SB-0468, As Passed House, September 24, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

SENATE BILL No. 468

(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.>>