Section 338.3132. Activities requiring separate licenses.

Rule 32. (1) The following activities are deemed to be  independent  of each other, shall be conducted under separate licenses, and shall comply with all of the requirements

and duties prescribed by law for persons who are licensed to  engage  in   such coincidental activities:

(a)    Manufacturing and distributing a controlled substance.  A   person  who is licensed to manufacture a controlled substance listed in schedules 2 to 5 may conduct chemical analysis and research with a substance that is listed in the schedules.

(b)    Dispensing a controlled substance  listed   in  schedules   2  to  5. A physician   who is  licensed  to   prescribe   or    dispense    controlled substances listed in schedules  2   to

5 may conduct research with those substances.

(c)        Conducting research and instructional   activity  with  a controlled substance listed in schedule 1 as follows:

(i)    A person who  is licensed  to conduct research with  controlled substances listed in schedule 1 may do both of the following:

(A)   Manufacture the substances as set forth in the research protocol that is filed and approved by the federal food and drug administration and the drug enforcement administration (DEA) pursuant to the provisions of 21 C.F.R.§1301.18 and submitted with the application for licensure.  The Code of

Federal Regulations, Title 21, Food and Drugs, part 1301, containing §1301.18 is available   free   of    charge   via   the   Internet   at   web-site http://www.gpoaccess.gov. Printed copies may be purchased by mail order from the United States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954, USA, by  calling  toll free   at   1-866-512-1800, or   via   the   Internet    at    web-site http://bookstore.gpo.gov at a cost of $24.00 as of the time of adoption of

these amendments. Printed copies of 21 C.F.R. §1301.18 also are available for inspection and for distribution to the public at cost at the Department of Community Health, Bureau of Health Professions, Ottawa Building - First Floor, 611 West Ottawa, Lansing, MI 48909.

(B)     Distribute the substances to other persons who are licensed or authorized to conduct research or chemical analysis with the schedule 1 substances.

(ii)    A licensed physician who is authorized to conduct research with schedule 1 substances under federal law may conduct research with those substances, upon furnishing the administrator with evidence of that federal authorization. A separate license is not required for the research activity.

(d)     Conducting research with a controlled substance listed in schedules 2 to 5. A person who is licensed or authorized to conduct research with the controlled substances listed in schedules 2 to 5 may conduct chemical analysis with the substances   listed  in   those   schedules, manufacture  the substances if, and to the extent that, such manufacture  is set  forth  in  a  statement  filed  with  the   application for licensure, distribute the substances to other persons who are licensed or authorized to conduct research, chemical analysis, or instructional activity with the substances, and conduct instructional activities with the substances.

(e)      Conducting instructional activities with a  controlled  substance listed in schedules 2 to 5.

(f)      Prescribing, dispensing, or administering a controlled substance to a drug- dependent person in a drug treatment and rehabilitation program.

(g)    Conducting chemical analysis with a controlled substance    listed   in any schedule. A person who is licensed or authorized  to conduct chemical analysis with all controlled substances may  manufacture  such  substances  for  analytical  or instructional  purposes,   distribute  the substances   to   other persons    who   are licensed or authorized to conduct  chemical  analysis, instructional  activity  or research with the substances,  and   conduct instructional activities with the substances.

(2)   A separate license is required for each principal place of business or professional practice.   A  principal    place   of   business   or   a professional practice   is   the physical   location   where    controlled substances   are manufactured, grown, cultivated, processed, or by other means produced or prepared, distributed, stored, or dispensed by a licensee.

(3)    If a principal place of business or professional practice consists of multiple locations, then each location shall  obtain   a   separate controlled  substance   license if controlled  substances  are received,   stored, administered, or dispensed at that location.

(4)   A prescriber or practitioner who holds a controlled substance license to prescribe, administer, or dispense controlled substances at a principal place of business or professional practice consisting of multiple locations shall not be required to obtain a separate controlled substance license for each physical location of the principal place of business or professional practice if the prescriber or practitioner only prescribes at the location.

(5)   A pharmacist who holds a controlled substance license may dispense from any licensed pharmacy.

(6)   A separate controlled substances license is required, as provided in R 338.3154(4), when controlled substances are stored in an automated device and the automated device is not located at  the  same  address  as  the pharmacy responsible for the device.

History:  1979 AC; 1992 AACS; 2002 AACS; 2004 AACS; 2007 AACS.