, governmental agency or institution or other place of similar character which dispenses controlled substances.8.8. Dispensing of narcotic drugs for maintenance purposes.8.8.1. The administering or dispensing directly, but not prescribing, of narcotic drugs listed in any schedule to a narcotic drug dependent person for "detoxification treatment" or "maintenance treatment" shall be considered to be within the meaning of the term "in the course of his or her professional practice or research." The practitioner shall be separately registered with the U.S. Attorney General as required by section 303(g) of the federal Controlled Substances Act 21 U.S.C. 823(g) and then thereafter comply with the regulatory standards imposed relative to treatment qualification, security, records and unsupervised use of drugs pursuant to the Act.8.8.2. A physician who is not specifically registered to conduct a narcotic treatment program may administer, but not prescribe, narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. No more than one day's medication may be administered to the person or for the person's use at one time. The emergency treatment may be carried out for not more than three days and may not be renewed or extended.8.8.3. This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.8.9. Controlled substances listed in Schedule II.8.9.1. Requirement of prescription. 8.9.1.a. A pharmacist may dispense a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to a paper prescription manually signed by the prescribing individual practitioner, or by electronic prescribing, except as allowed by subdivision 8.9.2. of this rule. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment or other electronic transmission other than electronic prescribing, provided that the original paper, manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as provided by West Virginia Code of State Rules § 15-1-21, 15 CSR 1. A prescription for a Schedule II controlled substance is valid for ninety days from the date issued. A pharmacist may fill the prescription after ninety days if the prescriber confirms to the pharmacist that he or she still wants the prescription filled and the pharmacist documents upon the prescription that the confirmation was obtained.8.9.1.b. An individual practitioner may administer or dispense a controlled substance listed in Schedule II in the course of his or her professional practice without a prescription, subject to subsection 8.8.1. of this rule.8.9.1.c. An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedule II only pursuant to a paper prescription manually signed by the prescribing individual practitioner, an electronic prescription, or an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.8.9.2. In the case of an emergency situation, a practitioner may communicate a prescription for a Schedule II controlled substance orally or by way of electronic transmission other than electronic prescribing, provided that if the prescribing practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a call-back to the practitioner using the practitioner's phone number as listed in the telephone directory and other good faith efforts to insure his or her identity; and:8.9.2.a. the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Dispensing beyond the emergency period shall be pursuant to a prescription issued in the normal course of practice as authorized in subsection 8.9.1. of this rule.8.9.2.b. the orally communicated prescription is immediately reduced to writing by the pharmacist, or, if necessary, the prescription communicated by way of electronic transmission other than electronic prescribing is immediately reduced to a hard copy;8.9.2.c. within seven days after authorizing an emergency oral prescription, the practitioner delivers a valid paper or electronic prescription for the emergency quantity prescribed to the dispensing pharmacist. The prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the orally or electronically transmitted prescription. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it shall be postmarked within the seven day period; if sent by electronic prescription, it must be transmitted by the prescriber within the seven day period. Upon receipt, the dispensing pharmacist shall attach this written prescription to the emergency oral prescription which had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription. The pharmacist shall notify the nearest office of the U.S. Drug Enforcement Administration and the Board if the prescribing practitioner fails to deliver a written prescription.8.10. Refilling Schedule II prescriptions; issuance of multiple prescriptions. 8.10.1. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. However, a prescriber may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided each separate prescription provides instructions other than the first prescription if the prescriber intends for that prescription to be filled immediately indicating the earliest date on which each prescription may be dispensed. The signatures on such prescriptions must be dated as of the date they were actually signed, and may provide the instructions for when they may be filled by indicating "do not full until", "may not be filled before", or other similar language, followed by the earliest date on which it may be dispensed.8.11. Partial filling of Schedule II prescriptions.8.11.1. A pharmacist may dispense a partial filling of a prescription for a controlled substance listed in Schedule II, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the written prescription or written record of the emergency oral prescription. The remaining portion of the prescription may be filled within seventy-two hours of the first partial filling, however, if the remaining portion is not or cannot be filled within the seventy-two hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity of controlled substances may be supplied beyond seventy-two hours without a new prescription.8.12. Labeling of Schedule II prescriptions.8.12.1. The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner and directions for use and cautionary statements, if any, contained in the prescription or required by law.8.13. Filing of prescriptions.8.13.1. All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of the Uniform Controlled Substances Act and this rule.8.14. Controlled substances listed in Schedules III, IV, and V. 8.14.1. Requirement of prescription. 8.14.1.a. A pharmacist may dispense a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to either a paper prescription manually signed by a prescribing individual practitioner, a facsimile of a paper prescription or order for medication, an electronic prescription, or an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required by this rule, except for the signature of the prescribing individual practitioner.8.14.1.b. An individual practitioner may administer or dispense a controlled substance listed in Schedule III, IV, or V in the course of his or her professional practice without a prescription, subject to the provisions of section 8.8. of this rule.8.14.1.c. An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedules III, IV, or V pursuant to a paper prescription signed by a prescribing individual practitioner, an electronic prescription, or an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in section 8.5. of this rule, except for the signature of the prescribing individual practitioner, or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to section 8.8. of this rule.8.15. Refilling of Schedule III, IV, or V prescriptions.8.15.1. A pharmacist shall not fill or refill a prescription for a controlled substance listed in Schedule III, IV, or V more than six months after the date on which the prescription was issued and any prescription authorized to be refilled may not be refilled more than five times. Each refilling of a prescription shall be entered on the back of the prescription, or on another uniformly maintained appropriate record, such as medication records, which indicate prescription refills, initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed. If the pharmacist merely initials and dates the back of the prescription, he or she shall be considered to have dispensed a refill for the full face amount of the prescription. Additional quantities of controlled substances listed in Schedule III, IV, or V may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in section 8.14. of this rule, which shall be a new and separate prescription. The number of partial fills may be more than five times as long as the total quantity prescribed is not exceeded. No refill may be provided more than three days prior to the date the prior dispensing would be exhausted unless special circumstances justifying the early refill exist. If an early refill is made, the pharmacist is encouraged to consult with the prescriber, and must document on the prescription record the special circumstances justifying the early dispensing.8.16. Partial Filling of Schedule III, IV, or V prescriptions. 8.16.1. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible provided that:8.16.1.a. Each partial filling is recorded in the same manner as a refilling;8.16.1.b. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and8.16.1.c. No dispensing occurs after six months after the date on which the prescription was issued.8.17. Labeling of Schedule III, IV, or V prescriptions.8.17.1. The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in the prescription as required by law.8.18. Filing of Schedule III, IV, or V prescriptions.8.18.1. All prescriptions for controlled substances listed in Schedules III, IV, or V shall be kept in accordance with section 7.15. of this rule.8.19. Dispensing without prescription. 8.19.1. A pharmacist may dispense a controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined by the Federal Food, Drug, and Cosmetic Act, without a prescription to a purchaser at retail, unless: 8.19.1.a. The dispensing is made only by a pharmacist and not by a nonpharmacist employee even if under the direct supervision of a pharmacist. After the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction or delivery, may be completed by a nonpharmacist;8.19.1.b. Not more than 240 cc. of any controlled substance containing opium, nor more than 120 cc. of any other controlled substance nor more than 48 dosage units of any controlled substance containing opium, nor more than 24 dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given 48 hour period;8.19.1.c. The purchaser is at least 18 years of age;8.19.1.d. The pharmacist requires every purchaser of a controlled substance under this section not known to him or her to furnish suitable identification, including proof of age where appropriate;8.19.1.e. A bound record book for distributions of controlled substances under this section, other than by prescription, is maintained by the pharmacist. The book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase and the name or initials of the pharmacist who dispensed the substance to the purchaser. The book shall be maintained in accordance with the record keeping requirement of section 7.2. of this rule; and8.19.1.f. A prescription is not required for distribution or dispensing of the substance pursuant to any other federal, state or local law.