2 ADMINISTRATIVE RULES

 

 

ORR #1996-148

 

DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES DIRECTOR'S OFFICE

CONTROLLED SUBSTANCES

 

Filed with the Secretary of State on April 3, 2002.

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

 

(By authority conferred on the director of the department of consumer and industry services by sections 7201, 7301, 7333, and 16145 of Act No. 368 of the Public Acts of 1978, as amended, and Executive Reorganization Order No. 1996-2, MCL 333.7201, 333.7301, 333.7333, 333.16145, and 445.2001)

 

R 338.3101, R 338.3102, R 338.3113, R 338.3113a, R 338.3114a, R 338.3117, R 338.3119a,  R 338.3120, R 338.3123, R 338.3125, R 338.3127, R 338.3132, R 338.3136, R 338.3138, R 338.3139, R

338.3141, R 338.3143, R 338.3145, R 338.3151, R 338.3152, R 338.3153, R 338.3153a, R 338.3154, R

338.3161, R 338.3162, R 338.3162a, R 338.3163, R 338.3167, R 338.3168, R 338.3169, and R 338.3170

of the Michigan Administrative Code are amended, R 338.3121a and R 338.3126 are added to the Code, and R 338.3133 and R 338.3134 of the Code are rescinded as follows:

 

PART 1. GENERAL PROVISIONS

 

R 338.3101 Definitions; A to H.

Rule 1. As used in these rules:

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

(b)  "Deleterious drug" means a drug, other than a proprietary medicine, that is likely to be destructive to adult human life in quantities of 60 grains or less.

(c)  “Department” means the department of consumer and industry services.

(d)  “Electronic signature” is a unique identifier protected by appropriate security measures such that it is only available for use by the intended individual and ensures nonrepudiation so that the signature could not be rejected based on its validity.

(e)  “Sign” means to affix a signature manually in the same manner as signing a check or legal document or to use an electronic signature, as defined in subdivision d of this rule.

(F)        "Hearing" means a hearing that is held pursuant to the grant, denial, revocation, or suspension of a license issued under the act.

 

R 338.3102 Definitions; I to P.

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

 

 

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

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

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

(d)        “Prescriber” of “practitioner” means any of the following entities who are licensed to prescribe the laws of this state:

(i)  A dentist.

(ii) A doctor of medicine.

(iii) A doctor of osteopathic medicine and surgery.

(iv) A doctor of podiatric medicine and surgery.

(v)  A veterinarian.

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

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

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

 

PART 2. SCHEDULES

 

R 338.3113 Schedule 1; hallucinogenic substances.

Rule 13. Unless specifically excepted, any material, compound, mixture, or preparation which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers when the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, is included in schedule 1:

(a)  Alpha-ethyltryptamine. Some trade or other names:

(i)  etryptamine.

(ii) monase.

(iii) a? ethyl- 1h-indole-3-ethanamine.

(iv) 3-(2-aminobutyl) indole.

a-et. AET.

(b)  4-bromo-2,5-dimethoxyamphetamine Some trade or other names:

(i)   4-bromo-2,5 dimethoxy-alpha-methylphenethylamine.

(ii)   4-bromo-2,5-DMA.

(c)  2,5-dimethoxyamphetamine. Some trade or other names:

(i)  2,5-dimethoxy-alpha-methylphenethylamine.

(ii)  2,5-DMA.

(d)  4-bromo-2,5-dimethoxphenethylamine. Some trade or other names:

(i)  2-(4-bromo-2-5-dimethoxyphenyl)-1-aminoethae.

 

 

(ii) desmethyl DOB.

(iii) 2c-b, nexus.

(e)  2,5-dimethoxy-4-ethylamphetamine. A trade or other name:

DOET.

(f) 4-methoxyamphetamine. Some trade or other names:

(i)  4-methoxy-alpha-methylphenethylamine.

(ii) paramethoxyamphetamine.

(iii) PMA.

(g)  5-methoxy-3,4-methylenedioxyamphetamine.

(h)  4-methyl-2,5-dimethoxyamphetamine. Some trade or other names:

(i)  4-methyl-2,5-dimethoxy-alpha-methylphenethylamine.

(ii)      DOM.

(iii)      STP.

(i)  3,4-methylenedioxyamphetamine.

(j)  3,4-methylenedioxymethamphetamine(MDMA).

(k)  3,4-methylenedioxy-n-ethylamphetamine.

(l)  N-hydroxy-3,4-methylenedioxyamphetamine.

(m)  3,4,5-trimethoxyamphetamine.

(n)  Bufotenine.

Some trade or other names:

(i)  3-(beta-dimethylaminoethyl)-5-hydroxyindole.

(ii) 3-(2-dimethylaminoethyl)-5-indolol.

(iii) N,N-dimethyserotonin.

(iv)  5-hydroxy-N-N-dimethyltryptamine mappine.

(o)  Diethyltryptamine. Some trade or other names:

(i)  N,N-Diethyltryptamine.

(ii) DET.

(p)  Dimethyltryptamine. A trade or other name: DMT.

(q)  Ibogaine.

Some trade or other names:

(i) 7-Ethyl-6,6beta,7,8,9,10,12,13-octahydro-2-methoxy-6, 9-methano-5H-pyrido.

(ii)       [1',2':1,2]azepino[5,4-b] indole.

(iii)      tabernanthe iboga.

(r)  Lysergic acid diethylamide.

(s)  Marihuana.

(t)  Mescaline.

(u)  Parahexyl.

Some trade or other names:

 

 

(v)3-hexyl-l-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl- 6H-dibenzo[b,d]pyran.

(ii) synhexyl.

(v) Peyote.

(w)  N-ethyl-3-piperidyl benzilate.

(x)  N-methyl-3-piperidyl benzilate.

(y)  Psilocybin.

(z)  Psilocyn.

(aa) Ethylamine analog of phencyclidine. Some trade or other names:

(i)  n-ethyl-l-phenylcyclohexylamine.

(ii) (l-phenylcyclohexyl) ethylamine.

(iii) n-(l-phenylcyclohexyl)ethylamine.

(iv) cyclohexamine.

(v)  PCE.

(bb) Pyrrolidine analog of phencyclidine. Some trade or other names:

(i)  1-(l- phenylcyclohexyl)-pyrrolidine.

(ii) PCPy.

(iii) PHP.

(cc) Thiophene analog of phencyclidine. Some trade or other names:

(i)  1-[l-(2-thienyl)-cyclohexyl]-piperidine.

(ii) 2-thienyl-analog of phencyclidine.

(iii) TPCP.

(iv) TCP.

(dd) 1-(l-(2-thienyl)cyclohexyl)pyrrolidine. Another name:

TCPY.

For the purpose of this rule only, "isomer" includes the optical, position, and geometric isomers.

 

R 338.3113a Schedule 1; depressants.

Rule 13a. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers when the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation is included in schedule 1:

(a)  Gamma-hydroxbutyric acid. Some other names:

(i)  GHB.

(ii) gamma-hydroxybutyrate.

(iii)  4-hydroxybutyrate.

(iv) 4-hydroxybutanoic acid.

(v)  sodium oxybate.

(vi) sodium oxybutyrate.

(b)  Mecloqualone.

 

 

(c)  Methaqualone.

 

R 338.3114a Schedule 1; stimulants.

Rule 14a. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers, is included in schedule 1:

(a)  Aminorex. Some other names:

(i)  aminoxaphen.

(ii)  2-amino-5-phenyl-2-oxazoline.

(iii)  4,5-dihydro-5-phenly-2-oxazolamine.

(b)  Cathinone.

Some trade or other names:

(i)  2-amino-1-phenyl-1-propanone.

(ii) alpha-aminopropiophenone.

(iii)  2-aminopropiophenone.

(iv) norephedrone.

(c)  Methcathinone.

Some trade or other names:

(i)  2-methyiamino-l-phenylpropan-1-one.

(ii)  CAT.

(iii) Ephedrone.

(d)  Fenethylline.

(e)  (±)cis-4-methylaminorex([(±)cis-4,5-dihydro-4-methyl-5phenyl-2-oxazolamine).

(f) N-ethylamphetamine.

(g)  N,N-dimethylamphetamine. Some trade or other names:

(i)  N,N-alpha-trimethyl-benzeneethanimine.

(ii)  N,N-alpha-trimethylphenethylamine.

 

R 338.3117 Schedule 2; opiates.

Rule 17. Unless specifically excepted, the following opiates, including their isomers, esters, and ethers, when the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation, are included in schedule 2:

(a)  Alfentanil.

(b)  Alphaprodine.

(c)  Anileridine.

(d)  Benzitramide.

(e)  Bulk dextropropoxyphene (nondosage forms).

(f) Carfentanil.

(g)  Dihydrocodeine.

(h)  Diphenoxylate.

(i)  Fentanyl.

(j)  Isomethadone.

(k)  Levo-alphacetylmethadol.

 

 

Some other names:

(i)  Levo-alpha-acetylmethadol.

(ii) Levomethadyl Acetate.

(iii) LAAM.

(l)  Levomethorphan.

(m)  Levorphanol.

(n)  Metazocine.

(o)  Methadone.

(p)  Methadone-Intermediate, 4 cyano-2-dimethylamino-4,4 diphenyl butane.

(q)  Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenyl-propane-carboxylic acid.

(r)  Pethidine (meperidine).

(s)  Pethidine-Intermediate-A, 4-cyano-1-1 methyl-4-phenylpiperidine.

(t)  Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.

(u)  Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid.

(v)  Phenazocine.

(w)  Piminodine.

(x)  Racemethorphan.

(y)  Racemorphan.

(z)  Remifentanil. (aa) Sufentanil.

 

R 338.3119a Schedule 2; hallucinogenic substances.

Rule 19a. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of nabilone, including its salts, isomers, and salts of isomers when the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation, is included in schedule 2.

 

R 338.3120 Schedule 3; stimulants; depressants; nalorphine.

Rule 20. (1) Unless specifically excepted or unless listed in another schedule, a material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers whether optical, position, or geometric, and the salts of such isomers, when the existence of such salts, isomers, and the salts of isomers is possible within the specific chemical designation, is included in schedule 3:

(a)  Benzphetamine.

(b)  Chlorphentermine.

(c)  Clortermine.

(d)  Phendimetrazine.

(2)          Unless specifically excepted or unless listed in another schedule, a material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers whether optical, position, or geometric, and the salts of such isomers, when the existence of such salts, isomers, and the salts of isomers is possible within the specific chemical designation, is included in schedule 3:

(a)  Chlorhexadol.

 

 

(b)  Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the federal food, drug, and cosmetic act of 1938, 21

U.S.C. §301 et seq.

(c)  Ketamine.

(d)  Lysergic acid.

(e)  Lysergic acid amide.

(f)   Methyprylon.

(g)  Pentazocine.

(h)  Sulfondiethylmethane.

(i)  Sulfonethylmethane.

(j)  Sulfonmethane.

(k)  Tiletamine-zolazepam.

(3)       A compound, mixture, or preparation containing amobarbital, secobarbital, pentobarbital, or a salt thereof and 1 or more other active medicinal ingredients that are not listed in a schedule is included in schedule 3.

(4)      A suppository dosage form which contains amobarbital, secobarbital, pentobarbital, or a salt of any of these drugs and which is approved by the food and drug administration for marketing only as a suppository is included in schedule 3.

(5)       A substance that contains any quantity of a derivative of barbituric acid or any salt thereof is included in schedule 3.

(6)       Nalorphine is included in schedule 3.

 

R 338.3121a Schedule 3; hallucinogenic substances.

Rule 21a. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a United States food and drug administration approved drug product and that has a hallucinogenic effect on the nervous system, including its salts, isomers, and salts of isomers when the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation, is included in schedule 3.

 

R 338.3123 Schedule 4; depressants; drugs affecting the central nervous system; stimulants; exempt chemical preparations for industrial use; exceptions; narcotic drugs.

Rule 23. (1) Unless specifically excepted, a material, compound, mixture, or preparation that contains any quantity of the following substances having a potential for abuse associated with a depressant effect on the central nervous system, including its salts, isomers, and the salts of isomers when the existence of such salts, isomers, and the salts of isomers is possible within the specific chemical designation, is included in schedule 4:

(a)  Alprazolam.

(b)  Barbital.

(c)  Bromazepam.

(d)  Camazepan.

(e)  Chloralbetaine.

(f) Chloral hydrate.

(g)  Chlordiazepoxide.

(h)  Clobazam.

(i)  Clonazepam.

(j)  Clorazepate.

(k)  Clotiazepam.

 

 

(l)  Cloxazolam.

(m)  Dichloralphenazone.

(n)  Delorazepam.

(o)  Dextropropoxyphene.

(p)  Diazepam.

(q)  Estazolam.

(r)  Modafinil.

(s)  Ethchlorvynol.

(t)  Ethinamate.

(u)  Ethyl loflazepate.

(v)  Fludiazepam.

(w)  Flunitrazepam.

(x)  Flurazepam.

(y)  Halazepam.

(z)  Haloxazolam. (aa) Ketazolam. (bb) Loprazolam. (cc) Lorazepam. (dd) Lormetazepam. (ee) Mebutamate. (ff) Medazepam. (gg) Meprobamate. (hh) Methohexital.

(ii) Methylphenobarbital (mephobarbital) (jj) Midazolam.

(kk) Nimetazepam. (ll) Nitrazepam. (mm) Nordiazepam. (nn) Oxazepam. (oo) Oxazolam. (pp) Paraldehyde. (qq) Petrichloral. (rr) Phenobarbital. (ss) Pinazepam.

(tt) Prazepam. (uu) Quazepam.

(vv) Temazepam. (ww) Tetrazepam.

(xx) Triazolam. (yy) Zaleplon. (zz) Zolpidem.

(2)        Unless specifically excepted, a material, compound, mixture, or preparation that contains any quantity of fenfluramine having a potential for abuse associated with an effect on the central nervous system, including its salts, isomers, whether optical, position, or geometric, and the salts of such isomers when the existence of such salts, isomers, and the salts of isomers is possible, is included in schedule 4.

 

 

(3)      Unless specifically excepted, a material, compound, mixture, or preparation that contains any quantity of the following substances having a potential for abuse associated with a stimulant effect on the central nervous system, including its salts, isomers, whether optical, position, or geometric, and the salts of such isomers when the existence of such salts, isomers, and the salts of isomers is possible within the specific chemical designation, is included in schedule 4:

(a)  Cathine ((+)-norpseudoephedrine).

(b)  Dexfenfluramine.

(c)  Diethylpropion.

(d)  Fencamfamin.

(e)  Fenproporex.

(f) Mazindol.

(g)  Mefenorex.

(h)  Phentermine.

(i)  Pemoline, including organometallic complexes and chelates thereof.

(j)  Pipradrol.

(k)  Sibutramine.

(l)  SPA((-)-l-dimethylamino-1,2-diphenylethane).

(4)          Unless specifically excepted or unless listed in another schedule, any natural compound, mixture, or prescription which contains butorphanol, including its optical isomers and its salts, is included in schedule 4.

(5)        Chloral hydrate is designated as an exempt chemical preparation for industrial use when packaged in a sealed, oxygenfree environment under nitrogen pressure and safeguarded against exposure to air.

(6)          Unless specifically excepted or unless listed in another schedule, a material, compound, mixture, or preparation containing limited quantities of not more than 1 milligram of difenoxin and not less that 25 micrograms of atropine sulfate per dosage unit or any salts thereof is included in schedule 4.

 

R 338.3125 Schedule 5; narcotics added to nonnarcotic compounds.

Rule 25. (1) Schedule 5 includes the drug  buprenophine by whatever official, common, usual, chemical, or brand name designated.

(2)       A compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs or salts thereof, which includes 1 or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation a valuable medicinal quality other than that possessed by the narcotic drug alone, is included in schedule 5:

(a)         Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams, and not more than 10 milligrams per dosage unit.

(b)     Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams, and nor more than 4 milligrams per dosage unit.

(c)      Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams, and not more than 5 milligrams per dosage unit.

(d)     Not more than 100 milligrams of opium per 100 milliliters or per 100 grams, and nor more than 5 milligrams per dosage unit.

(e)       Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.

(f)     Not more than 0.5 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.

 

 

(3)        Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of either of the following substances which have a stimulate effect on the central nervous system, including its salts, isomers, and salts of isomers, is included in schedule 5:

(a)       Propylhexedrine.

(b)       Pyrovalerone.

 

R 338.3126 Schedule 5; ephedrine; exceptions.

Rule 26. (1) Except as otherwise provided in subrule (2) of this rule, ephedrine, a salt of ephedrine, an optical isomer of ephedrine, a salt of an optical isomer of ephedrine, or a compound, mixture, or preparation containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine is included in schedule 5.

(2) The following are not included in schedule 5:

(a)       A product containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine if the drug product may lawfully be sold over the counter without a prescription under federal law, is labeled and marketed in a manner consistent with the pertinent over the counter tentative final or final monograph, is manufactured and distributed for legitimate medical use in a manner that reduces or eliminates the likelihood for abuse, and is not marketed, advertised, or labeled for an indication of stimulation, mental alertness, energy, weight loss, appetite control, or muscle enhancement and if the drug product is 1 of the following:

(i)  A solid dosage form, including but not limited to a soft gelatin caplet, that combines as active ingredients not less than 400 milligrams of guaifenesin and not more than 25 milligrams of ephedrine per dose, packaged in blister packs with not more than 2 tablets or caplets per blister.

(ii) An anorectal preparation containing not more than 5% ephedrine.

(b)        A food product or a dietary supplement containing ephedrine, if the food product or dietary supplement meets all of the following criteria:

(i)  It contains, per dosage unit or serving, not more than the lesser of 25 milligrams of ephedrine alkaloids or the maximum amount of ephedrine alkaloids provided in applicable regulations adopted by the United States food and drug administration and contains no other controlled substance.

(ii)  It does not contain hydrochloride or sulfate salts of ephedrine alkaloids.

(iii)  It is packaged with a prominent label securely affixed to each package that states all of the following:

(A)  The amount in milligrams of ephedrine in a serving or dosage unit.

(B)  The amount of the food product or dietary supplement that constitutes a serving or dosage unit.

(C)   That the maximum recommended dosage of ephedrine for a healthy adult human is the lesser of 100 milligrams in a 24-hour period or the maximum recommended dosage or period of use provided in applicable regulations adopted by the United States food and drug administration.

(D)  That improper use of the product may be hazardous to a person's health.

 

R 338.3127 Exclusions for nonnarcotic substances which are not scheduled.

Rule 27. (1) A nonnarcotic substance which, under the federal food, drug, and cosmetic act of 1938, 21 U.S.C.

§301 et seq., may be lawfully dispensed without a prescription is excluded from all schedules pursuant to the provisions of section 7208(2) of the act. A substance which contains 1 or more controlled substances in such a proportion or concentration to vitiate the potential for abuse is an excluded substance.

(2)        An excluded substance is a deleterious drug as defined in section 7104(6) of the act and may only be manufactured, distributed, or dispensed by a person who is licensed to manufacture, distribute, or dispense a controlled substance under the act.

 

 

 

PART 3. LICENSES

 

R 338.3132 Activities requiring separate licenses.

Rule 32. (1) The following activities are deemed to be independent of each other, shall be conducted under separate licenses, and shall comply with all of the requirements and duties prescribed by law for persons who are licensed to engage in such coincidental activities:

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

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

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

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

(A)  Manufacture the substances as set forth in the research protocol that is filed and approved by the federal food and drug administration and the drug enforcement administration (DEA) pursuant to the provisions of 21

C.F.R. §1301.18 and submitted with the application for licensure. The Code of Federal Regulations, Title 21, Food and Drugs, part 1301, containing §1301.18 is available via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased from the United States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954, USA, by calling toll free at 1-866-512-1800, or via the Internet at web-site: http://bookstore.gpo.gov at a cost of $20.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. §1301.18 also are available for inspection and for distribution to the public at cost at the Department of Consumer and Industry Services, Bureau of Health Services, Ottawa Building, - First Floor, 611 West Ottawa, Lansing, MI 48909.

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

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

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

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

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

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

 

 

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

 

R 338.3133 Rescinded.

 

R 338.3134 Rescinded.

 

R 338.3136 Information in applications.

Rule 36. (1) A researcher shall include, in his or her application for licensure, all of the following information:

(a)  His or her credentials to conduct the proposed research.

(b)  The protocol and description of the nature of the proposed research.

(c)  A list of the controlled substances and doses to be used.

(2)      A person who conducts instructional activity shall include, with his or her application for licensure, all of the following information:

(a)      His or her credentials to conduct the proposed instructional activity.

(b)      A course outline for the proposed instructional activity.

(c)       A list of the controlled substances and doses to be used.

 

R  338.3138  Animal  euthanasia;  permit  application;  records;  storage  of  pentobarbital;  facility inspections; facility registration; personnel training; written administration procedures.

Rule 38. (1) A dog pound, class b dealer, or animal shelter licensed or registered by the Michigan department of agriculture pursuant to 1969 PA 287, MCL 287.331 et seq., may apply for a permit to store, handle, and use a commercially prepared, pre-mixed solution of sodium pentobarbital to practice euthanasia on animals.

(2)         A dog pound, class b dealer, or animal shelter holding a current registration or license issued by the Michigan department of agriculture shall apply, on a form provided by the administrator, for a permit to store, handle, and use sodium pentobarbital. The application submitted to the administrator shall contain all of the following information:

(a)  The name, address, and department of agriculture registration number of the dog pound, class b dealer or animal shelter.

(b)  The name, address, and biographical data of the person who is in charge of the day-to-day operation of the dog pound, class b dealer, or animal shelter and who is responsible for the storage and recordkeeping of the sodium pentobarbital.

(c)   The name, address, and biographical data of the person responsible for designating employees  who will practice euthanasia pursuant to the act.

(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.

(3)      Records of the receipt and dispensation of sodium pentobarbital shall be maintained at the animal shelter or dog pound. These records shall indicate all of the following information:

(a)  The date of acquisition.

(b)  The quantity acquired.

(c)  The trade name.

(d) The lot number and strength of a commercially prepared, pre-mixed solution of sodium pentobarbital.

 

 

(e)  A complete record of the dispensation of the pre-mixed solution for the purpose of practicing euthanasia, showing the quantity used, time, date, and the name of the administering individual.

(4)        Records of receipt shall be kept on drug enforcement administration (DEA) order forms pursuant to 21

C.F.R. part 1305. The Code of Federal Regulations, Title 21, Food and Drugs, part 1305 is available via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased from the United States Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA, 15250-7954, USA, by calling toll free at 1-866-512-1800, or via the Internet at web-site: http://bookstore.gpo.gov at a cost of

$20.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. part 1305 also are available for inspection and for distribution to the public at cost at the Department of Consumer and Industry Services, Bureau of Health Services, Ottawa Building – First Floor, 611 West Ottawa, Lansing, MI 48909.

(5)       Records of dispensation shall be kept pursuant to 21 C.F.R. part 1304. The Code of Federal Regulations, Title 21, Food and Drugs, part 1304 is available via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased from the United States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA, 15250-7954, USA, by calling toll free at 1-866-512-1800, or via the Internet at web-site: http://bookstore.gpo.gov at a cost of $20.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. part 1304 also are available for inspection and distribution to the public at cost at the Department of Consumer and Industry Services, Bureau of Health Services, Ottawa Building – First Floor, 611 West Ottawa, Lansing, MI 48909.

(6)      Records shall be kept for a period of 2 years and shall be available for inspection by the department.

(7)        The controlled substance covered by this permit shall be a commercially prepared, pre-mixed solution of sodium pentobarbital.

(8)      All stocks of the sodium pentobarbital shall be stored in a securely locked, substantially constructed cabinet located in the facility, with access limited to the persons described in subrule (2)(b) and (d) of this rule.

(9)           An inspection of the facility may be conducted by the department before issuance of the permit. Unannounced additional inspections may be made from time to time thereafter.

(10)       The permit issued by the administrator shall 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 shall be notified, in writing, within 10 days of a change in the person in charge of the day-to-day operation.

(11)          The facility shall promptly obtain a registration from the United States department of justice, drug enforcement administration, or its successor agency, before stocking, purchasing, and using sodium pentobarbital to practice euthanasia. Purchases shall be made in accordance with procedures established by the drug enforcement agency.

(12)       If the dog pound, class b dealer, or animal shelter issued a permit pursuant to section 7333(8) of the act, does not have in its employ an individual trained as described in section 7333(8), then the dog pound, class b dealer, or animal shelter shall immediately notify the administrator and shall securely store, and cease to administer, any commercially-prepared, pre-mixed solution of sodium pentobarbital until the administrator is notified that either of the following has occurred:

(a)      An individual trained as described in section 7333(8) of the act has been hired by the facility.

(b)      An employee of the facility has been trained as described in section 7333(8) of the act .

(13)         The administrator shall be notified of any change in the name and address of the individual trained as described in section 7333(8) of the act within 10 days of such change.

(14)         The list of persons certified to have received training and the veterinarians who trained them shall be updated in writing every 6 months, kept on site and available for inspection.

 

 

(15)        The dog pound, class b dealer or animal shelter shall establish and maintain written procedures for the administration of a commercially prepared, pre-mixed solution of sodium pentobarbital. These procedures shall be kept on the licensed premises and shall be available for inspection.

 

R 338.3139 Animal euthanasia; personnel training.

Rule 39. (1) An employee of a dog pound, class b dealer, or animal shelter who will practice euthanasia on animals shall be able to 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 doctor of veterinary medicine currently licensed in this state. The training shall include both lecture and self-study instruction and clinical experience. At a minimum, the individual shall demonstrate competency to give inter-cardial, intraperitoneal, and intravenous injections, in addition to making a positive determination of death.

(3)      Upon receipt of notification of the individual's successful completion of the minimum 8 hours of training from the licensed veterinarian/instructor, the department shall issue a permit to the dog pound or animal shelter. Proficiency may be shown by completion of a self-assessment program or other evaluation by the board of veterinary medicine. The permit is subject to the provisions of section 7334 of the act.

(4)       Continued proficiency and compliance with written procedures, in addition to compliance with all rules and regulations, may be monitored by the administrator or the board of veterinary medicine.

 

PART 4. SECURITY

 

R 338.3141 Thefts and diversions.

Rule 41. (1) An applicant or licensee shall provide effective controls against theft and diversion of controlled substances.

(2)      A licensee shall determine that a person is licensed to possess a controlled substance before distributing the substance to the person.

(3)      Within 10 days following discovery of a theft or loss of any controlled substance, a licensee shall notify the administrator of the theft or loss by submitting a United States drug enforcement administration theft and loss report form 106, a copy thereof, or equivalent document, whether or not the controlled substance is subsequently recovered or the responsible party is identified and action is taken against the party, and whether or not it is also reported to the DEA.

 

R 338.3143 Storage of controlled substances.

Rule 43. (1) A controlled substance that is listed in schedule 1 of R 338.3111 to R 338.3114a shall be stored in a securely locked, substantially constructed cabinet that is anchored to a wall or the floor.

(2)   A controlled substance that is listed in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3126 shall be stored in a securely locked, substantially constructed cabinet, room, or cart. However, in a pharmacy, the controlled substances may be dispersed throughout the stock of noncontrolled substances in a manner to obstruct the theft or diversion of controlled substances.

(3)  Parenteral dosage forms which contain amobarbital, secobarbital, pentobarbital, or any salt of any of these drugs and which are required by the federal food, drug, and cosmetic act of 1938, 21 U.S.C. §301 et seq., or by regulations promulgated thereunder, to be kept under refrigeration may be stored in compliance with the schedule III regulations set forth in the provisions of 21 C.F.R. §§1301.71 to 1301.76. The Code of Federal Regulations, Title 21, Food and Drugs, part 1301, containing 21 C.F.R. §§1301.71 to 1301.76, is available via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased from the United

 

 

States Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250- 7954, USA, by calling toll free at 1-866-512-1800, or via the Internet web-site: http://bookstore.gpo.gov at the cost of $20.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. §§1301.71 to

1301.76 also are available for inspection and for distribution to the public at cost at the Department of Consumer and Industry Services, Bureau of Health Services, Ottawa Building – First Floor, 611 West Ottawa, Lansing, MI 48909.

(4)  This rule applies to all licensees.

 

R 338.3145 Employees; disqualification.

Rule 45. (1) The following individuals shall not be employed or otherwise utilized, with or without compensation, by a person who is licensed by the administrator pursuant to section 7303, 17711, or 17748 of the act in any manner or capacity that allows the individuals access to controlled substances:

(a)   An individual who the licensee knows, or should reasonably know, to be a substance abuser as defined in section 6107 of the act. This subdivision does not apply to a licensee enrolled in the health professional recovery program under a current monitoring agreement.

(b)  An individual whose controlled substance license is suspended, revoked, or denied.

(c)  An individual whose license issued by this state or another state is under suspension or revoked in this state or another state for a violation that involves controlled substances.

(d)  An individual who has been convicted of a crime that involves controlled substances and who is currently under sentence for that conviction.

(2) Delegation pursuant to section 16215 of the act shall not be made by a licensed person to a licensed or unlicensed individual unless the delegation is in compliance with this rule.

 

PART 5. RECORDS

 

R 338.3151 Inventories.

Rule 51. (1) A licensee shall make and maintain a complete and accurate inventory of all stocks of controlled substances.

(2)      The inventory shall contain a complete and accurate record of all controlled substances in the possession or control of the licensee on the date the inventory is taken as follows:

(a)       If the substance is listed in schedule 1 or 2, then the licensee shall make an exact count or measure of the contents.

(b)      If the substance is listed in schedule 3, 4, or 5, then the licensee shall make an estimated count or measure of the contents, but if the container holds more than 1,000 dosage units, such as tablets or capsules, then the licensee shall make an accurate account of the contents.

(3)      A licensee shall make a separate inventory for each licensed location on the date that he or she first engages in the activity covered by his or her license. The beginning inventory record for a licensed location shall be kept at the licensed location and a copy shall be forwarded to the administrator upon request.

(4)        A licensee shall indicate on the inventory record whether the inventory was taken as of the opening or closing of the day that the inventory is taken.

(5)      A licensee shall maintain the inventory in a written, typewritten, or printed form. The inventory taken by use of an oral recording device shall be promptly transcribed.

(6)      A licensee shall sign and date the inventory record.

(7)      A licensee’s printed name, address, and DEA number shall be recorded on the inventory.

(8)      Schedule 2 drugs shall be separated on the inventory from all other drugs.

 

 

 

R 338.3152 Annual and changed inventories.

Rule 52. (1) Pursuant to the provisions of section 7321 of the act, an inventory shall be taken annually of all stocks of controlled substances in the possession or control of the licensee, in accordance with the requirements of R 338.3151.

(2) On the effective date of a rule by the administrator or DEA adding a controlled substance to a schedule, which substance was not previously listed in any schedule, a licensee who possesses the substance shall take an inventory of all stocks of the substance on hand and incorporate it in the current inventory. Thereafter, the substance shall be included in each inventory taken.

 

R 338.3153 Invoices, acquisition, dispensing, administration, and distribution records.

Rule 53. (1) A licensee shall keep and make available for inspection all records for controlled substances, including invoices and other acquisition records, but excluding sales receipts, however a copy of each receipt shall be retained for 90 days. Acquisition records, except for executed DEA 222 order forms, may be kept at a central location, subject to the approval of the administrator. The approval shall specify the nature of the acquisition records to be kept and the exact location where the acquisition records will be kept. All records shall be readily retrievable within 48 hours.

(2)      A licensee shall maintain acquisition records as follows:

(a)  Invoices and other acquisition records of all controlled substances listed in schedules 1 and 2 of R 338.3111 to R 338.3119a shall be maintained in a separate file.

(b)   Invoices and other acquisition records of all controlled substances listed in schedules 3, 4, and 5 of R 338.3120 to R 338.3126 shall be maintained in a separate file or in such form so that the information required is readily retrievable from the ordinary acquisition records maintained by the dispenser.

(3)      A licensee shall initial the invoice and indicate the date that the controlled substances are received.

(4)      A licensee shall keep a record of all controlled substances dispensed by him or her.

(5)       A  prescriber shall keep a record separate from the patient chart which contains all of the following information for controlled substances dispensed or administered by the prescriber:

(a)  Name of patient.

(b)  Name of substance and strength.

(c)  Quantity of substance.

(d) Date dispensed or administered.

(e)  Name of individual who dispensed or administered.

(6)      Except in medical institutions, patients’ original prescriptions shall be sequentially numbered and maintained in chronological order as follows:

(a)   A separate file shall be maintained for dispensed substances listed in schedule 2 of R 338.3116 to R 338.3119a.

(b)  A separate file shall be maintained for dispensed substances listed in schedules 3, 4, and 5 of R 338.3120 to R 338.3126.

(7)      Records of controlled substances distributed to another licensee, shall include all of the following information and be maintained in the appropriate file described in subrule (2) of this rule or in a separate record that is available for inspection:

(a)  Name, address, and dea number of receiver.

(b)  Name, address, and dea number of supplier.

(c)  Name and quantity of controlled substances distributed.

(d) Date distributed.

 

 

A DEA 222 order form shall be used for schedule 2 drugs.

(8)      Complete controlled substances records shall be maintained or controlled by the licensee for 2 years, except for controlled substance prescriptions, which shall be maintained for 5 years from the last date of dispensing.

 

R 338.3153a Medication orders for patients in medical institutions.

Rule 53a. (1) Prescriptions for controlled substance medications to be dispensed for administration to an inpatient in a medical institution shall contain all of the following information:

(a)  The patient's name.

(b)  The prescriber's name, address, and drug enforcement administration (DEA) number. In place of including the address and DEA number on each medication order, the pharmacy may maintain a separate list of authorized prescribers. The list shall contain the prescriber's name, address, and DEA number.

(c)  The prescriber's signature.

(d)  The name, dose, and frequency of administration of the medication.

(e)  The date of the medication order.

(2)         If alternative therapy has been evaluated and the immediate administration of a controlled substance, including a schedule 2 medication, is necessary for the proper treatment of a patient, then a pharmacist may dispense the controlled substance for administration to the inpatient if all of the following conditions are satisfied:

(a)  The oral order of the prescriber is committed to a written or electronic order in the patient chart by a nurse licensed under part 172 of the act, a physician's assistant licensed under part 170 or 175 of the act, or a pharmacist licensed under part 177 of the act who has communicated directly with the prescriber.

(b)  The order states the name of the prescriber and the name of the nurse, physician's assistant, or pharmacist who received the verbal order.

(c)  The order is forwarded to the pharmacy.

(d) The prescriber signs the original order at the time of next visit or within 7 days.

(3)       Original orders shall be preserved for a period of 5 years from the date of patient discharge and shall be readily retrievable for any specific time period. If patient records are kept electronically, then a printed copy shall be immediately available for a current inpatient and within 48 hours upon request of an authorized agent of the board for any patient of the previous 5 years.

 

R 338.3154 Medication records in medical institutions.

Rule 54. (1) A patient's chart shall constitute a record of medications ordered for, and actually administered to, a patient of medical institutions.

(2)   Medication records are required for all controlled substances listed in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3126. At a minimum, these records shall include all of the following information:

(a)  The number of doses of controlled substances purchased.

(b)  The number of doses dispensed to individual patients or distributed to nursing stations or both.

(c)  The number of doses administered.

(d) The number of doses dispensed, but not administered, to the patient.

(e)   An annual physical inventory and status of any discrepancies between the inventory and the records of acquisition and the dispensing records.

(3)  If the controlled substance is not dispensed to an individual patient, all of the following provisions shall be complied with:

(a)    Medication records for those controlled substances in schedules 2, 3, 4, and 5 of R 338.3116 to R 338.3126 shall be maintained.

(b)  Distribution of a controlled substance to a nursing unit shall not be more than 25 doses per container.

 

 

(c)  A distribution record for each multiple of 25 doses shall be used to account for delivery to a nursing unit. The record shall include all of the following information:

(i)  The name and dose of the controlled substance.

(ii) The quantity of the substance.

(iii) The date of delivery.

(iv) The location of the nursing unit.

(v)  The name of the distributing pharmacy and address if a different location from the medical institution.

(vi)  Name of distributing pharmacist.

(vii) The name of the individual on the nursing unit who receives the substance.

(d) A proof of use record shall be maintained to account for all doses of an administered substance. The record shall include all of the following:

(i)  The name of the substance.

(ii)  The dose administered.

(iii)  The date and time a dose was administered.

(iv) The name of the patient.

(v)  The signature of the individual who administered the dose.

(4) The use of mechanical devices in medical institutions is contingent upon any approval which may be required by rule. If a controlled substance or any medication or device is dispensed from an automated device, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility shall be maintained on-site in the pharmacy for review by the department. The documentation shall include at least all of the following information:

(a)  Name and address of the pharmacy or facility responsible for the operation of the automated device.

(b)  Manufacturer name and model number.

(c)   Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.

(d) Policy and procedure for system operation that includes all of the following:

(i)  Safety.

(ii) Security.

(iii) Accuracy.

(iv) Patient confidentiality.

(v)  Access.

(vi)  Controlled substances.

(vii)  Data retention or archival.

(viii)  Definitions.

(ix) Downtime procedures.

(x)  Emergency procedures.

(xi) Inspection.

(xii) Installation requirements.

(xiii)Maintenance.

(xiv) Medication security.

(xv) Quality assurance.

(xvi) Medication inventory.

(xvii) Staff education and training.

(xviii) System set-up and malfunction.

 

 

(xix)   List of medications qualifying for emergency dose removal without pharmacist prior review of the prescription or medication order.

(5)  Automated devices shall have adequate security systems and procedures, evidenced by written pharmacy policies and procedures that document all of the following information:

(a)  Prevention of unauthorized access or use.

(b)  Compliance with any applicable federal and state regulations.

(c)  Maintenance of patient confidentiality.

(6)  Records and electronic data kept by automated devices shall meet all of the following requirements:

(a)  All events involving access to the contents of the automated devices shall be recorded electronically.

(b)  Records shall be maintained by the pharmacy and shall be readily retrievable. The records shall include all of the following information:

(i)  The unique identity of device accessed.

(ii)  Identification of the individual accessing the device.

(iii) The type of transaction.

(iv)  The name, strength, dosage form and quantity of the drug accessed.

(v)  The name of the patient for whom the drug was ordered.

(vi) Identification of the pharmacist checking for the accuracy of the medications to be stocked or restocked in the device.

(vii)  If the pharmacist delegates the stocking of the device, then technologies shall be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that is in compliance with R 338.490. This subdivision takes effect 1 year after the effective date of this amendatory rule.

(viii) Additional information as the pharmacist-in-charge may deem necessary.

(7)  For medication removed from the system for on-site patient administration, the system shall document all of the following information:

(a)  The name of the patient.

(b)  The date and time medication was removed from the device.

(c)  The name, initials, or other unique identifier of the person removing the drug.

(d)   The name, strength, and dosage form of the drug. The documentation may be on paper or electronic medium.

(8)  The automated device shall provide a mechanism for securing and accounting for medications once removed from and subsequently returned to, the automated device return bin. Neither medication nor a device may be returned directly to the system for immediate reissue or reuse. Medication or devices once removed shall not be reused or reissued, except as indicated in R 338.486(7).

(9)   The automated device shall provide a mechanism for securing and accounting for wasted or discarded medications.

(10)  The internal quality assurance documentation for the use and performance of the automated device shall include at least all of the following:

(a)      Safety monitors that include wrong medications removed and administered to patient.

(b)      Accuracy monitors that include filling errors and wrong medications removed.

(c)      Security monitors that include unauthorized access, patients not in the system, system security breaches, and controlled substance audits.

(d)     Policies that establish corrective measures taken to address the problems and errors identified in the internal quality assurance program and its integration to the overall quality assurance policies.

 

 

(11)   Policy and procedures for the use of the automated device shall include a requirement for pharmacist review of the prescription or medication order before system profiling or removal of any medication from the system for immediate patient administration. This subrule does not apply to the following situations:

(a)      The system is being used as an after-hours cabinet for medication dispensing in the absence of a pharmacist as defined in R 338.486(4)(i).

(b)      The system is being used in place of an emergency kit as defined in R 338.486(4)(c).

(c)        The system is being accessed to remove medication required to treat the emergent needs of a patient as defined in R 338.486(4)(c). A sufficient quantity to meet the emergent needs of the patient may be removed until a pharmacist is available to review the medication order.

(d)      In each of the situations specified in subdivisions (a) to (c) of this subrule, a pharmacist shall review the orders and authorize any further dispensing within 48 hours.

(12)   A copy of all pharmacy policies and procedures related to the use of an automated device shall be maintained at the pharmacy responsible for the device’s specific location and be available for board of pharmacy review.

(13)  A controlled substance that is maintained at a nursing unit shall be stored in a securely locked cabinet or medication cart that is accessible only to an individual who is responsible for the administration or distribution of the medication.

(14)  Records and documents required under this rule shall be maintained or controlled by the pharmacist in charge for 2 years.

(15)  An individual who is responsible for administering a controlled substance or A portion thereof shall record the quantity, disposition, and an explanation of the destruction of the controlled substance on the proper accountability record. If the institution has a policy that reflects current practice standards and delineates the method of destruction, an explanation would only be required if policy was not followed.

 

PART 6. DISPENSING AND ADMINISTERING PRESCRIPTIONS

 

R 338.3161 Prescriptions.

Rule 61. (1) A prescription that is issued for a controlled substance shall be dated and signed when issued and shall contain all of the following information:

(a)  The full name and address of the patient for whom the substance is being prescribed.

(b)  The prescriber's DEA registration number, printed name, address, and professional designation.

(c)  The drug name, strength, and dosage form.

(d)  The quantity prescribed. For a prescription received in writing, the prescription shall contain the quantity in both written and numerical terms. A written prescription is in compliance if it contains preprinted numbers representative of the quantity next to which is a box or line the prescriber may check.

(e)  The directions for use.

(f) In addition, if the prescription is for an animal, then the species of the animal and the full name and address of the owner.

(2)       Where a written prescription is required, the prescription shall be written with ink or an indelible pencil, or prepared using a printer and shall be signed by the prescriber.

(3)        A prescription may be prepared by an agent of the prescriber for the signature of the prescriber, but, pursuant to the act, the prescriber is liable if the prescription does not conform to these rules. A pharmacist who dispenses a controlled substance pursuant to a prescription not prepared in the form required by these rules is liable pursuant to the act.

 

 

(4)      If the controlled substance prescription or order in a medical institution is issued pursuant to delegation under R 338.2304, R 338.2305, R 338.108a, or R 338.108b, then the printed name of the delegatee, the licensure designation, the delegating prescriber, and the signature of the delegatee shall be on the written prescription. In medical facilities, orders shall contain the signatures of the delegatee and the printed name of the delegating prescriber.

(5)      A prescription shall not be issued by a prescriber to obtain a stock of a controlled substance for the purpose of dispensing or administering the substance to patients.

 

R 338.3162 Dispensing by pharmacists.

Rule 62. (1) A controlled substance shall be dispensed by a pharmacist or a pharmacy intern in the presence, and under the immediate supervision, of a pharmacist.

(2)  Except as provided by R 338.3162a, a pharmacist may dispense a controlled substance which is listed in schedules 3 to 5 and which is a prescription drug pursuant to the provisions of the federal food, drug, and cosmetic act of 1991, 21 U.S.C. §201.100(b)(i) et seq., only pursuant to a written, electronically transmitted, or oral order of a prescriber that contains all of the required information under R 338.3161, except that the signature of the prescriber is not required if the controlled substance is obtained pursuant to an oral order.

(3)  If an oral order for a controlled substance listed in schedule 3 to 5 is transmitted by the prescriber’s agent under delegation, then all of the following shall be recorded on the prescription generated at the pharmacy:

(a)  The information required by R 338.3161.

(b)  The transmitting agent’s identity.

(c)  The individual who received the prescription at the pharmacy.

(4)  Only an order that is issued in the usual course of professional treatment or in the course of legitimate and authorized research is a prescription.

 

R 338.3162a Electronic transmission of prescriptions ; "electronically transmitted prescription drug order” defined.

Rule 62a. (1) As used in this rule, "electronically transmitted prescription drug order" means a prescription drug order that is communicated from the prescriber directly to the pharmacy by electronic means, so that the data cannot be altered, modified, extracted, viewed, or manipulated in the transmission process.

(2)       An electronically transmitted prescription order shall be transmitted to the pharmacy of the patient's choice and shall occur only at the option of the patient.

(3)      A pharmacist may dispense an electronically transmitted prescription drug order only if both of the following conditions are satisfied:

(a)      The electronically transmitted prescription drug order includes all of the following information:

(i)  The name and address of the prescriber.

(ii) An electronic signature or other board-approved means of ensuring prescription validity.

(iii) The prescriber's telephone number for verbal confirmation of the order.

(iv) The time and date of the transmission.

(v)  The name of the pharmacy intended to receive the transmission.

(vi) All other information that is required to be contained in a prescription under the provisions of R 338.3161.

(b)        The pharmacist exercises professional judgment regarding the accuracy or authenticity of the transmitted prescription. Technological devices shall not be used to circumvent any applicable prescription documentation and verification requirement.

(4)       An electronically transmitted prescription drug order that meets the requirements of subrule (3) of this rule shall be deemed to be the original prescription.

 

 

(5)       This rule does not apply to the use of electronic equipment to transmit prescription orders within inpatient medical institutions.

 

R 338.3163 Drug-dependent person; prescribing, dispensing, and administering controlled substance. Rule 63. (1) A prescription shall not be issued for a controlled substance nor shall a controlled substance be dispensed or administered to a drug dependent person for the purpose of continuing his or her drug dependency, except as follows:

(a)      A prescriber, licensed in accordance with federal and state law to conduct the drug treatment of a drug dependent person in a program may prescribe a controlled substance for the purpose of legitimate treatment of the drug-dependent person.

(b)        A controlled substance may be administered or dispensed, or both, by a dispenser, directly to a drug- dependent person for the purpose of continuing his or her dependence who is enrolled in a drug treatment and rehabilitation program.

(2)  A controlled substance may be prescribed and dispensed in an acute care hospital to continue maintenance treatment for drug dependency for a patient whose hospitalization is for treatment of a medical condition other than addiction. The enrollment of the patient in an approved maintenance treatment program shall be verified.

 

R 338.3167 Dispensing schedule 5 substances without prescriptions.

Rule 67. (1) A pharmacist may, without a prescription, dispense a controlled substance listed in schedule 5 which is not a prescription medication as determined under the federal food, drug, and cosmetic act, 21 U.S.C.

§§301 to 392, if all of the following provisions are complied with:

(a)      The dispensing pharmacist has determined it is to be used for a medical purpose.

(b)      Not more than 240 cc (8 ounces) or 48 solid doses of a substance containing opium or more than 120 cc (4 ounces) or 24 solid doses of any other substance listed in schedule 5 is distributed at retail to the same purchaser in any single 48-hour period.

(c)      The purchaser is not less than 18 years of age.

(d)     The pharmacist requires a purchaser not known to the pharmacist to furnish suitable identification, including proof of age where appropriate.

(2)         When a pharmacist dispenses a controlled substance listed in schedule 5, he or she shall affix to the container in which the substance is dispensed a label showing the date, his or her own name, and the name and address of the place of practice in which the substance is dispensed.

(3)          A record of the dispensing of controlled substances listed in schedule 5 shall be maintained by the pharmacist. The record shall be immediately retrievable and may be maintained in the same manner as required for schedule 5 prescription medication. The record shall contain all of the following information:

(a)  The name and address of the patient.

(b)  The name and address of the purchaser if different from the patient.

(c)  The name and quantity of substance purchased.

(d)  The date purchased.

(e)  The name or initials of the pharmacist or pharmacy intern who dispensed the substance.

(f) The medical purpose for which the medication is being used as determined by the pharmacist.

 

R 338.3168 Refilling of prescriptions.

Rule 68. (1) A prescription for a controlled substance listed in schedule 2 shall not be refilled.

 

 

(2)      A prescription for a controlled substance listed in schedules 3 and 4 shall not be refilled more than 6 months after the issuance date of the prescription and shall not be refilled more than 5 times. Renewal of the prescription shall be effected and recorded in the same manner as an original prescription.

(3)        A partial filling of a controlled substance prescription in schedules 3, 4, and 5 is permissible if all of the following provisions are complied with:

(a)     Each partial filling is recorded in the same manner as a refilling.

(b)      The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

(c)      No dispensing occurs after 6 months after the date on which the prescription was issued for schedules 3 and 4.

(4)      A prescription for a controlled substance listed in schedule 5 may be refilled only as expressly authorized by the prescriber on the prescription; if no authorization is indicated, then the prescription shall not be refilled.

 

R 338.3169 Labels.

Rule 69. In addition to all other labeling requirements, a practitioner who dispenses a controlled substance prescription shall affix to the container any cautionary statement required by 21 C.F.R. §290.5. The Code of Federal Regulations, Title 21, Food and Drugs, part 290, containing 21 C.F.R. §290.5, is available via the Internet at web-site http://www.access.gpo.gov/nara/cfr. Printed copies may be purchased from the United State Government Printing Office, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250- 7954 USA, by calling toll free at 1-866-512-1800, or via the Internet at web-site: http://bookstore.gpo.gov at a cost of $16.00 as of the time of adoption of these amendments. Printed copies of 21 C.F.R. §290.5 also are available for inspection and distribution to the public at cost at the Department of Consumer and Industry Services, Bureau of Health Services, Ottawa Building – First Floor, 611 West Ottawa, Lansing, MI 48909.

 

R 338.3170 Dispensing and administering controlled substances by prescribers.

Rule 70. (1) A prescriber in the course of his or her professional practice only, may dispense or administer, or both, a controlled substance listed in schedules 2 to 5 or he or she may cause them to be administered by an assistant under personal charge supervision.

(2)  A prescriber may dispense or administer, or both, in the course of professional practice, a controlled substance listed in schedules 2 to 5, directly to a drug-dependent person for the purpose of continuing the dependence in a drug treatment and rehabilitation program, if the prescriber is appropriately registered under federal law and licensed under state law to treat a drug-dependent person with controlled substances.

(3)  A veterinarian, in the course of professional practice only and not for use by a human being, may dispense or administer, or both, a controlled substance listed in schedules 2 to 5 or may cause them to be administered by an assistant or orderly under his or her direction and personal charge supervision.