reglab/statecodes huggingface dataset:
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3168 - Refilling of prescriptions

Current through Vol. 24-12, July 15, 2024
Rule 68.
(1) A
					 prescription for a controlled substance listed in schedule 2 may not be
					 refilled.
(2) A prescription for a
					 controlled substance listed in schedules 3 and 4 may not be refilled more than
					 6 months after the prescription's date of issuance and may not be refilled more
					 than 5 times. Renewal of the prescription must be consistent with the
					 requirements for original prescriptions.
(3) A prescription for a controlled substance
					 listed in schedule 5 may be refilled only as expressly authorized by the
					 prescriber on the prescription up to 1 year; if no authorization is indicated,
					 then the prescription may not be refilled.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 6 - DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS › Section R. 338.3170 - Dispensing and administering controlled substances by prescribers

Current through Vol. 24-12, July 15, 2024
Rule 70.
(1) A
					 prescriber in the course of the prescriber's professional practice may
					 dispense, administer, or delegate under direct supervision the administering of
					 a controlled substance listed in schedules 2 to 5.
(2) A veterinarian, in the course of the
					 veterinarian's professional practice may dispense, administer, or delegate the
					 administering under direct supervision of a controlled substance listed in
					 schedules 2 to 5 to an animal.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 7 - DISTRIBUTIONS › Section R. 338.3181 - Distributions by dispensers

Current through Vol. 24-12, July 15, 2024
Rule 81.
(1) A
					 dispenser who is not licensed as a wholesale distributor may distribute a
					 controlled substance to another dispenser for the purpose of general dispensing
					 to the dispenser's patients if all of the following conditions are satisfied:
(a) The receiving dispenser is licensed to
					 dispense the substance.
(b) The
					 distribution is recorded by the distributing dispenser and a receipt record is
					 maintained by the receiving dispenser.
(c) An order form for substances listed in
					 schedules 1 and 2 is used.
(d) The
					 total number of dosage units of all controlled substances distributed by the
					 distributing dispenser during the 12-month period the dispenser is licensed is
					 not more than 5% of the total number of all dosage units distributed and
					 dispensed during the 12-month period.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 7 - DISTRIBUTIONS › Section R. 338.3183 - Distribution to suppliers

Current through Vol. 24-12, July 15, 2024
Rule 83.
(1) An
					 individual who is lawfully in possession of a controlled substance that is
					 listed in a schedule may return the substance to the individual who gave the
					 person the substance or to the manufacturer of the substance without obtaining
					 a license to distribute. The individual who distributes the substance shall
					 maintain a written record that contains all of the following information:
(a) The date of the distribution.
(b) The name, form, and quantity of the
					 substance.
(c) The name, address,
					 and license number of the individual who distributes the substance.
(d) The name, address, and license number, if
					 known, of the supplier or manufacturer.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 7 - DISTRIBUTIONS › Section R. 338.3185 - Discontinuances and transfers

Current through Vol. 24-12, July 15, 2024
Rule 85. A licensee who wants to discontinue or transfer
						business activities or a professional practice altogether or only with respect
						to controlled substances state-controlled substances license to the department.
						The transfer of the controlled substances is subject to approval by the DEA
						under 21 CFR
						1301.52 and written notification must be
						provided to the department 15 days before the controlled substances are
						transferred.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 7 - DISTRIBUTIONS › Section R. 338.3186 - Use of order forms and invoices

Current through Vol. 24-12, July 15, 2024
Rule 86. An order form must be used to distribute
						schedule 2 substances and an invoice must be used to distribute schedules 3 to
						5 substances. The order form may be executed only by a practitioner who is
						licensed under article 7 of the code, MCL 333.7101 to 333.7545, to prescribe or
						dispense controlled substances.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 1 - General Provisions › Section R. 338.3501 - Definitions

Current through Vol. 24-12, July 15, 2024
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.
(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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3502 - Animal euthanasia; animal control shelters, animal protection shelters, class B dealers; authorization to apply for permit

Current through Vol. 24-12, July 15, 2024
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.
An
						obvious error in R 338.3502 was corrected at the request of the promulgating
						agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL
						24.256. The rule containing the error was published in Michigan Register, 2021
						MR 20. The memorandum requesting the correction was published in Michigan
						Register, 2021 MR 20
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3503 - Animal euthanasia; application for permit

Current through Vol. 24-12, July 15, 2024
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,
					 premixed 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.
(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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3504 - Permit for animal euthanasia; form; non-transferable; change in responsible person

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3505 - Registration with United States Department of Justice

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3506 - Animal euthanasia; trained personnel; notification of changes; documentation of training

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3507 - Animal euthanasia; training of personnel

Current through Vol. 24-12, July 15, 2024
Rule 7. An applicant for a permit pursuant to
						R 338.3502(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.
An
						obvious error in R 338.3507 was corrected at the request of the promulgating
						agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL
						24.256. The rule containing the error was published in Michigan Register, 2021
						MR 20. The memorandum requesting the correction was published in Michigan
						Register, 2021 MR 20
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3509 - Animal euthanasia; establish and maintain written procedures; monitoring continued proficiency and compliance

Current through Vol. 24-12, July 15, 2024
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 preeuthanasia 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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3510 - Animal euthanasia; retention of records regarding receipt and administration of sodium pentobarbital and animal tranquilizers

Current through Vol. 24-12, July 15, 2024
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.
(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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3511 - Storage of drugs used for euthanasia on animals

Current through Vol. 24-12, July 15, 2024
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).
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 2 - ANIMAL EUTHANASIA › Section R. 338.3512 - Inspections

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3513 - Animal field sedation; authorization to apply for permit

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3514 - Animal sedation; application for permit

Current through Vol. 24-12, July 15, 2024
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 dayto-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 dayto-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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3515 - Permit for animal sedation; form; non-transferable; change in responsible person

Current through Vol. 24-12, July 15, 2024
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
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3516 - Registration with United States department of justice

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3517 - Animal sedation; trained personnel; notification of changes; documentation of training

Current through Vol. 24-12, July 15, 2024
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(16)(f) of the code MCL 333.7333.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3518 - Animal sedation; training of personnel

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3520 - Animal sedation; establish and maintain written procedures; monitoring continued proficiency and compliance

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3521 - Animal sedation; retention of records for receipt and administration of tranquilizing drugs

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3522 - Storage of animal tranquilizers

Current through Vol. 24-12, July 15, 2024
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).
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Animal Euthanasia and Sedation Rules › Part 5 - ANIMAL SEDATION › Section R. 338.3523 - Inspections

Current through Vol. 24-12, July 15, 2024
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.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3601 - Definitions

Current through Vol. 24-12, July 15, 2024
Rule 1. As used in this part:
(a) "Charitable clinic" means a charitable
				  nonprofit corporation or facility that meets all of the following requirements:
(i) Is organized as a not-for-profit
				  corporation pursuant to the nonprofit corporation act, 1982 PA 162, MCL
				  450.2101 to 450.3192.
(ii) Holds a
				  valid exemption from federal income taxation issued pursuant to section 501(a)
				  of the internal revenue code,
				  26 USC
				  501.
(iii) Is listed as an exempt organization
				  under section 501(c) of the internal revenue code,
				  26 USC
				  501.
(iv) Is organized under or operated as a part
				  of a health facility or agency licensed under article 17 of the code, MCL
				  333.20101 to 333.20211.
(v)
				  Provides on an outpatient basis for a period of less than 24 consecutive hours
				  to persons not residing or confined at the facility advice, counseling,
				  diagnosis, treatment, surgery, care, or services relating to the preservation
				  or maintenance of health.
(vi) Has
				  a licensed pharmacy.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3603 - Eligibility criteria; pharmacy; charitable clinics; requirements; withdrawal

Current through Vol. 24-12, July 15, 2024
Rule 3.
(1) To be
				  eligible for participation in the program, a pharmacy or charitable clinic
				  shall comply with all applicable federal and state laws, including laws
				  applicable to the storage and distribution of drugs and the appropriate
				  licensure standards, and shall hold an active, nonrestricted, state of Michigan
				  license in good standing.
(2)
				  Participation in the program is voluntary.
(3) A pharmacy or charitable clinic may elect
				  to participate in the program by providing, on a form provided by the
				  department, written notification to the department of all of the following:
(a) The name, street address, and telephone
				  number of the pharmacy or charitable clinic, and any state of Michigan license
				  or registration number issued to the pharmacy or charitable clinic.
(b) For a charitable clinic, evidence that
				  the charitable clinic meets the requirements defined in
				  R
				  338.3601(a).
(c) The name and license number of the
				  responsible pharmacist employed by or under contract with the pharmacy or
				  charitable clinic.
(d) A statement
				  signed and dated by the responsible pharmacist indicating that the pharmacy or
				  charitable clinic meets the eligibility requirements under this rule and shall
				  comply with the requirements of the program.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3605 - Eligible prescription drugs

Current through Vol. 24-12, July 15, 2024
Rule 5.
(1) All
				  non-controlled prescription drugs, except those specified in
				  R 338.3607, that have been approved
				  for medical use in the United States, are listed in the United States
				  pharmacopeia and the national formulary (usp-nf), and meet the criteria for
				  donation established by these rules may be accepted for donation under the
				  program.
(2) A new prescription may
				  be transferred to another participating pharmacy or charitable clinic for
				  dispensing.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3607 - Ineligible drugs; controlled substances prohibited

Current through Vol. 24-12, July 15, 2024
Rule 7.
(1) The
				  following shall not be accepted for dispensing under the program:
(a) Controlled substances, as defined in
				  article 7 of the code or by federal law.
(b) Expired prescription drugs.
(c) Drugs that may be dispensed only to a
				  patient registered with the drugs manufacturer under federal food and drug
				  administration requirements.
(d)
				  Drugs that have been held outside of a health professionals control where
				  sanitation and security cannot be assured.
(e) Compounded drugs.
(f) Drugs that require storage temperatures
				  other than normal room temperature as specified by the manufacturer or the
				  usp-nf shall not be donated or accepted as part of the program. Excluded from
				  this restriction are drugs donated directly from a drug manufacturer.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3609 - Donated prescription drugs; participating pharmacy or charitable clinic requirements

Current through Vol. 24-12, July 15, 2024
Rule 9.
(1) A
				  participating pharmacy or charitable clinic may accept a prescription drug only
				  if all of the following requirements are met:
(a) The drug is in its original sealed and
				  tamper-evident packaging. However, a drug in a single-unit dose, unit of issue
				  package, or blister pack with the outside packaging opened may be accepted if
				  the single-unit-dose packaging or unit of issue packaging is
				  unopened.
(b) The drug has been
				  stored according to manufacturer or usp-nf storage requirements.
(c) The packaging contains the lot number and
				  expiration date of the drug. If the lot number is not retrievable, all
				  specified medications shall be destroyed in the event of a recall.
(d) The drug has an expiration date that is
				  more than 6 months after the date that the drug was donated.
(e) The drug does not have any physical signs
				  of tampering or adulteration, and there is no reason to believe that the drug
				  is adulterated.
(f) The packaging
				  does not have any physical signs of tampering, deterioration, compromised
				  integrity, or adulteration.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3611 - Donated prescription drugs; eligible facility requirements

Current through Vol. 24-12, July 15, 2024
Rule 11.
(1) An
				  eligible facility or manufacturer may donate unused or donated prescription
				  drugs, other than controlled substances, to a participating pharmacy or
				  charitable clinic, if the drug meets the requirements of these rules.
(2) A manufacturer or its representative may
				  donate prescription drugs in complimentary starter doses, other than controlled
				  substances, to a charitable clinic under the program, if the drug meets the
				  requirements of these rules.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3613 - Resident of eligible facility; donations permitted

Current through Vol. 24-12, July 15, 2024
Rule 13.
(1) A
				  resident of an eligible facility or the representative or guardian of a
				  resident of an eligible facility may donate unused prescription drugs to be
				  dispensed under the terms of the program.
(2) A resident of an eligible facility or the
				  residents representative or guardian shall complete a resident donation form
				  prior to the eligible facility taking possession of the drugs to be donated. A
				  copy of the resident donation form shall be sent to the participating pharmacy
				  or charitable clinic with the donated drugs.
(3) The prescription drugs donated under the
				  method described in this rule shall have originated from the eligible facility,
				  and prescription drugs obtained prior to the resident being admitted to the
				  facility shall not be accepted.
(4)
				  The prescription drugs donated under the method described in this rule are
				  subject to all the requirements of these rules.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3615 - Transfer and shipment of donated drugs; requirements

Current through Vol. 24-12, July 15, 2024
Rule 15.
(1) Prior
				  to the initial transfer of donated drugs from an eligible facility or
				  manufacturer to a participating pharmacy or charitable clinic, the eligible
				  facility or manufacturer shall complete the eligible facility donation form.
				  The eligible facility or manufacturer shall transmit the completed eligible
				  facility donation form to the participating pharmacy or charitable clinic and
				  retain a copy for its records.
(2)
				  A completed transfer form shall be included in each shipment of donated drugs
				  from an eligible facility or manufacturer to a participating pharmacy or
				  charitable clinic.
(3) Donated
				  drugs under the program shall be shipped from the eligible facility or
				  manufacturer to the participating pharmacy or charitable clinic via common or
				  contract carrier.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3617 - Inspection and storage of donated prescription drugs; destruction; recall

Current through Vol. 24-12, July 15, 2024
Rule 17.
(1) A
				  licensed pharmacist employed by or under contract with the participating
				  pharmacy or charitable clinic shall inspect donated prescription drugs to
				  determine, in the professional judgment of the pharmacist, that the drugs are
				  not adulterated, are safe and suitable for dispensing, and are eligible drugs.
				  The pharmacist who inspects the drugs shall sign the transfer form included
				  with the shipment of donated drugs attesting to the above.
(2) The participating pharmacy or charitable
				  clinic shall store donated drugs pursuant to the manufacturers guidelines or
				  usp-nf guidelines. Donated drugs shall not be stored with non-donated inventory
				  at any time.
(3) When donated drugs
				  are not inspected immediately upon receipt, a participating pharmacy or
				  charitable clinic shall quarantine the donated drugs separately from all
				  dispensing stock until the donated drugs have been inspected and approved for
				  dispensing under the program.
(4) A
				  participating pharmacy or charitable clinic shall destroy donated prescription
				  drugs that are not suitable for dispensing pursuant to protocols currently
				  established by the pharmacy or charitable clinic for the destruction of
				  prescription drugs.
(5) A
				  participating pharmacy or charitable clinic shall create and maintain a
				  destruction and disposal record for donated drugs that are destroyed and
				  disposed of as a result of being expired, adulterated, recalled, or otherwise
				  not eligible for dispensing. A participating pharmacy or charitable clinic
				  shall maintain a destruction record for 5 years after destruction of the
				  donated drugs.
(6) If a
				  participating pharmacy or charitable clinic receives a recall notification, the
				  participating pharmacy or charitable clinic shall perform a uniform destruction
				  of all of the recalled prescription drugs in the participating pharmacy or
				  charitable clinic and complete the destruction record for all donated drugs
				  destroyed. The destruction shall be done pursuant to protocols currently
				  established by the pharmacy or charitable clinic for the destruction and
				  disposal of prescription drugs.
(7)
				  If a recalled drug has been dispensed, the participating pharmacy or charitable
				  clinic shall immediately notify the eligible participant of the recalled drug
				  pursuant to established drug recall procedures.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3619 - Record keeping; inventory; requirements

Current through Vol. 24-12, July 15, 2024
Rule 19.
(1) A
				  participating pharmacy or charitable clinic shall keep records in conformance
				  with these rules and all applicable federal and state laws, rules, and
				  regulations.
(2) A participating
				  pharmacy or charitable clinic shall maintain documented policies and procedures
				  that will address all the requirements of these rules.
(3) A participating pharmacy or charitable
				  clinic shall document all of the following for each drug accepted for the
				  program:
(a) Brand name or generic name of
				  the drug.
(b) Name of the
				  manufacturer or national drug code number (ndc#).
(c) Quantity and strength of the
				  drug.
(d) Lot number of medication,
				  if available.
(e) Expiration date
				  of medication.
(f) Date the drug
				  was donated and the date the drug was subsequently dispensed.
(g) Name of the eligible facility that
				  donated the drug and the eligible participant subsequently dispensed the
				  drug.
(h) The prescription from a
				  health care professional.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3621 - Forms; eligible facility donation form, resident donation form, eligible participant form, transfer form, destruction form; requirements

Current through Vol. 24-12, July 15, 2024
Rule 21.
(1) An
				  eligible facility donation form shall include all of the following information:
(a) An eligible facility's or manufacturer's
				  name, address, and telephone number; the name, dated signature, and license
				  number of pharmacist or health care provider authorized to donate the drugs;
				  and, the license number of the facility or manufacturer.
(b) A statement of the facility's intent to
				  participate in the program and donate eligible prescription drugs to the
				  participating pharmacy or charitable clinic identified on the form.
(c) The receiving participating pharmacy's or
				  charitable clinic's name, address, and telephone number.
(d) The name, state of Michigan license
				  number, and dated signature of the responsible pharmacist authorized to receive
				  the donation.
(e) The date the
				  donation was received.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3623 - Eligible participants; requirements

Current through Vol. 24-12, July 15, 2024
Rule 23. The eligible participant shall complete the
					 eligible participant form attesting to the following statements:
(a) The eligible participant is a resident of
				  the state of Michigan.
(b) The
				  eligible participant is eligible to receive medicare or medicaid or does not
				  have insurance or prescription drug coverage. Verification or written
				  documentation shall not be required.
(c) The eligible participant acknowledges
				  that the drugs have been donated.
(d) The eligible participant consents to a
				  waiver of the requirement for child resistant packaging, as required by the
				  poison prevention packaging act,
				  15
				  U.S.C. §1471 -
				  1477.
Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Program for Utilization of Unused Prescription Drugs › Section R. 338.3625 - Dispensing donated prescription drugs; requirements

Current through Vol. 24-12, July 15, 2024
Rule 25.
(1) A
				  participating pharmacy or charitable clinic shall dispense donated prescription
				  drugs in compliance with applicable federal and state laws and regulations for
				  dispensing prescription drugs, including all requirements relating to
				  packaging, labeling, record keeping, drug utilization review, and patient
				  counseling.
(3) The department and
				  a local participating pharmacy or charitable clinic shall remove any patient
				  identifying information from the package prior to dispensing the
				  drugs.
(4) Prescription drugs
				  donated under this program shall not be resold; however, a participating
				  pharmacy or charitable clinic may collect a handling fee pursuant to the terms
				  of
				  R
				  338.3627.