Pennsylvania Code & Bulletin

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The Pennsylvania Code website reflects the Pennsylvania Code changes effective through 52 Pa.B. 5624 (August 27, 2022).

28 Pa. Code § 1171.23. Approval of laboratories.

§ 1171.23. Approval of laboratories.

 (a)  A laboratory wishing to identify, collect, handle and conduct tests on samples and test samples and other items used by a grower/processor in the growing and processing of medical marijuana and medical marijuana products as required under the act and this part shall submit an application for approval to the Department on a form and in a manner prescribed by the Department.

 (b)  An application submitted under this section must include the following information:

   (1)  The name and address of the laboratory applicant or its authorized agent.

   (2)  The name and address of the owner of the laboratory applicant, and, if applicable, the medical or pharmacy licensure information regarding the owner.

   (3)  The name of the laboratory applicant’s proposed director and technical personnel who are or will be employed by the laboratory at the location to be approved.

   (4)  A copy of the laboratory applicant’s most recent certificate of accreditation.

   (5)  Copies of the standard operating procedures and sampling procedures adopted by the laboratory applicant and approved by the accreditation body that issued the certificate of accreditation to the laboratory applicant.

   (6)  A list of the specialized laboratory equipment utilized or to be utilized by the laboratory applicant in its testing operations, including the manufacturer’s name and the serial and model number of the equipment, and other specifications as may be required by the Department.

   (7)  A description of the tests which are capable of being conducted by the laboratory applicant at the location to be approved.

   (8)  A description of the laboratory applicant’s quality assurance program, which must be in compliance with §  1171.32 (relating to quality assurance program).

   (9)  The procedures to be followed to establish chain of custody when collecting samples or test samples.

   (10)  A copy of the evaluation process that the laboratory applicant uses or will use to monitor, evaluate and document the competency of employees when testing samples and test samples and overseeing quality assurance controls.

   (11)  Other information required by the Department.

 (c)  By submitting an application for approval to the Department, a laboratory applicant consents to an investigation of any person, information or physical location the Department or its authorized agents deem appropriate for the Department to make a determination of the laboratory applicant’s ability to meet the requirements under the act and this part.

 (d)  An application for approval submitted under this chapter must include a statement that a false statement made in the application is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).

 (e)  The Department may issue an approval under this chapter if the Department determines that the laboratory applicant is financially and professionally suitable to conduct the testing required under the act and this part.

Cross References

   This section cited in 28 Pa. Code §  1171.22 (relating to laboratories generally); and 28 Pa. Code §  1171.25 (relating to renewal of an approval issued to a laboratory).

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