Pennsylvania Code & Bulletin
COMMONWEALTH OF PENNSYLVANIA

• No statutes or acts will be found at this website.

The Pennsylvania Code website reflects the Pennsylvania Code changes effective through 51 Pa.B. 3586 (June 26, 2021).

28 Pa. Code § 1171.21. Definitions.

§ 1171.21. Definitions.

 The following words and terms, when used in this part, have the following meanings, unless the context clearly indicates otherwise:

   Accreditation body—An organization which:

     (i)   Certifies the competency, expertise and integrity of a laboratory and operates in conformance with the current version of International Organization Standard ISO/IEC 17011.

     (ii)   Determines a laboratory’s compliance with and conformance to the relevant standards established by the International Organization for Standardization, including ISO/IEC 17025.

     (iii)   Is a signatory to the International Accreditation Cooperation Mutual Recognition Arrangement for Testing.

     (iv)   Is not affiliated with a laboratory applicant for which it has or will issue a certificate of accreditation.

   Approved laboratory—A laboratory that has applied for, and received, the approval of the Department to identify, collect, handle and conduct tests on samples from a grower/processor and test samples from the Department used in the growing and processing of medical marijuana or dispensing of medical marijuana products as required by the act and this part.

   Certificate of accreditation—A document issued by an accreditation body evidencing that a laboratory is in compliance with International Organization for Standardization Standard ISO/IEC 17025 or other standards relevant to the operation of laboratories conducting tests on medical marijuana, medical marijuana products and other items used in the growing and processing of medical marijuana or dispensing of medical marijuana products.

   Certificate of analysis—A document that confirms that the test performed by an approved laboratory on a harvest batch, harvest lot or process lot meets the testing requirements set forth by the Department.

   Certified registered nurse practitioner—The term as defined in section 2 of The Professional Nursing Law (63 P.S. §  212).

   Chain of custody—The written procedures used by employees of an approved laboratory to record the possession and transfer of samples and test samples from the time the samples and test samples are collected until the test of the sample or test sample is completed.

   Harvest batch—A specifically identified quantity of medical marijuana plant that is uniform in strain, cultivated utilizing the same growing practices, harvested at the same time and at the same location, and cured under uniform conditions.

   Harvest lot—A specifically identified quantity of medical marijuana plant taken from a harvest batch.

   Laboratory applicant—A laboratory that submits an application to the Department for approval to identify, collect, handle and test medical marijuana, medical marijuana products and other items used by a medical marijuana organization in the growing and processing of medical marijuana or dispensing of medical marijuana products as required under the act and this part for the Department or a grower/processor.

   Medical marijuana extract—A substance obtained by separating cannabinoids from medical marijuana plants by a mechanical, chemical or other process.

   Medical marijuana product—The final form and dosage of medical marijuana that is grown, processed, produced, sealed, labeled and tested by a grower/processor and sold to a dispensary.

   Pharmacist—The term as defined in section 2 of the Pharmacy Act (63 P.S. §  390-2).

   Physician—The term as defined in section 2 of the Medical Practice Act of 1985 (63 P.S. §  422.2) and section 2 of the Osteopathic Medical Practice Act (63 P.S. §  271.2).

   Physician assistant—The term as defined in section 2 of the Medical Practice Act of 1985 and section 2 of the Osteopathic Medical Practice Act.

   Process lot—Any amount of a medical marijuana product of the same type and processed using the same medical marijuana extract, standard operating procedures and the same or combination of different harvest lots.

   Processing—The compounding or conversion of medical marijuana extract by a grower/processor into a medical marijuana product.

   Sample—Medical marijuana or medical marijuana products collected by an employee of an approved laboratory from a grower/processor facility for testing by the laboratory.

   Test sample—An amount of medical marijuana, medical marijuana products or an amount of soil, growing medium, water or solvents used to grow or process medical marijuana, dust or other particles obtained from the swab of a counter or equipment used in the growing or processing of medical marijuana, or other item used in the growing or processing of medical marijuana in a grower/processor facility taken by an employee of an approved laboratory or an agent of the Department at the request of the Department from a grower/processor facility and provided to an approved laboratory for testing.



No part of the information on this site may be reproduced for profit or sold for profit.


This material has been drawn directly from the official Pennsylvania Code full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.