reglab/statecodes huggingface dataset:
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.533 - Compounding standards and requirements; outsourcing facilities; requirements

Current through Vol. 24-12, July 15, 2024
Rule 33.
(1)
						The board approves and adopts by reference the compounding standards of USP,
						published by the United States Pharmacopeial Convention, 12601 Twinbrook
						Parkway, Rockville, Maryland 20852-1790. This includes USP Chapters 795
						(revised 2023) and 797 (revised 2023), with the exception of
						flavoring.
(2) The standards
						adopted by reference in subrule (1) of this rule are available at a cost of
						$250.00 at
http://www.usp.org/compounding
, or
						can be viewed at the Bureau of Professional Licensing, Michigan Department of
						Licensing and Regulatory Affairs, Ottawa Building, 611 West Ottawa, P.O. Box
						30670, Lansing, Michigan 48909.
(3)
						A pharmacy that provides compounding services shall comply with the standards
						adopted in subrule (1) of this rule.
(4) An outsourcing facility located outside
						of this state that dispenses, provides, distributes, or otherwise furnishes
						compounded pharmaceuticals in this state shall be inspected and registered as
						an outsourcing facility by the FDA before applying for a pharmacy license in
						this state.
(5) An outsourcing
						facility located within this state that is applying for licensure as a pharmacy
						shall complete both of the following:
(a)
						Obtain an inspection from the department or its designee for the purpose of
						meeting R 338.536 and
						R 338.537 for initial
						licensure.
(b) Within 6 months
						after initial licensure under this subrule, a pharmacy shall obtain, and
						provide to the department, a subsequent inspection to assess adherence to the
						current and as amended good manufacturing practices for finished
						pharmaceuticals set forth in 21 CFR 211.1 to
						211.208.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.534 - Out-of-state pharmacy licensure inspection; in-state pharmacy licensure renewal inspection

Current through Vol. 24-12, July 15, 2024
Rule 34.
(1) A
						pharmacy located outside of this state that applies for licensure in this state
						as a pharmacy that will not ship compounded sterile pharmaceutical products
						into this state shall submit to the department a copy of its most recent
						resident state board of pharmacy inspection or an NABP-VPP inspection that was
						performed within the last 2 years before the date of application.
(2) Unless accredited by a national
						accrediting organization, recognized by the board, an applicant for renewal of
						an in-state pharmacy license, or an applicant for an initial or renewal of an
						out-of-state pharmacy license, that will provide sterile compounded
						pharmaceuticals in this state shall have an inspection and submit the
						inspection report to the department, completed no more than 18 months before
						the date of application, that demonstrates compliance with all applicable
						standards that are adopted by reference in
						R 338.533. The inspection must be
						conducted by 1 of the following:
(a) The
						department.
(b) The
						NABP-VPP.
(c) An accrediting
						organization according to
						R 338.532.
(d) A state licensing agency of the state in
						which the applicant is a resident and in accordance with the NABP's multistate
						pharmacy inspection blueprint program.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.534a - In-state initial pharmacy license inspections

Current through Vol. 24-12, July 15, 2024
Rule 34a.
(1)
						An in-state pharmacy that will not compound sterile pharmaceutical products
						that is applying for initial licensure shall be inspected by the department or
						its designee before licensure.
(2)
						An applicant for an in-state pharmacy license that intends to compound sterile
						pharmaceutical products shall complete both of the following:
(a) Obtain an inspection from the department
						or its designee for the purpose of meeting
						R 338.536 and
						R 338.537 for initial
						licensure.
(b) Within 6 months
						after initial licensure under this subrule, a pharmacy shall obtain, and
						provide to the department, a subsequent inspection to assess USP compliance or
						achieve accreditation from 1 of the entities listed in
						R 338.534(2)(a) to
						(c).
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.535 - Discontinuing, starting, or resuming sterile compounding services; requirements to resume sterile compounding services

Current through Vol. 24-12, July 15, 2024
Rule 35.
(1) A
						sterile compounding pharmacy or outsourcing facility that ceases to provide
						sterile compounding services in this state shall notify the department within
						30 days after ceasing to provide sterile compounding services.
(2) A pharmacy shall apply for approval to
						start or resume sterile compounding services by submitting to the department an
						application on a form provided by the department together with the requisite
						fee.
(3) A pharmacy shall not start
						or resume sterile compounding services in this state until the pharmacy submits
						to the department an inspection report, as required in
						R 338.534(2), is
						approved by the department, and is accredited, or an organization satisfying
						the requirements of R
						338.532(1) verifies that the pharmacy
						is USP compliant.
(4) An
						outsourcing facility shall not start or resume providing sterile compounding
						services in this state until the outsourcing facility is approved by the
						department, and the department verifies that it is compliant with the
						requirements of R 338.533(4) to
						(7).
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.536 - Housing of a pharmacy

Current through Vol. 24-12, July 15, 2024
Rule 36.
(1)
						All professional and technical equipment and supplies and prescription drugs
						must be housed in a suitable, well-lighted, and well-ventilated room or
						department with clean and sanitary surroundings.
(2) All pharmacies shall have a prescription
						department that is devoted primarily to the practice of pharmacy that occupies
						not less than 150 square feet of space, and that includes a prescription
						counter that provides not less than 10 square feet of free working surface. For
						each additional pharmacist on duty at any 1 time, the free working space must
						be increased by not less than 4 square feet. The prescription counter must be
						orderly and clean. The space behind the prescription counter must be sufficient
						to allow free movement within the area and must be free of obstacles.
(3) Except as allowed in
						R 338.588a(2),
						pharmacies that occupy less than the entire area of the premises owned, leased,
						used, or controlled by the licensee shall be permanently enclosed by partitions
						from the floor to the ceiling. All partitions must be of substantial
						construction and must be securely lockable so that drugs and devices that can
						be sold only by a pharmacist are unobtainable during the absence of the
						pharmacist. Only the area of the premises owned, leased, used, or controlled by
						the licensee may be identified by the terms "drugstore," "apothecary," or
						"pharmacy," or by use of a similar term or combination of terms as listed in
						section 17711(2) of the code, MCL
						333.17711. A pharmacy department
						must be locked when the pharmacist is not on the premises.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.537 - Professional and technical equipment and supplies

Current through Vol. 24-12, July 15, 2024
Rule 37.
(1) A
						pharmacy shall be equipped with both of the following:
(a) The necessary facilities, apparatus,
						utensils, and equipment to allow the pharmacy to provide prompt and efficient
						services.
(b) Current print,
						electronic, or unabridged computerized versions of the pharmacy laws and rules
						of this state, and not less than 2 current pharmacy reference texts that
						pertain to pharmacology, drug interactions, or drug composition, or other
						information necessary for the delivery of safe and effective practice of
						pharmacy.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.538 - Closing pharmacy

Current through Vol. 24-12, July 15, 2024
Rule 38.
(1) A
						pharmacy that is ceasing operations shall provide the department with written
						notification of all of the following not less than 15 days before closing:
(a) The effective date of closing.
(b) How controlled substances will be
						disposed.
(c) How non-controlled
						substances will be disposed.
(d)
						The location where records and prescription files will be stored.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.539 - Relicensure and renewal

Current through Vol. 24-12, July 15, 2024
Rule 39.
(1)
						An applicant with an expired license may apply for relicensure of a pharmacy
						license by submitting to the department a completed application on a form
						provided by the department, satisfying all the requirements for licensure in
						part 3 of these rules, R 338.531 to R 338.539, and paying the requisite
						fee.
(2) A pharmacy that renews its
						license during the license renewal period submit to the department a completed
						application, on a form provided by the department, together with the requisite
						fee.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 4 - MANUFACTURER LICENSE › Section R. 338.553 - Persons to whom prescription drugs or devices may be sold

Current through Vol. 24-12, July 15, 2024
Rule 53. A manufacturer may only supply, distribute,
						  sell, barter, or otherwise transfer prescription drugs or devices to persons
						  who are licensed by the board to distribute, prescribe, or dispense
						  prescription drugs or devices in or outside this state.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 4 - MANUFACTURER LICENSE › Section R. 338.555 - Federal regulation on good manufacturing practice for finished pharmaceuticals; adoption by reference; compliance

Current through Vol. 24-12, July 15, 2024
Rule 55.
(1)
						The board approves and adopts by reference the current and as amended good
						manufacturing practice for finished pharmaceuticals regulations set forth in
						21 CFR
						211.1 to
						211.208 (2022).
(2) A manufacturer shall comply with the
						standards adopted in subrule (1) of this rule.
(3) The standards adopted by reference in
						subrule (1) of this rule are available at no cost at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=211
,
						  or at 10 cents per page from the Board of Pharmacy, Bureau of Professional
						  Licensing, Michigan Department of Licensing and Regulatory Affairs, Ottawa
						  Building, 611 West Ottawa, P.O. Box 30670, Lansing, Michigan
						  48909.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 4 - MANUFACTURER LICENSE › Section R. 338.557 - Closing of a manufacturer

Current through Vol. 24-12, July 15, 2024
Rule 57.
(1) A
						manufacturer that is ceasing operations shall return the manufacturer license
						and the controlled substance license, if applicable, to the department, and
						provide the department with written notification of all of the following not
						less than 15 days before closing:
(a) The
						effective date of closing.
(b) How
						controlled substances will be disposed.
(c) How non-controlled substances will be
						disposed.
(d) The location where
						records and prescription files will be stored.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 4 - MANUFACTURER LICENSE › Section R. 338.559 - Relicensure and renewal

Current through Vol. 24-12, July 15, 2024
Rule 59.
(1)
						An applicant with an expired license may apply for relicensure of a
						manufacturer license by submitting to the department a completed application on
						a form provided by the department, satisfying all the requirements for
						licensure in part 4 of these rules,
						R 338.551 to
						R 338.559, and paying the requisite
						fee.
(2) A manufacturer that renews
						its license during the license renewal period shall submit to the department a
						completed application on a form provided by the department together with the
						requisite fee.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.561 - Pharmacy as wholesale distributor; licensure

Current through Vol. 24-12, July 15, 2024
Rule 61. A pharmacy shall obtain a license as a
						  wholesale distributor under this part if the total number of dosage units of
						  all prescription drugs distributed by the pharmacy to a person during any
						  consecutive 12-month period is more than 5% of the total number of dosage units
						  of prescription drugs distributed and dispensed by the pharmacy during the same
						  12-month period. The calculation of this 5% threshold must not include a
						  distribution of a prescription drug that is exempt from the definition of
						  wholesale distribution under
						  21
						  USC
						  353(e)(4).
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.565 - Persons to whom prescription drugs and devices may be sold

Current through Vol. 24-12, July 15, 2024
Rule 65 A wholesale distributor of prescription drugs
						  or devices may supply, distribute, sell, barter, or otherwise transfer
						  prescription drugs or devices only to persons who are licensed by the board to
						  distribute, prescribe, or dispense prescriptions drugs or devices in or outside
						  this state.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.567 - Wholesale distributor practices; control of prescription drugs or devices; inspections

Current through Vol. 24-12, July 15, 2024
Rule 67.
(1) A
						wholesale distributor that does not physically touch prescription drugs or
						devices shall file an affidavit with the department signed by the PIC or
						facility manager attesting to this fact.
(2) A wholesale distributor that previously
						filed an affidavit under subrule (1) of this rule shall not obtain custody and
						control of drugs or devices until both of the following have occurred:
(a) The licensee provides written
						notification to the department of physical custody.
(b) The department conducts an inspection of
						the premises.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.569 - Wholesale distributor and wholesale distributor-broker recordkeeping and policy requirements

Current through Vol. 24-12, July 15, 2024
Rule 69.
(1) A
						wholesale distributor shall establish and maintain inventories and records of
						transactions regarding the receipt, if applicable, and the distribution or
						other disposition of prescription drugs or devices. These records must include
						all of the following information:
(a) The
						source of the prescription drugs or devices, including the name and principal
						address of the seller or transferor and the address from which the prescription
						drugs or devices were shipped.
(b)
						The identity and quantity of the prescription drugs or devices received, if
						applicable, and distributed or disposed of.
(c) The dates of receipt, if applicable, and
						distribution of the prescription drugs or devices.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.571 - Facility requirements

Current through Vol. 24-12, July 15, 2024
Rule 71.
(1) A
						wholesale distributor that has physical custody or control of the prescription
						drugs or devices shall satisfy all of the following facility requirements:
(a) Be of suitable size and construction to
						facilitate cleaning, maintenance, and proper operations.
(b) Have storage areas that are designed to
						provide adequate lighting, ventilation, temperature, sanitation, humidity,
						space, equipment, and security conditions.
(c) Have a quarantine area for the storage of
						prescription drugs or devices that are outdated, damaged, deteriorated,
						misbranded, adulterated, or that are in immediate or sealed secondary
						containers that are opened.
(d) Be
						maintained in a clean and orderly condition.
(e) Be free from infestation by insects,
						rodents, birds, or vermin of any kind.
(f) Be secure from unauthorized entry by
						complying with all of the following:
(i)
						Access from outside the premises must be kept to a minimum and be
						well-controlled. The outside perimeter of the premises must be well-lighted.
						Entry into areas where prescription drugs or devices are held must be limited
						to authorized personnel.
(ii) Be
						equipped with an alarm system to detect entry after hours.
(iii) Be equipped with a security system that
						provides protection against theft and diversion. If appropriate, the security
						system must provide protection against theft or diversion that is facilitated
						or hidden by tampering with computers or electronic records.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.573 - Examination of materials; returned, damaged and outdated prescription drugs or devices

Current through Vol. 24-12, July 15, 2024
Rule 73.
(1) A
						wholesale distributor shall comply with both of the following provisions that
						pertain to the examination of materials:
(a)
						Each outside shipping container must be visually examined upon receipt for the
						identity of the prescription drug or devices and to prevent the acceptance of
						contaminated prescription drugs or devices or prescription drugs or devices
						otherwise unfit for distribution. The examination must be adequate to reveal
						container damage that would suggest possible contamination or other damage to
						the contents.
(b) Each outgoing
						shipment must be visually inspected for identity of the prescription drug
						products and to ensure that prescription drugs or devices that have been
						damaged in storage or held under conditions that are inconsistent with USP
						compendium standards are not delivered.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.575 - Closing a wholesale distributor or wholesale distributor-broker

Current through Vol. 24-12, July 15, 2024
Rule 75.
(1) A
						wholesale distributor that is ceasing operations shall return the wholesale
						distributor license and controlled substance license, if applicable, to the
						department, and provide the department with written notification of all of the
						following not less than 15 days before closing:
(a) The effective date of closing.
(b) How controlled substances will be
						disposed.
(c) How non-controlled
						substances will be disposed.
(d)
						The location where records and prescription files will be stored.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.577 - Relicensure and renewal of wholesale distributor and wholesale distributor-broker

Current through Vol. 24-12, July 15, 2024
Rule 77.
(1)
						An applicant with an expired license may apply for relicensure of a license by
						submitting to the department a completed application on a form provided by the
						department, satisfying all the requirements for licensure in part 5 of these
						rules, R 338.563 to
						R 338.577, and paying the requisite
						fee.
(2) An applicant that renews
						its license during the license renewal period shall submit to the department a
						completed application on a form provided by the department together with the
						requisite fee.
(3) A wholesale
						distributor-broker seeking renewal shall submit an affidavit, at the time of
						the application for renewal that the applicant facilitates deliveries or trades
						for not less than 50 qualified pharmacies and that each pharmacy holds a
						license in good standing as a pharmacy from the state in which it is located at
						the time of renewal.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.582 - Prescription drug labeling and dispensing

Current through Vol. 24-12, July 15, 2024
Rule 82.
(1)
						All labeling of prescription drugs must comply with the requirements of the
						code and sections 351 to 399f of the Federal Food, Drug, and Cosmetic Act,
						21 USC
						351 to
						399f.
(2) All containers in which prescription
						medication is dispensed must bear a label that contains, at a minimum, all of
						the following information:
(a) Pharmacy name
						and address.
(b) Prescription
						number.
(c) Patient's
						name.
(d) Date the prescription was
						dispensed.
(e) Prescriber's
						name.
(f) Directions for
						use.
(g) The name of the medication
						and the strength, unless the prescriber indicates "do not label."
(h) The quantity dispensed, if
						applicable.
(i) The name of the
						manufacturer or supplier of the drug if the drug has no brand name, unless the
						prescriber indicates "do not label."
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.583 - Prescription drug receipts

Current through Vol. 24-12, July 15, 2024
Rule 83.
(1)
						The purchaser of a prescription drug shall receive, when the drug is delivered
						to the purchaser, a receipt that contains all of the following information:
(a) The brand name of the drug dispensed, if
						applicable, unless the prescriber indicates "do not label."
(b) The name of the manufacturer or supplier
						of the drug if the drug has no brand name, unless the prescriber indicates "do
						not label."
(c) The strength of the
						drug, if significant, unless the prescribed indicates "do not label."
(d) The quantity dispensed, if
						applicable.
(e) The name and
						address of the pharmacy.
(f) The
						serial number of the prescription.
(g) The date the prescription was
						dispensed.
(h) The name of the
						prescriber.
(i) The name of the
						patient for whom the drug was prescribed.
(j) The price for which the drug was sold to
						the purchaser.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.583a - Pharmacy acquisition and distribution records

Current through Vol. 24-12, July 15, 2024
Rule 83a.
(1)
						A pharmacy shall keep and make available for inspection all acquisition and
						distribution records for prescription drugs and devices, including invoices,
						packing slips or receipts, for 5 years. All records, which may be electronic,
						must be readily retrievable within 48 hours.
(2) Acquisition and distribution records must
						include the following information:
(a) The
						source of the prescription drugs or devices, including the name and principal
						address of the seller or transferor and the address from which the prescription
						drugs or devices were shipped.
(b)
						The identity and quantity of the prescription drugs or devices received, if
						applicable, and distributed or disposed of.
(c) The dates of receipt, if applicable, and
						distribution of the prescription drugs or devices.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.584 - Non-controlled prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 84.
(1) A
						prescriber who issues a prescription for a non-controlled prescription drug
						shall date the prescription; provide a manual signature on the prescription;
						and ensure that the prescription contains all of the following information:
(a) The full name of the patient for whom the
						drug is being prescribed.
(b) The
						prescriber's preprinted, stamped, typed, or manually printed name and
						address.
(c) The drug name and
						strength, and dosage form if necessary.
(d) The quantity prescribed.
(e) The directions for use.
(f) The number of refills
						authorized.
(g) The date the
						prescription was issued.
(h) If the
						prescription is for an animal, the species of the animal and the full name of
						the owner.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.584a - Electronic transmission of prescription; waiver of electronic transmission

Current through Vol. 24-12, July 15, 2024
Rule 84a.
(1)
						Until the enforcement date established by the federal Centers for Medicare and
						Medicaid Services for the Medicare electronic transmission requirement a
						prescription may be electronically transmitted, and a pharmacist may dispense
						the electronically transmitted prescription, if all of the following conditions
						are satisfied:
(a) The prescription is
						transmitted to the pharmacy of the patient's choice and occurs only at the
						option of the patient.
(b) The
						electronically transmitted prescription includes all of the following
						information:
(i) The name and address of the
						prescriber.
(ii) An electronic
						signature or other board-approved means of ensuring prescription
						validity.
(iii) The prescriber's
						telephone number for verbal confirmation of the order.
(iv) The time and date of the electronic
						transmission.
(v) The name of the
						pharmacy intended to receive the electronic transmission.
(vi) Unless as otherwise authorized under
						section 17754(1)(b) of the code, MCL 333.17754, the full name of the patient
						for whom the prescription is issued.
(vii) All other information that must be
						contained in a prescription under R 338.584.
(c) The pharmacist exercises professional
						judgment regarding the accuracy, validity, and authenticity of the transmitted
						prescription.
(d) All requirements
						in section 17754 of the code, MCL 333.17754, are met.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.585 - Customized patient medication package

Current through Vol. 24-12, July 15, 2024
Rule 85.
(1) A
						pharmacist may, with the consent of the patient, the patient's caregiver, or a
						prescriber, provide a CPMP. The CPMP is designed and labeled to indicate the
						day and time or period of time that the contents within each CPMP are to be
						taken. The individual that dispenses the medication shall instruct the patient
						or caregiver on the use of the CPMP.
(2) If medication is dispensed in a CPMP, all
						of the following conditions must be met:
(a)
						Each CPMP must bear a readable label that states all of the following
						information:
(i) A serial number for the CPMP
						and a separate identifying serial number for each of the prescription orders
						for each of the drug products contained in the CPMP.
(ii) The name, strength, physical
						description, and total quantity of each drug product contained in the
						CPMP.
(iii) The name of the
						prescriber for each drug product.
(iv) The directions for use and cautionary
						statements, if any, contained in the prescription order for each drug product
						in the CPMP.
(v) The date of the
						preparation of the CPMP.
(vi) An
						expiration date for the CPMP. The date must not be later than the earliest
						manufacturer's expiration date for any medication included in the CPMP or 60
						days after the date of dispensing.
(vii) The name, address, and telephone number
						of the dispenser.
(viii) Any other
						information, statements, or warnings required for any of the drug products
						contained in the CPMP.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.586 - Prescription records; nonapplicability to inpatient medical institution service

Current through Vol. 24-12, July 15, 2024
Rule 86.
(1)
						Each prescription must be chronologically numbered, and the pharmacist
						performing final verification before dispensing shall record, manually or
						electronically, the prescription number, dispensing date, and the pharmacist's
						initials when the prescription is first filled at the pharmacy.
(2) If final product verification is
						completed by a pharmacy intern under the supervision of a pharmacist, both the
						initials of the pharmacy intern and the delegating pharmacist must be
						recorded.
(3) If final product
						verification is completed by a pharmacy technician, under
						R 338.3665(b), both
						the initials of the pharmacy technician and delegating pharmacist must be
						recorded.
(4) If the drug that is
						dispensed is other than the brand prescribed or if the prescription is written
						generically, the name of the manufacturer or supplier of the drug dispensed
						must be indicated on the prescription.
(5) This rule does not apply to pharmacy
						services provided in a medical institution.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.587 - Prescription refill records; manual systems; profile systems; automated pharmacy data systems; nonapplicability to medical institution service; record confidentiality; and access

Current through Vol. 24-12, July 15, 2024
Rule 87.
(1) A
						pharmacist shall record prescription refills using only 1 of the systems
						described in subrule (2), (3), or (4) of this rule and in compliance with the
						provisions of subrule (2), (3), or (4) of this rule, as applicable.
(2) A pharmacy may utilize a manual system of
						recording refills if the system complies with both of the following criteria:
(a) The amount and date dispensed must be
						entered on the prescription in an orderly fashion and the dispensing pharmacist
						initials the entry. If the pharmacist only initials and dates the prescription,
						then the full-face amount of the prescription must be considered
						dispensed.
(b) If the drug that is
						dispensed is other than the brand prescribed or if the prescription is written
						generically, then the name of the manufacturer or supplier of the drug
						dispensed must be indicated on the prescription.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.588 - Automated devices

Current through Vol. 24-12, July 15, 2024
Rule 88.
(1)
						"Automated device" means a mechanical system that performs an operation or
						activity, other than compounding or administration, relating to the storage,
						packaging, dispensing, or delivery of a drug and that collects, controls, and
						maintains transaction information.
(2) An automated device may be used only in
						the following locations:
(a) A pharmacy, or at
						the same physical address as the pharmacy if the location of the automated
						device is owned and operated by the same legal entity as the
						pharmacy.
(b) A hospital.
(c) A county medical care facility.
(d) A hospice.
(e) A nursing home.
(f) Other skilled nursing facility, as that
						term is defined in section 20109 of the code, MCL
						333.20109.
(g) An office of a dispensing prescriber,
						where the device is operated by the dispensing prescriber, not a
						pharmacy.
(h) A location affiliated
						with a hospital, but not at the same physical address as the pharmacy, which is
						owned and operated by the hospital, consistent with section 17760 of the code,
						MCL 333.17760.
(i) A location other than subdivisions (a) to
						(h) of this subrule, where the automated device acts as an extension of a
						pharmacy. In addition to the requirements in this rule, the automated device
						must meet the requirements in
						R 338.588a.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.588a - Automated devices in non-inpatient settings

Current through Vol. 24-12, July 15, 2024
Rule 88a.
(1)
						A pharmacy that operates an automated device to deliver prescription medication
						directly to an ultimate user that is not included in
						R 338.588(2)(a) to
						(h) shall comply with all of the following
						requirements:
(a) The automated device may
						only deliver non-controlled drugs.
(b) The automated device is operated as an
						extension of a pharmacy, under the control of a pharmacist.
(c) The automated device is secured,
						lockable, and privacy enabled.
(d)
						Prescriptions must contain a label that identifies the automated device where
						the medication was dispensed.
(e)
						In order for the automated device to be operable, a pharmacist shall be
						available to provide patient consultation through real-time audio and visual
						communication. The pharmacist may provide consultation from a remote
						location.
(f) Before the automated
						device is put into service, the pharmacy shall notify the department of the
						location of the automated device on a form provided by the
						department.
(g) Dispensing
						activities through the automated device must comply with all recordkeeping,
						drug utilization review, and patient counseling requirements that are
						applicable to a pharmacy.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.588b - Automated devices in medical institutions

Current through Vol. 24-12, July 15, 2024
Rule 88b.
(1)
						An automated device used by staff to store medications intended for patient
						administration in any hospital, county medical care facility, nursing home,
						hospice, or another skilled nursing facility, as that term is defined in
						section 20109 of the code, MCL
						333.20109, must comply with all
						of the following:
(a) The automated device
						must be stocked, maintained, and controlled by a pharmacy that is licensed in
						this state.
(b) If the stocking of
						the automated device is performed by non-pharmacist personnel, then
						technologies must be in place and utilized to ensure that the correct drugs are
						stocked in their appropriate assignment utilizing bar-coding or another
						board-approved error-prevention technology that complies with
						R 338.3154.
(c) A pharmacy operating an automated device
						is responsible for all medications that are stocked and stored in that device,
						as well as removed from that device.
(d) If any medication or device is dispensed
						from an automated device, then documentation as to the type of equipment,
						serial numbers, content, policies, procedures, and location within the facility
						must be maintained by the pharmacy for review by an agent of the board. The
						documentation must include all of the following information:
(i) Name and address of the pharmacy
						responsible for the operation of the automated device.
(ii) Name and address of the facility where
						the automated device is located.
(iii) Manufacturer name and model
						number.
(iv) Quality assurance
						policy and procedure to determine continued appropriate use and performance of
						the automated device.
(v) Policy
						and procedures for system operation that address, at a minimum, all of the
						following:
(A) Accuracy.
(B) Patient confidentiality.
(C) Access.
(D) Data retention or archival
						records.
(E) Downtime
						procedures.
(F) Emergency
						procedures.
(G) Medication
						security.
(H) Quality
						assurance.
(I) Ability to provide
						on demand to an agent of the board a list of medications qualifying for
						emergency dose removal without pharmacist prior review of the prescription or
						medication order.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.589 - Professional responsibility; patient counseling; "caregiver" defined

Current through Vol. 24-12, July 15, 2024
Rule 89.
(1) A
						pharmacist has a professional responsibility for the strength, quality, purity,
						and the labeling of all drugs and devices dispensed under a prescription. In
						discharging this responsibility, a pharmacist shall utilize only those drugs
						and devices that are obtained from manufacturers and wholesale distributors
						licensed under section 17748 of the code, MCL
						333.17748, or from other lawful
						channels of distribution.
(2) A
						pharmacist shall not fill a prescription order if, in the pharmacist's
						professional judgment, any of the following provisions apply:
(a) The prescription appears to be improperly
						written.
(b) The prescription is
						susceptible to more than 1 interpretation.
(c) The pharmacist has reason to believe that
						the prescription could cause harm to the patient.
(d) The pharmacist has reason to believe that
						the prescription may be used for other than legitimate medical
						purposes.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.590 - Hospice emergency drug box

Current through Vol. 24-12, July 15, 2024
Rule 90.
(1) A
						pharmacy that establishes a medication box exchange program for hospice
						emergency care services rendered in patients' homes under section 17746 of the
						code, MCL
						333.17746, shall establish drug
						boxes that comply with this rule. Before providing drug boxes for a hospice
						emergency care system, the pharmacist in charge shall ensure that the hospice
						has developed policies and procedures that require all of the following:
(a) Maintenance by the hospice of a drug box
						exchange log that accounts for the hospice's receipt of the boxes from the
						pharmacy, assignment of the boxes to registered nurses or physicians'
						assistants, and return of the boxes to the pharmacy for restocking.
(b) A procedure to ensure that the drug boxes
						are inspected not less than weekly to determine if they have expired or have
						been opened.
(c) Procedures for the
						storage and control of a drug box while it is assigned to, and being used by,
						the prescriber, a registered nurse, or a physician's assistant.
(d) A procedure for implementing the hospice
						medical director's responsibility for ensuring that prescriptions for drugs
						removed from the drug boxes are obtained from an appropriate
						prescriber.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 6 - PRACTICE OF PHARMACY › Section R. 338.591 - Dispensing emergency supply of insulin

Current through Vol. 24-12, July 15, 2024
Rule 91.
(1) A
						pharmacist may dispense an emergency supply of insulin to an individual if the
						pharmacist complies with all of the following:
(a) The requirements in section 17744f of the
						code, MCL
						333.17744f.
(b) An emergency supply of insulin may only
						be dispensed from a pharmacy with real time access to the qualified
						prescription for insulin.
(c) Only
						1 emergency supply, as that term is defined in MCL
						333.17744f, per patient, may be
						dispensed for each of 3 qualified prescriptions per year.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Radiopharmaceuticals - Rescinded

Current through Vol. 24-12, July 15, 2024
DEPARTMENT OF LICENSING AND REGULATORY
				  AFFAIRS
DIRECTOR'S OFFICE
BOARD OF PHARMACY
RADIOPHARMACEUTICALS
By authority conferred on the director of the department of
					 licensing and regulatory affairs by sections 16145 and 17722 of 1978 PA 368,
					 MCL 333.16145 and 333.17722 and Executive Reorganization Order Nos. 1996-1,
					 1996-2, 2003-1, and 2011-4, being MCL 330.3101, 445.2001, 445.2011 and
					 445.2030
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Public Participation at Open Board Meetings - Rescinded

Current through Vol. 24-12, July 15, 2024
DEPARTMENT OF LICENSING AND REGULATORY
				  AFFAIRS
DIRECTOR'S OFFICE
BOARD OF PHARMACY
PUBLIC PARTICIPATION AT OPEN BOARD
				  MEETINGS
By authority conferred on the director of the department of
					 licensing and regulatory affairs by section 263 of 1976 PA 306, MCL15.263 and
					 16145 of 1978 PA 368, MCL 333.16145 and Executive Reorganization Order Nos.
					 1996-1, 1996-2, 2003-1 and 2011-4, being MCL 333.3101, 445.2001, 445.2011, and
					 445.2030.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Continuing Education › Section R. 338.3041 - Definitions

Current through Vol. 24-12, July 15, 2024
Rule 1.
(1) As used
				  in these rules:
(a) "Board" means the Michigan
				  board of pharmacy, created in section
				  17721 of the code, MCL
				  333.17721.
(b) "Code" means the public health code, 1978
				  PA 368, MCL
				  333.1101 to
				  333.25211.
(c) "Department" means the department of
				  licensing and regulatory affairs.