reglab/statecodes huggingface dataset:
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 8 - Requirements For Controlled Substances › Section Phar 8.04 - Notification of suspicious orders for and theft or loss of controlled substances

Current through June 24, 2024
A pharmacy or pharmacist shall notify the board of a
				suspicious order or series of orders for controlled substances or the theft or
				loss of controlled substances on the same day notification is required to be
				provided to the drug enforcement administration. Notification to the board
				shall include all information required to be provided in the notification to
				the drug enforcement administration.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 8 - Requirements For Controlled Substances › Section Phar 8.05 - Recordkeeping

Current through June 24, 2024
(1) Records shall be maintained as required
			 by the federal controlled substances act, ch. 961, Stats., and s.
			 450.11(2),
			 Stats.
(2) The managing pharmacist
			 shall oversee quarterly inspections, maintenance, and reconciliation of all
			 controlled substances, including maintaining a perpetual inventory for all
			 Schedule II controlled substances.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 8 - Requirements For Controlled Substances › Section Phar 8.06 - Identification card requirement under s. 450.11 (1b), Stats

Current through June 24, 2024
(1) DEFINITION. In
			 this section and s.
			 450.11(1b)
			 (e) 3, Stats., "health care facility" means a
			 facility, as defined in s.
			 647.01(4),
			 Stats.; any hospital, nursing home, community-based residential facility,
			 county home, county infirmary, county hospital, county mental health complex,
			 or other place licensed or approved by the department of health services under
			 s.
			 49.70,
			 49.71,
			 49.72,
			 50.03,
			 50.032,
			 50.033,
			 50.034,
			 50.35,
			 51.08,
			 or
			 51.09, Stats.; a
			 facility under s.
			 45.50,
			 51.05,
			 51.06,
			 233.40,
			 233.41,
			 233.42, or
			 252.10,
			 Stats.; and a hospice facility under s.
			 50.90(1)
			 (c), Stats.
(2) EXEMPTION. There shall be an exemption to
			 the requirement for an identification card when the drug is lawfully delivered
			 to the patient's home, or any address requested by the patient, through mail,
			 common carrier or delivery service. A valid signature is required upon
			 delivery.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 8 - Requirements For Controlled Substances › Section Phar 8.07 - Partial Dispensing

Current through June 24, 2024
(1) A pharmacist may partially dispense a
			 prescription containing a controlled substance listed in schedule III, IV and
			 V.
(2)
(a) The partial dispensing of a prescription
			 containing a controlled substance listed in schedule II is permissible, if one
			 of the following conditions applies:
1. If
			 the pharmacist is unable to supply the full quantity called for in a written,
			 electronic, or emergency oral prescription order, and the pharmacist makes a
			 notation of the quantity supplied on the face of the written hard copy
			 prescription order or written record of the electronic or emergency oral
			 prescription order.
2. If the
			 patient requests partial dispensing.
3. If the prescribing practitioner requests
			 partial dispensing.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 8 - Requirements For Controlled Substances › Section Phar 8.08 - Controlled substances in emergency kits for long-term care facilities

Current through June 24, 2024
long-term care facilities which are not registered with the
				DEA shall meet all of the following requirements regarding emergency kits
				containing controlled substances:
(1)
			 The source of supply must be a DEA registered hospital, pharmacy or
			 practitioner.
(2) The
			 pharmaceutical services committee of the facility shall establish security
			 safeguards for each emergency kit stored in the LTCF which shall include the
			 designation of individuals who may have access to the emergency kits and a
			 specific limitation of the type and quantity of controlled substances permitted
			 to be placed in each emergency kit.
(3) A pharmacist shall be responsible for
			 proper control and accountability for such emergency kits within the LTCF which
			 includes the requirement that the LTCF and the providing DEA registered
			 hospital, pharmacy or practitioner maintain complete and accurate records of
			 the controlled substances placed in the emergency kits, the disposition of
			 those controlled substances, plus the requirement to take at least monthly
			 physical inventories.
(4) The
			 pharmaceutical services committee will establish the emergency medical
			 conditions under which the controlled substances may be administered to
			 patients in the LTCF which shall include the requirement that medication be
			 administered by authorized personnel only as expressly authorized by an
			 individual DEA registered practitioner and in compliance with all applicable
			 federal and state laws.
(5)
			 Noncompliance with this section may result in revocation, denial or suspension
			 of the privilege of having or placing emergency kits, containing controlled
			 substances, in LTCF.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 10 - Standards Of Professional Conduct › Section Phar 10.02 - Definitions

Current through June 24, 2024
In this chapter:
(1)
			 "Dispense" has the meaning given in s.
			 450.01(7),
			 Stats.
(2) "Drug" has the meaning
			 given in s.
			 450.01(10),
			 Stats.
(3) "Patient" has the
			 meaning given in s.
			 450.01(14),
			 Stats.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 12 - Manufacturer Requirements › Section Phar 12.02 - Definitions

Current through June 24, 2024
In this chapter:
(1)
			 "Device" has the meaning set forth in s.
			 450.01(6),
			 Stats.
(2) "Drug" has the meaning
			 set forth in s.
			 450.01(10),
			 Stats.
(3) "Establishment" means a
			 place of business under one management at one general physical
			 location.
(4) "Manufacturer" means
			 a person licensed by the board under this chapter.
(5) "Manufacturing" has the meaning set forth
			 in s.
			 450.01(13),
			 Stats.
(6) "Prescription drug" has
			 the meaning set forth in s.
			 450.01(20),
			 Stats.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 12 - Manufacturer Requirements › Section Phar 12.03 - License; application

Current through June 24, 2024
(1) No person may engage in the manufacturing
			 of any drug or device in this state unless a license is granted to the person
			 by the board under this chapter.
(2) To obtain a license a person shall do all
			 of the following:
(a) Submit an application on
			 a form provided by the board.
(b)
			 Pay the fee specified in s.
			 440.05(1),
			 Stats.
(c) Meet the inspection
			 requirement under s.
			 Phar
			 12.04.
(d)
			 Register with the food and drug administration and comply with all applicable
			 requirements of 21 CFR 200, 201, 202, 207, 210 and 211.
(e) If applicable, register with the drug
			 enforcement administration and comply with all appropriate requirements of 21
			 CFR 1301, 1302, 1303, 1304, 1305, 1307, 1311 and 1312.
Note: An application form may be obtained from the board
				office, 1400 East Washington Avenue, Madison, Wisconsin 53702. Copies of
				federal applications, laws and regulations may be obtained from the Food and
				Drug Administration, 5600 Fischers Lane, Rockville, Maryland 20857 and the Drug
				Enforcement Administration, 500 Dirksen Federal Building, 219 Dearborn,
				Chicago, Illinois 60604.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 12 - Manufacturer Requirements › Section Phar 12.04 - Inspections

Current through June 24, 2024
Before a license is granted, an inspection of the establishment shall be
										conducted by the board or its representative to determine if the location meets the standards in  21 USC 351 and  352  (2022) and  21 CFR 210 and  211  (2022).
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.01 - Authority

Current through June 24, 2024
The rules in this chapter are adopted under authority in ss.
				15.08(5)
				(b),
				227.11(2)
				(a),
				450.02(3)
				(a) and
				450.07(4),
				Stats.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.05 - License; other requirements

Current through June 24, 2024
In addition to providing the application information, to obtain
				a license a person shall:
(1) Pay the
			 fee specified in s.
			 440.05(1),
			 Stats.
(2) Pass an inspection of
			 the facility conducted by the board or its representative in the 3-year period
			 immediately preceding the date of the application by the board, a pharmacy
			 examining board of another state, the National Association of Boards of
			 Pharmacy, or another accrediting body recognized by the board, with the date of
			 each inspection to determine if the location meets standards specified in ss.
			 Phar
			 13.08 to
			 13.11.
(3) Register with the drug enforcement
			 administration, if intending to distribute controlled substances.
Copies of federal applications may be obtained from the Drug
				  Enforcement Administration, Suite 500, Dirksen Federal Building, 219 South
				  Dearborn Street, Chicago, Illinois 60604. Copies of federal statutes and rules
				  may be obtained from the Superintendent of Documents, Government Printing
				  Office, Washington DC 20402-9325.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.055 - Surety bond, irrevocable letter of credit

Current through June 24, 2024
The applicant shall supply a surety bond or irrevocable letter
				of credit in the amount of $5,000.00, which is issued by a company authorized
				to do business in Wisconsin. The form of the bond or letter of credit shall be
				approved by the department and conditioned so that the state shall be fully
				compensated or reimbursed for, and shall be used to, secure payment of fees or
				costs that relate to the issuance of a wholesale distributor's license that
				have not been paid within 30 days after the fees or costs have become final.
				The bond or letter shall be valid for the entire period of an unexpired license
				issued to the applicant. No claim may be made against a bond or other security
				under this section more than one year after the date on which the applicant's
				wholesale distributor's license expires.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.06 - License; factors considered

Current through June 24, 2024
In determining eligibility for a distributor's license, the
				board shall consider the following factors:
(1) Any convictions of the applicant under
			 any federal, state, or local laws relating to drug samples, wholesale or retail
			 drug or device distribution, or distribution of controlled
			 substances;
(2) Any felony
			 convictions of the applicant under federal, state, or local laws, the
			 circumstances of which are substantially related to the practice of a
			 distributor;
(4) The furnishing by
			 the applicant of false or fraudulent material in any application made in
			 connection with drug manufacturing or distribution;
(5) Suspension or revocation by federal,
			 state, or local government of any license currently or previously held by the
			 applicant for the manufacture or distribution of any devices or drugs,
			 including controlled substances;
(6) Compliance with licensing requirements
			 under previously granted licenses, if any;
(7) Compliance with the requirements to
			 maintain or make available to a state licensing authority or to federal, state,
			 or local law enforcement officials those records required to be maintained by
			 wholesale drug or device distributors; and
(8) Any other factors or qualifications the
			 board considers relevant to and consistent with the public health and
			 safety.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.07 - Application review

Current through June 24, 2024
The board shall act upon an application for a license within 60
				business days after receiving the completed application, as provided in s.
				SPS
				4.03. If the license is denied, the applicant may
				request a hearing pursuant to ch. SPS 1.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.09 - Facility requirements

Current through June 24, 2024
All facilities at which prescription drugs are stored,
				warehoused, handled, held, offered, marketed, or displayed shall:
(1) Be of suitable size and construction to
			 facilitate cleaning, maintenance, and proper operations;
(2) Have storage areas designed to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
(3) Have a quarantine area for storage of
			 prescription drugs that are outdated, damaged, deteriorated, misbranded, or
			 adulterated, or that are in immediate or sealed secondary containers that have
			 been opened;
(4) Be maintained in a
			 clean and orderly condition; and
(5) Be free from infestation by insects,
			 rodents, birds, or vermin of any kind.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.10 - Security requirements

Current through June 24, 2024
All facilities shall require that:
(1) Access from outside the premises is kept
			 to a minimum and be well controlled;
(2) The outside perimeter of the premises is
			 well lighted;
(3) Entry into areas
			 where prescription drugs are held is limited to authorized personnel;
(4) An alarm system is maintained to detect
			 entry after hours; and
(5) A
			 security system is maintained that will provide suitable protection against
			 theft and diversion, including, when appropriate, a system that provides
			 protection against theft or diversion that is facilitated or hidden by
			 tampering with computers or electronic records.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.11 - Storage requirements

Current through June 24, 2024
(1) All prescription drugs stored in a
			 facility shall be stored at appropriate temperatures and under appropriate
			 conditions in accordance with requirements, if any, in the labeling of such
			 products, or with requirements in the current edition of an official
			 compendium.
(2) If no storage
			 requirements are established for a prescription drug, the product may be held
			 at a controlled room temperature, as defined in an official compendium, to help
			 ensure that its identity, strength, quality, and purity are not adversely
			 affected.
(3) Appropriate manual,
			 electromechanical, or electronic temperature and humidity recording equipment,
			 or logs shall be utilized to document proper storage of prescription
			 drugs.
(4) The recordkeeping
			 requirements in s.
			 Phar
			 13.14 shall be followed for all stored
			 drugs.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.12 - Examination of materials requirements

Current through June 24, 2024
(1) Upon receipt by
			 a facility, each outside shipping container shall be visually examined for
			 identity and to prevent the acceptance of contaminated prescription drugs, or
			 prescription drugs that are otherwise unfit for distribution. This examination
			 shall be adequate to reveal container damage that would suggest possible
			 contamination or other damage to the contents.
(2) Each outgoing shipment from a facility
			 shall be carefully inspected for identity of the prescription drug and to
			 ensure that there is no delivery of prescription drugs that have been damaged
			 in storage or held under improper conditions.
(3) The recordkeeping requirements in s.
			 Phar
			 13.14 shall be followed for all incoming and outgoing
			 prescription drugs at a facility.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.13 - Returned, damaged and outdated prescription drug requirements

Current through June 24, 2024
(1) Prescription
			 drugs in a facility that are outdated, damaged, deteriorated, misbranded, or
			 adulterated shall be quarantined and physically separated from other
			 prescription drugs until they are destroyed or returned to their
			 supplier.
(2) Any prescription
			 drugs in a facility whose immediate or sealed outer or sealed secondary
			 containers have been opened or used shall be identified as such, and shall be
			 quarantined and physically separated from other prescription drugs until they
			 are either destroyed or returned to the supplier.
(3) If the conditions under which a
			 prescription drug has been returned to a facility cast doubt on the product's
			 safety, identity, strength, quality, or purity, then the product shall be
			 destroyed, or returned to the supplier, unless examination, testing, or other
			 investigation proves that the product meets appropriate standards of safety,
			 identity, strength, quality, and purity. In determining whether the conditions
			 under which a product has been returned cast doubt on its safety, identity,
			 strength, quality, or purity, the distributor shall consider, among other
			 things, the conditions under which the product has been held, stored, or
			 shipped before or during its return and the condition of the product and its
			 container, carton, or labeling, as a result of storage or shipping.
(4) The recordkeeping requirements in s.
			 Phar
			 13.14 shall be followed for all outdated, damaged,
			 deteriorated, misbranded, or adulterated prescription drugs.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.14 - Recordkeeping requirements

Current through June 24, 2024
(1) A distributor
			 shall establish and maintain inventories and records of all transactions
			 regarding the receipt and distribution or other disposition of prescription
			 drugs. These records shall include the following information:
(a) The source of the drugs, including the
			 name and principal address of the seller or transferor, and the address of the
			 location from which the drugs were shipped:
(b) The identity and quantity of the drugs
			 received and distributed or disposed of; and
(c) The dates of receipt and distribution or
			 other disposition of the drugs.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.15 - Written policies and procedures

Current through June 24, 2024
A distributor shall establish, maintain, and adhere to written
				policies and procedures, which shall be followed for the receipt, security,
				storage, inventory, and distribution of prescription drugs, including policies
				and procedures for identifying, recording, and reporting losses or thefts, and
				for correcting all errors and inaccuracies in inventories. A distributor shall
				include in their written policies and procedures the following:
(1) A procedure to ensure that the oldest
			 approved stock of a prescription drug is distributed first. The procedure may
			 permit deviation from this requirement if the deviation is temporary and
			 appropriate.
(2) A procedure to be
			 followed for handling recalls and withdrawals of prescription drugs. The
			 procedure shall be adequate to deal with recalls and withdrawals due to:
(a) Any action initiated at the request of
			 the food and drug administration or other federal, state, or local law
			 enforcement or other governmental agency, including the board;
(b) Any voluntary action by the manufacturer
			 to remove defective or potentially defective drugs from the market;
			 or
(c) Any action undertaken to
			 promote public health and safety by the replacing of existing merchandise with
			 an improved product or new package design.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.17 - Compliance with federal, state and local laws

Current through June 24, 2024
(1) A distributor
			 shall operate in compliance with applicable federal, state, and local laws and
			 regulations. A distributor shall operate in compliance with any applicable
			 federal electronic track and trace pedigree system implemented after July 1,
			 2011, unless an earlier implementation date is mandated by federal law which
			 explicitly preempts state law. A distributor that deals in controlled
			 substances shall register with the drug enforcement administration.
(2) Failure to comply with applicable
			 federal, state, and local laws and regulations constitutes unprofessional
			 conduct for purposes of s.
			 450.10,
			 Stats.
(3) A distributor shall
			 permit the board or its authorized representatives and authorized federal,
			 state and local law enforcement officials to enter and inspect their premises
			 and delivery vehicles, and to audit their records and written operating
			 procedures, at reasonable times and in a reasonable manner, to the extent
			 authorized by law. Such officials shall be required to show appropriate
			 identification prior to being permitted access to a distributor's premises and
			 delivery vehicles.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 14 - Home Medical Oxygen Providers › Section Phar 14.01 - Application

Current through June 24, 2024
Each applicant for licensure as a home medical oxygen provider
				shall submit all of the following:
(1)
			 An application for licensure on a form provided by the board.
(2) The fee specified in s.
			 440.05(1),
			 Stats.
(3) Evidence of
			 accreditation by an organization deemed an accreditation organization for
			 suppliers of durable medical equipment, prosthetics, orthotics, and supplies by
			 the United States department of health and human services, centers for medicare
			 and medicaid services.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 14 - Home Medical Oxygen Providers › Section Phar 14.02 - Standards of Professional Conduct

Current through June 24, 2024
Licensed home medical oxygen providers and their employees and
				agents shall do all of the following:
(1) Maintain accreditation status by an
			 organization deemed an accreditation organization for suppliers of durable
			 medical equipment, prosthetics, orthotics, and supplies by the United States
			 department of health and human services, centers for medicare and medicaid
			 services.
(2) Comply with all
			 federal and state laws regarding transporting oxygen in cylinder or liquid
			 form.
(3) Comply with the United
			 States food and drug administration rules and regulations regarding
			 transporting medical oxygen systems.
(4) Demonstrate that oxygen provided to
			 cylinder or liquid form meets purity standards for medical grade
			 oxygen.
(5) Meet safety inspection
			 requirements including all of the following:
(a) Maintain documentation demonstrating each
			 piece of oxygen or respiratory equipment has been checked, is free of defect,
			 and operates within the manufacturer's specifications.
(b) Equipment shall not be modified to the
			 extent that the modification may reasonably cause harm.
(c) Maintain all electrical components so
			 that they do not present a fire or shock hazard.
(d) Ensure that all appropriate warning
			 labels, including tags, are present on the equipment provided.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Section Phar 15.015 - Definitions

Current through June 24, 2024
In this chapter:
(1)
			 "Active pharmaceutical ingredient" or "API" means any substance or mixture of
			 substances intended to be used in the compounding of a drug preparation and
			 that, when used in the compounding of a drug preparation, becomes an active
			 ingredient in the preparation intended to furnish pharmacological activity or
			 other direct effect in the diagnosis, cure, mitigation, treatment, or
			 prevention of disease in humans and animals or affecting the structure and
			 function of the body.
(2) "Added
			 substances" means ingredients that are necessary to compound a drug preparation
			 that are not intended or expected to cause a pharmacologic response if
			 administered alone in the amount or concentration contained in a single dose of
			 the compounded preparation.
(3)
			 "Adverse drug event" means an injury resulting from the use of a
			 drug.
(4) "Beyond use date" or
			 "BUD" means one of the following:
(a) The date
			 after which a non-sterile compounded preparation shall not be used.
(b) The date and time after which a sterile
			 compounded preparation shall not be used.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.10 - Facilities

Current through June 24, 2024
A pharmacist engaged in compounding shall ensure all of the
				  following:
(1) An area designated for
				compounding.
(2) Orderly placement
				of compounding equipment, materials, and components in order to minimize the
				potential for compounding errors.
(3) The compounding area is maintained in a
				clean and sanitary condition.
(4)
				The compounding area is easily accessible to all of the following:
(a) Hot and cold running water, exclusive of
				the bathroom sink.
(b) Soap or
				detergent.
(c) Single-use
				towels.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.11 - Equipment and Drug Preparation Containers

Current through June 24, 2024
(1) A pharmacy
				shall possess equipment and drug preparation containers or packaging
				appropriate to the type of compounding performed at the pharmacy.
(2) Equipment and drug preparation containers
				or packaging used in compounding shall be of appropriate design and capacity,
				and shall be suitably stored in a manner to facilitate use, cleaning,
				maintenance, and protect it from contamination.
(3) Equipment and drug preparation containers
				or packaging used in compounding drug products shall be of suitable composition
				and may not be reactive, additive, adsorptive, or absorptive so as to alter the
				stability of the compounded preparation.
(4) Equipment used in compounding shall be
				thoroughly cleaned and sanitized after each use, and when necessary, prior to
				use, according to written policies and procedures, in order to reduce bioburden
				and reduce the opportunity for cross-contamination.
(5) All equipment utilized in compounding
				preparations shall be inspected, maintained, calibrated, and validated at
				appropriate intervals, consistent with manufacturer's recommendations, to
				ensure the accuracy and reliability of equipment performance. Records shall be
				kept indicating the equipment was inspected, maintained, calibrated, and
				validated.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.12 - Records of compounding

Current through June 24, 2024
The managing pharmacist shall ensure written or electronic
				  compounding documentation to systematically trace, evaluate, and replicate the
				  compounding steps throughout the process of a preparation. The compounding
				  documentation shall be maintained for a period of 5 years after the date of the
				  last refill. The compounding documentation shall include all of the
				  following:
(1) Official or assigned
				name, strength, and dosage form of the preparation.
(2) List of all APIs and added substances and
				their quantities.
(3) Vendor or
				manufacturer, lot number and expiration date of each APIs and added
				substances.
(4) Equipment and
				supplies needed to prepare the preparation.
(5) Mixing instructions pertinent to the
				replication of the preparation as compounded.
(6) Compatibility and stability information,
				including references or laboratory testing.
(7) Container or container-closure system
				used in dispensing.
(8) Packaging
				and storage requirements.
(9)
				Quality control procedures.
(10)
				Sterilization method when using non-sterile ingredients to make a sterile
				preparation.
(11) Total quantity
				compounded.
(12) Name of the person
				who prepared the preparation.
(13)
				Name of the person who performed the quality control procedures.
(14) Name of the person who approved the
				preparation.
(15) Date of
				preparation.
(16) Assigned control
				or prescription number.
(17)
				Assigned BUD.
(18) Copy of the
				label to dispense final product.
(19) Documentation of any adverse reactions
				or preparation problems reported by the patient or caregiver.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.13 - Quality control

Current through June 24, 2024
(1) One or more pharmacists shall complete a
				verification of all the following before dispensing:
(a) Written procedures were followed in the
				compounding process.
(b)
				Preparation instructions were followed.
(c) Finished preparation appears as
				expected.
(d) Label includes all
				required elements.
(e) Quality
				control procedures were completed.
(f) Compounding records are
				complete.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.14 - Training, Policies, and Procedures

Current through June 24, 2024
(1) TRAINING. All
				personnel involved in the compounding, evaluation, packaging, and dispensing of
				compounded preparations shall be properly trained and competency is assessed
				for the type of compounding conducted. It is the responsibility of the managing
				pharmacist to ensure personnel training and competency assessments are
				completed and documented.
(2)
				POLICIES AND PROCEDURES. The pharmacy and managing pharmacist shall establish
				written policies and procedures governing all of the following:
(a) Personnel qualifications and training,
				responsibilities, and competencies.
(b) Personal hygiene, garb, garbing, and
				personal protective gear.
(c) Use
				and maintenance of compounding facilities and equipment, including applicable
				certifications.
(d) Environmental
				monitoring.
(e) Cleaning and
				disinfection of compounding area.
(f) Component selection.
(g) Sterilization and depyrogenation, if
				pharmacy does sterilization and depyrogenation.
(h) Documentation requirements.
(i) Establishing BUD.
(j) Reporting of adverse drug
				events.
(k) A risk management
				program, including documentation of incidents, adverse drug reactions and
				product contamination.
(L) A
				quality assurance program.
(m)
				Maintaining the integrity of any classified work areas.
(n) Handling small and large spills of
				antineoplastic agents and other hazardous substances.
(o) Notification to patients or practitioners
				of a preparation which is recalled when there is potential for patient
				harm.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.15 - Labeling

Current through June 24, 2024
The label of a compounded preparation shall include all of
				  the following:
(1) Labeling
				requirements in s.
				Phar
				7.02 and 8.08.
(2) Storage conditions if other than
				controlled room temperature.
(3)
				BUD.
(4) Special handling
				instructions, when applicable.
(5)
				Indication that the preparation is compounded unless administered by health
				care personnel.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.16 - Component Selection

Current through June 24, 2024
(1) Active pharmaceutical ingredients or
				added substances used in compounding shall be manufactured by an FDA registered
				facility or accompanied by a certificate of analysis.
(2) APIs and added substances shall meet USP
				or NF monograph specifications when monographs are available. A pharmacist
				shall use professional judgement in selection of APIs if USP or NF grade is not
				available.
(3) All components shall
				be stored and handled consistent with the manufacturer's labeling or USP or NF
				monographs and in a manner that prevents contamination and
				deterioration.
(4) A pharmacist
				compounding for human use may not use components that have been withdrawn or
				removed from the market for safety or efficacy reasons by the FDA. A pharmacist
				compounding for food producing animal use may not use components prohibited for
				use in food producing animals.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter I - General › Section Phar 15.17 - Non-patient specific compounding

Current through June 24, 2024
Compounded preparations dispensed or distributed to a
				  practitioner pursuant to a non-patient specific order to be administered by a
				  practitioner or practitioner's agent shall meet all of the following:
(1) The order shall include the name and
				address of the practitioner, drug, strength, quantity, and the purpose of the
				compounded preparation.
(2) The
				label shall include the practitioner's name in place of the patient's name and
				state "For Practitioner Administration Only - Not for Dispensing or
				Distribution." If the sterility or integrity of the compounded preparation is
				not maintained after the initial opening of the container, the label shall
				state "Single-Dose Only."
(3) The
				pharmacist shall record the name and address of the location the compounded
				preparation was dispensed or distributed, and the lot number and BUD of all
				preparations dispensed or distributed to the practitioner.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter II - Non-sterile Compounding › Section Phar 15.20 - Component Selection

Current through June 24, 2024
(1) Components with an expiration date from
				the manufacturer or distributor may be used before the expiration date provided
				all of the following:
(a) The component is
				stored in its original container under conditions to avoid
				decomposition.
(b) There is minimal
				exposure of the remaining component each time component is withdrawn from the
				container.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter II - Non-sterile Compounding › Section Phar 15.21 - Assigning BUD

Current through June 24, 2024
(1) The BUD shall not be later than the
				expiration date on the container of any component.
(2) Only in the absence of stability
				information that is applicable to a specific drug product and preparation, the
				maximum BUD for a non-sterile compounded drug preparation that is packaged in a
				tight, light-resistant container is as follows:
(a) For nonaqueous formulations stored at
				controlled room temperature, the BUD shall not be later than the time remaining
				until the earliest expiration date of any active pharmaceutical ingredient or 6
				months, whichever is earlier.
(b)
				For water-containing oral formulations, the BUD shall not be later than 14 days
				when stored in a refrigerator.
(c)
				For water-containing semisolid mucosal liquid, topical, or dermal formulations,
				stored at controlled room temperature, the BUD shall not be later than 30
				days.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.31 - Facility design and environmental controls

Current through June 24, 2024
(1) GENERAL.
				Facilities shall meet all of the following requirements:
(a) Be physically designed and
				environmentally controlled to minimize airborne contamination from contacting
				critical sites.
(b) Be accessible
				only to designated personnel.
(c)
				Have a heating, ventilation, and air conditioning system controlling the
				temperature and humidity.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.32 - Personnel hygiene, garbing and protective gear

Current through June 24, 2024
(1) Personnel
				suffering from rashes, sunburn, oozing tattoos or sores, conjunctivitis, active
				respiratory infection, or other active communicable disease shall be excluded
				from working in compounding areas until the condition is resolved.
(2) All personnel who engage in compounding
				sterile preparations shall comply with all of the following requirements before
				entering the compounding area:
(a) Remove
				personal outer garments, all cosmetics, exposed jewelry and piercings,
				headphones, ear buds, and cell phones.
(b) Abstain from eating, chewing gum or
				drinking in the compounding area or bringing food, gum, or drink into the
				compounding area.
(c) Artificial
				nails, nail extenders or nail polish may not be worn while working in the
				compounding area. Nails shall be neat and trim.
(d) Don personnel protective equipment and
				perform hand hygiene in the following order:
1. Low-lint, disposable shoe
				covers.
2. Low-lint, disposable
				covers for head and facial hair that cover the ears and forehead and face
				masks.
3. Eye shields, if required
				due to working with irritants or hazardous drugs.
4. Wash hands and forearms up to the elbows
				with unscented soap and water for at least 30 seconds. Hands and forearms to
				the elbows shall be completely dried using either lint-free disposable towels
				or wipes.
5. Don low lint
				disposable gown or overalls.
6.
				Prior to donning sterile gloves, hand antisepsis shall be performed using an
				alcohol-based hand rub with sustained antimicrobial activity following the
				manufacturers labeled instructions and application times.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.33 - Cleaning and Disinfecting the Compounding Area and Supplies

Current through June 24, 2024
(1) Compounding
				personnel are responsible determining the cleaning and disinfecting products to
				be used and for ensuring that the frequency of cleaning and disinfecting
				compounding area is done.
(2)
				Compounding personnel shall clean in accordance with the following:
(a) Primary engineering control work
				surfaces, counters, floors and work surfaces in the buffer zone area, ante room
				and segregated compounding areas daily.
(b) Walls, ceilings and storage shelving
				monthly.
(c) When a spill occurs or
				the surface is visibly soiled.
(d)
				Sporicidal agents shall be used at least weekly to clean compounding
				areas.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.34 - Immediate-use compounded sterile preparations

Current through June 24, 2024
Immediate-use compounded sterile preparations are exempt
				  from the requirements described for low-risk level, Category 1, and Category 2
				  compounding sterile preparations only when all the following criteria are
				  met:
(1) The compounding process
				involves simple transfer of not more than three commercially manufactured
				sterile nonhazardous products or diagnostic radiopharmaceutical products from
				the manufacturers' original containers and not more than two entries into any
				one container or product of sterile infusion solution or administration
				container or device.
(2) Unless
				required for the preparation, the compounding procedure is a continuous process
				not to exceed 1 hour.
(3) During
				preparation, aseptic technique is followed and, if not immediately
				administered, the finished compound sterile preparation is under continuous
				supervision to minimize the potential for contact with nonsterile surfaces,
				introduction of particulate matter or biological fluids, mix-ups with other
				compound sterile preparations, and direct contact of outside
				surfaces.
(4) Administration begins
				not later than 4 hours following the start of the preparation.
(5) Unless immediately and completely
				administered by the person who prepared it or immediate and complete
				administration is witnessed by the preparer, the compounded sterile preparation
				shall bear a label listing patient identification information, the names and
				amounts of all ingredients, the name or initials of the person who prepared it,
				and the exact 4-hour BUD and time.
(6) If administration of the compounded
				sterile preparation has not begun within 4 hours following the start of
				preparation, it shall be promptly, properly, and safely discarded.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.35 - Sterilization methods

Current through June 24, 2024
(1) Sterilization methods employed shall
				sterilize while maintaining its physical and chemical stability and the
				packaging integrity of the compounding sterile preparations. The efficacy of
				sterilization and depyrogenation of container closure systems performed in the
				pharmacy shall be established, documented, and reproducible.
(2) Pre-sterilization requirements shall meet
				all of the following:
(a) During all
				compounding activities that precede terminal sterilization, including weighing
				and mixing, compounding personnel shall be garbed and gloved in the same manner
				as when performing compounding in an ISO Class 5 environment. All
				pre-sterilization procedures shall be completed in an ISO Class 8 or better
				environment.
(b) Immediately before
				use, all nonsterile measuring, mixing, and purifying devices used in the
				compounding process shall be thoroughly rinsed with sterile, pyrogen-free water
				and then thoroughly drained or dried.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.36 - Inspection, sterility testing and antimicrobial effectiveness

Current through June 24, 2024
(1) PHYSICAL
				INSPECTION.
(a) At the completion of
				compounding, the compounded sterile preparation shall be inspected by
				performing all of the following:
1. Visually
				inspect the container closure for leakage, cracks in the container, or improper
				seals.
2. Visually check the
				compounded sterile preparation for phase separation.
3. Each individual injectable unit shall be
				inspected against a lighted white background and a black background for
				evidence of visible particulates or other foreign matter or
				discoloration.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.37 - Beyond use dating

Current through June 24, 2024
(1) Sterility and stability considerations
				shall be taken into account when establishing a BUD. Either Category 1 and 2,
				or low, medium, and high-risk compounding preparation standards may be used,
				but not a combination of the two within the same pharmacy. The following dates
				and times for storage and initiation of administration of the compounded
				sterile preparations shall apply:
(a) For
				compounded sterile preparations including components from conventionally
				manufactured products, the BUD shall not exceed the shortest expiration of any
				of the starting components. If the compounded sterile preparation includes
				non-conventionally manufactured products, the BUD may not exceed the shortest
				BUD of any of the starting components.
(b) For Category 1 compounded sterile
				preparations, one of the following:
1. May
				not exceed 12 hours when the preparation is stored at controlled room
				temperature.
2. May not exceed 24
				hours when the preparation is stored in a refrigerator.
(c) For aseptically processed Category 2
				processed sterile preparations, one of the following:
1. No sterility testing performed or
				sterility testing not passed, and prepared with one or more nonsterile starting
				components, one of the following:
a. Within 1
				day when the preparation is stored at controlled room temperature.
b. Within 4 days when the preparation is
				stored in a refrigerator.
c. Within
				45 days when the preparation is stored in a freezer.
2. No sterility testing performed or
				sterility testing not passed, and prepared with only sterile starting
				components, one of the following:
a. Within 4
				days when the preparation is stored at controlled room temperature.
b. Within 10 days when the preparation is
				stored in a refrigerator.
c. Within
				45 days when the preparation is stored in a freezer.
3. Sterility testing performed and passed,
				one of the following:
a. Within 30 days when
				the preparation is stored at controlled room temperature.
b. Within 45 days when the preparation is
				stored in a refrigerator.
c. Within
				60 days when the preparation is stored in a freezer.
(d) For Category 2 compounded
				sterile preparations, terminally sterilized by a validated procedure, one of
				the following:
1. No sterility testing
				performed or sterility testing not passed, one of the following:
a. Within 14 days when the preparation is
				stored at controlled room temperature.
b. Within 28 days when the preparation is
				stored in a refrigerator.
c. Within
				45 days when the preparation is stored in a freezer.
2. Sterility testing performed and passed,
				one of the following:
a. Within 45 days when
				the preparation is stored at controlled room temperature.
b. Within 60 days when the preparation is
				stored in a refrigerator.
c. Within
				90 days when the preparation is stored in a freezer.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 15 - Compounding Pharmaceuticals › Subchapter III - Sterile Compounding › Section Phar 15.38 - Training and evaluation

Current through June 24, 2024
(1) GENERAL. The managing pharmacist,
				pharmacists, pharmacy technicians, pharmacy interns and pharmacy externs
				compounding sterile preparations shall successfully complete didactic or
				practical training. The didactic or practical training shall be done before any
				compounding personnel initially prepares compounded sterile preparations and
				annually thereafter and shall include all of the following:
(a) Hand hygiene and garbing.
(b) Cleaning and disinfection.
(c) Measuring and mixing.
(d) Aseptic manipulation.
(e) Cleanroom behavior.
(f) Sterilization and
				depyrogenation.
(g) Use of
				equipment.
(h)
				Documentation.
(i) Use of primary
				engineering controls.
Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 16 - Continuing Education For Pharmacists › Section Phar 16.01 - Authority and purpose

Current through June 24, 2024
The rules in this chapter are adopted by the pharmacy examining
				board pursuant to the authority delegated by ss.
				15.08(5)
				(b),
				227.11(2)
				and
				450.02(2g)
				(a), Stats.