reglab/statecodes huggingface dataset:
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Continuing Education › Section R. 338.3042 - License renewals; continuing education requirements; applicability

Current through Vol. 24-12, July 15, 2024
Rule 2.
(1) These
				  rules apply to applications for renewal of a pharmacist's license and a special
				  retired volunteer pharmacist's license under sections
				  16201 and
				  16184 of the code, MCL
				  333.16201 and
				  333.16184. A licensee seeking
				  renewal shall comply with all of the following:
(a) Submit a completed application on a form
				  provided by the department, together with the requisite fee.
(b) Beginning with renewals on January 1,
				  2020, an applicant for license renewal shall have completed a 1-time training
				  identifying victims of human trafficking as required in
				  R 338.511 and section
				  16148 of the code, MCL
				  333.16148.
(c) An applicant for license renewal, who
				  also applies for a controlled substance license, shall have completed a 1-time
				  training in opioids and other controlled substances awareness as required in
				  R 338.3135.
(d) The continuing education requirements
				  apply to an applicant for license renewal, who has been licensed for the 2-year
				  period immediately preceding the end of the license cycle.
(e) An applicant for license renewal shall
				  furnish the board with satisfactory evidence that the applicant completed not
				  less than 30 hours of continuing education approved by the board, under
				  R 338.3043 and
				  R 338.3044, during the license cycle
				  before the application for renewal. Continuing education that is earned during
				  the 60-day grace period may be included up to the date the application for
				  renewal is filed. An applicant for license renewal shall complete all of the
				  following continuing education requirements:
(i) At least 1 hour of the 30 required hours
				  of continuing education in pharmacy ethics and pharmacy law, which may be
				  completed in 1 or more courses.
(ii) At least 10 hours of the 30 required
				  hours of continuing education must be live, synchronous, courses or programs,
				  in-person or virtual, that provide for the opportunity of direct interaction
				  between faculty and participants, including but not limited to, lectures,
				  symposia, live teleconferences, and workshops. Accreditation Council for
				  Pharmacy Education (ACPE) courses designated as live meet this
				  requirement.
(iii) At least 1 hour
				  of the 30 required hours of continuing education in pain and symptom
				  management, as required under section
				  16204(2) of
				  the code, MCL
				  333.16204. Continuing education
				  in pain and symptom management includes, but is not limited to, courses in
				  behavior management, psychology of pain, pharmacology, behavior modification,
				  stress management, clinical applications, and drug interventions as they relate
				  to professional practice.
(iv) Not
				  more than 12 hours of continuing education during a 24-hour period.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Continuing Education › Section R. 338.3043 - Continuing education courses and programs; standards for approval

Current through Vol. 24-12, July 15, 2024
Rule 3. The board shall approve continuing education
					 courses or programs pursuant to the following standards in this rule:
(a) A continuing education course or program
				  sponsor shall submit a completed application on forms provided by the
				  department and provide a "Patient Protection" form for any course or program
				  that involves treatment of live patients.
(b) A completed application form shall be
				  submitted to the department at least 70 days before the date the continuing
				  education course or program is conducted for the proposed continuing education
				  to be considered for approval by the board.
(c) A continuing education course or program
				  must meet the standards and criteria for an acceptable category of continuing
				  education under this rule and
				  R 338.3044 and must be relevant to
				  health care services, pharmacy operations, or advancement of the licensee's
				  pharmacy education.
(d) A
				  continuing education course or program shall be developed and presented by a
				  sponsor and must provide all of the following:
(i) Availability of adequate records of
				  participation.
(ii) Qualified
				  teaching staff.
(iii) A statement
				  of educational objectives.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 1 - GENERAL PROVISIONS › Section R. 338.3051 - 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) "Central fill pharmacy" means a pharmacy
					 that engages in dispensing functions of centralized prescription processing at
					 the request of an originating pharmacy.
(c) "Code" means the public health code, 1978
					 PA 368, MCL
					 333.1101 to
					 333.25211.
(d) "Deliver," as used in this part, means
					 the actual, constructive, or attempted transfer of a prescription drug,
					 including a controlled substance, directly to a patient or a patient's agent by
					 the lawful order of a practitioner. Deliver does not include a central fill
					 pharmacy that provides a prescription product to another pharmacy for
					 subsequent issuance to a patient or a patient's agent.
(e) "Delivering pharmacist" means a
					 pharmacist who is responsible for delivering a prescription directly to a
					 patient or a patient's agent.
(f)
					 "Delivering pharmacy" means the pharmacy that delivers the filled or refilled
					 prescription to the patient or the patient's agent. The delivering pharmacy
					 must be either the originating pharmacy or the central fill pharmacy.
(g) "Department" means the department of
					 licensing and regulatory affairs (LARA).
(h) "Originating pharmacy" means a pharmacy
					 that initially receives a patient's or a prescribing practitioner's request to
					 fill or refill a prescription.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 1 - GENERAL PROVISIONS › Section R. 338.3052 - Central fill and shared pharmacy services rules; prevail over other pharmacy rules

Current through Vol. 24-12, July 15, 2024
Rule 2.
(1) In
					 addition to these rules, pharmacies must follow all applicable board rules.
					 However, to the extent that these rules conflict with other board rules, the
					 provisions in these rules must prevail.
(2) Shared pharmacy services for processing
					 functions of centralized pharmacy processing that do not involve the dispensing
					 process, such as completing claims adjudication or remote data entry, may be
					 performed under the general supervision of a pharmacist. For this subrule,
					 dispensing process means the physical preparing, compounding, packaging, or
					 labeling of a drug product intended for delivery to the patient.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 1 - GENERAL PROVISIONS › Section R. 338.3053 - Centralized prescription processing; dispensing requirements

Current through Vol. 24-12, July 15, 2024
Rule 3.
(1) In
					 addition to complying with the requirements of section
					 17753 of the code, MCL
					 333.17753, a pharmacy must meet
					 all of the following requirements before it either performs centralized
					 prescription processing or outsources centralized prescription processing to
					 another pharmacy:
(a) Hold a pharmacy license
					 in this state.
(b) Share sufficient
					 patient and drug information to minimize the possibility of an adverse drug
					 event.
(c) Maintain records
					 required in R 338.3054, for 5 years from the
					 date of dispensing. The pharmacy shall ensure that the records are readily
					 retrievable within 48 hours after the department makes a request for the
					 records. If the records are maintained in a digital format, a printed copy must
					 be made available to the department or other authorized individual upon
					 request.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 1 - GENERAL PROVISIONS › Section R. 338.3054 - Records maintenance; requirements for central fill pharmacies

Current through Vol. 24-12, July 15, 2024
Rule 4.
(1) An
					 originating pharmacy shall maintain records that indicate all of the following:
(a) The date the request for centralized
					 prescription processing was transmitted to a central fill pharmacy.
(b) The method of transmittal.
(c) The identification of the pharmacist
					 responsible for the transmission.
(d) The name and address of the central fill
					 pharmacy where the request for centralized prescription processing was
					 transmitted.
(e) The date the
					 delivering pharmacy received the filled prescription from the central fill
					 pharmacy.
(f) The name of the
					 pharmacy employee who accepted the transfer of a filled prescription from a
					 central fill pharmacy.
(g) The
					 identification of the pharmacist who was responsible for delivering the
					 prescription to the patient or the patient's agent.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 2 - CONTROLLED SUBSTANCES PRESCRIPTIONS › Section R. 338.3055 - Schedule 2, 3, 4, or 5 controlled substances prescriptions; requirements for central fill pharmacies

Current through Vol. 24-12, July 15, 2024
Rule 5.
(1) In
					 addition to complying with the requirements of part 1 of these rules, a
					 pharmacy that performs or contracts for centralized prescription processing
					 shall comply with this rule if processing a prescription for a schedule 2, 3,
					 4, or 5 controlled substance.
(2)
					 Prescriptions for controlled substances may be transmitted electronically,
					 including by facsimile, from an originating pharmacy to a central fill
					 pharmacy.
(3) An originating
					 pharmacy that transmits prescription information for a controlled substance to
					 a central fill pharmacy shall comply with all of the following:
(a) Ensure that the words "CENTRAL FILL" are
					 on the face of the original prescription and the originating pharmacy shall
					 record all of the following information:
(i)
					 The name, address, and the Federal Drug Enforcement Administration (DEA)
					 registration number of the central fill pharmacy where the prescription was
					 transmitted.
(ii) The name of the
					 pharmacist at the originating pharmacy who transmitted the
					 prescription.
(iii) The date of
					 transmittal.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Centralized Prescription Processing Pharmacies › Part 2 - CONTROLLED SUBSTANCES PRESCRIPTIONS › Section R. 338.3056 - Reporting to the electronic system for monitoring controlled substances

Current through Vol. 24-12, July 15, 2024
Rule 6. As used in this part, the pharmacy that uses its
						stock to fill a prescription for a controlled substance is the pharmacy
						responsible to report to the department or the department's contractor the
						information required in
						R 338.3162b for each controlled
						substance prescription.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 1 - GENERAL PROVISIONS › Section R. 338.3101 - Definitions; A to H

Current through Vol. 24-12, July 15, 2024
Rule 1. As used in these rules:
(a) "ASAP" means the American Society for
					 Automation in Pharmacy.
(b)
					 "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.
(c) "Board" means the board of
					 pharmacy.
(d) "CMS" means the
					 United States Centers for Medicare and Medicaid Services.
(e) "Code" means the public health code, 1978
					 PA 368, MCL
					 333.1101 to
					 333.25211.
(f) "CSA" means the controlled substances
					 act, Public Law 91-513.
(g) "DEA"
					 means the United States Drug Enforcement Administration.
(h) "Department" means the department of
					 licensing and regulatory affairs.
(i) "Electronic signature" means an
					 electronic sound, symbol, or process attached to or associated with a record
					 and executed or adopted by an individual with the intent to sign the record. An
					 electronic signature also is a unique identifier protected by appropriate
					 security measures that is only available for use by the intended individual and
					 ensures nonrepudiation so that the signature may not be rejected based on its
					 validity.
(j) "FDA" means the
					 United States Food and Drug Administration.
(k) "FDCA" means the Federal Food, Drug, and
					 Cosmetic Act, 21 USC
					 301 to
					 399g.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 1 - GENERAL PROVISIONS › Section R. 338.3102 - Definitions; I to P

Current through Vol. 24-12, July 15, 2024
Rule 2. As used in these rules:
(a) "Inventory" means all stocks in finished
					 form of a controlled substance that are manufactured or otherwise acquired by a
					 licensee, whether in bulk or commercial containers or contained in
					 pharmaceutical preparations in the possession of the licensee.
(b) "Licensee" means a person that is
					 licensed under section 7303 of the code, MCL
					 333.7303.
(c) "MAPS" means the Michigan automated
					 prescription system.
(d) MAPS claim
					 form" means a form determined by the department that is in the format and
					 includes the information as specified by the ASAP 5.0 Standard for Prescription
					 Drug Monitoring Programs and contains the information specified in R
					 338.3162b.
(e) "Medical
					 institution" means that term as defined in R 338.486.
(f) "NDC" means a national drug code number
					 that identifies the labeler, product, and package size and is assigned to each
					 drug product listed under section 510 of the FDCA,
					 21 USC
					 360.
(g) "Officer" means a federal, state, county,
					 or local law enforcement officer who enforces the laws of this state.
(h) "Patient identifier" means all of the
					 following information about a patient:
(i)
					 Full name.
(ii) Address, including
					 zip code.
(iii) Date of
					 birth.
(iv) One of the following
					 identification numbers:
(A) A state-issued
					 driver's license number obtained from a state-issued driver's
					 license.
(B) A state-issued
					 identification number obtained from a state-issued photo identification
					 card.
(C) A federal passport number
					 obtained from a federal passport.
(D) A tribal government identification number
					 obtained from a tribal government issued identification.
(E) The number zero. Zeroes must be entered
					 as the identification number, if the positive identification presented for the
					 patient or client does not include a license number, identification number, or
					 passport number as listed in subparagraphs (A) to (C) of this paragraph, the
					 patient is under the age of 16, or the animal's owner cannot be
					 identified.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 1 - GENERAL PROVISIONS › Section R. 338.3104 - Definitions; R, S

Current through Vol. 24-12, July 15, 2024
Rule 4. As used in these rules:
(a) "Readily retrievable" means a record that
					 is maintained and can be separated from all other records within 48 hours and
					 is a listed controlled substance that is marked with an asterisk, redlined, or
					 in some other manner visually identifiable apart from the other substances
					 listed in the record.
(b)
					 "Substance" means a controlled substance unless the context indicates
					 otherwise.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 1 - GENERAL PROVISIONS › Section R. 338.3108 - Terms defined in code

Current through Vol. 24-12, July 15, 2024
Rule 8. Unless otherwise defined in these rules, the
						terms defined in the code have the same meaning when used in these
						rules.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 2 - SCHEDULES › Section R. 338.3111 - Schedules; federal controlled substance schedules adopt by reference; exceptions

Current through Vol. 24-12, July 15, 2024
Rule 11.
(1) The
					 board approves and adopts by reference the complete list of drugs and other
					 substances that are considered controlled substances under the CSA, that have
					 been divided into 5 schedules as published in
					 21 CFR
					 1308.11 to
					 1308.15, except for the following:
(a) Drugs or other substances scheduled,
					 rescheduled, or descheduled by this state's laws enacted after January 6,
					 2022.
(b) Drugs listed in subrule
					 (3) of this rule, which are scheduled differently than scheduled in
					 21 CFR
					 1308.11 to
					 1308.15.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 3 - LICENSES › Section R. 338.3135 - Opioids and other controlled substances awareness training standards for prescribers and dispensers of controlled substances; requirements

Current through Vol. 24-12, July 15, 2024
Rule 35.
(1) An
					 individual who is applying for or renewing a controlled substance license shall
					 complete a training in opioids and controlled substances awareness before
					 applying for the license or renewal. The training must meet the following
					 standards:
(a) Training content must cover
					 both of the following topics:
(i) Utilizing
					 the MAPS.
(ii) State and federal
					 laws regarding prescribing and dispensing controlled substances.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 4 - SECURITY › Section R. 338.3141 - Thefts and diversions

Current through Vol. 24-12, July 15, 2024
Rule 41.
(1) An
					 applicant or licensee shall provide effective controls against theft and
					 diversion of controlled substances.
(2) A licensee shall confirm that a person is
					 licensed to possess a controlled substance before distributing the substance to
					 the person.
(3) Within 45 days
					 after completion of an investigation regarding a suspected theft or significant
					 loss of a controlled substance, a licensee shall notify the department of the
					 suspected theft or significant loss of a controlled substance and submit a copy
					 of the DEA theft and loss report form 106, or equivalent document, to the
					 department, whether or not the controlled substance is recovered or the
					 responsible individual is identified and action is taken against the
					 responsible individual, and whether or not it is also reported to the
					 DEA.
(4) A licensee shall use all
					 of the following criteria to determine if the loss in subrule (3) of this rule
					 is significant:
(a) The quantity of the
					 controlled substance lost in relation to the type of business.
(b) The specific controlled substance
					 lost.
(c) Whether the loss of the
					 controlled substance can be associated with access to the controlled substance
					 by specific individuals, or whether the loss can be attributed to unique
					 activities that may take place involving the controlled substance.
(d) A pattern of loss over a specific time
					 period, whether the loss appears to be random, and the results of efforts taken
					 to resolve the loss.
(e) Whether
					 the specific controlled substance is a likely candidate for
					 diversion.
(f) Local trends and
					 other indicators of the diversion potential of the missing controlled
					 substance.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 4 - SECURITY › Section R. 338.3143 - Storage of controlled substances

Current through Vol. 24-12, July 15, 2024
Rule 43.
(1) A
					 licensee shall store controlled substances that are listed in schedule 1 in a
					 securely locked, substantially constructed cabinet that is anchored to a wall
					 or the floor.
(2) A licensee shall
					 store controlled substances that are listed in schedules 2, 3, 4, and 5 in a
					 securely locked, substantially constructed cabinet, room, or cart. However, in
					 a pharmacy, the controlled substances may be dispersed throughout the stock of
					 noncontrolled substances in a manner to obstruct the theft or diversion of
					 controlled substances.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 4 - SECURITY › Section R. 338.3145 - Employees; disqualification

Current through Vol. 24-12, July 15, 2024
Rule 45.
(1) An
					 individual, partnership, cooperative, association, private corporation, other
					 legal entity, or governmental entity that is licensed by the department under
					 section 7303 or 17748 of the code, MCL
					 333.7303, or
					 333.17748, shall not employ or
					 utilize, with or without compensation, or allow the following individuals
					 access to controlled substances:
(a) An
					 individual who the licensee knows, or reasonably should know, has a substance
					 use disorder, as that term is defined in section 1100d of the mental health
					 code, 1974 PA 258, MCL
					 330.1100d. This subdivision does
					 not apply to a licensee enrolled in the health professional recovery program
					 under a current monitoring agreement.
(b) An individual whose controlled substance
					 license is suspended, revoked, or denied.
(c) An individual whose license issued by
					 this state or another state is under suspension or revoked for a violation that
					 involves controlled substances.
(d)
					 An individual who has been convicted of a crime that involves controlled
					 substances and is currently under sentence for that conviction.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 5 - RECORDS › Section R. 338.3151 - Inventories

Current through Vol. 24-12, July 15, 2024
Rule 51.
(1) An
					 individual, partnership, cooperative, association, private corporation, other
					 legal entity, or governmental entity licensed to manufacture, distribute,
					 prescribe, or dispense controlled substances shall annually perform and
					 maintain a complete and accurate inventory of all stocks of controlled
					 substances in the possession and control of the licensee.
(2) The inventory must contain a complete and
					 accurate record of all controlled substances in the possession or control of
					 the licensee on the date the inventory is taken as follows:
(a) If the substance is listed in schedule 1
					 or 2, the licensee shall make an exact count or measure of the
					 contents.
(b) If the substance is
					 listed in schedule 3, 4, or 5, the licensee shall estimate the count or measure
					 of the contents, but if the container holds more than 1,000 dosage units, the
					 licensee shall make an accurate account of the contents.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 5 - RECORDS › Section R. 338.3153 - Invoices, acquisition, dispensing, administration, and distribution records

Current through Vol. 24-12, July 15, 2024
Rule 53.
(1) For
					 2 years, a licensee shall maintain in the pharmacy for review by the
					 department, an agency, or the board, all records for controlled substances,
					 including invoices and acquisition records as follows:
(a) A licensee may keep acquisition records,
					 except for executed or voided DEA 222 order forms, in an electronic form at a
					 central location with notice to the department.
(b) A licensee shall maintain invoices and
					 other acquisition records of all controlled substances listed in schedules 1
					 and 2 in a separate file from invoices and other acquisition records of
					 controlled substances listed in schedules 3, 4, and 5. The information must be
					 readily retrievable from the ordinary acquisition records maintained by the
					 dispenser.
(c) A licensee shall
					 initial or electronically initial the invoice and indicate the date that the
					 controlled substances are received.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 5 - RECORDS › Section R. 338.3153a - Medication orders for patients in medical institutions

Current through Vol. 24-12, July 15, 2024
Rule 53a.
(1) A
					 licensee shall include all of the following information in a prescription for
					 controlled substance medications to be dispensed for administration to an
					 inpatient in a medical institution:
(a) The
					 patient's name.
(b) The
					 prescriber's name, address, and DEA number. In place of including the address
					 and DEA number on each medication order, the pharmacy may maintain a separate
					 list of prescribers. The list must contain the prescriber's name, address, and
					 DEA number.
(c) The prescriber's
					 signature.
(d) The name, dose, and
					 frequency of administration of the medication.
(e) The date of the medication
					 order.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 5 - RECORDS › Section R. 338.3154 - Medication records in medical institutions

Current through Vol. 24-12, July 15, 2024
Rule 54.
(1) A
					 patient's chart must constitute a record of medications ordered for, and
					 actually administered to, a patient of medical institutions.
(2) Medication records are required for all
					 controlled substances listed in schedules 2, 3, 4, and 5. At a minimum, these
					 records must include all of the following information:
(a) The number of doses of controlled
					 substances purchased.
(b) The
					 number of doses dispensed to individual patients or distributed to nursing
					 stations or both.
(c) The number of
					 doses administered.
(d) The number
					 of doses dispensed, but not administered, to the patient.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3161 - Controlled substance prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 61.
(1) A
					 prescription that is issued for a controlled substance must be dated and signed
					 by the prescriber, when issued, and contain all of the following information:
(a) The full name and address of the patient
					 for whom the substance is being prescribed.
(b) The prescriber's DEA registration number,
					 preprinted, stamped, typed, or manually printed name, address, and telephone
					 number or pager number, and professional designation that is either written on
					 the prescription or stored in the pharmacy's automated data processing
					 system.
(c) The drug name,
					 strength, and dosage form.
(d) The
					 quantity prescribed. For a paper prescription received in writing, the
					 prescription must contain the quantity in both written and numerical terms. A
					 paper prescription complies if it contains preprinted numbers representative of
					 the quantity next to a box or line that the prescriber may check.
(e) The directions for use.
(f) If the prescription is for an animal, the
					 species of the animal and the full name and address of the owner.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3161a - Exception to bona fide prescriber-patient relationship; alternative requirements

Current through Vol. 24-12, July 15, 2024
Rule 61a.
(1)
					 Except as provided in subrule (2) of this rule and for a patient who is under
					 the care of a hospice, a bona fide prescriber-patient relationship is required
					 before a licensed prescriber may prescribe a controlled substance listed in
					 schedules 2 to 5.
(2) Under section
					 16204e of the code, MCL
					 333.16204e, a licensed prescriber
					 may prescribe a controlled substance listed in schedules 2 to 5 without first
					 establishing the bona fide prescriber-patient relationship required under
					 section 7303a of the code, MCL
					 333.7303a, in the following
					 situations:
(a) The prescriber is providing
					 on-call coverage or cross-coverage for another prescriber who is not available
					 and has established a bona fide prescriber-patient relationship with the
					 patient for whom the on-call or covering prescriber is prescribing a controlled
					 substance, the prescriber, or an individual licensed under article 15 of the
					 code, MCL
					 333.16101 to
					 333.18838, reviews the patient's
					 relevant medical or clinical records, medical history, and change in medical
					 condition, and provides documentation in the patient's medical record
					 consistent with medically accepted standards of care.
(b) The prescriber is following or modifying
					 the orders of a prescriber who has established a bona fide prescriber-patient
					 relationship with a hospital in-patient or nursing care facility resident and
					 provides documentation in the patient's medical record consistent with
					 medically accepted standards of care.
(c) The prescriber is prescribing for a
					 patient that has been admitted to a licensed nursing care facility, completes
					 the tasks identified in subdivisions (a) and (b) of this subrule in compliance
					 with R 325.45377, as applicable, and provides documentation in the patient's
					 medical record consistent with medically accepted standards of care.
(d) The prescriber is prescribing for a
					 patient for whom the tasks listed in subdivisions (a) and (b) of this subrule
					 are performed by an individual licensed under article 15 of the code, MCL
					 333.16101 to
					 333.18838, and the prescriber
					 provides documentation in the patient's medical record consistent with
					 medically accepted standards of care.
(e) The prescriber is treating a patient in a
					 medical emergency. As used in this subdivision, "medical emergency" means a
					 situation that, in the prescriber's good-faith professional judgment, creates
					 an immediate threat of serious risk to the life or health of the patient for
					 whom the controlled substance prescription is being prescribed.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3162 - Dispensing by pharmacists; delivery of controlled substances

Current through Vol. 24-12, July 15, 2024
Rule 62.
(1)
					 Except for a remote pharmacy that is regulated by section 17742a of the code,
					 MCL 333.17742a, and that allows a
					 qualified pharmacy technician to assist in the dispensing process while being
					 overseen by a pharmacist through the use of a surveillance system and
					 telepharmacy system, a controlled substance must be dispensed by a pharmacist
					 or a pharmacy intern in the presence, and under the personal charge of, a
					 pharmacist.
(2) A pharmacist shall
					 require positive identification of individuals to whom controlled substances
					 are dispensed or delivered if the individual is not known to the pharmacist or
					 pharmacy employees, except if positive identification is not available and a
					 pharmacist, who in exercising professional judgment, determines that a delay in
					 dispensing the controlled substance may be detrimental to a patient.
(3) Subrule (2) of this rule does not exempt
					 a pharmacist from the requirement to submit a patient identifier to the
					 electronic system for monitoring controlled substances.
(4) The dispensing pharmacist and pharmacy
					 are both responsible for complying with this rule.
(5) A pharmacist may dispense a controlled
					 substance that is listed in schedules 3 to 5 and that is a prescription drug
					 under section 503 of the FDCA,
					 21 USC
					 353, under a prescription on a prescription
					 form, an oral prescription of a practitioner, or a prescription that is
					 electronically transmitted pursuant to R 338.3162a and that contains all of the
					 required information under R 338.3161, except that the signature of the
					 prescriber is not required if the controlled substance is obtained under an
					 oral order.
(6) In addition to the
					 requirements in section 17744 of the code, MCL
					 333.17744, if a prescriber's
					 agent under delegation transmits an oral prescription for a controlled
					 substance to a pharmacy, all of the following must be recorded on the
					 prescription generated at the pharmacy:
(a)
					 The information required by R 338.3161.
(b) The transmitting agent's
					 identity.
(c) The individual who
					 received the prescription at the pharmacy.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3162a - Electronic transmission of prescription; waiver of electronic transmission

Current through Vol. 24-12, July 15, 2024
Rule 62a.
(1)
					 Effective on January 1, 2023 prescribers shall, unless an exception under
					 section 17754a of the code, MCL
					 333.17754a, applies,
					 electronically transmit a prescription 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 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 338.3161.
(c) The pharmacist exercises professional
					 judgment regarding the accuracy, validity, and authenticity of the transmitted
					 prescription.
(d) All requirements
					 in section 17754a of the code, MCL
					 333.17754a, are
					 met.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3162b - Electronic system for monitoring schedules 2, 3, 4, and 5 controlled substances

Current through Vol. 24-12, July 15, 2024
Rule 62b.
(1)
					 Except as otherwise exempt under section 7333a of the code, MCL
					 333.7333a, a pharmacist,
					 dispensing prescriber, or veterinarian licensed under part 177 of the code, MCL
					 333.17701 to
					 333.17780, who dispenses a
					 prescription drug that is a controlled substance listed in schedules 2 to 5 or
					 a pharmacy licensed by this state that dispenses in this state or dispenses to
					 an address in this state a controlled substance listed in schedules 2 to 5,
					 shall report to the department or the department's contractor by means of an
					 electronic data transmittal process, the following information for each
					 prescription of a scheduled 2 to 5 controlled substance that has been
					 dispensed:
(a) The patient identifier
					 identification number. As used in this subdivision, all of the following apply:
(i) An identification number, as specified in
					 R 338.3102(h)(iv)(A) to (E), is not required for patients under the age of
					 16.
(ii) If the patient is under 16
					 years of age, zeroes must be entered as the identification number.
(iii) If the medication being dispensed is
					 for an animal, the patient identification number applies to the animal's owner,
					 the client, that meets the requirements of R 338.3102(h)(iv). If the animal's
					 owner cannot be identified, zeroes must be entered as the identification
					 number.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3162c - Format for electronic transmission of data to electronic system for monitoring; waiver

Current through Vol. 24-12, July 15, 2024
Rule 62c.
(1) A
					 pharmacist, dispensing prescriber, or veterinarian who dispenses a prescription
					 drug that is a controlled substance listed in schedules 2 to 5 shall transmit
					 the data, as specified under R 338.3162b, by electronic media or other means as
					 approved by the department or the department's contractor.
(2) The data must be transmitted in the
					 format established by the ASAP 5.0 Standard for Prescription Drug Monitoring
					 Programs.
(3) A pharmacist,
					 dispensing prescriber, or veterinarian who dispenses controlled substances and
					 does not have an automated record-keeping system capable of producing an
					 electronic report in the format established by subrule (2) of this rule may
					 request a waiver from electronic reporting. The request must be made in writing
					 to the department.
(4) A
					 pharmacist, dispensing prescriber, or veterinarian may be granted a waiver, if
					 the pharmacist, dispensing prescriber, or veterinarian demonstrates an
					 inability to report as required by R 338.3162b and agrees in writing to report
					 the data to the department or the department's contractor by submitting a
					 completed MAPS claim form or transmitting data via an internet web portal that
					 is provided by the department or the department's contractor for this
					 purpose.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3162d - Required reporting of prescription data; error reporting

Current through Vol. 24-12, July 15, 2024
Rule 62d.
(1) A
					 pharmacist, pharmacy, dispensing prescriber, or veterinarian shall report all
					 scheduled 2 to 5 controlled substances dispensed.
(2) The licensee shall forward the data
					 required by R 338.3162b by online transmission, computer diskette, compact
					 disk, or other approved medium, as specified in R 338.3162c to the department
					 or the department's contractor, on a daily basis, by the end of the next
					 business day and include the data for all controlled substances dispensed since
					 the previous transmission or report.
(3) A pharmacist, pharmacy, dispensing
					 prescriber, or veterinarian that does not have the capacity to forward the
					 information as specified in R 338.3162b, shall mail or deliver the information
					 to a location specified by the department or the department's contractor not
					 later than 7 calendar days after the date that the controlled substance has
					 been dispensed, and include the data for all controlled substances dispensed
					 since the previous transmission or report.
(4) The department or the department's
					 contractor shall notify a pharmacist, pharmacy, dispensing prescriber, or
					 veterinarian of an error in data reporting. If a pharmacist, pharmacy,
					 dispensing prescriber, or veterinarian receives notification of an error in
					 data reporting, the pharmacist, pharmacy, dispensing prescriber, or
					 veterinarian shall take appropriate measures to correct the error and transmit
					 the corrected data to the department or the department's contractor within 7
					 calendar days after being notified of the error.
(5) A pharmacist, pharmacy, dispensing
					 prescriber, or veterinarian that fails to report the dispensing of a
					 prescription for a controlled substance listed in schedules 2 to 5 as required,
					 is subject to the penalty provisions in section 16221, 17741, or 17768 of the
					 code, MCL
					 333.16221,
					 333.17741, or
					 333.17768.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3164 - Emergency dispensing of schedule 2 substances; oral prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 64.
A pharmacist may dispense a controlled substance listed
						in schedule 2 in an emergency if all the following conditions are met:
(a) The prescriber advises the pharmacist of
					 all of the following:
(i) Immediate
					 administration of the controlled substance is necessary for proper treatment of
					 the patient.
(ii) Appropriate
					 alternative treatment is not available, including administration of a drug that
					 is not a controlled substance under schedule 2.
(iii) It is not reasonably possible for the
					 prescriber to provide a written prescription to the dispenser before the
					 dispensing.
(iv) The quantity
					 prescribed and dispensed is limited to the amount adequate to treat the patient
					 during the emergency period and under a written prescription.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3165 - Emergency dispensing of schedule 2 substances; written prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 65.
(1)
					 After authorizing an emergency oral prescription of a controlled substance
					 listed in schedule 2, the prescriber shall comply with all of the following
					 within 7 days:
(a) The prescriber shall
					 deliver to the dispensing pharmacist a written prescription postmarked within 7
					 days after the date the prescription was dispensed, or electronically transmit
					 the prescription under R 338.3162a.
(b) The prescriber shall include on the
					 prescription both "Authorization for Emergency Dispensing" and the date of the
					 oral order.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3166 - Partial dispensing of controlled substances

Current through Vol. 24-12, July 15, 2024
Rule 66.
(1) A
					 pharmacist may partially dispense a controlled substance listed in schedule 2
					 in conformance with the following:
(a) The
					 pharmacist is unable to supply the full quantity called for in a written or
					 emergency oral prescription.
(b)
					 The pharmacist notes the quantity supplied on the face of the written
					 prescription, written record of the emergency oral prescription, or in the
					 electronic prescription record.
(c)
					 The pharmacist may dispense the remainder of the prescription within 72 hours
					 after the first partial dispensing.
(d) If the remainder of the prescription is
					 not or cannot be dispensed within the 72 hours, the pharmacist shall notify the
					 prescriber.
(e) The pharmacist
					 shall not dispense an additional quantity of the drug beyond 72 hours without a
					 new prescription.
(f) The pharmacy
					 has the balance of the prescription ready for dispensing before the 72-hour
					 limit, but the patient is not required to pick up the balance of the
					 prescription within that 72-hour limit.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3167 - Dispensing schedule 5 substances without prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 67.
(1) A
					 pharmacist may, without a prescription, dispense a controlled substance listed
					 in schedule 5 that is not a prescription medication as determined under the
					 FDCA, if all of the following provisions are met:
(a) The dispensing pharmacist determines the
					 controlled substance is intended to be used for a medical purpose.
(b) Not more than 240 cc, 8 ounces, or 48
					 solid doses of a substance containing opium or more than 120 cc, 4 ounces, or
					 24 solid doses of another substance listed in schedule 5 are distributed at
					 retail to the same purchaser in a 48-hour period.
(c) The purchaser is not younger than 18
					 years of age.
(d) The dispensing
					 pharmacist requires a purchaser, not known to the pharmacist, to furnish
					 suitable identification, including proof of age where
					 appropriate.