SB-0468, As Passed House, September 24, 2015
(As amended September 17, 2015)
September 9, 2015, Introduced by Senator GREEN and referred to the Committee on Health Policy.
<<A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 17739a, 17739b, 17739c, and 17748a
(MCL 333.17739a, 333.17739b, 333.17739c, and 333.17748a), sections
17739a, 17739b, 17739c as added by 2014 PA 285 and section 17748a
as added by 2014 PA 280.>>
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 17739a. (1) Subject to subsection (2), the department may
license an individual who meets all of the following requirements
as a pharmacy technician under this part:
(a) Submits a completed application to the department on a
form prescribed by the department.
(b)
Graduated Except as
otherwise provided in subsection (4),
graduated from an accredited high school or comparable school or
educational institution or passed the general educational
development test or other graduate equivalency examination.
(c) Satisfies the requirements of section 16174.
(d) Except as otherwise provided in subsection (4), passes and
submits proof to the department of passage of any of the following:
(i) The certified pharmacy technician examination given by the
pharmacy
technician certification board.Pharmacy
Technician
Certification Board.
(ii) The certified pharmacy technician examination given by
the
national healthcareer association.National Healthcareer
Association.
(iii) Any other nationally recognized and administered
certification examination approved by the board.
(iv) An employer-based training program examination that is
approved by the board and covers job descriptions, pharmacy
security, commonly used medical abbreviations, routes of
administration, product selection, final check by pharmacists,
guidelines for the use of pharmacy technicians, pharmacy
terminology, basic drug information, basic calculations, quality
control procedures, state and federal laws and regulations
regarding pharmacy technician duties, pharmacist duties, pharmacy
intern duties, prescription or drug order processing procedures,
drug record-keeping requirements, patient confidentiality, and
pharmacy security and drug storage.
(2) An individual who is not a pharmacist, pharmacist intern,
or pharmacy technician shall not perform any of the functions
described in section 17739(1) for a pharmacy.
(3) A pharmacist shall not allow any individual employed or
otherwise under the personal charge of the pharmacist to violate
subsection (2). A person that owns, manages, operates, or conducts
a pharmacy shall not allow any individual employed or otherwise
under the control of that person to violate subsection (2).
(4) An individual who meets any of the following is not
required
to meet the examination requirement described in
subsection
(1)(d) requirements of
subsection (1)(b) and (d) to be
eligible for a license under subsection (1):
(a) As provided in section 16171(a), is a student in a
pharmacy technician program approved by the board.
(b) Is applying for a temporary license under section 17739b.
(c) Is applying for a limited license under section 17739c.
Sec. 17739b. (1) Subject to section 17739a(4), the department
may issue a temporary license as a pharmacy technician to an
individual who is preparing for the examination under section
17739a(1)(d). Notwithstanding section 16181, the term of a
temporary
license issued under this section expires 210 days 1 year
after the date the temporary license is issued.
(2) An individual requesting a temporary license under this
section shall submit a completed application, on a form prescribed
by the department, to the department and pay the applicable fee
under section 16333.
(3) An individual who holds a temporary license as a pharmacy
technician issued under subsection (1) is subject to all of the
requirements of this part, and rules promulgated by the department
in consultation with the board, applicable to pharmacy technicians
except the examination requirement under section 17739a(1)(d).
Sec. 17739c. (1) In addition to the requirement of section
16182 and subject to section 17739a(4), the department may issue a
limited license as a pharmacy technician to an individual if all of
the following are met:
(a) The individual was employed as a pharmacy technician by a
pharmacy
on the effective date of the amendatory act that added
this
section December 22, 2014 and has been continuously employed
by that pharmacy since that date.
(b) The individual submits a completed application to the
department on a form prescribed by the department and meets the
requirements of section 16174.
(c) The individual provides documentation of satisfactory
employment as a pharmacy technician for a minimum of 1,000 hours
during the 2-year period immediately preceding the date of his or
her application under subdivision (b).
(d) The applicable fee under section 16333 is paid.
(2)
An Except as otherwise
provided in subsection (5), an
individual who holds a limited license under this section may only
act as a pharmacy technician for the pharmacy described in
subsection (1)(a) and only until 1 of the following occurs:
(a) He or she is no longer employed by that pharmacy to
perform those functions.
(b) He or she performs any of those functions for another
pharmacy.
(3) The term of a limited pharmacy technician license issued
by the department under this section is the same as a pharmacy
technician license issued by the department under section 17739a.
(4) An individual who holds a limited pharmacy technician
Senate Bill No. 468 as amended September 16, 2015 (1 of 2)
license issued under this section is subject to all of the
requirements of this part, and the rules promulgated by the
department in consultation with the board, except the examination
requirement under section 17739a(1)(d).
(5) An individual who is employed as a pharmacy technician by
an employer that operates multiple licensed pharmacy locations may
work as a limited license pharmacy technician at any of the
employer's licensed pharmacy locations in this state.
<<Sec. 17748a. (1) Beginning on the
effective date of this
section, September 30, 2014,
an applicant for a new pharmacy
license for a pharmacy that will provide compounding services for
sterile pharmaceuticals shall submit verification of current accreditation through a national accrediting organization approved
by the board or verify the pharmacy is in the accreditation
process. The department shall not issue a license to a pharmacy
described in this subsection that is not accredited unless the
applicant demonstrates compliance with USP standards in a manner
determined by the board.
(2) By 1 year after the effective date of this
section,
September 30, 2016, a pharmacy that is licensed on the effective
date of this section September 30, 2014 and that provides
compounding services for sterile pharmaceuticals must be accredited
by a national accrediting organization approved by the board, be
verified by the board as being in the accreditation process, or be
in compliance with USP standards in a manner determined by the
board.
(3) Notwithstanding any provision of part 161 to the contrary,
a pharmacy that provides compounding services for sterile
pharmaceuticals shall submit with a license renewal application
verification of current accreditation or compliance with USP
standards, as applicable.
(4) A person that provides services consistent with an
outsourcing facility shall comply with requirements of the FDA
applicable to compounding services for sterile pharmaceuticals.
(5) A pharmacy shall notify the department of a complaint
filed by another state in which the pharmacy is licensed for
violations of that state's pharmacy laws, an investigation by
federal authorities regarding violations of federal law, or an
investigation by any agency into violations of accreditation
standards regarding compounding activities within 30 days of
knowledge of the complaint or investigation.
(6) Except for distribution within a hospital or another
health care entity under common control when regulated by federal
law, a pharmacist shall maintain a record of a compounded sterile
pharmaceutical in the same manner and for the same retention period
as prescribed in rules for other prescription records. The
pharmacist shall include, but is not limited to including, all of
the following information in the record required under this
subsection:
(a) The name, strength, quantity, and dosage form of the
compounded pharmaceutical.
(b) The formula to compound that includes mixing instructions,
all ingredients and their quantities, and any additional
information needed to prepare the compounded pharmaceutical.
(c) The prescription number or assigned internal
identification number.
(d) The date of preparation.
(e) The manufacturer and lot number of each ingredient.
(f) The expiration or beyond-use date.
(g) The name of the person who prepared the compounded
pharmaceutical.
(h) The name of the pharmacist who approved the compounded
pharmaceutical.
(7) A pharmacist shall not offer excess compounded
pharmaceuticals to other pharmacies for resale. A compounding
pharmacy shall not distribute samples or complimentary starter
doses of a compounded pharmaceutical to a health professional.
(8) A compounding pharmacy may advertise or otherwise promote
the fact that they provide compounding services.
(9) Based on the existence of a health professional/patient
relationship and the presentation of a valid prescription, or in
anticipation of the receipt of a prescription based on routine,
regularly observed prescription patterns, a pharmacist may compound
for a patient a nonsterile or sterile pharmaceutical that is not
commercially available in the marketplace.
(10) Notwithstanding any provision of this act to the
contrary, a person shall not compound and manufacture drug products
or allow the compounding and manufacturing of drug products at the
same location.
(11) The department, in consultation with the board, may
promulgate rules regarding conditions and facilities for the
compounding of nonsterile and sterile pharmaceuticals.>>