DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
DIRECTOR'S OFFICE
PHARMACY - GENERAL RULES
Filed with the secretary of state on
These rules take
effect become effective immediately uponafter filing
with the secretary of state unless adopted under section 33, 44, or 45a(9) of
the administrative procedures act of 1969, 1969 PA 306, MCL 24.233, 24.244, or
24.245a. Rules adopted under these sections become effective 7 days after
filing with the secretary of state.
(By authority conferred on the director of the department of licensing and regulatory affairs by sections 16141, 16145, 16148, 16174, 16175, 16178, 16182, 16186, 16204, 16205, 16215, 16287, 17707, 17721, 17722, 17731, 17737, 17739, 17742a, 17742b, 17744f, 17746, 17748, 17748a, 17748b, 17748e, 17751, 17753, 17754a, 17757, 17760, 17767, and 17775 of the public health code, 1978 PA 368, MCL 333.16141, 333.16145, 333.16148, 333.16174, 333.16175, 333.16178, 333.16182, 333.16186, 333.16204, 333.16205, 333.16215, 333.16287, 333.17707, 333.17721, 333.17722, 333.17731, 333.17737, 333.17739, 333.17742a, 333.17742b, 333.17744f, 333.17746, 333.17748, 333.17748a, 333.17748b, 333.17748e, 333.17751, 333.17753, 333.17754a, 333.17757, 333.17760, 333.17767, and 333.17775 and Executive Order Nos. 1991-9, 1996-2, 2003-1, and 2011-4, MCL 338.3501, 445.2001, 445.2011, and 445.2030)
R 338.486, R 338.501, R 338.505, R 338.511, R 338.513, R 338.515, R 338.517, R 338.519, R 338.521, R 338.523, R 338.525, R 338.531, R 338.531a, R 338.532, R 338.533, R 338.534, R 338.535, R 338.536, R 338.537, R 338.538, R 338.551, R 338.555, R 338.557, R 338.559, R 338.563, R 338.569, R 338.571, R 338.575, R 338.577, R 338.583, R 338.583a, R 338.584, R 338.585, R 338.586, R 338.587, R 338.588, R 338.589, and R 338.590 of the Michigan Administrative Code are amended, and R 338.534a, R 338.588a, R 338.588b, and R 338.591 are added, as follows:
ADMINISTRATIVE HEARINGSPHARMACY SERVICES IN MEDICAL INSTITUTIONS
R 338.486 “Medical institution” and “pharmacy services” defined; pharmacy services in
medical institutions.
Rule 16. (1) As used in this rule:
(a) "Medical institution" means a hospital, skilled nursing facility, county medical care facility, nursing home, freestanding surgical outpatient facility, hospice, or other health facility that is licensed or approved by the state, which directly or indirectly provides or includes pharmacy services.
(b) "Pharmacy services" means the direct and indirect patient care services for patients in a medical institution, associated with the practice of pharmacy.
(2) Pharmacy services in a medical institution must be directed and provided by a licensed pharmacist.
(3) Pharmacy personnel who assist the
pharmacist by performing delegated functions in the care of patients of a
medical institution shall beare supervised by a pharmacist who is
on the premises of the medical institution.
(4) The pharmacist who directs the pharmacy services shall develop, implement, supervise, and coordinate the services provided, including, at a minimum, all of the following:
(a) Dispensing medications in a form that minimizes additional preparation before administration to the patient, including the admixture of parenterals.
(b) Obtaining the prescriber's original medication order, a direct carbonized copy, an electromechanical facsimile, or other electronic order transmission. Security measures must be in place to ensure that system access by unauthorized individuals is not allowed.
(c) Interpreting and reviewing the
prescriber's medication orders and communicating problems with these orders to
the prescriber before the administration of first doses. If the interpretation
and review will cause a medically unacceptable delay that would
adversely affect a patient’s medical condition, then
a limited number of medications may be stocked at the patient care areas for the
administration of first doses. Medications must be provided in a manner that
ensures security and immediate availability, such asincluding
sealed or secured medication kits, carts, or treatment trays. A pharmacist shall
routinely inspect the medications and, after use, shall verify the contents and
replace the medications as necessary.
(d) Furnishing medications for
administration to registered patients under R 338.588 and 338.588b. Delegating
the stocking of an automated device. 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.
(e) Monitoring medication therapy to promote positive patient outcomes while evaluating clinically significant chemical and therapeutic incompatibilities.
(f) Establishing the specifications for the procurement of all pharmaceuticals and related biologicals and chemicals approved for use in the medical institution.
(g) Inspecting all areas in the medical institution where medications are stored to verify compliance with the standards for the safe use and storage of the medications, not less than once every 6 months.
(h) Maintaining proper security for all
medications stored or kept maintained within the medical
institution.
(i) Providing educational programs regarding
that include, but are not limited to, medications used by the medical
institution and their safe use.
(j) Providing a methodprocess
by which medications can be obtained during the absence of a pharmacist in a
medical institution where a pharmacist is not available 24 hours a day. The
process must comply with all of the following:
(i) The method shall
minimizeMinimize the potential for medication error.
(ii) During the absence of a pharmacist, the services of a pharmacist must be available on an on-call basis.
(iii) Only a limited number of medications that are packaged in units of use must be available.
(iv) The medications must be approved
and reviewed periodically as determined deemed necessary, but not
less than once a year, by an appropriate interdisciplinary practitioner committee
of the medical institution.
(v) The medication must be kept
maintained in a securely locked, substantially constructed cabinet
or its equivalent in an area of limited access in a centralized area outside
the pharmacy.
(vi) Each medication must be
labeled to include the name of the medication,; the strength,;
the expiration date, if dated,; and the lot number.
(vii) A written order and a
proof of removal and use document must beare obtained for each
medication unit removed and The order and document shall be reviewed
by the pharmacist within 48 hours of removing medication from the cabinet or its
equivalent.
(viii) The pharmacist who
directs pharmacy services in the medical institution shall designate the practitioners
who are permitted allowed to remove the medication.
(ix) A pharmacist shall audit the storage locations as often as needed to guarantee control, but not less than once every 30 days.
(5) Upon On the recommendation
of an interdisciplinary practitioners’ committee, the pharmacist who directs pharmacy
services in the medical institution shall adopt written policies and procedures
to promote safe medication practices, to conduct medication utilization review,
to approve medications for the medical institution's formulary or medication
list, and to promote positive patient outcomes. A pharmacist shall meet with
the committee at leastnot less than quarterly to conduct assigned
responsibilities.
(6) A pharmacy shall ensure that every medication dispensed is identified with its name and strength labeled on the container in which it is dispensed or on each single unit package. A pharmacy that is engaged in drug distribution to medical institutions which use unit-of-use packaging shall place identification on the label of its package to allow the package to be readily traced. The name of the patient, or a unique identifier, must be labeled on the medication container. The container may be the individual patient’s assigned medication drawer. The directions for use must be on the label of the container if the directions are not communicated in another effective manner. If the medication is to be self-administered, then directions for use must be on the container. The provisions of this subrule are minimum labeling standards only and do not supersede other applicable laws or rules.
(7) A pharmacist shall supervise the
destruction of unused portions of prescription medication, other than controlled
substances under part 71 of the code, MCL 333.7101 to 333.7125, dispensed to
patients. However, medications in single-unit packages and intravenous
solutions whichthat are designed to be tamper-evident, and
which show no evidence that tampering has occurred, may be
returned to stock. Medications that leave the medical institution or its legal
affiliates may must not be returned to stock for dispensing.
(8) The licensed pharmacist who that
directs pharmacy services in the medical institution shall make the
policies, and procedures, and written reports required by this
rule available to an agent of the board, upon request.
PHARMACY
SERVICES IN MEDICAL INSTITUTIONS
PART 1. GENERAL PROVISIONS
R 338.501 Definitions.
Rule 1. (1) As used in these rules:
(a) “ACPE” means Accreditation Council for Pharmacy Education.
(ab) “Approved education
program” means a school of pharmacy that is accredited by or has candidate status
by the Accreditation Council for Pharmacy Education (ACPE).
(bc) “Board” means the
Michigan board of pharmacy, created in section 17721 of the code, MCL
333.17721.
(cd) “Code” means the public
health code, 1978 PA 368, MCL 333.1101 to 333.25211.
(de) “Compounding” means the preparation,
mixing, assembling, packaging, and labeling of a drug or device by a pharmacist
under any of the following circumstances:
(i) Upon the On receipt
of a prescription for a specific patient.
(ii) Upon the On receipt
of a medical or dental order from a prescriber or agent for use in the treatment
of patients within the course of the prescriber's professional practice.
(iii) In anticipation of the receipt of a prescription or medical or dental order based on routine, regularly observed prescription, or medical or dental order patterns.
(iv) For the purpose of or incidental to research, teaching, or chemical analysis and not for the purpose of sale or dispensing.
(ef)
"Compounding" does not include any of the following:
(i) Except as provided in section 17748c of the code, MCL 333.17748c, the compounding of a drug product that is essentially a copy of a commercially available product.
(ii) The reconstitution, mixing, or other
similar act that is performed pursuant tounder the directions contained
in approved labeling provided by the manufacturer of a commercially available
product.
(iii) The compounding of allergenic extracts or biologic products.
(iv) Flavoring agents added to conventionally manufactured and commercially available liquid medications. Flavoring agents must be nonallergenic and inert, not exceeding 5% of a drug product’s total volume.
(g) “CPMP” means customized patient medication package that is prepared by a pharmacist for a specific patient and contains 2 or more prescribed solid oral dosage forms.
(h) “DEA” means the Federal Drug Enforcement Administration.
(fi) “Department” means
the department of licensing and regulatory affairs.
(gj) “Electronic signature”
means an electronic sound, symbol, or process attached to or logically
associated with a record and executed or adopted by an individual with the intent
to sign the record. An electronic signature is a unique identifier protected
by appropriate security measures that is only available for use by the intended
individual and ensures non-repudiation so that the signature may not be rejected
based on its validity.
(hk)
“Error prevention technology” means machinery and equipment used in a pharmacy setting
to reduce dispensing medication errors including, but not limited to, barcode verification
and radio frequency identification.
(l) “FDA” means the United States Food and Drug Administration.
(m) “FEIN” means a federal employer identification number.
(n) “FPGEC” means the Foreign Pharmacy Graduate Examination Committee.
(o) “GED” means a general education development certificate.
(p) “Manual signature” means a signature
that is handwritten or computer-generated if a prescription is electronically transmitted,
as that term is defined in section 17703(8) of the code, MCL
333.17703.
(q) “NABP” means the National Association of Boards of Pharmacy.
(r) “NABP-VPP” means the NABP Verified Pharmacy Program.
(s) “NAPLEX” means the North American pharmacist licensure examination.
(t) “PIC” means pharmacist in charge.
(ju) “Practical experience”
means professional and clinical instruction in, but not limited to, all of the
following areas:
(i) Pharmacy administration and management.
(ii) Drug distribution, use, and control.
(iii) Legal requirements.
(iv) Providing health information services and advising patients.
(v) Pharmacist’s ethical and professional responsibilities.
(vi) Drug and product information.
(vii) Evaluating drug therapies and preventing or correcting drug-related issues.
(v) “USP” means the United States Pharmacopeia.
(kw) “Virtual manufacturer” means a person who
engages in the manufacture of prescription drugs or devices and meets all of
the following:
(i) Owns either of the following:
(A) The new prescription drug application or abbreviated new prescription drug application number.
(B) The unique device identification number, as available, for a prescription device.
(ii) Contracts with a contract manufacturing organization for the physical manufacture of the drugs or devices.
(iii) Is not involved in the physical manufacture of the drugs or devices.
(iv) At no time takes physical possession of or stores the drugs or devices.
(v) Sells or offers for sale to other persons, for resale, compounding, or dispensing of, drugs or devices, salable on prescription only.
(lx)
“Written” includes both paper and electronic forms.
(2) Unless otherwise defined in these rules,
the terms defined in the code have the same meaning whenas used
in these rules.
R 338.505 Inspection of applicants and licensees.
Rule 5. (1) The board, board inspector,
board agent, or an entity approved pursuant tounder R 338.532,
may enter at reasonable times, any building, place, or facility that is owned
or controlled by any applicant for, or holder of, a license to inspect to enable
the board to determine if the applicant possesses the qualifications and competence
for the license sought or to determine whether a license holder is and has been
complying with the code and rules. The inspection must concern only matters relevant
to the applicant’s or license holder’s practice of pharmacy, manufacturing, and
wholesale distributing distribution of drugs and devices saleable
by prescription only.
(2) Inspections in subrule (1) of this rule must not extend to any of the following information, however, the following information is subject to a disciplinary investigation:
(a) Financial data.
(b) Sales data Purchasing data,
other than shipment data, and the current and historical selling price
of a drug.
(c) Pricing data.
(d)(c) Personnel data,
other than data as to the qualifications of personnel performing functions
subject to the acts and rules enforced by the board.
(e)(d) Research data,
other than research data that confirms the appropriate use of controlled substances
for research purposes, or research data for accountability for reconciliation
of prescription drug inventories.
(3) An applicant or license holder shall
allow permit and cooperate with the inspection.
PART 2. PHARMACIST LICENSES
R 338.511 Training standards for identifying victims of human trafficking; requirements.
Rule 11. (1) Pursuant
toUnder section 16148 of the code, MCL 333.16148, an the individual
seeking licensure or who is licensed shall have completed
training in identifying victims of human trafficking that meets the following
standards:
(a) Training content must cover all of the following:
(i) Understanding the types and venues of human trafficking in the United States.
(ii) Identifying
victims of human trafficking in health carehealthcare settings.
(iii) Identifying
the warning signs of human trafficking in health carehealthcare
settings for adults and minors.
(iv) Identifying
Resources resources for reporting the suspected victims of human
trafficking.
(b) Acceptable providers or methods of training include any of the following:
(i) Training offered by a nationally recognized or state-recognized, health-related organization.
(ii) Training offered by, or in conjunction, with a state or federal agency.
(iii) Training obtained in an educational program that has been approved by the board for initial licensure, or by a college or university.
(iv) Reading
an article related to the identification of victims of human trafficking that
meets the requirements of subdivision (a) of this subrule and is published in a
peer reviewed peer-review journal, health carehealthcare
journal, or professional or scientific journal.
(c) Acceptable modalities of training may include any of the following:
(i) Teleconference or webinar.
(ii) Online presentation.
(iii) Live presentation.
(iv) Printed or electronic media.
(2) The department
may select and audit an individual a sample of individuals and
request documentation of proof of completion of training. If audited by the department,
an the individual shall provide an acceptable proof of completion
of training, including either of the following:
(a) Proof of completion certificate issued by the training provider that includes the date, provider name, name of training, and individual’s name.
(b) A
self-certification statement by an the individual. The certification
statement must include the individual’s name and either 1 of the
following:
(i) For training
completed pursuant tounder subrule (1)(b)(i) to (iii) of this
rule, the date, training provider name, and name of training.
(ii) For training
completed pursuant tounder subrule (1)(b)(iv) of this rule, the title
of article, author, publication name of peer review the peer-review
journal, health carehealthcare journal, or professional or
scientific journal, and the date, volume, and issue of publication as
applicable.
(3) Pursuant to
section 16148 of the code, MCL 333.16148, the requirements specified in subrule
(1) of this rule apply for license renewals beginning January 1, 2020 and for
initial licenses issued after November 13, 2022.
R 338.513 Educational limited license; application and renewal; practices.
Rule 13. (1) An applicant for an educational
limited license shall submit to the department a completed application on a form
provided by the department with the requisite fee. In addition to satisfying
the requirements of sections 16174 and 17737 of the code, MCL 333.16174 and MCL
333.17737, the applicant shall establish either 1 of the
following:
(a) That the applicant is actively enrolled in, or is within 180 days of completing, an approved educational program.
(b) That the applicant has received a Foreign Pharmacy Graduate Examination Committee (FPGEC) certification from the National
Association of Boards of Pharmacy (NABP) Foreign Pharmacy Graduate Examination
Committee, 1600 Feehanville Drive., Mount Prospect, Illinois, 60056,
https://nabp.pharmacy/programs/fpgec/.)
(2) The educational limited license must be renewed annually as follows:
(a) At the time of renewal, the applicant
shall submit verification to the department that he or she the applicant
is actively enrolled in, or is within 180 days of completing, an approved
educational program. The educational limited license is valid for 1 year.
(b) If an applicant is a graduate of a non-accredited college or school of pharmacy at the time of renewal, the applicant shall submit verification to the department from his or her preceptor that the applicant is currently in an internship program under the preceptor’s supervision. The educational limited license is valid for 1 year and may be renewed 1 time.
(3) An educational limited licensee may engage in the practice of pharmacy only under the personal charge of a pharmacist.
(4) An educational limited licensee
shall verify that his or her the licensee's pharmacy preceptor holds
a valid preceptor license prior to before engaging in the practice
of pharmacy if the internship hours will be submitted to the department for
credit.
(5) An educational limited licensee shall
notify the board within 30 days if he or she the licensee is
no longer actively enrolled in an approved educational program.
(6) An applicant for an educational limited license shall meet the requirements of R 338.511 and R 338.7004.
R 338.515 Internship requirements.
Rule 15. (1) An An applicant
for a pharmacist license shall acquire a minimum internship must be a
minimum of 1,600 internship hours, which may be completed through
an educational program, under the personal charge of a preceptor, through a
preapproved unconventional internship, or through an educational program outside
of the United States under subrule (2) of this rule. An internship is subject
to all of the following:
(a) Not more than 40 hours per week may be earned.
(b) An
unconventional internship requires prior board approval and is limited to a
maximum of 400 hours, with a maximum of 16 hours earned per week, and not more
than 40 hours earned per week when the intern’s pharmacy school is not in
session. “Unconventional As used in
this subdivision, "unconventional internship” means an educational
program of professional and practical experience involving the pharmacy or
related pharmaceutical experiences which, through on-the-job training, provides
knowledge useful to the practice of the profession of pharmacy.
(c) The licensed pharmacy preceptor,
an approved education program, or other individual person
previously approved by the board shall verify the internship hours.
(d) An individual participating in a preapproved unconventional internship shall annually submit to the department an affidavit from the internship supervisor that includes the type of activities performed and the number of internship hours completed.
(2)(e) The internship
must provide professional and practical experience.
(3)(2) An individual
who graduated from a program outside the United States may petition the board for
approval of a maximum of 1,400 internship hours If if an internship
is not completed through an approved educational program or under the personal
charge of a preceptor licensed in this state, the individual shall petition
the board for approval of hours. The internship hours must be obtained through
an educational program experience.
(4)(3) An individual
shall obtain an educational limited license pursuant tounder R
338.513 before starting an internship that includes the practice of pharmacy in
this state.
R 338.517 Preceptor license and responsibilities.
(2) The applicant shall satisfy both of the following:
(a) Have an unrestricted pharmacist license from this state that is in good standing for the past year.
(b) Have been engaged in the practice
of pharmacy in this state for at least 1 year.
(3) A preceptor shall do all of the following:
(a) Ensure that the pharmacist on duty is supervising not more than 2 pharmacist interns at the same time. The approved preceptor is responsible for the overall internship program at the pharmacy.
(b) Determine the degree of the intern’s
professional skill on the topics listed in R 338.501(1)(ju) and develop
a training program whereby the intern can improve his or her the
intern's skill in these areas.
(4) (d) Annually submit to
the department training affidavits that include the number of internship hours
completed by the intern in the practice of pharmacy.
Unless the hours are completed in an educational program, the preceptor shall submit to the department a training affidavit that includes the number of internship hours completed by the intern in the practice of pharmacy.
R 338.519 Examinations adoption; passing scores; reexamination.
Rule 19. (1) The board adopts the North
American pharmacist licensure examination (NAPLEX) developed and administered
by the NABP.
(2) The board adopts the Michigan
multistate pharmacy jurisprudence examination (MPJE) that is developed and
administered by NABP.
(32) The passing score for
the NAPLEX or the MPJE accepted for licensure is will be the
passing score established by the NABP.
(43) An applicant that
who fails to pass the NAPLEX shall wait at leastnot less than
45 days to retest or comply with the current waiting period established by NABP,
whichever is longer. An applicant that who has not achieved a
passing score on the NAPLEX may not take the NAPLEX more than 3 times in a 12-month
period.
(5) An applicant who fails to pass the
MPJE shall wait at least 30 days to retest or comply with the current waiting period
established by NABP, whichever is longer.
(64) If an applicant for licensure
fails to pass either of these examinations ,the NAPLEX within 3
attempts, the applicant shall request preapproval from the department, after consultation
with a board member, if necessary, of a live or interactive examination preparation
course, or instruction with an instructor with expertise on the subject matter,
for the examination that he or she the applicant failed. After
participating in the course or instruction the applicant shall provide the department
with proof that he or she the applicant completed the course
or instruction.
(8) An applicant may not sit for the
MPJE specified in subrule (5) of this rule more than 5 times, unless he or she successfully
repeats an approved pharmacy law course in an educational program, as specified
in R 338.521(2)(a)(i) and provides proof of completion to the department.
R 338.521 Pharmacist licensure by examination.
Rule 21. (1) An applicant for licensure as a pharmacist by examination shall submit to the department a completed application on a form provided by the department with the requisite fee.
(2) In addition to meeting the requirements
of section 16174 of the code, MCL 333.16174,; R 338.7001 to R
338.7005; and any other rules promulgated under the code, an applicant
for licensure shall satisfy all of the following requirements:
(a) Have earnedObtain eitherone
of the following:
(i) A professional degree from a school of pharmacy accredited by the ACPE.
(ii) A FPGEC
certification from the NABP. An applicant that who has an FPGEC
certification from NABP has met the English proficiency
requirement as the applicant’s credentials and English proficiency have been evaluated
and determined to be equivalent to the credentials required in this state.
(iii) A score transfer from NABP if the applicant has been licensed in another state for 1 day to 1 year.
(b) PassedPass the MPJE
and the NAPLEX.
(c) CompletedComplete an internship
as set forth in R 338.515.
(d) CompletedComplete
a 1-time training identifying victims of human trafficking as required in R 338.511 and section 16148
of the code, MCL 333.16148.
(e) CompletedComplete a 1-time
training in opioids and other controlled substances awareness as required in R 338.3135.
(f) Submitted proof to the department of
meeting the English language requirement under R 338.7002b and the implicit bias
training required in R 338.7004. An applicant who has an FPGEC certification
from NABP has met the English proficiency requirement
as the applicant’s credentials and English proficiency have been evaluated and determined
to be equivalent to the credentials required in this state.
(f) Provide an attestation to the department that the applicant has sufficient knowledge of the code and the board’s rules to competently practice pharmacy in this state.
(a) Disclose each license, registration, or certification on the application form.
(b) Satisfy the requirements of section
16174(2) of the code, MCL 333.16174, including which includes verification
from the issuing entity showing that disciplinary proceedings are not pending against
the applicant and sanctions are not in force at the time of application.
R 338.523 Pharmacist license by endorsement; requirements.
Rule 23. (1) An applicant that has
never held a pharmacist license in this state and is licensed in another state
or Canada, may apply for licensure as a pharmacist by endorsement shall
submit by submitting to the department a completed application on a
form provided by the department with the requisite fee. An applicant that who
meets the requirements of this rule, R 338.7001 to R 338.7005, and any other
rules promulgated under the code is presumed to meet the requirements of section
16186 of the code, MCL 333.16186.
(2) An applicant shall satisfy all of the following requirements:
(a) Establish 1 of the following:
(i) He or she The applicant
holds a license in good standing as a pharmacist in another state and submits
the NABP licensure transfer report to the department.
(ii) He or she The applicant
holds a pharmacy license in Canada that is in good standing and meets all of the
following:
(A) He or she The applicant
has passed the NAPLEX or both part I and part II of the Pharmacy Examining Board
of Canada (PEBC) Pharmacists Qualifying Examination.
(B) He or she The applicant
completed educational requirements for a pharmacist license from a school of
pharmacy accredited by the ACPE or accredited by the Canadian Council for Accreditation
of Pharmacy Programs (CCAPP).
(C) If he or she the
applicant held a pharmacist license for less than 1 year in Canada, he
or she the applicant had acquired a minimum of 1,600 hours of
pharmacy practice either through an approved internship or hours engaged in the
practice as a pharmacist.
(b) Pass the MPJE as required under
R 338.519Provide an attestation to the department that the applicant has
sufficient knowledge of the code and the board’s rules to competently practice
pharmacy in this state.
(c) An applicant that who
is or has ever been licensed, registered, or certified in a health profession
or specialty by any otheranother state, the United States military,
the federal government, or another country, shall do both of the following:
(i) Disclose each license, registration, or certification on the application form.
(ii) Satisfy the requirements of section
16174(2) of the code, MCL 333.16174, including which include verification
from the issuing entity showing that disciplinary proceedings are not pending
against the applicant and sanctions are not in force at the time of application.
(d) He or she The applicant
meets section 16174 of the code, MCL 333.16174, and submits his or her fingerprints
to the department of state police to have a criminal background check conducted
by the state police and the federal bureau of investigationFederal
Bureau of Investigation.
(e) He or she The applicant completes
a 1-time training identifying victims of human trafficking as required in R 338.511 and section 16148
of the code, MCL 333.16148.
(f) He or she The applicant
completes a 1-time training in opioids and other controlled substances awareness
as required in R 338.3135.
(g) He or she submits proof to the department
of meeting the English language requirement under R 338.7002b and the implicit
bias training required in R 338.7004.
(3)(2) An applicant that
who has an FPGEC certification from NABP has
met the English proficiency requirement. The applicant’s credentials and English
proficiency have been evaluated and determined to be equivalent to the credentials
required in this state.
R 338.525 Relicensure of a pharmacist license; requirements.
Rule 25. (1) An applicant for relicensure
whose pharmacist license has lapsed in this state, under sections 16201(3) or
(4) and 17733 of the code, MCL 333.16201 and MCL 333.17733, as applicable,
may be relicensed by complying with the following requirements as noted by (x):
|
For a pharmacist who has let his or her license
lapse in this state and |
License lapsed 0-3 years. |
License lapsed more than 3 years, but less than 8 years. |
License lapsed 8 or more years. |
|
(a) |
X |
X |
X |
|
(b) |
X |
X |
X |
|
(c) |
|
X |
X |
|
(d) |
X |
X |
X |
|
(e) |
|
X |
X |
|
(f) |
X |
X |
X |
|
(g) |
|
X |
|
|
(h) |
|
|
X |
|
(i) |
|
|
X |
|
(j) An applicant that (i) Disclose each license, registration, or certification on the application form. (ii) Satisfy the requirements of section
16174(2) of the code, MCL 333.16174, |
X |
X |
X |
(2) For purposes of As used in
subrule (1)(g) and (h) of this rule, an applicant may be granted a non-renewable
limited license to complete the practical experience.
(3) To demonstrate compliance with subrule (1)(g) or (h), the supervising pharmacist shall provide verification to the department of the applicant’s completion of the experience on a form provided by the department.
|
(4) For a pharmacist who has let his or her pharmacist license lapse in this state, but who holds a current and valid pharmacist license in good standing in another state or a Canadian province: |
License lapsed 0-3
|
License lapsed more than 3 years, but less than 8 years. |
License lapsed 8 or more years.
|
|
(a) |
X |
X |
X |
|
(b) |
X |
X |
X |
|
(c) |
|
X |
X |
|
(d) R 338.3041 to R 338.3045 in the 2 years
immediately |
X |
X |
X |
|
(e) |
X |
X |
X |
|
(f) |
|
X |
X |
|
(g) An applicant that (i) Disclose each license, registration, or certification on the application form. (ii) Satisfy the requirements of section
16174(2) of the code, MCL 333.16174, |
X |
X |
X |
(5) If relicensure is granted and it is determined that a sanction has been imposed by another state, the United States military, the federal government, or another country, the disciplinary subcommittee may impose appropriate sanctions under section 16174(5) of the code, MCL 333.16174.
PART 3. PHARMACY LICENSES
R 338.531 Pharmacy license; remote pharmacy license; applications; requirements.
Rule 31. (1) An applicant for a pharmacy license or a remote pharmacy license shall submit to the department a completed application on a form provided by the department together with the requisite fee.
(2) An applicant shall submit all of the following information:
(a) Certified copies of articles of incorporation or partnership certificates and certified copies of assumed name certificates, if applicable.
(b) Submission of fingerprints for the purpose of a criminal history background check required under section 17748(6) of the code, MCL 333.17748.
(c) A federal employer identification
number (FEIN) certificate.
(d) The name and license number of the
pharmacist in this state designated as the pharmacist in charge (PIC)
pursuant tounder section 17748(2) of the code, MCL 333.17748, who
must have a valid and unrestricted license. If a PIC is unable to fulfill his
or her duties for 120 consecutive days, the pharmacy shall appoint a new PIC
and notify the department as required in section 17748(4) of the code, MCL 333.17748.
(e) The identity and address of each partner, officer, or owner, as applicable.
(f) A completed self-inspection form.
(g) If the applicant intends to
provide compounding services, proof of application with an entity that
satisfies the requirements of R 338.532.
(hg) AnIf the
applicant is an out-of-state pharmacy that will not provide sterile compounding
services, an inspection report that satisfies the requirements of R 338.534.
(ih) If the applicant is
an in-state pharmacy that intends to compound sterile pharmaceutical
products, the applicant shall submit to an inspection under R 338.534a
from an approved accrediting organization under R 338.532.
(ji) If the applicant is
a governmental entity, an individual must shall be designated as
the licensee. The licensee and the pharmacist on duty shall beare
responsible for complying with all federal and state laws regulating the practice
of pharmacy and the dispensing of prescription drugs.
(kj) If the applicant is applying
for a remote pharmacy license, the applicant shall submit the following:
(i) Ownership documents to demonstrate to the satisfaction of the department that the parent pharmacy and the proposed remote pharmacy share common ownership.
(ii) Copies of the policies and procedure manual required in section 17742b of the code, MCL 333.17742b.
(iii) A map showing all of the existing pharmacies within 10 miles of the proposed remote pharmacy if the remote pharmacy will not be located at a hospital or mental health facility.
(lk) If the applicant is
or has ever been licensed, registered, or certified as a pharmacy by any otheranother
state, the United States military, the federal government, or another country, the
applicant shall do both of the following:
(i) Disclose each license, registration, or certification on the application form.
(ii) Submit verification from the issuing entity showing that disciplinary proceedings are not pending against the applicant and sanctions are not in force at the time of application.
(3) The department shall issue only 1 pharmacy license per address. If an applicant has more than 1 location at which drugs are prepared or dispensed, each address location must obtain a separate license.
R 338.531a Remote pharmacy waiver from mileage requirement.
Rule 31a. (1) An applicant seeking a remote pharmacy license may apply to the board for a waiver from the prohibition of locating a remote pharmacy within 10 miles of another pharmacy in section 17742a(2)(c) of the code, MCL 333.17742a, by submitting a completed application to the department, on a form provided by the department.
(2) The applicant shall submit the following with the application:
(a) A map showing the location of any existing pharmacies within 10 miles of the proposed remote pharmacy if the remote pharmacy will not be located at a hospital or mental health facility.
(b) A list and explanation of the services or availability of services that will be offered at the remote pharmacy or otherwise not readily available to patients that are different from the services offered at a pharmacy located within 10 miles of the proposed remote pharmacy.
(c) A statement of facts to support the statement of 1 or more of the following:
(i) The proposed remote pharmacy is located in an area where there is limited access to pharmacy services.
(ii) The proposed remote pharmacy will offer a service or the availability of a service that is unique from other pharmacies in the 10-mile radius from the remote pharmacy and the service will satisfy an unmet need of the surrounding community.
(iii) There exists a limitation on travel that justifies waiving the requirement.
(iv) There are other compelling circumstances that justify waiving the requirement.
(3) If the waiver is denied,
the application is considered closed unless within 30 days ofafter receipt
of the denial, the applicant notifies the department that it is requesting a hearing
on the matter.
R 338.532 Sterile Compounding
compounding accrediting organizations; board
approval; inspection entities.
Rule 32. (1) The board shall approve, under section 17748a of the code,
MCL 333.17748a, accrediting organizations or inspection entities for pharmacies
that compound pharmaceuticals according to standards adopted by
reference in R 338.533.
(2) The department shall post on its website, the list of organizations approved under subrule (1) of this rule.
(3) An organization may petition the board
for approval under subrule (1) of this rule. The petition must include, but is
not be limited to, all of the following:
(a) Requirements for accreditation or compliance.
(b) Requirements for inspectors.
(c) Training provided to inspectors.
(d) Copy of the most current inspection form.
(e) The length of accreditation.
(f) Agreement and plan to share results of inspections with the department.
(4) If the board approves the petition,
the approval is valid for 3 years fromafter the date of approval.
The organization may submit a petition that complies with subrule (3) of this
rule to seek continuing approval.
(5) The board may rescind approval of an
organization upon just cause. The rescission will not immediately affect the compliance
of a pharmacy using the accreditation. Within 12 months of after the
rescission date or by the next licensure renewal date, whichever is later, the
accreditation is void, and a pharmacy shall obtain accreditation or an inspection
from an organization that satisfies subrule (1) of this rule.
R 338.533 Compounding standards and requirements; outsourcing facilities;
requirements.
Rule 33. (1) The board approves and adopts
by reference the compounding standards of the United States Pharmacopeia (USP),
published by the United States Pharmacopeial Convention, 12601 Twinbrook Parkway,
Rockville, Maryland, 20852-1790. This includes, but is not limited
to, 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 noa cost of $250.00
at http://www.usp.org/compounding, or can be viewed at the a
cost of 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.
(3) A pharmacy that provides compounding
services shall comply with all currentthe standards adopted
in subrule (1) of this rule.
(4) An outsourcing facility
located inoutside of this state or that dispenses, provides,
distributes, or otherwise furnishes compounded pharmaceuticals in this
state shall must be inspected and registered as an outsourcing
facility by the United States Food and Drug Administration (FDA)
prior to before applying for a pharmacy license in this state.
(5) A licensed outsourcing facility
shall submit to the board a copy of the biannual report it provided to the
FDA that identifies the drugs compounded in the previous 6-month period, including
a drug’s active ingredients, strength, and dosage form.
(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 good manufacturing practices for finished pharmaceuticals set forth in 21 CFR 211.1 to 211.208.
(6) An outsourcing facility shall do all of the following:
(a) Compound drugs by or under the supervision of a licensed pharmacist.
(b) Compound drugs pursuant tounder current good
manufacturing practices for finished pharmaceuticals
set forth in 21 CFR 211.1 to 211.208 (2021).
(c) Ensure that a pharmacist who conducts or oversees compounding at an outsourcing facility is proficient in the practice of compounding and has acquired the education, training, and experience to maintain that proficiency by doing any of the following:
(i) Participating in seminars.
(ii) Studying appropriate literature.
(iii) Consulting with colleagues.
(iv) Being certified by a compounding certification program approved by the board.
(d) Label compounded drugs and
compounded drugs that are patient specific in compliance with the requirements
in R 338.582 and with all of the following and label compounded drugs
that are patient specific with include all of the following and
consistent with the requirements in R 338.582:
(i) Required drug and ingredient information.
(ii) Facility identification.
(iii) The following or similar statement: “This is a compounded drug. For office use only” or “Not for resale.”
(e) Ensure that bulk drug substances used for compounding meet specified FDA criteria.
(7) An outsourcing facility may compound drugs that appear on an FDA shortage list, if the bulk drug substances used to compound the drugs comply with the criteria specified in this rule.
R 338.534 Inspections Out-of-state
pharmacy licensure inspection; in-state
pharmacy licensure renewal inspection.
(2) An applicant for a new pharmacy located
in this state shall have an inspection conducted by the department or its designee
prior to licensure.
(3)(2) Unless accredited by a national accrediting organization, recognized
by the board, an applicant for licensure or 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-Verified Pharmacy
Program (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.
R 338.534a In-state initial pharmacy license inspections.
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).
(3) Approval to engage in sterile compounding will end 6 months after initial licensure if a subsequent inspection to assess USP compliance or accreditation is not successful.
R 338.535 Discontinuing, starting, or resuming sterile compounding services;
requirements to resume sterile compounding services.
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 ofafter 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(3)(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).
R 338.536 Housing of a pharmacy.
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 who is 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 kept
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),
All pharmacies that occupy less than the entire area of the premises
owned, leased, used, or controlled by the licensee shall must 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 will be 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.
R 338.537 Professional and technical equipment and supplies.
Rule 37. (1) A pharmacy must
shall be equipped with both of the following:
(a) The necessary facilities, apparatus,
utensils, and equipment to allow permit the pharmacy to provide prompt
and efficient services.
(b) Current print, electronic, or internet
accessible editionsunabridged computerized versions of the Michigan
pharmacy laws and rules of this state, and at leastnot 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.
(2) In addition to subrule (1) of this rule, a pharmacy that dispenses drugs shall maintain, at a minimum, all of the following equipment:
(a) A sink with running water.
(b) A refrigerator for the exclusive use of prescription drugs. Personal or food items must not be stored in the refrigerator. Refrigeration must be capable of maintaining temperature within a range compatible with the proper storage of drugs requiring refrigeration or freezing. Temperatures must be monitored at all times for out-of-range temperatures during business closure.
(c) A telephone.
Rule 38. (1) A pharmacy that is ceasing
operations shall return to the department the pharmacy license and the
controlled substance license, if applicable, and provide the department with
written notification of all of the following at leastnot less than
15 days prior to 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.
(2) A pharmacy shall comply with all applicable federal requirements for discontinuing operation as a pharmacy that dispenses controlled substances.
(3) Records must be maintained for the same amount of time that is required if the pharmacy remained open.
PART 4. MANUFACTURER LICENSE
R 338.551 Manufacturer license; application.
Rule 51. (1) An applicant for a manufacturer license shall submit to the department a completed application on a form provided by the department with the requisite fee.
(2) An applicant shall provide all of the following information:
(a) A criminal history background check
required pursuant tounder section 17748(6) of the code, MCL 333.17748.
(b) A FEIN certificate.
(c) Certified copies of articles of incorporation or certificates of partnership and assumed name certificates, if applicable.
(d) The identity and address of each partner, officer, or owner, as applicable.
(e) A completed compliance checklist for manufacturers.
(f) A list or a catalog of all drug products or devices to be manufactured by the facility.
(g) Unless exempt under section 17748(2) of the code, MCL 333.17748, the name and license number of the pharmacist designated as the PIC or the name of the facility manager. If a PIC or facility manager is unable to fulfil his or her duties for 120 consecutive days, the pharmacy shall appoint a new PIC or facility manager and notify the department as required in section 17748(4) of the code, MCL 333.17748. For an individual who is designated as a facility manager, the applicant shall provide proof, in the form of an affidavit, that the facility manager has achieved the following:
(i) A high school equivalency education, or higher, defined as 1 of the following:
(A) A high school diploma.
(B) A general education development
certificate (GED).
(C) A parent-issued diploma for home schooled individuals.
(D) Completion of post-secondary education,
including either an associate’s degree, a bachelor’s degree,
or a master’s degree.
(ii) Completion of a training program that includes, but is not limited to, all of the following subjects:
(A) Knowledge and understanding of laws in this state and federal laws relating to the distribution of drugs and devices.
(B) Knowledge and understanding of laws in this state and federal laws relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the USP standards relating to the safe storage and handling of prescription drugs.
(E) Knowledge and understanding of pharmaceutical terminology, abbreviations, dosages, and format.
(iii) Experience equal to either of the following:
(A) A minimum of 1 year of work experience related to the distribution or dispensing of prescription drugs or devices where the responsibilities included, but were not limited to, recordkeeping.
(B) Previous or current employment as a designated representative of a manufacturer.
(iv) Employment with the applicant.
(h) A copy of the FDA certification for the site to be licensed, if an applicant is a manufacturer of biologicals.
(i) An inspection from the FDA, or manufacturer’s
resident state board of pharmacy, that is dated not more than 2 years before
application or verified-accredited wholesale distributors (VAWD) current
NABP drug distributor accreditationaccreditation dated not more
than 2 years prior to the application.
(j) An applicant that is or has ever been
licensed, registered, or certified as a manufacturer by any otheranother
state, the United States military, the federal government, or another country,
shall do both of the following:
(i) Disclose each license, registration, or certification on the application form.
(ii) Submit verification from the issuing entity showing that disciplinary proceedings are not pending against the applicant and sanctions are not in force at the time of application.
(3) A separate license is required for each location where prescription drugs or devices are manufactured.
(4) A manufacturer who changes its facility
manager shall submit all of the information required in subrule (2)(g)(i)
of this rule to the department within 30 days ofafter the change.
R 338.555 Federal regulation on good manufacturing practice for finished
pharmaceuticals; adoption by reference; compliance.
Rule 55. (1) The board approves and adopts
by reference the current good manufacturing practice for finished
pharmaceuticals regulations set forth in 21 CFR 211.1 to 211.208 (20212022).
(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.
R 338.557 ClosureClosing of
a manufacturer.
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 at leastnot less than 15 days before
prior to 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.
(2) A manufacturer shall comply with all applicable federal requirements for discontinuing a controlled substance business.
(3) Records must be maintained for the same amount of time that is required if the manufacturer remains open.
R 338.559 Relicensure and renewal.
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 34 of these
rules, R 338.531 to R 338.539R 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.
PART 5. WHOLESALE DISTRIBUTOR AND
WHOLESALE DISTRIBUTOR-BROKER LICENSE
R 338.563 Wholesale distributor, wholesale distributor-broker; application for licensure;
requirements.
Rule 63. (1) An applicant for a wholesale distributor or wholesale distributor-broker license shall submit to the department a completed application on a form provided by the department with the requisite fee. A wholesale distributor includes virtual manufacturers.
(2) An applicant shall comply with all of the following:
(a) Provide a criminal history
background check required pursuant tounder section 17748(6) of the
code, MCL 333.17748.
(b) Disclose on the application form each
license, registration, or certification in a health profession or specialty
issued by any otheranother state, the United States military, the
federal government, or another country.
(c) Satisfy the requirements of section
16174(2) of the code, MCL 333.16174, which include including verification
from the issuing entity showing that disciplinary proceedings are not pending
against the applicant and sanctions are not in force at the time of application.
(d) Provide certified copies of articles of incorporation or certificates of partnership and assumed names if applicable.
(e) Provide the identity and address of each partner, officer, or owner as applicable.
(f) Provide a completed compliance checklist.
(g) Provide a FEIN certificate.
(h) Provide a copy of the FDA certification,
if a certification is required by the FDA, for the site to be licensed, if the
applicant is distributing biologicals.
(ih) Unless exempt under section
17748(2) of the code, MCL 333.17748, provide the name and the license number of
the pharmacist designated as the PIC or the name of the facility manager. If
a PIC or facility manager is unable to fulfil his or her duties for 120 consecutive
days, the pharmacy shall appoint a new PIC or facility manager and notify the
department as required in section 17748(4) of the code, MCL 333.17748. For
individuals designated as a facility manager, the applicant shall provide proof,
in the form of an affidavit, that the facility manager has achieved the following:
(i) A high school equivalency education, or higher, defined as 1 of the following:
(A) A high school diploma.
(B) A GED.
(C) A parent-issued diploma for home schooled individuals.
(D) Completion of post-secondary education, including an associate’s, bachelor’s, or master’s degree.
(ii) Completion of a training program that
includes, but is not limited to, all of the following subjects:
(A) Knowledge and understanding of laws in this state and federal laws relating to the distribution of drugs and devices.
(B) Knowledge and understanding of laws in this state and federal laws relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the USP standards relating to the safe storage and handling of prescription drugs.
(E) Knowledge and understanding of pharmaceutical terminology, abbreviations, dosages, and format.
(iii) Experience equal to either of the following:
(A) A minimum of 1 year of work experience related to the distribution or dispensing of prescription drugs or devices where the responsibilities included, but were not limited to, recordkeeping.
(B) Previous or current employment as
a designated representative of a wholesale distributor certified by the VAWD
of NABP drug distributor accreditation or of a wholesale distributor-broker.
(iv) Current employment with the applicant.
(ji) Provide a list or catalog
of all drug products and devices to be distributed, if a wholesale distributor.
(kj) If a wholesale distributor-broker,
Ssubmit an affidavit, at the time of the application for initial licensure,
that the applicant facilitates deliveries or trades for at leastnot 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
application, if a wholesale distributor-broker.
(3) A wholesale distributor or wholesale
distributor-broker that changes its facility manager shall submit all of the information
required in subrule (2)(ih) of this rule to the department within
30 days ofafter the change.
R 338.569 Wholesale distributor and wholesale distributor-broker recordkeeping and
policy requirements.
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.
(2) A wholesale distributor shall establish
and maintain a list of officers, directors, managers, and other individuals persons
who are in charge of wholesale drug distribution, storage, and handling, including
a description of their duties and a summary of their qualifications.
(3) A wholesale distributor shall have written policies and procedures that include all of the following:
(a) A procedure whereby the oldest
stock of a prescription drug is distributed first. The procedure may permit allow
deviation from this requirement if the deviation is temporary and appropriate.
(b) A procedure for handling recalls and withdrawals of the prescription drugs or devices. The procedure must deal with recalls and withdrawals due to any of the following:
(i) Any action initiated at the request of the FDA; other federal, state, or local law enforcement agency; or other governmental agency.
(ii) Any voluntary action by the manufacturer to remove defective or potentially defective prescription drugs or devices from the market.
(iii) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.
(c) A procedure to ensure that a wholesale
distributor prepares for, protects against, and handles, any crises that
affects security or operation of any facility, including in the event
of employee strike, flood, fire, or other natural disaster, or other local,
state, or national emergency.
(d) A procedure to ensure that any outdated
prescription drugs or devices are will be segregated from other prescription
drugs or devices and either returned to the manufacturer or destroyed. This
procedure must include a provision for the written documentation of the disposition
of outdated prescription drugs or devices that must be maintained for 2 years after
the disposition of the outdated prescription drugs or devices.
(e) Procedures for identifying, recording, and reporting losses or thefts of prescription drugs or devices and for correcting errors and inaccuracies in inventory.
(4) A wholesale distributor-broker shall
establish and maintain a list of officers, directors, managers, and other individuals
persons who are in charge of wholesale drug delivery and trade, including
a description of their duties and a summary of their qualifications.
(5) A wholesale distributor-broker shall
maintain for at leastnot less than 7 years the transaction
history, transaction statements, and transaction information required by section
17748e of the code, MCL 333.17748e.
(8) A purchasing pharmacy using a wholesale
distributor-broker to facilitate a transaction from a pharmacy that is not licensed
in this state Michigan shall request the transaction history, transaction
statement, or transaction information for the drugs supplied.
R 338.571 Facility requirements.
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 for 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 have been 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 will provides protection against theft and diversion.
WhenIf appropriate, the security system must provide protection against
theft or diversion that is facilitated or hidden by tampering with computers or
electronic records.
(2) All prescription drugs or devices must
be stored at temperatures and under appropriate conditions pursuant tounder
the label requirements or pursuant to the requirements set forth in the
current edition of the USP compendium. If storage requirements are not established
for a prescription drug, the drug may be held at a controlled room temperature
to help ensure that its identity, strength, quality, and purity are not adversely
affected. Appropriate manual, electromechanical, or electronic temperature and
humidity recording equipment devices, or logs must be utilized to document the
proper storage of prescription drugs or devices.
R 338.575 Closing a wholesale distributor or wholesale distributor-broker.
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 shall provide
the department with written notification of all of the following at leastnot
less than 15 days before prior to closing:
(a) The effective date of closing.
(b) How controlled substances will be disposed.
(c) How noncontrollednon-controlled
substances will be disposed.
(d) The location where records and prescription files will be stored.
(2) A wholesale distributor shall comply with all applicable federal requirements for discontinuing a business that handles a controlled substance.
(4) Records must be maintained for the same amount of time that is required if the wholesale distributor or wholesale distributor-broker remained open.
R 338.577 Relicensure and renewal of wholesale distributor and wholesale distributor-
broker.
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 35 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 at leastnot 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.
PART 6. PRACTICE OF PHARMACY
R 338.583 Prescription drug receipts.
Rule 83. (1) The purchaser of a prescription
drug shall receive, at the timewhen 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.
(2) Notwithstanding R 338.582, the information required in this rule must appear on either the prescription label or on a combination label and receipt.
(3) For prescription services that are covered by a third-party pay contract, the price included in the receipt is the amount paid by the patient.
(4) A pharmacist shall retain a copy of the receipt for a period of 90 days. The inclusion of the information required in this rule in the automated data processing system or on the written prescription form and the retention of the form constitutes retaining a copy of the receipt. The physical presence of the prescription form in the pharmacy or the ability to retrieve the information from the automated data processing system constitutes compliance with the requirement of having the name and address of the pharmacy on the form.
(5) This rule does not apply to pharmacy services provided in a medical institution.
R 338.583a Pharmacy acquisition and distribution records.
Rule 83a. (1) A pharmacy must shall
keep and make available for inspection all acquisition and distribution
records for prescription and non-prescription drugs and devices, such
asincluding 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.
R 338.584 NoncontrolledNon-controlled
prescriptions.
Rule 84. (1) A prescriber who issues a prescription
for a noncontrollednon-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,
then the species of the animal and the full name of the owner.
(2) A prescriber shall ensure that a prescription is legible, and that the information specified in subrule (1)(c) to (h) of this rule is clearly separated.
(3) A prescriber shall not prescribe
more than either 1 of the following on a single prescription form
as applicable:
(a) For a prescription prescribed in handwritten form, up to 4 prescription drug orders.
(b) For a prescription prescribed on a computer-generated form or a preprinted list or produced on a personal computer or typewriter, up to 6 prescription drug orders.
(4) A prescription is valid for 1 year fromafter
the date the prescription was issued.
(6) This rule does not apply to pharmacy services provided in a medical institution.
R 338.585 Customized patient medication package.
Rule 85. (1) A pharmacist may, with the consent
of the patient, or the patient’s caregiver, or a prescriber, provide a customized
patient medication package (CPMP). A CPMP is a package that is
prepared by a pharmacist for a specific patient and that contains 2 or more prescribed
solid oral dosage forms. 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 person that who 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.
(b) A CPMP must be accompanied by any mandated patient information required under federal law. Alternatively, required medication information may be incorporated by the pharmacist into a single educational insert that includes information regarding all of the medications in the CPMP.
(c) At a minimum, each CPMP must comply
with the United States Pharmacopeia (USP) and national formularyNational
Formulary, as defined in section 17706(2) of the code, MCL 333.17706,
for moisture permeation requirements for a class b single-unit or unit-dose container.
Each container must be either non-reclosable or so designed as to show
evidence of being opened. Each CPMP must comply with all of the provisions of
the poison prevention packaging act of 1970, 15 USC 1471 to 1477.
(d) WhenIf preparing a CPMP,
the dispenser shall consider any applicable compendial requirements or guidelines,
the physical and chemical compatibility of the dosage forms placed within each container,
and any therapeutic incompatibilities that may attend the simultaneous administration
of the medications. Medications must not be dispensed in CPMP packaging in any
of the following situations:
(i) The USP monograph or official labeling requires dispensing in the original container.
(ii) The drugs or dosage forms are incompatible with packaging components or each other.
(iii) The drugs are therapeutically incompatible when administered simultaneously.
(iv) The drug products require special packaging.
(e) If 2 medications have physical characteristics that make them indistinguishable from each other, then the medication must not be packaged together in the same CPMP.
(f) Medications that are have
been dispensed in CPMP packaging may not be returned to stock or dispensed
to another patient when returned to the pharmacy for any reason. If a prescription
for any drug contained in the CPMP is changed, then a new appropriately labeled
CPMP must be prepared for the patient.
(g) In addition to all individual prescription filing requirements, a record of each CPMP dispensed must be made and filed. At a minimum, each record must contain all of the following information:
(i) The name and address of the patient.
(ii) The serial number of the prescription order for each drug product contained in the CPMP.
(iii) Information identifying or describing the design, characteristics, or specifications of the CPMP sufficient to allow subsequent preparation of an identical CPMP for the patient.
(iv) The date of preparation of the CPMP and the expiration date assigned.
(v) Any special labeling instructions.
(vi) The name or initials of the pharmacist who prepared the CPMP.
R 338.586 Prescription records; nonapplicability to inpatient medical institution service.
Rule 86. (1) Each prescription must be chronologically
numbered, and the pharmacist performing final verification before dispensing must
shall record, manually or electronically, the prescription number, dispensing
date, and his or her the pharmacist's initials at the time of
when the prescription is first fillingfilled 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.
(2)(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.
(34) 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.
(45) This rule does not
apply to pharmacy services provided in a medical institution.
R 338.587 Prescription refill records; manual systems; profile systems; automated
pharmacy data systems; nonapplicability to medical institution service; record
confidentiality; and access.
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 deemed
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.
(3) A pharmacy may utilize a uniform system of recording refills if the system complies with all of the following criteria:
(a) Records must be created and maintained in written form. All original and refill prescription information for a particular prescription appears on single documents in an organized format. The records are subject to inspection by the board or its agents.
(b) The following information for each prescription must be entered on the record:
(i) The prescription number.
(ii) The patient's name and address.
(iii) The prescriber's name.
(iv) The prescriber's federal drug
enforcement administration (DEA) number, if appropriate.
(v) The number of refills authorized.
(vi) The "dispense as written" instructions, if indicated.
(vii) The name, strength, dosage form,
quantity, and name of the manufacturer of the drug prescribed, and the drug dispensed
originally and after upon each refill. If the drug 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.
(viii) The date of issuance of the prescription.
(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill. If a pharmacy technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must be recorded.
(c) Prescription entries must be made on
the record at the timewhen the prescription is first filled and
at the time of each refill, except that the format of the record may be
organized so that information already entered on the record may appear for a prescription
or refill without reentering the information. The dispensing pharmacist is responsible
for the completeness and accuracy of the entries and must shall initial
the record each time a prescription is filled or refilled.
(d) The information required by subdivision (b) of this subrule must be entered on the record for all prescriptions filled at a pharmacy, including nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.
(a) All information that is pertinent to a prescription must be entered on the record, including all of the following information:
(i) The prescription number.
(ii) The patient's name and address.
(iii) The prescriber's name.
(iv) The prescriber's federal DEA
number, if appropriate.
(v) The number of refills authorized.
(vi) Whether the drug must be dispensed as written.
(vii) The name, strength, dosage form, quantity,
and name of the manufacturer of the drug prescribed and the drug dispensed originally
and after upon each refill. If the drug 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.
(viii) The date of issuance of the prescription.
(ix) The date and identifying designation of the dispensing pharmacist for the original filling and for each refill. If a pharmacy technician performs final product verification, the identification of the delegating pharmacist and pharmacy technician must be recorded.
(b) Prescription entries must be made
on the record at the timewhen the prescription is first filled
and at the time of each refill, except that the format of the record may
be organized so that information already entered on the record may appear for a
prescription or refill without reentering the information. The dispensing pharmacist
is responsible for the completeness and accuracy of the entries. A pharmacy
shall keep the original prescription record on site for 5 years. After 2
Two years fromafter the date of the prescription’s issue date,
a pharmacy may make an electronic duplicate of the original non-controlled paper
prescription, which will becomes the original prescription. The
records are subject to inspection by the board or its agents. A procedure must
be established to facilitate inspections.
(c) The required information must be entered on the record for all prescriptions filled at the pharmacy, including nonrefillable prescriptions. This requirement is in addition to the requirements set forth in R 338.586.
(d) The recording system must provide adequate safeguards against improper manipulation, the alteration of records, and the loss of records.
(f) If the automated data processing system is inoperative for any reason, then the pharmacist shall ensure that all refills are authorized and that the maximum number of refills is not exceeded. When the automated data processing system is restored to operation, the pharmacist shall enter the information regarding prescriptions filled and refilled during the inoperative period into the automated data processing system within 48 hours.
(g) A pharmacy shall make arrangements with the supplier of data processing services or materials to ensure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with the supplier terminates for any reason. A pharmacy shall ensure continuity in the maintenance of records.
(h) The automated data processing system
must be an integrated system that is capable of complying complies with
all of the requirements of these rules.
(5) This rule does not apply to pharmacy services provided in a medical institution.
(6) Records that are created under subrule (2), (3), or (4) of this rule are subject to the same requirements regarding confidentiality and access that apply to original prescriptions.
R 338.588 Automated devices.
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 provided that 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(4) 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, thatwhich
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.
(73) Records and electronic
data kept maintained by automated devices must meet all of the following
requirements:
(a) All events involving access to the contents of the automated devices must be recorded electronically.
(b) Records must be maintained for 5 years by the pharmacy or dispensing prescriber and must be retrievable on demand for review by an agent of the board. The records must include all of the following information:
(i) The unique identifier of the automated device accessed.
(ii) Identification of the individual accessing the automated device.
(iii) The type of transaction.
(iv) The name, strength, dosage form, quantity, and name of the manufacturer of the drug accessed.
(v) The name of the patient for whom the drug was ordered.
(vi) Identification of the pharmacist responsible for the accuracy of the medications to be stocked or restocked in the automated device.
(84)
Except for devices allowed under R 388.588a(2), Policypolicy
and procedures for the use of the automated device must include a requirement
for pharmacist review of the prescription or medication order before system profiling
or removal of any medication. from the system for immediate patient
administration.
This subrule does not apply to the following situations:
(a) The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as provided in R 338.486(4)(j). A pharmacist shall review the orders and authorize any further dispensing within 48 hours.
(b) The system is being used in place of an emergency kit as provided in R 338.486(4)(c). A pharmacist shall review the orders and authorize any further dispensing within 48 hours.
(c) The system is being accessed to remove medication required to treat the emergent needs of a patient as provided in R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order. A pharmacist shall review the orders and authorize any further dispensing within 48 hours.
(d) In each of the situations specified
in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders
and authorize any further dispensing within 48 hours.
(ed) The automated device
is located in a dispensing prescriber's office to facilitate dispensing by the
dispensing prescriber.
(95) A copy of all policies
and procedures related to the use of an automated device must be maintained at the
pharmacy responsible for the device's specific location or at the dispensing prescriber's
office and be available for review by an agent of the board.
(3) A pharmacy that operates an automated
device under this section only to deliver a non-controlled drug or device directly
to an ultimate user or health care provider shall notify the department of the
automated device’s location on a form provided by the department. An automated
device located within a licensed pharmacy must be under the control of a pharmacist
or his or her pharmacy personnel under the personal charge of a pharmacist. A
secured, lockable, and privacy enabled automated device located on the premise
of the licensed pharmacy may be utilized as a means for a patient or an agent of
the patient to pick up prescription medications.
(4) If an automated
device is used in a dispensing prescriber's office, the device must be used only
to dispense medications to the dispensing prescriber's patients and only under the
control of the dispensing prescriber. A pharmacy shall not own, control, or operate
an automatic dispensing device in a dispensing prescriber's office, unless the
prescriber’s office is affiliated with a hospital consistent with section 17760
of the code, MCL 333.17760, and subrule (2)(h) of this rule. All of the following
apply to the use of an automated device in a dispensing prescriber's office:
(a) If a dispensing prescriber delegates
the stocking of the automated device, then technologies must be in place and utilized
to ensure that the correct drugs are stocked in their appropriate assignment
utilizing a board-approved error prevention technology that complies with R 338.3154.
(b) A dispensing prescriber operating an
automated device is responsible for all medications that are stocked and stored
in that device as well as removed from that device.
(c) If any medication or device is dispensed
from an automated device in a dispensing prescriber’s office, then documentation
as to the type of equipment, serial numbers, content, policies, procedures, and
location within the facility must be maintained by the dispensing prescriber for
review by an agent of the board. This documentation must include at least all of
the following information:
(i) Manufacturer name and model.
(ii) Quality assurance policy and procedure
to determine continued appropriate use and performance of the automated device.
(iii) Policy and procedures for system
operation that addresses, 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.
(5) An automated device that is to be used
for furnishing medications for administration to registered patients in any hospital,
county medical care facility, nursing home, hospice, or any other skilled nursing
facility, as defined in section 20109(4) of the code, MCL 333.20109, must be supplied
and controlled by a pharmacy that is licensed in this state. The use of an automated
device in these locations is not limited to the provisions of subrule (3) of this
rule. If a pharmacist delegates the stocking of the device, 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.
Each automated device must comply with all of the following provisions:
(a) 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.
(b) 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 at least 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.
(6) An automated device that is operated
at a location affiliated with a hospital, but not at the same physical address
as the pharmacy, that is owned and operated by the hospital, must comply with section
17760 of the code, MCL 333.17760.
R 338.588a Automated devices in non-inpatient settings.
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.
(2) A pharmacy licensee may locate a non-dispensing storage and pick up device inside of the pharmacy that is used for a patient or agent of the patient to pick up prescription medication if the automated device is secured, lockable, and privacy enabled.
(3) If an automated device is used in a dispensing prescriber's office, and the automated device is not affiliated with a pharmacy, the device must be used only to dispense medications to the dispensing prescriber's patients and only under the control of the dispensing prescriber. All of the following apply to the use of an automated device in a dispensing prescriber's office:
(a) If a dispensing prescriber delegates the stocking of the automated device, then technologies must be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that complies with R 338.3154.
(b) A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in that device, as well as removed from that device.
(c) If any medication or device is dispensed from an automated device in a dispensing prescriber’s office, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility must be maintained by the dispensing prescriber for review by an agent of the board. This documentation must include all of the following information:
(i) Manufacturer name and model.
(ii) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.
(iii) Policy and procedures for system operation that addresses, 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.
R 338.588b Automated devices in medical institutions.
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.
(2) An automated device that is operated at a location affiliated with a hospital, but not at the same physical address as the pharmacy, which is owned and operated by the hospital, must comply with section 17760 of the code, MCL 333.17760.
R 338.589 Professional responsibility; patient counseling; “caregiver” defined.
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 will may be used for other than legitimate
medical purposes.
(3) A prescription drug must be dispensed only when the pharmacy is open and under the personal charge of a pharmacist.
(4) To encourage intended, positive
patient outcomes, a pharmacist shall communicate to the patient, or the patient’s
caregiver, necessary and appropriate information regarding safe and effective
medication use at the timewhen a prescription is dispensed. As used
in this subrule, “caregiver” means the parent, guardian, or other individual
who has assumed responsibility for providing a patient’s care. All of the following
provisions apply to communicating medication safety and effectiveness information:
(a) The information must be communicated orally and in person, except when the patient or patient’s caregiver is not at the pharmacy or when a specific communication barrier prohibits oral communication. In either situation, providing printed or electronic/digital material designed to help the patient use the medication safely and effectively satisfies the requirements of this subrule.
(b) The information must be provided with each prescription for a drug not previously prescribed for the patient.
(c) If the pharmacist deems determines
it appropriate, the information must be provided with prescription refills.
(d) The information must be provided if requested by the patient or patient’s caregiver or agent for any prescription dispensed by the pharmacy. This subrule does not require that a pharmacist provide consultation if a patient or a patient’s caregiver refuses consultation. This subrule does not apply to prescriptions dispensed for administration to a patient while the patient is in a medical institution.
(5) Pharmacist delegation of acts,
tasks, or functions shall be in compliance must comply with
section 16215 of the code, MCL 333.16215, and be under the personal charge
of the delegating pharmacist, except as provided in section 17742b of the
code, MCL 333.17742b, R 338.486, and R 338.3665(c). A pharmacist who
that delegates acts, tasks, or functions to a licensed or unlicensed individual
person shall do all of the following:
(a) Determine the knowledge and skill required to safely and competently complete the specific act, task, or function to be delegated.
(b) Before delegating an act, task, or
function, make a determination determine whether that the
delegate has the necessary knowledge and skills to safely and competently complete
the act, task, or function.
(c) Provide written procedures or protocols, or both, to be followed by the delegatee in the performance of the delegated act, task, or function.
(d) Supervise and evaluate the performance of the delegatee.
(e) Provide remediation of the performance of the delegatee, if indicated.
(6) A delegating pharmacist shall
bears the ultimate responsibility for the performance of delegated acts,
tasks, and functions performed by the delegatee within the scope of the delegation.
(7) A pharmacist may remotely access a pharmacy database as well as any other necessary databases that are routinely accessed to perform their functions. In accessing any database, a pharmacist shall provide adequate security to protect the confidentiality and integrity of a patient’s protected health information.
R 338.590 Hospice emergency drug box.
Rule 90. (1) A pharmacy that establishes
a medication box exchange program for hospice emergency care services rendered
in patients' homes pursuant tounder the provisions of section
17746 of the code, MCL 333.17746, shall establish drug boxes that are in
compliance 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 at leastnot 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 prescFriptionsprescriptions
for drugs removed from the drug boxes are obtained from an appropriate prescriber.
(2) A pharmacy shall stock drug boxes for a hospice emergency care system in accordance with the policies and procedures developed by the hospice and approved by the hospice medical director.
(3) The drugs contained in each drug box
must be listed inside the front cover of the box. Each box must be equipped
with only 1 nonreusable, tamper-evident seal or sealing system whichthat
is a color that designates that the box has not been opened and several nonreusable,
tamper-evident seals or sealing systems whichthat are a different
color that designates that the box has been opened.
(4) A drug box must be numbered. A permanent record of all drug boxes must be maintained at the pharmacy.
(5) A label that contains all of the following information must be attached to the drug box so that it is visible from the outside of the box:
(a) The name and address of the pharmacy.
(b) The name and address of the hospice.
(c) The name of the pharmacist who last inspected and restocked the drug box.
(d) The date the drug box was last restocked.
(e) The date on which the drug box
must be returned to the pharmacy for the replacement of expired drugs.
(f) The number of the drug box.
(6) After the drug box has been stocked
and labeled, the pharmacist shall seal it with the nonreusable, tamper-evident
seal or sealing system which that is the color that designates that
the box has not been opened.
(7) A drug box must be kept maintained
in a substantially constructed, securely locked storage compartment when
not under the direct control of the pharmacist, prescriber, registered nurse,
or physician’s assistant. The box must be stored under conditions that will maintain
the stability, integrity, and effectiveness of the drugs. Access to the storage
compartment and to the drug box must be limited to individuals who are authorized
to stock the drug box or to dispense drugs from the drug box on the order of an
appropriate prescriber.
(8) The drug box must remain sealed at
all times, except when in use. All drugs removed from the box must be recorded
on a medication use form. After completing the form, the physician, registered
nurse, or physician's assistant who removed the drug must place the form
in the drug box and seal the box with a nonreusable, tamper-evident seal or sealing
system which that is a color that designates that the box has been
opened.
(9) Each drug box under the control of
the pharmacy must be examined at leastnot less than weekly to
ensure that the seal, which designates that the box has not been opened
is still intact and the expiration date, has not been exceeded. If the expiration
date has been exceeded or the box has been opened, the box must be returned to
the pharmacy. The written prescription for all drugs that have been administered
from the drug box must accompany the drug box when it is returned to the pharmacy
after opening.
(10) The pharmacy shall maintain a permanent record of drug box exchanges on a drug box exchange log. The record must contain all of the following information:
(a) The number of the box.
(b) The name of the hospice to which the box is released.
(c) The date the box is released to the hospice.
(d) The name and signature of the pharmacist who releases the box to the hospice.
(e) The expiration date assigned.
(f) The date the box is returned to the pharmacy for restocking.
(g) The name and signature of the pharmacist who received the box for restocking.
(11) Upon On the return of
the drug box to the pharmacy, the pharmacist shall reconcile the drugs dispensed
from the drug box with the prescriptions of the appropriate prescriber or medical
director of the hospice. The pharmacist shall note that the prescriptions were dispensed
from the hospice drug box on the back of the prescriptions. The prescriptions must
be filed in the same manner as other prescriptions are maintained at the pharmacy.
R 338.591 Dispensing emergency supply of insulin.
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.
(2) If the smallest single package of insulin available exceeds a 30-day supply, dispensing the package of insulin that is available complies with this rule and section 17744f of the code, MCL 333.17744f.