DEPARTMENT OF LICENSING AND REGULATORY AFFAIRS
DIRECTOR’S OFFICE
BOARD OF PHARMACY
- ANIMAL EUTHANASIA AND SEDATION RULES
Filed with the secretary of state on
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 sections 16145(3) and 7333(8)
of the public health code, 1978 PA 368, MCL 333.16145(3) and
333.7333(8) and Executive Reorganization Order Numbers Nos.
1996-11991-9, 1996-2, 2003-1, and 2011-4, MCL 330.3101 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338.3521, R 338.3522, and R 338.3523 of the Michigan Administrative Code are amended, and R 338.3508 and R 335.3519 are rescinded, as follows: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 Part 1. GENERAL PROVISIONS
R 338.3501 Definitions.
Rule 1. (1) As used in these rules:
(a) “Administrator”
means the board of pharmacy or its designated or established authority, as
defined in section 7103 of the code.
(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.
(b) (d) “Code”
means the public health code, 1978 PA 368, MCL 333.1101 to 333.25211.
(c) (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.
(d) (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 B dealer, as used in these rules and sections
section 7333(8)(9) to 7333(21) (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 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, or animal protection shelter registered by
the Michigan department of agriculture and rural development pursuant to 1969
PA 287, MCL 287.331 to 287.340, or a class b dealer licensed with the
United States department of agriculture pursuant to 7 U.S.C. § 2134, may apply
for a permit to buy, possess, store, handle, and use 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; renewal.
Rule 3. (1) An animal
control shelter, or animal protection shelter, that
holds a current registration issued by the Michigan department of agriculture and
rural development or a class b B dealer licensed
with the United States department of agriculture shall apply to the
department for a permit under R 338.3502, on a form provided by the administrator
department, together with the requisite fee, for a permit to
store, handle, and use sodium pentobarbital. The application submitted
to the administrator shall contain all of the which shall contain all of
the following information:
(a) The name, address, and
Michigan department of agriculture and rural development MDARD registration
number of the animal control shelter, or animal protection
shelter, or the U.S. department of agriculture USDA license
number of the class b 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 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 and
address of each individual certified to have received a minimum of 8 hours
of training in the use of sodium pentobarbital to practice euthanasia, and the
name of the veterinarian who trained each individual.
(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.
(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 administrator
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 administrator department shall 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 administrator permit
holder shall notify the department shall be notified, in writing, within
10 30 days of a change in the individual in charge of the
day-to-day operation.
R 338.3505 Registration with
United States department Department of justice Justice.
Rule 5. The facility shall
obtain a registration, in accordance with pursuant to 21 C.F.R.
part CFR 1301.11 (2009), from the United States department
of justice, drug enforcement administrationDepartment of Justice (DOJ)
Drug Enforcement Administration (DEA), or its successor agency, before
stocking, purchasing, or using a controlled substance sodium pentobarbital
to practice euthanasia. Purchases shall must be made in
accordance with pursuant to procedures established by the drug
enforcement administration 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 B dealer
has been issued a permit pursuant to R 338.3502, R 338.3503, and section
section 7333(8)(9) and (10) of the code, MCL 333.7333,
and does not employ an individual trained as described in R 338.3507 and section
section 7333(8)(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 B dealer shall
immediately notify the administrator department, and shall
securely store and cease to administer any commercially-prepared, pre-mixed solution
of sodium pentobarbital or animal tranquilizer until the administrator
department is notified that either both of the following
has occurred:
(a) An individual
trained as described in section 7333(8) of the code, has been hired by the
facility. 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 an employee of the animal control shelter,
or animal protection shelter, or the class B dealer facility has been
trained as described in R 338.3507 and section section 7333(8)(9)
and (10) of the code, MCL 333.7333.
(2) The administrator permit
holder shall be notified notify the department within 30 days of
any change in the name and address of the individual trained as described in section
section 7333(8)(9) and (10) of the code, MCL 333.7333 within
10 days of this change.
(3) A list of individuals
certified as having received training and the veterinarians who trained them
shall be updated in writing every 6 months, kept on site, and be available for
inspection. 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. (1) An employee
of an animal control shelter, animal protection shelter, or class b dealer who practices
euthanasia on animals shall document completion of a minimum of 8 hours
of training given by a licensed veterinarian in the use of sodium pentobarbital.
(2) Training of the individual
shall be under the instruction of a veterinarian who is currently licensed in
this state and is in good standing. The training shall include both lecture
and self-study instruction, and clinical experience. At a minimum, the individual
shall demonstrate competency to give intercardial, intraperitoneal, and intravenous
injections, in addition to making a positive determination of death.
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 Animal euthanasia;
notification of completion of training; issuance of permit. Rescinded.
Rule 8. Upon receiving notification
of an individual’s successful completion of the minimum of 8 hours of training from
a licensed veterinarian, the department shall issue a permit to the animal
control shelter, animal protection shelter, or class b dealer where the
individual is employed. An individual’s proficiency in the use of sodium
pentobarbital may be shown by completion of a self-assessment program or other
evaluation approved by the board of veterinary medicine. A self-assessment
program or other evaluation that examines an individual’s proficiency in the use
of sodium pentobarbital that has been approved by the Michigan department of
agriculture and rural development is deemed approved by the Michigan board of
veterinary medicine. The permit is subject to the provisions of section 7333
of the code.
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 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 shall must
be kept on the licensed permitted premises and shall 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 B dealer, in
addition to compliance with all rules and regulations, may be monitored by the administrator
department or the board of veterinary medicine.
R 338.3510 Animal euthanasia;
retention of records regarding receipt and administration dispensation
of sodium pentobarbital and animal tranquilizers.
Rule 10. (1) The permit
holder shall maintain separate records Records of the receipt of commercially
prepared, pre-mixed solution of sodium pentobarbital and animal
tranquilizers and dispensation the administration of a commercially
prepared, pre-mixed solution of sodium pentobarbital shall be maintained
and animal tranquilizers at the animal control shelter, animal protection
shelter, or by the class b B dealer.
(2) These records shall
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
name.
(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.
(f) (3) A
complete record of the dispensation The records of the administration of
the commercially prepared, pre-mixed solution of sodium
pentobarbital or animal tranquilizer for the purpose of practicing euthanasia,
that must include all of the following:
(a) shows the The
quantity used,.
(b) the The
time and date it was administered dispensed,.
(c) and the 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.
(2)
(4) The permit holder shall record Records of receipt shall be
kept of controlled substances on drug enforcement administration (
DOJ DEA) order forms pursuant to 21 C.F.R part CFR part 1305
(2019). The Code of Federal Regulations, Title 21, Food and Drugs,
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 http://www.access.gp.gov/nara/cfr. Printed copies of 21 C.F.R. CFR part
1305 are available for inspection and distribution at cost 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.
(3) (5) The
permit holder shall maintain records Records of dispensation administration
shall be kept of controlled substances pursuant to 21 C.F.R.
part CFR part 1304 (2019). The Code of Federal
Regulations, Title 21, Food and Drugs, 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 http://access.gpo.gov/nara/cfr. Printed copies of 21 C.F.R. CFR part
1304 also are available for inspection and distribution to the public at cost
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.
(4) (6) Permit
holders shall keep Records shall be kept records for a period
of 2 years and shall make them be available for inspection by the
department or other authorized individual upon request.
R 338.3511 Storage of sodium
pentobarbital drugs used for euthanasia on animals.
Rule 11. An animal
control shelter, an animal protection shelter, or and a class b
B dealer shall store all stocks of sodium pentobarbital 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), and (d)(e), and (f).
R 338.3512 Inspections.
Rule 12. The department
may conduct an inspection of an animal control shelter, an animal protection
shelter, or a class b B dealer before a permit is issued. The
department or authorized individual may make periodic, additional, unannounced
inspections.
PART 5 3. ANIMAL FIELD SEDATION
R 338.3513 Animal field sedation;
authorization to apply for permit; renewal.
Rule 13. (1) An animal
control shelter or animal protection shelter registered by the Michigan department
of agriculture and rural development pursuant to 1969 PA 287, MCL 287.331 to
287.340, may apply, on a form provided by the administrator, together
with the requisite fee, for a permit to buy, possess, store, handle,
and administer use a commercially-prepared and federally-approved animal
tranquilizer tranquilizers to sedate or immobilize,
feral, wild, difficult to handle, or other animals for euthanasia, or to
tranquilize 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.
(2) (3) A
permit issued under this subrule (1) of this rule is valid for 2 years
and may be renewed upon application to the administrator department and
payment of the requisite fee.
R 338.3514 Animal sedation; application for permit.
Rule 14. An animal
control shelter or animal protection shelter holding a current
registration issued by the Michigan department of agriculture and rural development
shall apply, on a form provided by the administrator department, for
a permit to buy, possess. store, handle, and use administer animal
tranquilizers. to sedate or immobilize an animal, to the department, together
with the requisite fee. The application must
The application submitted
to the administrator shall contain
contain all of the following information:
(a) The name, address, and
MDARD Michigan department of agriculture and rural development
registration number of the animal control shelter or animal protection 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 or animal protection 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 act code.
(d) The name and
address of each individual certified to have received a minimum of 16 hours of approved
training, including 3 hours of practical training, in the use of animal
tranquilizers to sedate feral, wild, difficult to handle, or other animal for
euthanasia, or to tranquilize an animal running at large that is dangerous or
difficult to capture, and the name of the veterinarian who trained each
individual, as required under section 7333(14)(c) of 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.
(e) (g) If
the trained individual is under contract with the shelter to perform tranquilizing
services, all of the following shall 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.
R 338.3515 Permit for animal sedation; form; non-transferable; change in responsible person.
Rule 15. A permit issued by
the administrator department shall 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 administrator
permit holder shall notify the department be notified, in
writing, within 10 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, in accordance with pursuant to 21 C.F.R.
part CFR 1301.11 (2009), from the United States department
of justice, drug enforcement administration DOJ DEA, or its successor
agency, when required by the drug enforcement agency DOJ DEA, before
stocking, purchasing, and using animal tranquilizers a controlled
substance. Purchases shall must be made in accordance with
pursuant to procedures established by the drug enforcement administration
DOJ DEA.
R 338.3517 Animal sedation; trained personnel; notification of changes; documentation of training.
Rule 17. (1) If an animal
control shelter or animal protection shelter has been issued a permit pursuant
to R 338.3513, R 338.3514, and section 7333(14) (16) and
to (15) (19) of the code, MCL 333.7333, and does
not employ an individual trained as described in R 338.3518 and in section
7333(14)(c) or (15)(c) 7333(16) to (19) of the code, MCL 333.7333,
then the animal control shelter or animal protection shelter shall
immediately notify the administrator department, and shall
securely store and cease to administer the animal tranquilizer until the administrator
department is notified that either both of the following
has occurred:
(a) An individual trained
as described in section 7333(14)(c) (16)(c) or (15)(c) of
the code, MCL 333.7333, has been hired by the facility.
(b) An employee The
individual in charge of the day-to-day operation of the facility has been trained
as described in section 7333(14)(c)(f) or (15)(c) of the code
MCL 333.7333.
(2) The permit holder administrator
shall be notified notify the department within 30 days of any change
in the name and address of the individual trained as described in section 7333(14)(c)
(16)(c), (d), or (f) (15)(c) of the act code,
MCL 333.7333 within 10 days of training.
(3) A permit holder shall comply with all of the following:
(a) Maintain a The list of individuals certified as having
who have received the training required in these rules.
(b) Maintain a list of
and the veterinarian or veterinarians who trained them,
each individual.
(c) as well as Maintain
documentation that the training has been approved by the Michigan board
of veterinary medicine, state veterinarian.
(d) shall be updated in writing Update the lists required in this subrule every
6 months,.
(e) kept Keep
the lists required in this subrule on the site, of the animal
control shelter.
(f) Make the lists and 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. (1) An individual
who practices sedation on animals shall document completion of 16 hours of approved
training, including 3 hours of practical training, in the use of animal
tranquilizers given by a licensed veterinarian, as required under section
7333(14)(c) of the code .
(2) Training of the
individual shall be under the instruction of a doctor of veterinary medicine currently
licensed in this state and is in good standing. The training shall include
all of the following:
(a) Lecture and
clinical experience.
(b) Instruction about types
of commercially-prepared, federally-approved animal tranquilizers currently available,
as well as their drug reversals.
(c) Proper doses of tranquilizing
drugs for each species for which the drugs are approved and drug dosage calculating.
(d) Administration
techniques for the animal tranquilizers and their reversals.
(e) Drug contraindications
and precautions.
(f) Animal monitoring techniques
for tranquilized animals.
(g) Methods for
identifying and handling drug-related emergencies.
(3) An outline of the training shall be presented to
the Michigan board of veterinary medicine for written approval prior to the
start of training. Training in the use of animal tranquilizers that has been approved
by the Michigan department of agriculture and rural development is deemed approved
by the Michigan board of veterinary medicine. Documentation that the individual’s
training has been approved by the Michigan department of agriculture and rural
development shall be submitted to the Michigan Department of Licensing and Regulatory
Affairs with the application for a permit.
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 Animal
sedation; notification of completion of training; issuance of permit. Rescinded.
Rule 19. Upon receiving
notification of an individual’s successful completion of the minimum 16 hours
of approved training from a licensed veterinarian, the department shall issue a
permit to the animal control shelter or the animal protection shelter. An
individual’s proficiency may be shown by completion of a self-assessment program
or other evaluation by the board of veterinary medicine.
R 338.3520 Animal sedation; establish and maintain written procedures; monitoring continued proficiency and compliance.
Rule 20. (1) An animal
control shelter or animal protection shelter shall establish and
maintain written procedures for the administration of animal tranquilizers.
These procedures shall must be kept on the licensed permitted
premises and shall 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 administrator
department or the board of veterinary medicine.
Rule 21. (1) Records
The permit holder shall maintain separate records of the receipt of
animal tranquilizers and dispensation administration of
animal tranquilizers shall be maintained at the animal control shelter or
animal protection shelter.
(2) The receipt of animal tranquilizer records shall
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.
(f) (3) A
complete record of the The dispensation administration of
the animal tranquilizer records must include all of the following:
(a) that shows the
The quantity used,.
(b) the The
time and date it was administered dispensed,.
(c) the The name
of the individual who administered the drug administering individual,.
(d) and a 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.
(2) (5) Records
The permit holder shall maintain records of dispensation administration
for controlled drugs substances shall be kept pursuant
to 21 C.F.R. part CFR part 1304 (2019). The code of
federal regulations title 21, food and drugs, 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 http://www.gpoaccess.gov/nara/cfr. Printed copies of 21 C.F.R. part CFR part
1304 are available for inspection and distribution at cost 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, MI Michigan, 48909.
(3) (6) Records
Permit holders shall keep records shall be kept for a period of 2
years and shall be make them available for inspection by the
department or other authorized official individual upon request.
R 338.3522 Storage of animal tranquilizers.
Rule 22. All stocks of
the controlled and noncontrolled animal tranquilizers shall 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) and (d).
R 338.3523 Inspections.
Rule 23. The department
may conduct an inspection of an animal control shelter or animal protection
shelter before a permit is issued. The department or other authorized
official may periodically make additional, unannounced inspections.