reglab/statecodes huggingface dataset:
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-4 - Organization and Personnel

Current through July 13, 2024
(a) The pharmacist
				has the responsibility and authority to inspect and approve or reject all
				components, drug product containers, closures, in-process materials, and
				labeling; and the authority to prepare and review all compounding records to
				assure that no errors have occurred in the compounding process. The pharmacist
				is also responsible for the proper maintenance, cleanliness, and use of all
				equipment used in prescription compounding practice.
(b) All pharmacists who engage in drug
				compounding shall be competent and proficient in compounding and shall maintain
				that proficiency through current awareness and training. Competency and
				proficiency in the art of compounding for all pharmacists shall be evaluated,
				documented, and maintained in the files of the pharmacy by the
				Pharmacist-in-Charge (PIC). Every pharmacist who engages in drug compounding
				must be aware of and familiar with all details of the good compounding
				practices.
(c) Personnel engaged in
				the compounding shall wear clean clothing appropriate to the operation being
				performed. Protective apparel, such as coats/jackets, aprons, gowns, hand or
				arm covering, or masks shall be worn as necessary to protect personnel from
				chemical exposure and medication or chemical contamination.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-5 - Drug Compounding Facilities

Current through July 13, 2024
(a) Pharmacies
				engaging in compounding shall have a specifically designated and adequate area
				(space) for the orderly compounding of prescriptions that is maintained in a
				good state of repair and for the placement of materials and equipment. Sterile
				compounding shall be performed in a separate area in compliance with Chapter
				17.
(b) To maintain stability, bulk
				medications and other chemicals or materials used in the compounding of
				medications must be stored in adequately labeled containers in a clean, dry,
				and temperature-controlled area or, if required, under proper refrigeration.
				The refrigerator shall provide a storage temperature of 36 to 46 degrees
				Fahrenheit (2 to 8 degrees Centigrade). If a freezer compartment is utilized,
				it must maintain a temperature of -13 to +14 degrees Fahrenheit (-25 to -10
				degrees Centigrade).
(c) Adequate
				lighting and ventilation shall be provided in all drug compounding areas.
				Potable water for drinking and washing shall be supplied under continuous
				positive pressure in a plumbing system free of defects that could contribute
				contamination to any compounded drug product. Adequate washing facilities,
				easily accessible to the compounding area(s) of the pharmacy, shall be
				provided. These facilities shall include, but not be limited to, hot and cold
				water, soap or detergent, and air-driers or single-use towels.
(d) The area(s) used for compounding shall be
				maintained in a clean and sanitary condition.
(e) If sterile products are being compounded,
				the pharmacist shall follow Chapter 17 of this regulation.
(f) If drug products with special precautions
				to prevent contamination, such as penicillin, are involved in a compounding
				procedure, appropriate measures, including either the dedication of equipment
				or meticulous cleaning of contaminated equipment prior to its use for the
				preparation of other drugs, must be utilized in order to prevent
				cross-contamination.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-6 - Equipment

Current through July 13, 2024
(a) Equipment and utensils used for
				compounding shall be of appropriate design and capacity, and shall be stored in
				a manner to protect from contamination. In addition, all equipment and utensils
				shall be cleaned prior to use to prevent contamination that would alter the
				safety or quality of the drug product beyond that desired.
(b) Automatic, mechanical, electronic, or
				other equipment used in compounding shall be routinely inspected, calibrated,
				or checked according to manufacturer's recommendations to ensure proper
				performance.
(c) It shall be the
				responsibility of the PIC to ensure that drug product containers, components,
				closures, and bagged or boxed components of drug product containers and
				closures used in compounding shall be handled and stored in a manner to prevent
				contamination and to permit unhindered inspection and cleaning of the work
				area.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-7 - Compounding Controls

Current through July 13, 2024
(a) A Master
				Compounding Record shall be established for each newly compounded item and
				followed thereafter to monitor the output and to validate the performance of
				those compounding processes. The Master Compounding Record shall contain:
(i) Official compound name, strength, and
				dosage form,
(ii) Calculations
				required to complete the compound,
(iii) Ingredient(s) description and
				amounts,
(iv) Compatibility and
				stability information (references when available)
(v) Equipment required to prepare the
				compound,
(vi) Mixing
				instructions,
(vii) Any other
				factors pertinent to the compound preparation,
(viii) A sample label meeting all legal
				requirements stated in Chapter 2,
(ix) The generic name, quantity and/or
				concentration of every active ingredient containedwithin, and
(x) An assigned BUD as applicable.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-8 - Labeling Control of Excess or Bulk Compounded Products

Current through July 13, 2024
The pharmacist shall label any excess or bulk compounded
				  product to reference it to the formula used and the assigned control number and
				  estimated BUD based on the pharmacist's professional judgment, appropriate
				  testing or published data. The product shall be stored
				  appropriately.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 13 - NON-STERILE COMPOUNDING › Section 13-9 - Records and Reports

Current through July 13, 2024
(a) Records
				required to be maintained in compliance with this Chapter shall be retained for
				a minimum period of two (2) years from the date of last activity and be
				available for inspection by the Board.
(b) For each drug product compounded in
				excess or bulk quantities, a log book, in addition to those requirements listed
				in this Chapter, shall be prepared containing the following information:
(i) Name of the product;
(ii) List of ingredients and quantities used,
				including manufacturer, lot number, and expiration dates;
(iii) Lot number assigned by a
				pharmacist;
(iv) Beyond use date
				assigned, as described in this Chapter;
(v) Date of preparation;
(vi) Initials of compounding pharmacist,
				pharmacy technician or pharmacy technician specialist;
(vii) Initials of supervising pharmacist, if
				prepared by a pharmacy technician or pharmacy technician specialist;
				and
(viii) Quantity
				prepared.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-4 - Definitions

Current through July 13, 2024
(a) "Adequate Supervision" means oversight by
				the parent pharmacy by which they maintain visual supervision and auditory
				communication with the telepharmacy and full supervisory control of the
				automated system, if applicable, and shall not be delegated to another person
				or entity.
(b) "Automated
				Dispensing Device" means a mechanical system which performs operations relative
				to distributing individual unit of issue packages, and which collects,
				controls, and maintains all transaction information.
(c) "Parent Pharmacy" means a pharmacy
				licensed by the Board which is authorized by the Board to operate a
				telepharmacy site via real-time data, video, and audio links.
(d) "Real-time" means that the transmission
				of information through data, video and audio links is so rapid that the
				information is available to the parent pharmacy and telepharmacy sites
				simultaneously.
(e) "Telepharmacy"
				means a site where prescription drugs are stored and dispensed that is remote
				from but under the active control and supervision of a parent pharmacy and a
				licensed pharmacist, and that is subject to the requirements of W.S. §
									
										33-24-156.
(f) "Single Unit Dose" means a package that
				contains one unit of medication.
(g) "Traditional Dispensing" means a drug
				package system in which individual doses are not packaged in single unit dose
				packages or unit of use packages.
(h) "Unit of Use package" means a package
				that provides multiple units of doses separated in a medication card or other
				similarly designed container.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-5 - Licensing of Facilities

Current through July 13, 2024
(a) An application for licensure to
				establish, operate or maintain a telepharmacy shall be made on an application
				provided by the Board and submitted to the Board no less than sixty (60) days
				prior to opening the telepharmacy.
(b) A set of blueprints shall be provided to
				the Board with the initial application for licensure.
(c) Prior to opening a telepharmacy site, the
				Board shall inspect the telepharmacy for minimum standards of this
				Chapter.
(d) The Board shall be
				notified with every change of pharmacist-in-charge (PIC).
(e) Every telepharmacy license shall expire
				on June thirty (30) of each year and shall be renewed annually by filing an
				application provided by the Board together with a fee set by the Board,
				postmarked no later than June thirty (30).
(f) Initial and renewal telepharmacy license
				fee shall be $150.00. Any application for renewal postmarked after June thirty
				(30) shall be subject to a late fee of $200.00 in addition to the renewal
				fee.
(g) A telepharmacy license
				shall not be renewed by the Board if a retail pharmacy opens for business
				within ten (10) miles of the telepharmacy site. A telepharmacy may continue to
				operate until the end of the current licensure year. The Board shall notify the
				telepharmacy's parent pharmacy when a retail pharmacy license has been issued
				to a site within ten (10) miles of the licensed telepharmacy, and shall include
				the last date the telepharmacy may remain open for business. This ten (10) mile
				restriction does not apply:
(i) In counties
				with a city of fifty thousand (50,000) or more persons as shown in the most
				recent federal census; or
(ii) To
				any facility owned or leased by the state or any subdivision of the state;
				or
(iii) To any facility located in
				a hospital or clinic setting.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-6 - Minimum Structural, Security and Equipment Requirements to Operate a Telepharmacy

Current through July 13, 2024
(a) All telepharmacies operating in Wyoming
				shall meet the following structural requirements:
(i) Shall consist of an area of no less than
				150 square feet exclusive of the patient consulting room;
(ii) Shall have a means of delivering a
				private, secure consultation;
(iii)
				Shall include a sink with a hot and cold water supply, exclusive of restroom
				facilities, with approved sewage disposal;
(iv) Shall be properly lighted and
				ventilated. The temperature of the telepharmacy shall be maintained within a
				range compatible with the proper storage of pharmaceuticals; and
(v) Shall have adequate shelving and counter
				space on which to work and the working surface shall be kept clear and
				uncluttered at all times.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-7 - Daily Operations

Current through July 13, 2024
(a) A telepharmacy site may not remain open
				for business if an interruption in data, video or audio link occurs. Whenever
				an interruption in data, video, or audio link occurs, no prescription shall be
				dispensed and a sign shall be posted noting the closure and an estimated time
				when resumption of services can be expected.
(b) The telepharmacy shall be staffed by a
				pharmacy technician or a pharmacy intern, licensed by the Board, or by a
				pharmacist whenever a pharmacy technician or intern is not available. Under no
				circumstance may the telepharmacy remain open for business unless a pharmacy
				technician, pharmacy intern or a pharmacist is on duty.
(c) A pharmacy technician may only perform
				those pharmacy functions as allowed in Chapter 10 of the Board's rules.
				Adequate supervision shall be provided by a pharmacist at the parent pharmacy
				utilizing the data, video and audio link.
(d) A pharmacy intern may only perform those
				duties as allowed in Chapter 3 of the Board's rules. Adequate supervision shall
				be provided by a pharmacist at the parent pharmacy utilizing the data, video
				and audio link.
(e) Data entry may
				be performed at the parent pharmacy or at the telepharmacy site. All entries
				performed at the telepharmacy site must be verified by a pharmacist at the
				parent pharmacy prior to dispensing of the prescription at the
				telepharmacy.
(f) Verification of
				prescriptions entered and dispensed at the telepharmacy site shall include:
(i) For a new prescription, the pharmacist at
				the parent pharmacy, utilizing the data/audio/video link, shall review the
				patient profile as required by the Board's rules, the original scanned
				prescription, the unit of use or stock package selected to be dispensed or the
				prescription vial that has been filled if traditional dispensing it utilized
				and the directions as entered by the pharmacy technician or intern. The
				pharmacist shall view the label affixed to the unit of use package or
				prescription container to assure accuracy using the image or video link. The
				offer to counsel shall be made by the pharmacist; or
(ii) For a refill prescription, the
				pharmacist at the parent pharmacy, utilizing the data/audio/video link, shall
				review the patient profile, the label, the filled prescription container to be
				dispensed and assure the label is affixed to the correct prescription
				container.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-8 - Recordkeeping Requirements

Current through July 13, 2024
(a) All written prescriptions presented to
				the telepharmacy site shall be scanned into the electronic data processing
				equipment, such that on initial dispensing and each refill, the original
				prescription may be viewed on the monitor at both the telepharmacy and parent
				pharmacy site. All scanned prescriptions shall be retained electronically for
				at least two (2) years from the date scanned. All written prescriptions shall
				be delivered to the parent pharmacy for filing within 72 hours. Records shall
				be maintained at the parent pharmacy in files separate from the parent pharmacy
				files.
(b) Controlled substance
				records shall be maintained at the telepharmacy unless specific approval is
				granted for central storage as permitted by state and federal law.
(c) Prescriptions required will be reported
				to WORx.
(d) The establishment of
				minimum standards and practices necessary to ensure safety, accuracy, security,
				sanitation, recordkeeping, and patient confidentiality shall include:
(i) Identification of personnel authorized to
				have access to the drug storage and dispensing areas at the telepharmacy and to
				receive drugs delivered to the telepharmacy;
(ii) Procedures for the procurement of drugs
				and devices to the telepharmacy and into any automated dispensing device used,
				as applicable; and
(iii) The
				criteria for monthly in-person pharmacist inspection of the telepharmacy and
				appropriate documentation on a form designated by the Board.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-9 - Pharmacist-in-Charge (PIC) Responsibilities

Current through July 13, 2024
(a) Unless an alternative PIC from the parent
				pharmacy is specifically designated in writing, the PIC of the parent pharmacy
				is the PIC for the telepharmacy.
(b) The PIC and pharmacist-on-duty are
				responsible for ensuring that the parent pharmacy and telepharmacy are staffed
				in accordance with Board rules.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 14 - TELEPHARMACY › Section 14-10 - Delivery and Storage of Drugs

Current through July 13, 2024
(a) Prescription drugs shall be delivered to
				the telepharmacy when a pharmacy technician or pharmacist is present to accept
				delivery and verify that the drugs were actually received;
(b) An automated dispensing device shall be
				stocked with drugs only by a pharmacist licensed by the Board, a registered
				pharmacy technician or pharmacy intern under the supervision of a pharmacist;
				and
(c) Prescription drugs shall be
				stored in accordance with Board rules.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-4 - Definitions

Current through July 13, 2024
(a) "Long Term Care Facility" (LTCF) means
				any skilled or intermediate care nursing home, board and care home, or any
				resident behavioral health facility subject to regulation and licensure by the
				department of health. For the purpose of this Chapter, long term care facility
				does not include adult day care facilities, home health agencies, or assisted
				living facilities.
(b) "Consultant
				Pharmacist" in a long-term facility means a pharmacist licensed to engage in
				the practice of pharmacy in this State who is responsible for developing,
				coordinating, and supervising pharmacy services in a long-term care facility on
				a regularly scheduled basis.
(c)
				"Medication Order," as used in this rule means a written, verbal, facsimile or
				electronic order from a practitioner or the practitioner's authorized agent to
				a licensed nurse in the LTCF for a resident of that facility for administration
				of a drug or device. For purposes of this Chapter, a "medication order" is
				considered a prescription, with the exception of controlled substances which
				require a prescription from the practitioner.
(d) "Provider Pharmacy" means any pharmacy
				licensed by the Board that provides medications to residents of any long-term
				care facility pursuant to a medication order or prescription. A provider
				pharmacy must have a written agreement with the long-term care facility in
				order to provide services to the residents.
(e) "First Dose Pharmacy" means a pharmacy
				contracting with a provider pharmacy to ensure that drugs or devices are
				attainable to meet the immediate needs of the resident or if the provider
				pharmacy cannot provide services on an ongoing basis.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-5 - Freedom of Choice

Current through July 13, 2024
No consultant pharmacist or provider pharmacy shall
				  participate in any agreement or plan that infringes on any resident's right to
				  freedom of choice as to the provider of pharmacy services. A resident in a
				  long-term care facility shall have a choice of a provider pharmacy provided the
				  provider pharmacy complies with this Chapter.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-6 - Pharmacy Responsibilities

Current through July 13, 2024
A provider pharmacy shall be responsible for:
(a) Dispensing drugs pursuant to a medication
				order for an individual resident, properly labeled for that resident, as
				addressed in Chapter 2 of these rules, including the manufacturer's expiration
				date. If prepackaged or repackaged by the pharmacy, the expiration date shall
				be the lesser of the manufacturer's expiration date or twelve (12) months from
				the date of prepackaging or repackaging;
(b) Dispensing drugs for residents of
				long-term care facilities in packaging consistent with the drug distribution
				system required by the facility's policies and procedures;
(c) Developing a drug recall procedure that
				protects the health and safety of residents including immediate discontinuation
				of any recalled drug or device and subsequent notification of the prescriber
				and director of nursing of the facility. The drug recall policy must be readily
				retrievable at the provider pharmacy and the facility;
(d) Providing service twenty-four (24) hours
				a day, seven (7) days per week, either directly or by contract with another
				pharmacy. All "on-call" services shall be verifiable by the board and its
				inspectors. Ancillary boxes or automated dispensing devices may be used as
				outlined in Chapter 2 of these rules;
(e) Performing prospective drug usage reviews
				for all new and refill medication orders as described in Chapter 9 of these
				rules;
(f) Providing sufficient and
				accurate information to facility staff regarding the appropriate administration
				and use of all dispensed drugs and devices;
(g) Providing intravenous (IV) services or
				contracting with another pharmacy to provide IV services, if the long term care
				facility is a skilled unit providing such services;
(h) Communicating with the consultant
				pharmacist and the facility regarding concerns and resolution thereof,
				including, but not limited to "on-call" services and IV services; and
(i) Returning non-controlled substance
				prescriptions dispensed to residents in long term care facilities for
				re-dispensing under specific conditions listed in Chapter 2. Controlled
				substance prescriptions dispensed to residents in long term care facilities
				cannot be returned to a pharmacy.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-7 - Consultant Pharmacist Responsibilities

Current through July 13, 2024
(a) The consultant pharmacist shall assist
				the long-term care facility in developing policy and procedures for the
				following:
(i) The manner of issuance of
				prescription drugs provided by a provider pharmacy to residents of the
				long-term care facility;
(ii)
				Storage, administration and record-keeping for all medications administered to
				residents of the long-term care facility;
(iii) Inspection of drug storage
				areas;
(iv) Destruction or
				recycling of unused or discontinued resident medications; and
(v) Continuing education for nursing
				personnel regarding medication administration.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-8 - Automated Dispensing Device

Current through July 13, 2024
(a) No drug shall be distributed or issued by
				the use of any automated dispensing device unless the device and method of
				operation have been found to ensure the purity, potency and integrity of the
				drug, and to protect the drug from diversion, and provide that:
(i) The device shall be stocked with drugs
				only by a pharmacist licensed by the Board or a registered pharmacy technician
				or pharmacy intern under his supervision;
(ii) The device shall be used only for the
				furnishing of drugs for administration to residents of that facility;
				and
(iii) At the time of removal of
				any drug from the device, it shall automatically make a written or electronic
				record to be retained by the pharmacist for at least one (1) year, indicating:
(A) The date of removal of the
				drug;
(B) The name, strength,
				dosage form and quantity of the drug removed;
(C) The name of the resident for whom the
				drug was ordered; and
(D) The name
				or identification code of the nurse removing the drug from the
				device.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 15 - LONG TERM CARE PHARMACY SERVICES › Section 15-9 - First Dose Pharmacy Services

Current through July 13, 2024
Provider pharmacy may contract with another pharmacy (first
				  dose pharmacy) for first dose services if in compliance as follows:
(a) Limited Purpose - Services are for the
				limited purpose of ensuring that drugs or devices are attainable to meet the
				needs of residents or if the provider pharmacy cannot provide services for the
				LTCF on an ongoing basis;
(b) Long
				Term Care Facility Approval - The provider pharmacy obtains approval from the
				LTCF to obtain first dose services for its residents;
(c) Written Contract - The provider pharmacy
				has a written contract with the first dose pharmacy outlining the services to
				be provided and the responsibilities and accountabilities of each party in
				fulfilling the terms of the contract; and
(d) Medication Orders - The provider pharmacy
				provides a valid verbal, electronic or paper medication order to the first dose
				pharmacy. A single medication order may be shared by a provider pharmacy and a
				first dose pharmacy with no transfer required.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-2 - Definitions

Current through July 13, 2024
(a) "Healthy Adults" means those individuals
				who are eighteen (18) years of age or older and have no absolute
				contraindications to receive immunizations allowed by this Chapter.
(b) "Healthy Minor" means those individuals
				who are seven (7) years of age or older but have not attained the age of
				eighteen (18) years old and have no absolute contraindications to receive
				immunizations allowed by this Chapter.
(c) "High Risk Adults" means those adults
				eighteen (18) years of age or older who may have an absolute or relative
				contraindication to receive immunizations for whom a physician has issued a
				prescription authorizing a pharmacist to dispense and administer an
				immunization.
(d) "High Risk
				Minors" means those individuals seven (7) years of age or older but who have
				not attained the age of eighteen (18) who may have an absolute or relative
				contraindication to receive immunizations for whom a physician has issued a
				prescription authorizing a pharmacist to dispense and administer an
				immunization.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-3 - Qualifications

Current through July 13, 2024
(a) A pharmacist shall meet the following
				qualifications to prescribe and administer and a pharmacy intern shall meet the
				following qualifications to administer immunizations:
(i) Successfully complete:
(A) The American Pharmacists Association's
				(APhA) immunization training certification program entitled "Pharmacy-Based
				Immunization Delivery" or
(B) Other
				immunization training certification program accredited by ACPE specific to
				pharmacists.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-4 - Persons who may receive immunizations

Current through July 13, 2024
(a) Pharmacists shall utilize the
				manufacturer's package insert for indications, contraindications, adverse
				reactions, dosing, route of administration, specifics regarding administration,
				and storage requirements for immunizations when prescribing, administering, and
				supervising the administration of vaccines.
(b) Parental or legal guardian consent shall
				be required for all minors receiving a immunization. The parent or legal
				guardian shall be present during the administration.
(c) A current Vaccine Information Statement,
				as provided by the CDC, shall be provided to each person receiving an
				immunization for each immunization administered. The Vaccine Information
				Statement is available from the CDC's website (
http://www.cdc.gov
).
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-5 - Record-keeping

Current through July 13, 2024
(a) An Immunization Questionnaire and Consent
				Form shall be completed for each individual receiving and immunization. The
				consent form shall include:
(i) Documentation
				that the pharmacist has discussed the side effects with the patient, including
				seeking treatment for side effects if they occur; and
(ii) A recommendation that the patient stays
				in the vicinity for fifteen (15) minutes after immunization
				administration.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-6 - Emergencies

Current through July 13, 2024
(a) A pharmacist authorized to prescribe and
				administer immunizations and a pharmacy intern or pharmacy technician
				authorized to administer immunizations may administer epinephrine in the
				management of an acute allergic reaction to an immunization. The pharmacist,
				pharmacy intern, or pharmacy technician shall follow the Advisory Committee on
				Immunization Practices (ACIP) Preventing and Managing Adverse Reactions General
				Best Practice Guidelines for Immunization. The ACIP Preventing and Managing
				Adverse Reactions General Best Practice Guidelines for Immunization
				incorporated by reference in this Chapter of these rules is the Vaccine
				Recommendations and Guidelines of the ACIP Preventing and Managing Adverse
				Reactions as existing on the effective date of this chapter. Copies of this
				document can be obtained from the Board at 1712 Carey Avenue, Suite 200,
				Cheyenne, Wyoming, 82002.
(b) The
				pharmacy shall post ACIP's Preventing and Managing Adverse Reactions in the
				private space or maintain a handout within the emergency kit. The emergency kit
				shall be maintained and immediately available to manage an immunization-related
				acute allergic reaction.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-7 - Immunization Administration Space Requirements

Current through July 13, 2024
(a) The space to provide immunizations must
				provide reasonable privacy for the patient and be of capacity to perform CPR
				and any other life-saving measures necessary in the event of an
				immunization-related emergency.
(b)
				Immunizations may be administered by a pharmacist, or by a pharmacy intern or
				pharmacy technician under a qualified pharmacist's supervision at a site away
				from the pharmacy if proper storage, transportation and disposal of
				immunizations and supplies are followed.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 16 - IMMUNIZATION REGULATIONS › Section 16-8 - Incorporation by Reference

Current through July 13, 2024
(a) For any code, standard, rule or
				regulation incorporated by reference in these Rules:
(i) The Board has determined that
				incorporation of the full text in these rules could be cumbersome or
				inefficient given the length or nature of the rules;
(ii) The incorporation by reference does not
				include any later amendments or editions of the incorporated matter beyond the
				applicable date identified in subsection (ii) of this section;
(iii) The incorporated codes, standards,
				rules or regulations are maintained at 1712 Carey Avenue, Suite 200, Cheyenne,
				Wyoming 82002 and are available for public inspection any copying at cost as
				the same location.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-3 - Pharmacy Staff Training and Evaluation

Current through July 13, 2024
(a) Each sterile compounding pharmacy shall
				develop a written training program that describes the required training, the
				frequency of training, and the process for evaluating the performance of
				pharmacy staff involved in preparing CSPs.
(b) Compounding pharmacy staff shall be
				initially trained and qualified by demonstrating knowledge of principles and
				proficiency in core competencies for performing sterile manipulations and
				achieving and maintaining appropriate environmental conditions. A designated
				person shall oversee the training of pharmacy staff.
(c) Training and evaluation of pharmacy staff
				shall be documented.
(d)
				Compounding pharmacy staff shall be able to demonstrate knowledge and
				competency in the following:
(i) Using proper
				aseptic technique
(A) All compounding
				pharmacy staff shall perform a media-fill test to assess aseptic technique. The
				media-fill test shall simulate the most difficult and challenging compounding
				procedures and processing conditions encountered by the person replacing all
				the components used in the CSPs with soybean-casein digest media.
(B) Gloved fingertip and thumb sampling shall
				be performed inside the PEC following the media-fill test to evaluate aseptic
				technique.
(C) If using commercial
				sterile microbial growth media, a certificate of analysis (COA) shall be
				obtained from the supplier stating that the lot of the growth media will
				support the growth of microorganisms.
(D) If preparing sterile microbial growth
				media in-house for sterile to sterile media fill testing, the growth promotion
				capability of the media shall be demonstrated for each batch and documented as
				described in USP.
(E) Failure of
				the media fill test is indicated by visible turbidity or other visual
				manifestation of growth in the media in one or more container-closure unit(s)
				on or before the end of the incubation period.
(F) Results of the evaluation and corrective
				actions, in the event of failure, shall be documented and include, at a minimum
				the name of the person evaluated, evaluation date/time, media and components
				used, including manufacturer, expiration date and lot number, starting
				temperature for each interval of incubation, dates of incubation, the results,
				and the identification of the observer and the person who reads and documents
				the results.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-4 - Personal Hygiene and Garbing

Current through July 13, 2024
(a) Pharmacy staff shall not handle CSPs if
				they have open sores, infected wounds, or an upper respiratory
				infection.
(b) When entering a
				cleanroom suite or SCA, compounding pharmacy staff shall remove any items that
				are not easily cleanable or that are not necessary for compounding. At a
				minimum pharmacy staff shall:
(i) Remove all
				cosmetics and personal outer garments including, but not limited to bandanas,
				coats, hats, jackets, sweaters, and vests. If worn, eyeglasses shall be
				wiped;
(ii) Remove all hand, wrist,
				and other exposed jewelry including but not limited to piercings that could
				interfere with the effectiveness of garbing or otherwise increase the risk of
				contamination of the CSP. Compounding pharmacy staff shall cover any jewelry
				that cannot be removed;
(iii) Not
				wear earbuds or headphones;
(iv)
				Not bring electronic devices that are not necessary for required tasks into the
				cleanroom suite or SCA; and
(v)
				Keep nails clean and neatly trimmed to minimize particle shedding and avoid
				glove punctures. Nail products, including, but not limited to polish,
				artificial nails, or extenders shall not be worn.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-6 - Requirements for Certification and Recertification

Current through July 13, 2024
(a) Before a classified area or SCA can be
				used to compound CSPs, it shall be certified using procedures in the current
				controlled Environmental Testing Association (CETA) certification guideline for
				sterile compounding facilities or an equivalent guideline. Certifications hall
				be performed by properly trained individuals.
(b) Certification shall be performed
				initially, and recertification shall be performed at least every six (6)
				months. Recertification shall be performed if there are changes to the area
				including, but not limited to redesign, construction, replacement or relocation
				if a PEC, or alteration in the configuration of the room that could affect
				airflow or air quality.
(c)
				Certification shall include the following:
(i)
				Airflow testing to determine acceptable pressure differentials in doorways
				between adjacent rooms and ACPH from the HVAC, ACPH from the PEC and total
				ACPH;
(ii) HEPA filter integrity
				testing to include leak testing. HEPA filters shall be tested after
				installation and as part of recertification;
(iii) Total particle count testing in all
				classified areas under dynamic conditions;
(iv) Dynamic airflow smoke patter tests for
				each PED during dynamic operating conditions to demonstrate unidirectional
				airflow and sweeping action over and away from the CSP;
(v) Viable air and surface sampling in each
				classified area during dynamic operating conditions.
(A) Viable air sampled shall be take using an
				impaction device that tests at least 1,000 liters of air from each location
				sampled;
(B) A general microbial
				growth media that supports the growth of bacteria and fungi shall be used for
				surface samples;
(C) Action levels
				for viable air sampling are > 1CFU for ISO Class 5, > 10 CFU for ISO
				Class 7, and > 100 CFU for ISO Class 8; and
(D) Action levels for surface sampling are
				> 3 CFU for ISO Class 5, > 5 CFU for ISO Class 7, and > 50 CFU for ISO
				Class 8.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-7 - Cleaning, Disinfecting, and Applying Sporicidal Agents in Compounding Areas

Current through July 13, 2024
(a) All activities in this section shall be
				performed by trained and appropriately garbed facility staff.
(b) Facility staff shall clean surfaces prior
				to being disinfected. Facility staff may use an EPA-registered on-step
				disinfectant cleaner to accomplish cleaning and disinfection in one
				step.
(c) Facility staff shall
				perform cleaning in the direction of cleanest to dirtiest areas.
(d) Facility staff shall follow the
				manufacturer's directions or published data for the minimum contact time of the
				cleaning, disinfecting, and sporicidal agents.
(e) Facility staff shall apply sterile 70$
				isopropyl alcohol (IPA) after cleaning, disinfecting, or applications of a
				sporicidal agent in the PEC to remove any residue and allow it to
				dry.
(f) All cleaning supplies with
				the exception of toll handles and holders shall be low-lint.
(g) Wipers, pads, and mop heads should be
				disposable. Facility staff shall discard disposable cleaning supplies after
				each cleaning activity.
(h)
				Reusable cleaning tolls shall be made of cleanable materials, cleaned and
				disinfected before and after each use, dedicated for use in the classified are
				or SCA, and not removed except for disposal.
(i) Cleaning, disinfecting, and application
				of sporicidal agents in classifies areas and within the perimeter of the SCA
				shall occur at the following minimum frequencies and include the following
				surfaces, at a minimum:
(i) Facility staff
				shall clean and disinfect surfaces of sink(s) at least daily and a sporicidal
				agent shall be used at least monthly;
(ii) Facility staff shall clean and disinfect
				all interior surfaces and equipment inside the PEC, pass-through(s), work
				surfaces outside the PEC, and floors daily. A sporicidal agent shall be used on
				these surfaces at least monthly;
(iii) Facility staff shall perform cleaning
				and disinfecting before initiating compounding if compounding is not performed
				daily; and
(iv) Facility staff
				shall clean and disinfect walls, doors, door frames, ceilings, storage shelving
				and bins, and equipment outside the PEC monthly. A sporicidal agent shall be
				used on these surfaces.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-8 - Introducing Items into the SEC and PEC

Current through July 13, 2024
(a) Only furniture, equipment, and other
				materials necessary for compounding activities shall be permitted in a
				classified area or SCA. Items shall be placed in a manner that facilitates
				sterile compounding operations.
(b)
				Pharmacy staff shall not introduce shipping carton(s) or other corrugated or
				uncoated cardboard into a classified area or SCA.
(c) Pharmacy staff shall wipe down and item
				with a sporicidal agent, EPA-registered one-step disinfectant cleaner, or
				sterile 70% IPA using low-lint wipes prior to introducing the item into the
				clean side of the ante-room, pass-through, or inside the perimeter of the SCA.
				Pharmacy staff shall wear gloves when wiping down items.
(i) If a sporicidal agent or EPA-registered
				one-step disinfectant cleaner is used to wipe an item down, the item shall be
				allowed to dwell for the minimum contact time specified by the manufacturer
				before introducing the item into the classified area;
(ii) Pharmacy staff shall allow the item to
				dry if sterile 70% IPA is used to wipe it down; and
(iii) The wiping procedure shall not render
				the product label unreadable.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-9 - Equipment, Supplies, and Components

Current through July 13, 2024
(a) When using an automated compounding
				device (ACD), balance, or other automated or electronic equipment to compound a
				CAP, pharmacy staff shall:
(i) Calibrate all
				equipment to ensure proper operation;
(ii) Ensure all equipment shall not be
				reactive or sorptive with compounding components;
(iii) Conduct an accuracy assessment of the
				ACD before first use and again each day it is used to compound; and
(iv) Maintain records of all equipment
				calibration, verification, and maintenance.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-10 - Master Formulation Records, Compounding Records and Labeling

Current through July 13, 2024
(a) Sterile compounding pharmacies shall
				maintain a master formulation record:
(i) A
				master formulation record shall be maintained for CSPs prepared for more than
				one patient and for CSPs prepared from nonsterile ingredients;
(ii) Any changes or alterations to the master
				formulation record shall be approved by the designated person(s) and documents;
				and
(iii) The master formulations
				record shall include, but is not limited to, the following information:
(A) Name, strength or activity, and dosage
				form of the CSP;
(B) Identities and
				amounts of all ingredients;
(C)
				Type and size of container-closure system(s);
(D) Complete instructions for preparing the
				CSP, including equipment, supplies, a description of the compounding steps, and
				any special precautions;
(E)
				Physical description of the final CSP;
(F) BUD and storage requirements;
(G) Reference source to support the stability
				of the CSP;
(H) Quality control
				(QC) procedures; and
(I) Other
				information as needed to describe the compounding process and ensure
				repeatability.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-11 - Quality Assurance and Quality Control Programs

Current through July 13, 2024
(a) The designated person(s) shall establish
				a quality assurance (QA) and quality control (QC) program.
(b) The program shall be reviewed at least
				every twelve (12) months. The results of the review shall be documented and
				appropriate actions shall be taken if needed.
(c) The QA and QC program shall include
				systems to establish the following:
(i)
				Adherence to procedures;
(ii)
				Prevention and detection of errors and quality problems;
(iii) Evaluation of complaints and adverse
				events; and
(iv) Appropriate
				investigations and corrective actions.
Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 17 - STERILE COMPOUNDING › Section 17-12 - Establishing Beyond Use Dates

Current through July 13, 2024
(a) Low-risk level CSPs are prepared under
				the following conditions:
(i) The CSPs are
				compounded with aseptic manipulations entirely within ISO Class 5 or better air
				quality using only sterile ingredients, products, components, and
				devices;
(ii) Compounding only
				involved transferring, measuring and mixing manipulations using not more than
				three (3) commercially manufactured packages of sterile products, and no more
				than two (2) entries into any sterile container, product, or administration
				container/device;
(iii)
				Manipulations are limited to aseptically opening ampules, penetrating
				disinfected stoppers on vials with sterile needles and syringes, and
				transferring sterile liquids in sterile syringes to sterile administration
				devices, package containers of other sterile products, and containers for
				storage and dispensing; and
(iv) In
				the absence of passing a sterility test, the storage periods shall not exceed
				forty-eight (48) hours at controlled room temperature
				(20-25°C/68-77°F), fourteen (14) days at a cold temperature
				(2-8°C/36-46°F), and forty-five (45) days in a solid frozen state (-25
				to -10°C/-13 to 14°F).