Wyo. Code R. 059-0001-2
Pharmacy, Board of
Chapter 2: General Practice of Pharmacy Regulations
Effective Date: 02/23/2000 to 12/08/2000
Rule Type: Superceded Rules & Regulations
Reference Number: 059.0001.2.02232000
These regulations are promulgated as authorized by the Act.
The purpose of this regulation is to coordinate the requirements for pharmaceutical care by providing minimum standards, conditions and physical guidelines for facilities and pharmacists in professional settings.
This Chapter applies to any person, partnership, corporation, limited liability company or other entity engaging in the practice of pharmacy within this State.
(a) 'Administer' means the direct application of a drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:
(i) A practitioner (or by his authorized agent); or
(ii) The patient or research subject at the direction of the practitioner.
(b) 'Board of Pharmacy' or 'Board' means the Wyoming State Board of Pharmacy.
(c) 'Compounding' means the preparation, mixing, assembling, packaging or labeling of a drug or device -
(i) as the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or
(ii) for the purpose of research, teaching or chemical analysis or not for sale dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
(d) 'Confidential Information' means information maintained by the pharmacist in the patient's records or which is communicated to the patient as part of patient counseling, which is privileged and may be released only to the patient or, as the patient directs; to those practitioners and other pharmacists where, in the pharmacist's professional judgment, such release is necessary to protect the patient's health and well being; and to such other persons or governmental agencies authorized by law to investigate controlled substance law violations.
(e) “Consultant Pharmacist” shall mean a pharmacist who establishes policies and procedures for the distribution and storage of drugs and visits the facility on a regularly scheduled basis, but is not physically present at the facility for a set number of hours on a daily basis.
(f) “Deliver” or “Delivery” means the actual, constructive or attempted transfer from one person to another of a drug or device whether or not there is an agency relationship.
(g) “Device” means an instrument, apparatus, implement, machine, contrivance, implant or other similar or related article, including any component part or accessory, which is required under Federal law to bear the label “Caution: Federal law restricts this device to sale by or on the order of a physician.”
(h) “Dispense” means to deliver a drug to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.
(i) “Distribute” means the delivery of a drug or device other than by administering or dispensing.
(j) “Dosage Form” means the physical formulation or medium in which the product is manufactured and made available for use, including but not limited to: tablets, capsules, oral solutions, aerosols, inhalers, gels, lotions, creams, ointments, transdermals and suppositories.
(k) “Drug” means articles recognized as drugs in any official compendium, or supplement thereto designated for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals.
(l) “Institutional Facility Pharmacy” shall mean any organization whose primary purpose is to provide pharmaceutical services to patients or residents residing in the facility, including, but not limited to a hospital or nursing home.
(m) “Labeling” means the process of preparing and affixing a label to any drug container exclusive of the labeling by a manufacturer, packet or distributor. (See Section 11 of these regulations.)
(n) “Non-resident Pharmacy” means a licensed pharmacy located outside this State where drugs are dispensed and pharmaceutical care is provided to residents within the State.
(o) “Patient Counseling” means the oral communication by the pharmacist of information, as defined in the rules of the Board, to the patient or caregiver, in order to improve therapy by ensuring proper use of drugs and devices. Patient counseling may be supplemented with printed materials.
(p) “Pharmaceutical Care” is the provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to the cure or prevention or management of an illness or injury.
(q) “Pharmacist-in-Charge” or “PIC” means a pharmacist currently licensed in this State who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs.
(r) “Pharmacy” means any place within this State where drugs are dispensed and pharmaceutical care is provided.
(s) “Pharmacy Technician” means an individual other than an intern, who performs pharmacy functions under the direct supervision of a licensed pharmacist.
(t) “Practitioner” means an individual currently licensed, registered or otherwise authorized by the jurisdiction in which he/she practices to prescribe drugs in the course of professional practice.
(u) “Prescription Drug” or “Legend Drug” means a drug which, under Federal Law, is required to be labeled with one of the following statements:
(i) “Caution: Federal law prohibits dispensing without prescription”;
(ii) “Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian”;
(iii) “Rx Only”; or
(iv) is a drug included on the Wyoming Dangerous Substance Listing, as referenced in Wyoming Pharmacy Act Rules and Regulations, Chapter 11, section 2, and shall be dispensed pursuant to a prescription drug order.
(v) “Prescription Drug Order” means a lawful order of a practitioner for a drug or device for a specific patient.
(w) “Provider Pharmacist” shall mean a pharmacist who supplies medication to a nursing home or other long-term care facility and maintains separate pharmacy patient profiles independently of the facility.
(x) “Registered Pharmacist” means an individual currently licensed by this State to engage in the practice of pharmacy.
(y) “Wholesale Distributor” means any person or firm engaged in wholesale distribution of drugs, including but not limited to manufacturers; repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses and wholesale drug warehouses; independent wholesale drug traders and retail pharmacies that conduct wholesale distributions.
(z) “Agreement” means a voluntary agreement, written and signed, between a pharmacist and a prescribing physician that defines a collaborative practice for the purpose of drug therapy management of patients.
(aa) “Collaborative pharmacy practice” means a practice in which a prescribing physician makes a diagnosis, maintains ongoing supervision of patient care and refers the patient to a pharmacist under a protocol allowing the pharmacist to perform patient care functions authorized by the physician under specified conditions or limitations.
(bb) “Drug therapy management” means the review of drug therapy regimen(s) of patients by a pharmacist for the purpose of evaluating and rendering advice to the prescribing physician regarding adjustment of the regimen. Decisions involving drug therapy management shall be made in the best interest of the patient. “Drug therapy management” may include:
(i) Implementing, modifying, and managing drug therapy according to the terms of the agreement and the specific written orders.
(ii) Collecting and reviewing patient drug histories;
(iii) Obtaining and checking vital signs, including but not limited to pulse, temperature, blood pressure, and respiration; and
(iv) Ordering and evaluating the results of laboratory tests directly relating to drug therapy, when performed in accordance with approved protocols applicable to the practice setting.
(cc) “Pharmacist’s collaborative scope of practice” means those duties and limitations of duties agreed upon by a pharmacist and the collaborating physician (subject to Board’s approval and applicable law), and includes the limitations implied by the specialty practiced by the collaborating physician.
Examinations of candidates for registered pharmacist will be scheduled to coincide with regular meetings of the Board. Candidates shall be examined on such subjects and in such manner as determined by the Board. Examinations may be the standardized exam prepared and provided by the National Association of Boards of Pharmacy, in addition, all candidates shall be examined on federal laws and state laws pertinent to the practice of pharmacy.
(a) Candidates shall be required to make a grade of seventy-five (75) on both the standardized, or other general exam, and the law (jurisprudence) exam to be entitled to be licensed as a registered pharmacist.
(b) Applications for examinations must be completed on a form provided by the Board and received by the Board office at least twenty (20) days prior to the date of the examination. Applications must be accompanied by the proper fee, recent picture and other documentation determined by the Board. Fees for the standardized exam shall be paid directly to the National Association of Boards of Pharmacy. The Board shall charge fees to cover administrative costs and to cover costs incurred in developing the law exam.
(c) Applicants for licensure who have taken the standardized or other exam approved by the Board and have those exam scores transferred - shall be licensed by examination in Wyoming, provided all requirements are completed within one year from the initial exam date. Requirements include filing proper application with certification and picture, and taking/passing federal-state law exam.
(d) No candidate will be considered for licensure until required intern training is completed.
(e) Candidates for licensure who do not receive a passing grade on the exam shall be allowed two (2) retakes for a total of three (3) examinations within two (2) years. If candidate has not passed the third (3rd) exam, candidate shall not be eligible for further examinations until additional education, including review courses are completed.
Any pharmacist who is licensed by examination and is in good standing in any state which is a member of the National Association of Boards of Pharmacy (NABP) and who desires to be licensed by reciprocity into the State, shall proceed in the manner outlined by the NABP after first submitting the “Preliminary Application for Transfer of Pharmaceutic Licensure” obtained from any state or the NABP.
(a) The Board in its discretion may recognize the qualifications of the applicant as determined by NABP. Persons who have become registered as pharmacists by examinations in other states may be required to satisfy only the requirements which existed in this State at the time they became registered in the other state, provided that the state in which said persons is registered shall under like conditions grant reciprocal registration as pharmacist, without examination, to pharmacists duly registered by examination in this State. The Board reserves the right to reject any applicant pursuant to the Act.
(b) In the event of rejecting an application, the fee paid to the Board will be refunded. No applicant for reciprocal registration who has previously taken the examination and failed will be accepted, unless candidate can show satisfactory evidence of having acquired increased proficiency in the knowledge and practice of pharmacy equivalent to that required in the Wyoming examination
(c) All candidates for license transfer shall be required to file appropriate applications; pass the federal state law exam with an average grade of not less than seventy-five (75); complete required internship if not licensed in state of original licensure and actively practiced pharmacy for one (1) year or more; prove good moral character, pay required fees and meet all requirements under the Act.
(d) All applications for transfer of licensure (reciprocity) shall expire one (1) year from date of issue by NABP if not filed with the Board and licensure completed.
Every pharmacy shall be equipped with proper pharmaceutical equipment and references before it shall be licensed under the provisions of the Act. Requirements for proper equipment may vary between pharmacies, but must be adequate to ensure accuracy and safety of all pharmaceutical activity.
(a) The necessary equipment for dispensing and compounding shall include, but is not limited to basic equipment recognized by the latest edition of the United States Pharmacopeia/National Formulary (USP/NF), the USP/DI or Remington’s Pharmaceutical Sciences.
(b) A sequential numbering machine or electronic data device for the consecutive numbering of all prescriptions must be maintained along with appropriate printing equipment to produce prescription drug labels.
(c) Patient profile records, Schedule V - controlled substances record book and other records as subscribed by the Board shall be maintained as required by law.
(d) The professional reference library must maintain at least one (1) current edition of pharmacy laws as provided by the Board, the most current edition of the “USP/DI”, and/or the FDA “orange book” - Approved Drug Products with Therapeutic Equivalence Evaluations”, current edition of Facts and Comparisons, and a current drug interaction text which provides at a minimum quarterly updates.
(e) The prescription area shall be a well-lighted and ventilated room or department. Pharmacies shall be maintained in a clean and sanitary condition at all times. Any procedures used in the dispensing, compounding and admixture of drugs or drug related devices must be completed under clean and, when recommended, aseptic conditions.
(f) Appropriate sewage disposal and a hot and cold water supply must be available at the pharmacy.
(g) Adequate refrigeration must be available to insure storage space for drugs requiring refrigeration or freezing under temperatures adequate to maintain the drug products as recommended by the manufacturer and the latest reference material. Drugs and drug-related devices must be stored separately from food and other items.
(h) The area of the prescription department shall not be less than 150 sq. feet. There shall be adequate counter on which to work and the working surface shall be kept clear and uncluttered at all times for the compounding of prescriptions and other pharmaceutical manufacturing. The free floor space behind the counter shall not be less than thirty (30) inches in width.
(i) Pharmacies must maintain adequate security to deter theft of drugs by personnel or public. No person other than pharmacist, intern or technician employed by the pharmacy shall be permitted in the prescription compounding area without the express consent of the pharmacist-in-charge. If the pharmacy is located in a facility in which the public has access and the pharmacy’s hours of operation are different from the rest of the facility, pharmacy must be designed so that it can be securely locked and made inaccessible when the pharmacist is not present.
An application for registration to operate, maintain, open or establish a pharmacy or prescription department shall be made on a form provided by the Board prior to the opening of said pharmacy or prescription department.
(a) Prior to the issuing of the registration to operate a pharmacy or prescription department, the Board will inspect the pharmacy for minimum standards including space, fixtures, sanitation, reference library, technical equipment and security.
(b) The application shall list the names of all registered pharmacists employed specifically identifying the pharmacist-in-charge (PIC). Pharmacists are the only persons allowed to have keys to the prescription drug area of a pharmacy. The pharmacist-in-charge determines which pharmacists shall have keys.
(c) The Board shall be notified with every change of pharmacist-in-charge. A controlled substance inventory is required when there is a change in the pharmacist-in-charge, at the time of the change. Pharmacists and interns must report any change of address or place of employment to the Board within fifteen (15) days.
(d) Every pharmacy license shall expire on June thirtieth (30th) of each year and shall be renewed annually by filing an application together with a fee set by the Board no later than that date.
(e) When a pharmacy changes ownership, the original license becomes void and a new license must be secured by the new owner or owners. A new license is required even if there is no change in the name of the pharmacy or in the registered pharmacist in charge of the pharmacy.
In the case of a corporation, limited liability company or partnership holding a pharmacy license, the Board shall be notified and a new license applied for anytime the majority of stock in the corporation is sold or a majority of the partners of the partnership or members of the limited liability company change. This shall constitute new ownership. Requirements for the ownership are the same as outlined in this section.
(f) A pharmacy license registers the pharmacy to which it is issued only at the location specified on the application and is not transferable.
(g) All licenses and certificates issued by the Board shall be displayed in a prominent place within the facility and always in view to the public.
(h) When a pharmacy licensed by the Board permanently ceases operation for any reason, the Board is to be notified immediately and the pharmacist-in-charge is responsible for securing all drugs and records in the pharmacy and following other guidelines as directed by the Board - including, but not limited to: (1) Notification of all patients and availability of patient records; (2) notification of the Drug Enforcement Administration and inventory and transfer or destruction of all controlled substances; and (3) proper distribution, transfer or destruction of all other legend drugs;
(i) If closure is permanent, remove from inside and outside the area all references of 'Drug', 'Drugstore', 'Pharmacy' or other terms that might indicate or signify by any advertising medium that such establishment is a licensed pharmacy; and surrender retail pharmacy license and Wyoming controlled substances registration to the Board office. Federal DEA registration and all unused DEA Form 222 shall be marked 'Void' and returned to DEA.
Every licensed pharmacy must be in the continuous daily charge of a registered pharmacist. A pharmacist shall be designated as the pharmacist-in-charge and shall have direct control of the pharmaceutical affairs of said pharmacy. A pharmacist may not serve as the pharmacist-in-charge unless said pharmacist is physically present in the pharmacy a sufficient amount of time to provide supervision and control and not under subterfuge.
A pharmacist may not serve as pharmacist-in-charge for more than one pharmacy at any one time. The name of the pharmacist-in-charge shall be designated in the application of the pharmacy for license and in each renewal thereof.
(a) A corporation or other non-pharmacist owner must comply strictly with the above provisions and provide a pharmacist-in-charge who will have complete control over the pharmaceutical affairs of said pharmacy.
(b) Responsibility as the pharmacist-in-charge includes requiring that all federal and State pharmacy laws and regulations are complied with and enforced. It shall be the duty of the pharmacist-in-charge to report all pharmacy violations within their facility to the Board.
(c) Additional responsibilities of the pharmacist-in-charge shall be to:
(i) Establish policies and procedures for the procurement, storage, compounding and dispensing of pharmaceuticals.
(ii) Supervise the professional employees of the pharmacy.
(iii) Supervise the non-professional employees of the pharmacy.
(iv) Establish and supervise the record keeping for and security of all pharmaceuticals.
(v) Report any loss or theft of drugs to the Board and other authorities.
(vi) Ensure that all staff: registered pharmacists, interns, pharmacy technicians-in-training and certified pharmacy technicians have valid licenses or registrations in good-standing and that all certificates are on display.
(vii) Ensure that all pharmacy licenses, including state and federal controlled substances registrations are valid and posted.
(viii) Develop and implement a procedure for drug recall.
(ix) Be personally in full and actual charge of such pharmacy.
(d) Every pharmacy shall have at least one registered pharmacist on duty and physically present in the pharmacy area at all times that the prescription department is open for the transaction of business. If an emergency occurs and the pharmacist must be absent from a licensed pharmacy, the prescription department must be locked and kept so until that pharmacists' return and a sign saying - 'Prescription Department Closed - No Registered Pharmacist on Duty' shall be conspicuously posted.
(e) No pharmacy shall be permitted to operate without a pharmacist-in-charge. The Board shall be notified in writing of any newly designated pharmacist-in-charge. The Board shall record the PIC change and issue a corrected copy of the license.
A prescription label or a written copy of a prescription order from another pharmacy may be used for informational purposes only and shall not be considered to be a valid prescription order. A pharmacist who receives such a label or prescription order copy shall either contact the prescribing practitioner for authorization to dispense the prescription, or, alternatively, shall comply with (a) through (j) of this Section.
(a) A pharmacist may transfer prescription order information for the purpose of refilling a prescription subject to the following requirements. The information is communicated directly by one pharmacist to another pharmacist, or the information may be electronically transferred between pharmacies. Pharmacies electronically transferring information must satisfy all information requirements of a transferred prescription which is communicated directly by one pharmacist to another pharmacist.
(b) The transferring pharmacist shall:
(i) Write the word “void” across the face of the original prescription order to make the order invalid or electronically document that the prescription has been voided;
ii) Record on the reverse side of the invalidated prescription order or electronically document:
(F) In the case of a controlled substance in schedule III through V, the Drug Enforcement Administration registration number of the receiving pharmacy.
(c) The pharmacist receiving the transferred prescription order information shall reduce the transferred information to writing; write the word “transfer” or a word of similar import on the face of the transferred prescription order or electronically document that the prescription has been transferred, and provide all information required by law or regulation to be on the prescription order, including:
(vi) The prescription order number from which the prescription order information was transferred;
(vii) The name and license number of the transferring pharmacist;
(viii) The name and address of the transferring pharmacy.
(d) The transferring pharmacy shall retain the original prescription order.
(e) The receiving pharmacy shall retain the transferred prescription order.
(f) The pharmacist at the receiving pharmacy at the time of the dispensing of the transferred prescription, shall inform the patient that the prescription order is now invalid at the pharmacy from which it was transferred.
(g) A transferring pharmacy which utilizes a computer for recordkeeping of prescription order transactions shall comply with all requirements of this regulation including invalidation of the prescription order and deactivation of the order in the computer.
(h) Nothing in this regulation shall be deemed to permit the transfer of a prescription order for a schedule II controlled substance.
(i) In the case of a controlled substance in schedules III through V, the DEA number of the transferring pharmacy and the practitioner’s DEA number shall be recorded.
A prescription order for a controlled substance in schedule III through V may be transferred only one time, that transfer being from the pharmacy where the prescription was originally filled. It shall not be further transferred by, or to, any other pharmacy.
(j) A prescription order for a non-controlled prescription drug may be transferred from one pharmacy to another pharmacy only so long as there are refills remaining and each pharmacy can establish that a valid refill existed at the time of dispensing.
All original or refill prescription drug containers shall be labeled as follows: brand or generic name of the drug product dispensed unless otherwise specified; the name, address and phone number of the pharmacy; the practitioner’s name; the serialized number of the prescription; the date the prescription was filled or refilled; directions for use, including specific required auxiliary labels; the initials and license number of the dispensing pharmacist and any other information required by federal or state law.
(a) The Consumer Product Safety Commission enforces the Poison Prevention Packaging Act (PPPA) which requires that all prescription medication shall be dispensed in child-resistant packaging.
(b) Unless the prescription drug is expressly exempted from the federal regulations, the drug must be dispensed in a child-resistant package. Exceptions to this requirement do exist as follows:
(i) The purchaser may request either a one time or a blanket waiver from the requirement. A one-time request shall be documented on the prescription or patient profile records by the pharmacist.
(ii) The physician, at the request of the patient, may request a one-time waiver. However, the physician cannot request a blanket waiver.
(c) Child-resistant prescription containers cannot be reused for refills of prescriptions. However, glass containers may be reused, provided that a new safety closure is used.
The following information shall be recorded in a readily retrievable manner when a prescription is refilled: date refilled, quantity, pharmacist's initials and license number. If refill information was not authorized on the original prescription and authority must be obtained the name or identity of the authorizing agent must be recorded.
Both the supervising pharmacist and the intern must initial any prescription or prescription refilled by the intern.
Any prescription shall be considered null and void when the pharmacist learns that the professional relationship between a practitioner and patient has been terminated for any reason.
Pharmacists and pharmacies are prohibited from accepting from patients or their agent any prescription medications for redistribution. Hospitals and nursing homes that distribute medication in unit dose packaging to be administered by professional staff may return unused medication in tamper-proof containers in accordance with good professional practice.
This section shall not apply to the return of medical devices.
When a drug has been packaged and prepared pursuant to a prescription order, but has not been delivered to either another location or to the ultimate consumer, it may be returned to stock.
A record shall be made on the prescription order and the pharmacy's computer indicating a return to stock and the date of such return.
A prescription written outside the scope of practice of the prescribing practitioner shall not be considered a valid prescription.
Section 17. Identification of a Patient.
(a) The pharmacist or employee under supervision must verify the identity of the person receiving any drug at the time it is dispensed to that person. This may be done by visual recognition. If identity is not established by visual recognition, a driver's license or similar identification form is considered acceptable documentation.
(b) The name of the person receiving the dispensed drug is to be recorded on the prescription document, patient profile or signature log if an agent and not the patient receives the drug.
(c) This section shall not apply to pharmacies that mail prescriptions to their patients. A note shall be entered on the prescription or patient's profile with the name and address of where the medication was mailed. Additionally, the date of such mailing shall be entered.
Section 18. Reinstatement of Registered Pharmacist License After Failure to Renew, Returning from Inactive Status, Issuance of Duplicate License.
(a) If a person requests the reinstatement of their registered pharmacist license when said license has lapsed only for failure to pay renewal fees, the person shall:
(b) Minimum Competency for an Inactive Pharmacist Shall be Established to the Satisfaction of the Board.
When a registered pharmacist has been out of the practice of pharmacy for an extended period of time and wishes to reactivate that license, the Board shall determine on an individual basis the requirements needed to reactivate that license.
The requirements may include some or all of the following:
(iv) Internship under direct supervision may be required. Internship period may vary depending upon how long the individual was out of practice.
(v) Individual shall produce at least two (2) recent letters of character reference.
(c) Duplicate licenses may be issued upon request when licensees name changes or the license become damaged or destroyed. There shall be a fee charged for the duplicate license.
(a) To be valid the prescription as defined in §33-24-136(b) shall contain the following information:
(i) Name of patient;
(ii) Name and strength of drug;
(iii) Quantity to be dispensed;
(iv) Directions for using the drug;
(v) Name of the practitioner on the proper signature line to indicate whether or not generic substitution is to be permitted;
(vi) Date of issuance by practitioner;
(vii) Prescriptions for controlled substances shall include the DEA number and address of prescribing practitioner and address of the patient.
(b) Prescriptions may be transmitted to the pharmacist in written form; orally, including by telephone; or except for Schedule II Controlled Substances, by telephonic facsimile (FAX). Schedule II Controlled Substances may be transmitted by FAX if they meet the conditions as outlined in Section 20 (c).
The patient shall have the exclusive right to freedom of choice for any pharmacy to dispense their prescription orders. No agreement between prescriber and pharmacy shall require that prescription orders be transmitted from the prescriber to only that pharmacy.
The pharmacist shall be required to determine the accuracy and authenticity of all prescriptions received. Practitioners or their agents shall provide voice verification, when requested by the pharmacist. If refused the prescription shall not be filled.
Prescriptions transmitted by FAX shall include all of the features listed in Section 20 (b) including the practitioner's recognizable signature.
(a) Other requirements for FAX prescriptions include:
(i) A notation that this is a FAX prescription.
(ii) Telephone number and FAX number of the practitioner.
(iii) Name, address, telephone number and FAX number of pharmacy to which the prescription is being FAXed.
(iv) Date and time of FAX, if not otherwise programmed into transmission.
(v) Name of individual acting as practitioner's agent, if other than practitioner.
The originating FAX prescription shall be put into practitioner's patient file. It shall not be given to the patient.
All FAX machines which are to be used in transmitting prescriptions shall be programmed with FAX identification number, so that document received will show the sender's FAX identification number.
(b) The FAX machine for any receiving pharmacy shall be in the prescription department to protect patient confidentiality and shall utilize non-fading paper. Alternatively a non-fading photo copy or manually written copy of the FAXed prescription shall be stapled to the FAX copy.
A log of prescription orders received by FAX must be maintained for the two year period required for written prescription orders. The log shall contain the time and date of each transmission and the FAX I.D. number of the transmitter.
(c) Prescriptions for Schedule III, IV, and V controlled substances may be transmitted by FAX. Schedule II controlled substance prescriptions may be transmitted by FAX, if the schedule II controlled substance prescription meets one of the following conditions:
(i) A prescription for a schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion or;
(ii) A prescription written for a schedule II substance for a resident of a Long Term Care Facility or;
(iii) A prescription written for a schedule II substance for a 'terminally ill' patient. The pharmacist shall so annotate a FAXED schedule II prescription as being for a 'terminally ill' patient.
(d) The FAX copy received by the pharmacist shall be deemed the original prescription order and shall be maintained as required by statute.
(e) A FAXed prescription may be dispensed only by the pharmacy receiving the FAX.
(a) Prescription refill permission may be obtained in written form, by oral verification including telephone or FAX.
(b) If prescription refill authorization is obtained by FAX, it shall be initialed by the authorizing practitioner on the document. All other requirements for valid prescriptions shall apply, including pharmacist's responsibility to determine authenticity of information obtained by FAX.
(a) The use of FAX machines in hospitals to facilitate dispensing to inpatients shall be considered internal communication and shall not be governed by this section, 19(b), 20 and 21.
(b) Using FAX equipment to circumvent documentation, authenticity, verification or other standards of pharmacy practice shall be considered unprofessional conduct.
(a) Generic substitution is allowed only if approved by the prescribing practitioner and the patient or patient's agent.
(b) The recognized reference for generic substitution on a prescription order is the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the 'Orange Book'.
The Board recognizes other reference books to the extent they reprint 'Orange Book' information. The Board recognizes the USP/DI, Vol. III and 'Physicians' Generix' as two references to be used to replace or complement the FDA 'Orange Book'.
(c) If all conditions for generic substitution are met, only products bearing an 'A' rating shall be used as a substituted product. The substitution of pharmaceuticals with a 'B' rating is prohibited.
(d) The Board recognizes the list of Product Selection Codes of the National Council for Pharmacy Drug Programs (NCPDP) which shall be used for purposes of prescription billing.
Therapeutic equivalents do not include therapeutic substitutions. Therapeutic equivalent is defined in W.S. §33-24-147(a)(v). Therapeutic substitution is that class of drug having the same or similar action, but not the identical composition.
Pharmaceuticals which are considered to be therapeutic substitution instead of generic substitution, shall not be used for retail/non-resident pharmacies. A hospital pharmacy using a formulary may reach a written agreement with members of the medical staff under which therapeutic substitution is permitted for use of formulary drugs.
(a) When a manufacturer manufactures a drug product that is to be distributed under the manufacturers' brand name and holds either an approved New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), but distributes the drug under the generic drug name to a second distributor to be distributed only under the generic name, the second generic distributor doesn't need to hold either an NDA or an ANDA provided the label shows only the generic name and includes the name of the original manufacturer.
Before the generic drug distributor can resell to another distributor the generic drug distributor must apply for and receive the ANDA.
This section does not include any drug product that has unresolved bioequivalency concerns according to the FDA's most recent publication.
(a) Due to an exception clause in the Act - Section 33-24-113, the Board does not have authority to regulate the day to day activities of the hospital beyond the purchase, security, and accountability (audit) of all controlled substances coming into, going out of or otherwise dispensed or administered within the facility. All activities concerning controlled substances, including registration come under the purview of the Controlled Substances Act Section 35-7-1001, Article 10 et seq., and not the Pharmacy Act.
If a hospital/nursing home elects to provide out-patient services to employees, dismissed hospital patients or emergency room patients, the facility must register as a retail pharmacy, except as provided in Section 27. Records and physical inventory for the retail operation must be kept separate from all other pharmacy records and physical inventory pertaining to drugs dispensed or administered within the confines of the facility.
(b) Emergency Room Dispensing - Exception.
Administration and distribution of drugs from the emergency room of a hospital when no other pharmaceutical services are available in the community, as in week-end, holiday and nighttime may be accomplished by operating within hospital emergency room policy and by adhering to the following:
(i) Drugs shall be prepacked in appropriate containers and properly labeled with name of drug, including company name, strength, quantity, directions-for use and all cautionary labels, including expiration date and lot number. Only the name of the patient, name of practitioner, date and identification or serial number of the container shall be omitted. The name, address and telephone number of the hospital must be on all labels.
(ii) All drugs shall be prepackaged by the pharmacist.
(iii) All drugs shall be prepackaged in containers for twenty four (24) hour doses. Multiple containers may be presented to the patient by the physician or authorized agent under the order of the physician. Only the number of containers to accommodate the emergency period may be presented, not to exceed seventy two (72) hours. When appropriate, a prescription must be given to the patient to obtain the balance of the drug regimen.
(iv) A log book must be kept in the emergency room. The pharmacist shall enter information on each container into the log book at time of dispensing. The physician, or authorized agent shall enter name of patient, name of practitioner, date and identification or serial no. at the time the container is given to the patient.
(v) Daily or, as soon as possible, the pharmacist shall reconcile the drug supply with the log book and replenish supply.
(vi) Security of all drugs prepackaged must be maintained in a locked cabinet or storeroom location in the emergency room area to which only specifically authorized personnel shall have a key or combination.
At all times, including when working in a hospital
nal or nursing home, the pharmacist-in-charge and all staff pharmacists including consultant pharmacists and provider pharmacists shall adhere to the laws and regulations of the Board, as well as, other federal and state statutes and regulations pertaining to their professional activities and Code of Ethics.
The pharmacist shall be responsible for and supervise the actions of all supportive personnel within the hospital or nursing home, including, but not limited to pharmacy technicians.
(d) Controlled Substances Registration. No stock containers of controlled substances shall be stored at any facility if said facility is not registered with both the Board and the Drug Enforcement Administration.
The pharmacist for an institutional facility shall develop guidelines and implement policies to ensure that all discontinued or outdated drugs or containers with worn, illegible or missing labels are destroyed or disposed of so as to render them unusable.
The pharmacist shall develop and implement a recall procedure that can be readily activated so as to assure all drugs included in the recall are returned to the provider pharmacy for proper disposition.
(a) A pharmacy providing home health care pharmacy services shall be a licensed retail pharmacy that prepares and dispenses compounded sterile parenteral products to outpatients. Outpatients are patients in the home environment or an institutionalized patient who is receiving compounded sterile parenteral drugs from a pharmacy outside the institution setting.
(b) Requirements for licensure and pharmacist-in-charge as specified in Sections 7, 8 and 9 of this chapter shall be adhered to, as well as, other requirements of a retail pharmacy necessary for the site specific health care pharmacy, including labeling and counseling.
(c) The pharmacy providing home health care pharmacy services shall have a designated area called a “Clean Room” for preparing compounded sterile parenteral products. The “clean room” shall be a room in which a Class 100 cabinet is located and shall have all washable surfaces. The Class 100 cabinet is to be used in the preparation of sterile drugs. If cytotoxic drug products are prepared, appropriate environmental control also includes the appropriate biohazard cabinetry. This area shall be physically separate from other areas of activities and shall be designed to avoid unnecessary traffic and airflow disturbances. Entry to the clean room shall be restricted to designated personnel for purposes of preparing compounded parenteral products.
The area shall only be used for the preparation of those specialty products. It must be of sufficient size to accommodate a laminar airflow hood. All clean rooms and laminar flow hoods shall be certified by an independent contractor according to Federal Standard 209b or National Sanitation Foundation Standard 49 for operational efficiency at least annually and appropriate records shall be maintained at the site for two (2) years. It must provide for appropriate conditions of temperature, light, moisture, sanitation, ventilation and security.
Appropriate disposal containers for used needles, syringes, etc. and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents and infectious wastes from patient's homes shall be established.
(i) A policy and procedure manual as it relates to parenteral products shall be developed and shall be available for inspection at the pharmacy. The manual shall be reviewed and revised on an annual basis by the pharmacist-in-charge. The policy and procedure manual shall provide for:
(A) Adequate safety measures to be taken to protect personnel in the preparation of all drugs, including protective clothing.
(B) The education and training for pharmacists preparing the I.V. sterile products to have the appropriate knowledge and skills in aseptic compounding.
(C) Staff pharmacists shall be evaluated by the pharmacist-in-charge to determine that they have the requisite knowledge and skills.
(D) A process to evaluate (test) and confirm the quality of the prepared pharmaceutical product.
(ii) Current references which shall be maintained by the home health care pharmacy shall include:
(A) Copies of current Wyoming Pharmacy laws and regulations.
(B) ASHP Trissel's Handbook on Injectable Drugs. (ASHP - American Society of Health System Pharmacists).
(C) JCAHO - Home Health Care Standards. (JCAHO - Joint Commission on Accreditation of Health Care Organizations).
(D) ASHP Technical Assistance Manual for Handling Cytotoxic Drugs, if applicable.
Section 28. Specific Requirements for Licensure of Non-Resident Pharmacies to Ship Prescription Drugs into the State.
(a) Any pharmacy operating from outside the State which ships, mails or delivers, in any manner, a dispensed prescription drug or legend drug to a patient in Wyoming shall obtain and hold a non-resident pharmacy license and, if applicable, a controlled substance registration.
(b) Said pharmacy license and controlled substance registration shall be on forms supplied by the Board and shall be accompanied by the following information. Applicant shall:
(i) submit a copy of the pharmacy license from the state of residence;
(ii) submit a copy of the latest inspection report from the state of residence;
(iii) submit a copy of current D.E.A. registration
(iv) submit list of partners, members or principal officers and registered agent for service of process, if any;
(v) submit list of all registered pharmacists, specifying pharmacist-in-charge.
(c) Pharmacy license and controlled substance registrations shall be renewed annually by July 1st to continue doing business in the State.
(d) The Board office shall be notified of any change in ownership or the pharmacist-in-charge.
(e) Each non-resident pharmacy shall comply with statutory or regulatory requirements of the Board, including, but not limited to:
The 'Wyoming Drug Identification Act' and the Wyoming Generic Substitution Act.
(f) Each non-resident pharmacy shall maintain records of all prescriptions dispensed to patients in the State in readily retrievable form.
(g) Each non-resident pharmacy shall maintain pharmacy hours that permit the timely dispensing of prescriptions to patients in the State and provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist who has access to the patients' records.
Counseling shall be accomplished on new prescriptions orally and/or by written information accompanying the dispensed prescription.
(h) The Board may revoke, deny or suspend the licensure and registration of any non-resident pharmacy for violations of the Act - Section 33-24-152 and Board regulations, Chapter 2, Section 28.
Section 29. Fees (including Exam, Re-exam, License, License Renewal, Registration, Registration
istration renewal, and late fees);
(a) The Board shall charge the following fees as indicated:
(i) Pharmacist licensure by examination or reexamination shall be seventy five dollars ($75.00) plus The National Association of Boards of Pharmacy's (NABP) fee for the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE).
(ii) Pharmacist licensure by reciprocity shall be two hundred dollars ($200.00) plus NABP's fee for licensure transfer application and the MPJE.
(iii) Pharmacist licensure renewal shall be seventy-five dollars ($75.00) per year.
(iv) Pharmacy intern licensure shall be fifteen dollars ($15.00) and shall be renewed every 12 months. Renewal fee shall be ten dollars ($10.00).
(v) Pharmacy technician exam or re-examination fee shall be one hundred twenty-five dollars ($125.00).
(vi) Pharmacy technician-in-training permit shall be fifteen dollars ($15.00).
(vii) Pharmacy technician renewal fee shall be thirty-five dollars ($35.00) per year.
(viii) Resident retail pharmacy license and renewals shall be one hundred dollars ($100.00) per year.
(ix) Non-resident pharmacy license and renewals shall be two hundred dollars ($200.00) per year.
(x) A prescription drug manufacturer, distributor, reverse distributor, or wholesaler license and renewals shall be two hundred dollars ($200.00) per year. Oxygen manufacturer or distributor license and renewals shall be one hundred dollars ($100.00) per year.
(b) The Board shall assess a late fee in addition to the license or registration renewal fee of licensees or registrants as follows:
(i) A pharmacist whose license renewal application is postmarked or hand delivered to the Board’s office after December 31 shall be assessed a late fee of seventy-five dollars ($75.00) in addition to the license renewal fee;
(ii) A pharmacy technician whose license renewal application is postmarked or hand delivered to the Board’s office after December 31 shall be assessed a late fee of thirty-five dollars ($35.00) in addition to the license renewal fee;
(iii) A resident retail pharmacy whose license renewal application is postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee;
(iv) A non-resident pharmacy whose license renewal application is postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of three hundred dollars ($300.00) in addition to the license renewal fee; and
(v) A manufacturer, distributor, or wholesaler of prescription drug products (drugs or oxygen) whose license renewal application is postmarked or hand delivered to the Board’s office after June 30 shall be assessed a late fee of two hundred dollars ($200.00) in addition to the license renewal fee.
Section 30. Emergency Drug Supply for Nursing Homes, Hospices, Extended Care Facilities or Intermediate Care Facilities.
(a). Nursing Homes, Hospices, Extended Care Facilities, or Intermediate Care Facilities licensed by the Department of Health may be issued a permit, by the Board of Pharmacy, to maintain an emergency supply of drugs, both scheduled and non-scheduled, subject to approval by the Board. The drugs maintained in the emergency drug supply shall remain the property of the pharmacy to whom the permit was jointly issued.
(i) The pharmacy servicing the facility or facilities listed in section 30(a) shall make application to the Board, on an application provided by the Board. The Board may issue a permit, if the conditions of section 30 are met, in the name of the facility and the pharmacy authorizing the storage and use of an emergency drug supply at the facility. This registration shall be valid until June 30 of each year. The permit must be renewed annually.
(ii) The fee for the permit shall be fifteen dollars ($15.00) annually.
(iii) The permit may be revoked by the Board if conditions as outlined in this section are not followed, or for other violations of the Wyoming Pharmacy Act or Wyoming Controlled Substance Act and/or rules and regulations promulgated under said Acts.
(b) The number of drugs provided by a pharmacy to a facility listed in section 30(a) shall be limited to forty eight (48). Additional quantities require submission of an application listing the additional drugs requested with justification, and must be approved by the Board. The number of doses of each drug available shall be limited to thirty (30) doses of any separate drug dosage form in each emergency supply.
(c) The facility and the pharmacy servicing the facility shall develop and implement written policies and procedures to ensure safety, accuracy, accountability, security, patient confidentiality, and maintenance of the quality, potency, and purity of the emergency drug supply. Copies of the most recent policy and procedure manual shall be on file at both the facility and the pharmacy servicing the facility.
(i) The emergency drug supply policy and procedure’s manual shall be reviewed and approved annually, during the anniversary month of when the original permit was issued by the Board, by the pharmacist-in-charge of the pharmacy servicing the facility and the facility’s director of nursing.
(e) The emergency drug supply may only be stocked and restocked by a pharmacist licensed by this Board
ard or a technician under his supervision. Discrepancies in controlled substance inventories shall be documented and reported to the Board of Pharmacy, within seven days of discovery.
(f) Drugs administered from the emergency drug supply shall be limited to the following:
(i) A new drug order given by a prescriber for a patient of the facility for administration prior to the next scheduled delivery from the pharmacy, or 72 hours, whichever is less. The drugs shall be administered only upon authorization by a pharmacist and after the pharmacist has reviewed the prescriber's order and patient's profile for potential contraindications and adverse drug reactions.
(ii) Drugs that a prescriber has ordered for a patient on an as-needed basis, if the utilization and administration of those drugs are subject to ongoing review by a pharmacist.
(iii) Drugs designated by the patient care policy committee or similar facility committee as an 'emergency drug' may be administered from the emergency drug supply pursuant to the order of a prescriber for emergency or immediate administration to a patient of the facility. Within 72 hours after administration under this paragraph, the case shall be reviewed by a pharmacist.
(g) If the pharmacy servicing the facility discontinues their service, the Board must be notified and the
permit surrendered. If the new pharmacy provider desires to maintain an emergency drug supply, they must make application to the Board.
(h) Facilities described in section 30(a) are exempt from the provisions of section 30 provided the pharmacy providing their emergency drug supply is physically located at the same site as the facility and this pharmacy possesses a DEA registration and is licensed by the Wyoming State Board of Pharmacy.
(a). A pharmacist or pharmacy technician whose license has been revoked or suspended by the Board may file an application, supplied by the Board, requesting a hearing to present evidence to show why his pharmacist or pharmacy technician license should be reinstated subject to the following:
(i). A pharmacist or pharmacy technician whose license was revoked by the Board, may not file an application requesting a hearing until twelve (12) months has elapsed from the date the order revoking his pharmacist or pharmacy technician license has become final;
(ii) A pharmacist or pharmacy technician whose license was suspended by the Board, may not file an application requesting a hearing until one half (1/2) of the suspension so ordered by the Board has elapsed, or the order of suspension has become final, whichever is later;
(iii) A pharmacist shall submit an application fee of two hundred fifty dollars ($250.00), and pay for the cost of the hearing if the Board issues an order denying reinstatement. The $250.00 application fee shall be submitted with the application and is nonrefundable.
(iv) A pharmacy technician shall submit an application fee of one hundred twenty five dollars ($125.00), and pay for the cost of the hearing if the Board issues an order denying reinstatement. The $125.00 application fee shall be submitted with the application and is nonrefundable.