5 PROPOSED ADMINISTRATIVE RULES

 

 

ORR # 2004-018

 

DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES  COMMUNITY HEALTH

 

BOARD OF PHARMACY DIRECTOR’S OFFICE

 

CONTROLLED SUBSTANCES

 

Filed with the Secretary of State on

These rules take effect 7 days after filing with the Secretary of State

 

(By authority conferred on the director of the department of consumer and industry services by 1978 PA 368 and Executive Reorganization Order No. 1996-2, MCL 333.7201, 333.7301, 333.7333, 333.7333a,  333.16145, and 445.2001)

 

(By authority conferred on the director of the department of community health by section 7101 of 1978 PA 368, MCL 333.7101 et seq. and Executive Reorganization Order Nos. 1996-1, 1996-2 and

2003-18, MCL 330.3101, 445.2001 and 445.2011)

 

R 338.3101, R 338.3102 and R 338.3132 of the Administrative Code are amended as follows:

 

PART 1. GENERAL PROVISIONS

 

R 338.3101 Definitions; A to H.

Rule 1. As used in these rules:

(a)    “Act” means 1978 PA 368, MCL 333.1101 et seq.

(b)    “Deleterious drug” means a drug, other than a proprietary medicine, that is likely to be destructive to adult human life in quantities of 3.88 grams or less.

(c)        “Department” means the Department of Consumer and Industry Services department of community health.

(d)      “Electronic signature” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. An electronic signature also is a unique identifier protected by appropriate security measures such that it is only available for use by the intended individual and ensures nonrepudiation so that the signature could may not be rejected based on its validity.

 

R 338.3102 Definitions; I to P.

Rule 2. (1) As used in these rules:

(a)      “Inventory” means all stocks in finished form of a controlled substance that is manufactured or otherwise acquired by a licensee, whether in bulk or commercial containers or contained in pharmaceutical preparations in the possession of the licensee.

(b)    “Licensee” means a person who is licensed pursuant to section 7303 of the act.

 

 

(c)    “Michigan automated prescription system (maps) claim form” means a form, to be determined by the department, that is in the format and includes the information as specified by the american American society for automation in pharmacy (asap) and contains the information specified in R 338.3162b.

(d)      “National drug code number (ndc)” means an 11-digit, 3-segment number that identifies the labeler/vendor, product, and package size and is assigned to each drug product listed under section 510, registration of producers of drugs and devices, of the federal food, drug, and cosmetic act.

(e)    “Officer” means a state, county, or local law enforcement officer who has a duty to enforce the laws of this state.

(f)    “Patient identifier” includes all of the following information about a patient:

(i)      Full name.

(ii)    Address, including zip code.

(iii)    Date of birth.

(iv)    Any of the following:

(A)  Social security number.

(B)  Driver’s license number.

(C)  State-issued identification number.

(v)    If a patient is an animal, any of the following:

(A)  The owner’s social security number.

(B)  The owner’s driver’s license number.

(C)  The owner’s state-issued identification number.

(g)     “Prescriber” or “practitioner” means any of the following individuals who are licensed to prescribe by the laws of this state:

(i)    A dentist.

(ii)    A doctor of medicine.

(iii)    A doctor of osteopathic medicine and surgery.

(iv)    A doctor of podiatric medicine and surgery.

(v)    A veterinarian.

(vi) An optometrist.

(2)   As used in part 5 of these rules:

(a)     “Medical institution” means an inpatient health facility which is licensed or approved by the state and which directly or indirectly provides or includes pharmacy services.

(b)    “Pharmacy services” means the direct and indirect patient care services associated with the practice of pharmacy.

 

PART 3. LICENSES

 

R 338.3132 Activities requiring separate licenses.

Rule 32. 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 via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased 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 $20.00 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 Consumer and Industry Services, Bureau of Health Services 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.

(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, prescribed, 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 licensed physician 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 physician only prescribes at the location.

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