DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS  
DIRECTOR’S OFFICE  
PHARMACY - ANIMAL EUTHANASIA AND SEDATION RULES  
Filed with the secretary of state on October 28, 2021  
These rules take effect immediately upon filing with the secretary of state unless adopted  
under section 33, 44, or 45a(6) of the administrative procedures act of 1969, 1969 PA 306,  
MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections become effective 7  
days after filing with the secretary of state.  
(By authority conferred on the director of the department of licensing and regulatory affairs  
by section 7333 of the public health code, 1978 PA 368, MCL 333.7333 and Executive  
Reorganization Order Nos. 1991-9, 1996-2, 2003-1, and 2011-4, MCL 338.3501, 445.2001,  
445.2011, and 445.2030)  
R 338.3501, R 338.3502, R 338.3503, R 338.3504, R 338.3505, R 338.3506, R 338.3507,  
R 338.3509, R 338.3510, R 338.3511, R 338.3512, R 338.3513, R 338.3514, R 335.3515,  
R 338.3516, R 338.3517, R 338.3518, R 338.3520, R 338.3521, R 338.3522, and R 338.3523  
of the Michigan Administrative Code are amended, and R 338.3508 and R 335.3519 are  
rescinded, as follows:  
Part 1. GENERAL PROVISIONS  
R 338.3501 Definitions.  
Rule 1. (1) As used in these rules:  
(a) “Animal control shelter” means a facility operated by a municipality for the  
impoundment and care of animals that are found in the streets or at large, animals that are  
otherwise held due to the violation of a municipal ordinance or state law, or animals that are  
surrendered to the animal control shelter that holds a current registration issued by the  
Michigan department of agriculture and rural development (MDARD).  
(b) “Animal protection shelter” means a facility operated by a person, humane society,  
society for the prevention of cruelty to animals, or any other nonprofit organization for the  
care of homeless animals that holds a current registration issued by MDARD.  
(c) “Animal tranquilizer” means the term as defined in MCL 333.7333(20)(a), a  
commercially prepared solution of xylazine hydrochloride, a commercially prepared solution  
of ketamine, or a commercially prepared compound containing tiletamine and zolazepam.  
(d) “Code” means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.  
(e) “Department” means the department of licensing and regulatory affairs (LARA).  
(f) “Euthanasia” means a method of humane death that minimizes pain, distress, and  
anxiety experienced by the animal prior to loss of consciousness and causes rapid loss of  
consciousness followed by cardiac or respiratory arrest and death. The euthanasia training  
described in these rules and euthanasia provided under these rules must comply with the  
American Veterinary Medical Association’s guidelines for the euthanasia of animals.  
June 9, 2021  
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(g) “Individual” means an animal control officer; law enforcement officer; a person who is  
under contract with an animal control shelter or an animal protection shelter; or a person who  
is currently employed by an animal control shelter, an animal protection shelter, or a class B  
dealer, as used in these rules and section 7333(9) to (19) of the code, MCL 333.7333.  
(h) “Sedation” of an animal means a state of central nervous system depression caused by  
the administration of an animal tranquilizer in which the animal is awake but calm, and with  
sufficient stimuli may be aroused. Sedation of an animal must be accompanied by the  
additional use of an anesthetic agent inducing unconsciousness in the animal before euthanasia  
via intracardiac injection is allowed.  
(2) Unless otherwise defined in the rules, the terms defined in the code have the same  
meaning when used in these rules.  
PART 2. ANIMAL EUTHANASIA  
R 338.3502 Animal euthanasia; animal control shelters, animal protection shelters, class B  
dealers; authorization to apply for permit.  
Rule 2. (1) An animal control shelter, animal protection shelter, or a class b dealer, may  
apply for a permit to buy, possess, store, handle, and administer animal tranquilizers in  
addition to xylazine hydrochloride for pre-euthanasia sedation or a commercially prepared,  
pre-mixed solution of sodium pentobarbital to practice euthanasia on animals pursuant to the  
training required in R 338.3507.  
(2) Beginning no later than January 1, 2022, an animal control shelter, animal protection  
shelter, and class B dealer shall meet the training requirements in R 338.3507 in order to  
administer an animal tranquilizer for pre-euthanasia sedation or a commercially prepared,  
premixed solution of sodium pentobarbital to perform euthanasia on animals.  
R 338.3503 Animal euthanasia; application for permit.  
Rule 3. (1) An animal control shelter, animal protection shelter, or class B dealer shall apply  
to the department for a permit under R 338.3502, on a form provided by the department,  
together with the requisite fee, which shall contain all of the following information:  
(a) The name, address, and MDARD registration number of the animal control shelter,  
animal protection shelter, or the USDA license number of the class B dealer.  
(b) The name, address, and biographical data of the individual who is in charge of the day-  
to-day operation of the animal control shelter, animal protection shelter, or class B dealer and  
who is responsible for the storage and recordkeeping of the commercially prepared, pre-  
mixed solution of sodium pentobarbital and animal tranquilizers.  
(c) The name, address, and biographical data of the individual responsible for designating  
employees who will practice euthanasia pursuant to the code.  
(d) The name of the veterinarian who trained each individual.  
(e) Beginning no later than January 1, 2022, or earlier, if a class B dealer chooses to  
administer an animal tranquilizer for pre-euthanasia sedation before that date, a class B  
dealer shall submit both of the following:  
(i) The name and address of the class B dealer or an employee of the class B dealer and  
documentation from the trainer that he or she has completed the training required in R  
338.3507.  
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(ii) The name of the individual in charge of the day-to-day operation of the class B dealer  
and documentation from the trainer that the individual received and can document  
completion of the training described in R 338.3507.  
(f) Beginning no later than January 1, 2022, or earlier, if an animal control shelter or an  
animal protection shelter chooses to administer animal tranquilizers in addition to xylazine  
hydrochloride for pre-euthanasia sedation before that date, an animal control shelter or an  
animal protection shelter shall submit both of the following.  
(i) The name and address of an employee and documentation from the trainer that the  
employee has completed the training required in R 338.3507.  
(ii) The name of the individual in charge of the day-to-day operation and documentation  
from the trainer that the individual received and can document completion of the training  
described in R 338.3507.  
(2) A permit issued under this rule is valid for 2 years and may be renewed upon  
application to the department and payment of the requisite fee.  
R 338.3504 Permit for animal euthanasia; form; non-transferable; change in responsible  
person.  
Rule 4. A permit issued by the department must show the name and address of the facility  
and the name of the individual in charge of the day-to-day operation. The permit is not  
transferable. The permit holder shall notify the department, in writing, within 30 days of a  
change in the individual in charge of the day-to-day operation.  
R 338.3505 Registration with United States Department of Justice.  
Rule 5. The facility shall obtain a registration, pursuant to 21 CFR 1301.11 (2009), from the  
United States Department of Justice (DOJ) Drug Enforcement Administration (DEA), or its  
successor agency, before stocking, purchasing, or using a controlled substance to practice  
euthanasia. Purchases must be made pursuant to procedures established by the DOJ DEA.  
R 338.3506 Animal euthanasia; trained personnel; notification of changes; documentation of  
training.  
Rule 6. (1) If the animal control shelter, animal protection shelter, or class B dealer has been  
issued a permit pursuant to R 338.3502, R 338.3503, and section 7333(9) and (10) of the  
code, MCL 333.7333, and does not employ an individual trained as described in R 338.3507  
and section 7333(9) and (10) of the code, MCL 333.7333, or does not have a manager in  
charge of the day-to-day operation that is trained pursuant to section 7333(9) and (10) of the  
code, MCL 333.7333, then the animal control shelter, animal protection shelter, or class B  
dealer shall immediately notify the department, and shall securely store and cease to  
administer any commercially-prepared, pre-mixed solution of sodium pentobarbital or animal  
tranquilizer until the department is notified that both of the following has occurred:  
(a) The individual in charge of the day-to-day operation has been trained as described in R  
338.3507 and he or she has submitted documentation of the training to the department.  
(b) An individual has been hired or an employee of the animal control shelter, or animal  
protection shelter, or the class B dealer has been trained as described in R 338.3507 and  
section 7333(9) and (10) of the code, MCL 333.7333.  
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(2) The permit holder shall notify the department within 30 days of any change in the name  
and address of the individual trained as described in section 7333(9) and (10) of the code,  
MCL 333.7333.  
(3) A permit holder shall comply with all of the following:  
(a) Maintain a list of individuals who have received the training required in these rules.  
(b) Maintain a list of the veterinarians who trained each individual.  
(c) Update the lists required in this subrule every 6 months.  
(d) Keep the lists required in this subrule on the site of the class B dealer, animal control  
shelter, or animal protection shelter.  
(e) Make the lists required in this subrule available for inspection by the department or  
other authorized individual upon request.  
R 338.3507 Animal euthanasia; training of personnel.  
Rule 7. An applicant for a permit pursuant to R 338.3501(1) shall comply with the  
following requirements:  
(a) The applicant shall complete a training consistent with section 7333(9)(c) and (10)(c) of  
the code, MCL 333.7333.  
(b) The applicant shall complete a training that has been approved by the state veterinarian.  
(c) The applicant shall complete a training given by a veterinarian who is currently licensed  
in this state and is in good standing.  
R 338.3508 Rescinded.  
R 338.3509 Animal euthanasia; establish and maintain written procedures; monitoring  
continued proficiency and compliance.  
Rule 9. (1) An animal control shelter, animal protection shelter, or class B dealer shall  
establish and maintain written procedures for the administration of a commercially prepared,  
pre-mixed solution of sodium pentobarbital for euthanasia and animal tranquilizers for pre-  
euthanasia sedation. These procedures must be kept on the permitted premises and must be  
available for inspection by the department.  
(2) An individual’s continued proficiency and compliance with written procedures by an  
animal control shelter, an animal protection shelter, or a class B dealer, in addition to  
compliance with all rules and regulations, may be monitored by the department.  
R 338.3510 Animal euthanasia; retention of records regarding receipt and administration of  
sodium pentobarbital and animal tranquilizers.  
Rule 10. (1) The permit holder shall maintain separate records of the receipt of  
commercially prepared, pre-mixed solution of sodium pentobarbital and animal tranquilizers  
and the administration of a commercially prepared, pre-mixed solution of sodium  
pentobarbital and animal tranquilizers at the animal control shelter, animal protection shelter,  
or by the class B dealer.  
(2) These records must include all of the following information pertaining to the receipt of  
commercially prepared, pre-mixed solution of sodium pentobarbital and animal tranquilizers:  
(a) The date of acquisition.  
(b) The quantity acquired.  
(c) The name of the drug.  
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(d) The trade name of the drug.  
(e) The lot number and strength of a commercially prepared, pre-mixed solution of sodium  
pentobarbital or animal tranquilizer.  
(3) The records of the administration of the commercially prepared, pre-mixed solution of  
sodium pentobarbital or animal tranquilizer for the purpose of practicing euthanasia, must  
include all of the following:  
(a) The quantity used.  
(b) The time and date it was administered.  
(c) The name of the individual who administered the animal tranquilizer or pre-mixed  
solution of sodium pentobarbital.  
(d) The full description of the animal to which the commercially prepared, pre-mixed  
solution of sodium pentobarbital or animal tranquilizer was administered, which includes all  
of the following and is recorded in the animal’s medical or shelter record:  
(i) The species of the animal.  
(ii) The breed of the animal.  
(iii) The sex of the animal.  
(iv) The age of the animal.  
(v) The approximate weight of the animal.  
(vi) The number associated with the animal if a numbering system is used.  
(4) The permit holder shall record receipt of controlled substances on DOJ DEA order  
forms pursuant to 21 CFR part 1305 (2019). 21 CFR part 1305 is available at no cost on the  
internet at  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1305.  
Printed copies of 21 CFR part 1305 are available for inspection and distribution at 10 cents  
per page from the Michigan Board of Pharmacy, Department of Licensing and Regulatory  
Affairs, Bureau of Professional Licensing, 611 West Ottawa, P.O. Box 30670, Lansing,  
Michigan 48909.  
(5) The permit holder shall maintain records of administration of controlled substances  
pursuant to 21 CFR part 1304 (2019). 21 CFR part 1304 is available at no cost on the internet  
at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1304.  
Printed copies of 21 CFR part 1304 also are available for inspection and distribution to the  
public at 10 cents per page from the Michigan Board of Pharmacy, the Department of  
Licensing and Regulatory Affairs, Bureau of Professional Licensing, 611 West Ottawa, P.O.  
Box 30670, Lansing, Michigan 48909.  
(6) Permit holders shall keep records for a period of 2 years and shall make them available  
for inspection by the department or other authorized individual upon request.  
R 338.3511 Storage of drugs used for euthanasia on animals.  
Rule 11. An animal control shelter, an animal protection shelter, and a class B dealer shall  
store all drugs used for euthanasia on animals in a securely locked, substantially constructed  
cabinet located in the facility, with access limited to the individuals described in R  
338.3503(b), (e), and (f).  
R 338.3512 Inspections.  
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Rule 12. The department may conduct an inspection of an animal control shelter, an animal  
protection shelter, or a class B dealer before a permit is issued. The department or authorized  
individual may make periodic, additional, unannounced inspections.  
PART 3. ANIMAL FIELD SEDATION  
R 338.3513 Animal field sedation; authorization to apply for permit.  
Rule 13. (1) An animal control shelter, may apply for a permit to buy, possess, store,  
handle, and administer animal tranquilizers to sedate or immobilize an animal running at  
large that is dangerous or difficult to capture pursuant to the training required in R 338.3518.  
(2) Beginning no later than January 1, 2022, an individual in charge of the day-to-day  
operations of an animal control shelter shall meet the training requirements in R 338.3518 in  
order to administer any animal tranquilizers on animals running at large that are dangerous or  
difficult to capture.  
(3) A permit issued under this rule is valid for 2 years and may be renewed upon application  
to the department and payment of the requisite fee.  
R 338.3514 Animal sedation; application for permit.  
Rule 14. An animal control shelter shall apply, on a form provided by the department, for a  
permit to buy, possess. store, handle, and administer animal tranquilizers to sedate or  
immobilize an animal, to the department, together with the requisite fee. The application  
must contain all of the following information:  
(a) The name, address, and MDARD registration number of the animal control shelter.  
(b) The name, address, and biographical data of the individual who is in charge of the day-  
to-day operation of the animal control shelter and who is responsible for the storage and  
recordkeeping of the animal tranquilizing drugs.  
(c) The name, address, and biographical data of the individual responsible for designating  
employees who will practice tranquilizing pursuant to the code.  
(d) The name of the veterinarian who trained each employee.  
(e) Beginning no later than January 1, 2022, or earlier, if the animal control shelter uses an  
animal tranquilizer other than xylazine hydrochloride to sedate or immobilize animals before  
that date, the name and address of the employee and documentation from the trainer that he  
or she has completed the training required in R 338.3518.  
(f) Beginning no later than January 1, 2022, the name of the individual in charge of the day-  
to-day operation of the animal control shelter and documentation from the trainer that he or  
she has received and can document completion of the training described in R 338.3518.  
(g) If the trained individual is under contract with the shelter to perform tranquilizing  
services, all of the following must be provided:  
(i) An application indicating that tranquilizing services are being performed under  
contract.  
(ii) The name and address of the employment agency with whom the services are being  
offered under a contract.  
(iii) The name of the individual responsible for each individual under contract with the  
shelter.  
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R 338.3515 Permit for animal sedation; form; non-transferable; change in responsible person.  
Rule 15. A permit issued by the department must show the name and address of the facility  
and the name of the person in charge of the day-to-day operation. This permit is not  
transferable. The permit holder shall notify the department in writing, within 30 days of a  
change in the person in charge of the day-to-day operation.  
R 338.3516 Registration with United States department of justice.  
Rule 16. The facility shall obtain a registration pursuant to 21 CFR 1301.11 (2009), from  
the DOJ DEA, or its successor agency, when required by the DOJ DEA, before stocking,  
purchasing, and using a controlled substance. Purchases must be made pursuant to  
procedures established by the DOJ DEA.  
R 338.3517 Animal sedation; trained personnel; notification of changes; documentation of  
training.  
Rule 17. (1) If an animal control shelter has been issued a permit pursuant to R 338.3513, R  
338.3514, and section 7333(16) to (19) of the code, MCL 333.7333, and does not employ an  
individual trained as described in R 338.3518 and section 7333(16) to (19) of the code, MCL  
333.7333, then the animal control shelter shall immediately notify the department, and shall  
securely store and cease to administer the animal tranquilizer until the department is notified  
that both of the following has occurred:  
(a) An individual trained as described in section 7333(16)(c) of the code, MCL 333.7333,  
has been hired by the facility.  
(b) The individual in charge of the day-to-day operation of the facility has been trained as  
described in section 7333(f) of the code MCL 333.7333.  
(2) The permit holder shall notify the department within 30 days of any change in the name  
and address of the individual trained as described in section 7333(16)(c), (d), or (f) of the  
code, MCL 333.7333.  
(3) A permit holder shall comply with all of the following:  
(a) Maintain a list of individuals who have received the training required in these rules.  
(b) Maintain a list of the veterinarians who trained each individual.  
(c) Maintain documentation that the training has been approved by the state veterinarian.  
(d) Update the lists required in this subrule every 6 months.  
(e) Keep the lists required in this subrule on the site of the animal control shelter.  
(f) Make the lists required in this section available for inspection by the department or  
other authorized individual upon request.  
R 338.3518 Animal sedation; training of personnel.  
Rule 18. An applicant for a permit pursuant to R 338.3513(1) shall comply with the  
following requirements:  
(a) The applicant shall complete a training consistent with section 7333(16)(c) of the code,  
MCL 333.7333.  
(b) The applicant shall complete a training that has been approved by the state veterinarian.  
(c) The applicant shall complete a training given by a veterinarian who is currently licensed  
in this state and is in good standing.  
R 338.3519 Rescinded.  
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R 338.3520 Animal sedation; establish and maintain written procedures; monitoring  
continued proficiency and compliance.  
Rule 20. (1) An animal control shelter shall establish and maintain written procedures for  
the administration of animal tranquilizers. These procedures must be kept on the permitted  
premises and must be available for inspection by the department.  
(2) An individual’s continued proficiency and a shelter’s compliance with written  
procedures, in addition to compliance with all rules and regulations, may be monitored by the  
department.  
R 338.3521 Animal sedation; retention of records for receipt and administration of  
tranquilizing drugs.  
Rule 21. (1) The permit holder shall maintain separate records of the receipt of animal  
tranquilizers and administration of animal tranquilizers at the animal control shelter.  
(2) The receipt of animal tranquilizer records must include all of the following information  
pertaining to an animal tranquilizer:  
(a) The date of acquisition.  
(b) The quantity acquired.  
(c) The drug name.  
(d) The trade name of the drug.  
(e) The lot number and strength of the animal tranquilizer.  
(3) The administration of the animal tranquilizer records must include all of the following:  
(a) The quantity used.  
(b) The time and date it was administered.  
(c) The name of the individual who administered the drug.  
(d) The full description of the animal to which the animal tranquilizer was administered,  
which includes all of the following and is recorded in the animal’s shelter or medical record:  
(i) The species of the animal.  
(ii) The breed of the animal.  
(iii) The sex of the animal.  
(iv) The age of the animal.  
(v) The approximate weight of the animal.  
(vi) The number associated with the animal if a number system is used.  
(4) The permit holder shall record receipt of controlled substances on DOJ DEA order  
forms pursuant to 21 CFR part 1305 (2019). 21 CFR part 1305 is available at no cost on the  
internet at  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1305.  
Printed copies of 21 CFR part 1305 are available for inspection and distribution at 10 cents  
per page from the Michigan Board of Pharmacy, Department of Licensing and Regulatory  
Affairs, Bureau of Professional Licensing, 611 West Ottawa, P.O. Box 30670, Lansing,  
Michigan 48909.  
(5) The permit holder shall maintain records of administration for controlled substances  
pursuant to 21 CFR part 1304 (2019). The 21 CFR part 1304 is available at no cost on the  
internet at  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1304.  
Printed copies of 21 CFR part 1304 are available for inspection and distribution at 10 cents  
9
per page from the Michigan Board of Pharmacy, the Department of Licensing and  
Regulatory Affairs, Bureau of Professional Licensing, 611 West Ottawa, P.O. Box 30670,  
Lansing, Michigan, 48909.  
(6) Permit holders shall keep records for a period of 2 years and make them available for  
inspection by the department or other authorized individual upon request.  
R 338.3522 Storage of animal tranquilizers.  
Rule 22. All stocks of the animal tranquilizers must be stored in a securely locked,  
substantially constructed cabinet located in the facility, with access limited to the individuals  
described in R 338.3514(b), (f) and (g).  
R 338.3523 Inspections.  
Rule 23. The department may conduct an inspection of an animal control shelter before a  
permit is issued. The department or other authorized official may periodically make  
additional, unannounced inspections.  
;