PROPOSED ADMINISTRATIVE RULES

DEPARTMENT OF COMMUNITY HEALTH LICENSING AND REGULATORY AFFAIRS -DIRECTOR'S OFFICE

PHARMACY - CONTROLLED SUBSTANCES

Proposed Draft June 25, 2013

Filed with the Secretary of State on

These rules become effective immediately upon filing with the Secretary of State unless adopted under section 33, 44, or 45a(6) of 1969 PA 306. Rules adopted under these sections become effective 7 days after filing with the Secretary of State.

(By authority conferred on the director of the department of community health licensing and regulatory affairs by sections 7201, 7216 and 16145(2) and 17701 of 1978 PA 368, MCL 333.7201, 333.7216, and 333.16145(2), and 333.17701 et seq. and Executive Reorganization Order Nos. 1996-1, 1996-2, and 2003-01, and 2011-4, being MCL 330.3101, 445.2001, and 445.2011, and 445.2030)

R 338.3112, R 338.3113, R 338.3114, R 338.3114a, R 338.3116, R 338.3117, R 338.3118, R 338.3122, R 338.3123, R 338.3125, R 338.3153, and R 338.3162d of the of the Michigan Administrative Code are amended and R 338.3138, R 338.3139, and R 338.3169 of the Code are rescinded as follows:

PART 2 - SCHEDULES

R 338.3112 Schedule 1; opium derivatives.

Rule 12. Unless specifically excepted, the following opium derivatives, their salts, isomers and salts of isomers, when the existence of these salts, isomers and salts of isomers is possible within the specific chemical designation, are included in schedule 1:

Acetorphine

Acetyldihydrocodeine

Benzylmorphine

Codeine methylbromide

Codeine-N-Oxide

Cyprenorphine

Desomorphine

Dihydromorphine

Drotebanol

Etorphine (except hydrochloride salts)

Heroin

Hydromorphinol

Methyldesorphine

Methyldihydromorphine

Morphine methylbromide

Morphine methylsulfonate

Morphine-N-Oxide

Myrophine

Nicocodeine

Nicomorphine

Normorphine

Pholcodine

Thebacon

R 338.3113 Schedule 1; hallucinogenic substances.

Rule 13. Unless specifically excepted, any material, compound, mixture, or preparation that is not otherwise listed as a controlled substance in this schedule or in schedules II through V, is not approved by the federal food and drug administration as a drug, which and contains any quantity of the following hallucinogenic substances, or which contains any of its their salts, isomers (whether optical, positional, or geometric), homologues (analogs), and salts of isomers and homologues (analogs), whenever the existence of such these salts, isomers, homologues (analogs) and salts of isomers and homologues (analogs) 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.

(v) a-et.

(vi) 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:

(i) 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 338.3114 Schedule 1; tetrahydrocannabinols.

Rule 14. Synthetic equivalents of the substances contained in the plant or in the resinous extractives of cannabis and synthetic substances, derivatives, and their isomers with similar chemical structure or pharmacological activity, or both, such as the following, are included in schedule 1:

(a) Δ¹ cis or trans tetrahydrocannabinol and their optical isomers, excluding dronabinol in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved by the United States food and drug administration.

(b) Δ⁶ cis or trans tetrahydrocannabinol and their optical isomers.

(c) Δ^3,4 cis or trans tetrahydrocannabinol and their optical isomers. Since the nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions, are included.

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-phenyl-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 338.3116 Schedule 2; substances of vegetable origin or chemical synthesis.

Rule 16. (1) Unless specifically excepted, the following substances of vegetable origin, or independently derived by means of chemical synthesis or by combination of extraction and chemical synthesis, are included in schedule 2:

(a) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, dextrorphan, nalbuphine, nalmefene, naloxone, and naltrexone, and their respective salts, but including all of the following:

(i) Raw opium.

(ii) Opium extracts.

(iii) Opium fluid extracts.

(iv) Powdered opium.

(v) Granulated opium.

(vi) Tincture of opium.

(vii) Codeine.

(viii) Ethylmorphine.

(ix) Etorphine hydrochloride.

(x) Hydrocodone.

(xi) Hydromorphone.

(xii) Metopon.

(xiii) Morphine.

(xiv) Oxycodone.

(xv) Oxymorphone.

(xvi) Thebaine.

(b) A salt, compound, derivative, or preparation thereof which is chemically equivalent to or identical with a substance referred to in subdivision (a) of this subrule, except that these substances do not include the isoquinoline alkaloids of opium.

(c) Opium poppy, poppy straw, and concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid, or powder form, which contains the phenathrine alkaloids of the opium poppy).

(d) Coca leaves, and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, derivative, or preparation which is chemically equivalent to or identical with any of these substances.

(e) Cocaine; its salts; isomers; whether optical, position, or geometric; and salts of isomers.

(2) Decocainized coca leaves or the extraction of coca leaves, which extractions do not contain cocaine or ecgonine, are specifically excepted from schedule 2.

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 338.3118 Schedule 2; stimulants.

Rule 18. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances and which has a stimulant effect on the central nervous system is included in schedule 2:

(a) Amphetamine, its salts, optical isomers and salts of its optical isomers.

(b) Methamphetamine, its salts, isomers and salts of its isomers.

(c) Phenmetrazine and its salts.

(d) Methylphenidate and its salts.

R 338.3122 Schedule 3; anabolic steroids; exemptions.

Rule 22. (1) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of an anabolic steroid, including its salts, isomers, and salts of isomers if the existence of such salts of isomers is possible within the specific chemical designation, is included in schedule 3. As used in this rule, the term "anabolic steroid means any of the following drugs or hormonal substances which are chemically and pharmacologically related to testosterone, other than estrogens, progestins, and corticosteroids, and which promote muscle growth:

(a) Boldenone.

(b) 4-chlortestosterone (clostebol).

(c) Dehydrochlormethyltestosterone.

(d) Drostanolone.

(e) Ethylestrenol.

(f) Fluoxymesterone.

(g) Formebolone.

(h) Mesterolone.

(i) Methandriol.

(j) Methandrostenolone (methandienone).

(k) Metheno1one.

(l) Methyltestosterone.

(m) Mibolerone.

(n) Nandrolone.

(o) Norethandrolone.

(p) Oxandrolone.

(q) Oxymesterone.

(r) Oxymetholone.

(s) Stanolone (4-dihydrotestosterone).

(t) Stanozolol.

(u) Testolactone.

(v) Testosterone.

(w) Trenbolone.

(x) Any salt, ester, or isomer of a drug or substance described or listed in this subrule, if that salt, ester, or isomer promotes muscle growth.

(2) An anabolic steroid which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the United States drug enforcement administration for such administration is specifically excepted from schedule 3.

(3) The following anabolic steroid products are exempted from all schedules of controlled substances:

(a) Esterified estrogens 1.25 milligrams and methyl testosterone 2.5 milligram tablets.

(b) Esterified estrogens 0.625 milligrams and methyl testosterone 1.25 milligram tablets.

(c) Conjugated estrogens 1.25 milligrams and methyl testosterone 10 milligram tablets.

(d) Conjugated estrogens 0.625 milligrams and methyl testosterone 5 milligram tablets.

(e) Testosterone enanthate 90 milligram/milliliter and estradiol valerate 4 milligram/milliliter injection.

(f) Testosterone cypionate 50 milligram/milliliter and estradiol cypionate 2 milligram/milliliter injection.

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) Eszopiclone.

(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) Modafinil.

(ll) Nimetazepam.

(mm) Nitrazepam.

(nn) Nordiazepam.

(oo) Oxazepam.

(pp) Oxazolam.

(qq) Paraldehyde.

(rr) Petrichloral.

(ss) Phenobarbital.

(tt) Pinazepam.

(uu) Prazepam.

(vv) Quazepam.

(ww)Temazepam.

(xx) Tetrazepam.

(yy) Triazolam.

(zz) Zaleplon.

(aaa) 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, oxygen free 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 pregabalin and lacosamide by whatever official, common, usual, chemical, or brand name designated.

(2) Schedule 5 includes ezogabine by whatever official, common, usual, chemical, or brand name designated.

(2)(3) 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.

PART 3 - LICENSES

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

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. Rescinded.

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 5 - RECORDS

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 338.3125 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 338.3125.

(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 invoice.

PART 6. DISPENSING AND ADMINISTERING CONTROLLED SUBSTANCE PRESCRIPTIONS

R 338.3162d Required reporting of prescription data; error reporting.

Rule 62d. (1) A pharmacist, pharmacy, dispensing prescriber, or veterinarian shall report all schedules 2 to 5 controlled substances dispensed beginning on the date that these amendatory rules take effect.

(2) The data required by R 338.3162b shall be forwarded by on-line transmission, computer diskette, compact disk, or other approved medium, as specified in R 338.3162c to the department or the department's contractor by the end of the next business day, twice monthly, by the first calendar day and the 15^th calendar day of each month immediately following the month in which the prescription was dispensed, and shall include the data for all controlled substances dispensed since the previous transmission or report. A pharmacist, pharmacy, dispensing prescriber, or veterinarian may choose 2 different dates to report each month, provided that they are within 2 calendar days of the first calendar day and the 15^th calendar day of each month and they include all controlled substances dispensed since the previous transmission or report.

(3) For each pharmacist, pharmacy, dispensing prescriber, or veterinarian who does not have the capacity to forward the information as specified in R 338.3162b, the information shall be mailed or delivered to a location specified by the department or the department's contractor contractor not later than 7 calendar days after the date that the controlled substance has been dispensed, twice monthly by the first calendar day and the 15^th calendar day of the month following the month in which the prescription was dispensed, and shall include the data for all controlled substances dispensed since the previous transmission or report. The pharmacist, pharmacy, dispensing prescriber, or veterinarian may choose 2 different dates to report each month provided they are within 2 days of the first calendar day and the 15^th calendar day of each month and they include all controlled substances dispensed since the previous transmission or report.

(4) The department or the department's contractor shall notify a pharmacist, pharmacy, dispensing prescriber, or veterinarian of an error in data reporting. Upon receiving notification of an error in data reporting, a pharmacist, pharmacy, dispensing prescriber, or veterinarian shall take appropriate measures to correct the error and transmit the corrected data to the department or the department's contractor within 15 7 calendar days of being notified of the error.

(5) A pharmacist, pharmacy, dispensing prescriber, or veterinarian who fails to report the dispensing of a prescription for a controlled substance listed in schedules 2 to 5 as required, beginning on the date that these amendatory rules take effect, shall be subject to the penalty provisions in sections 16221, 17741, or 17768 in article 15 of the act.

R 338.3169 Labels. Rescinded.

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.

NOTICE OF PUBLIC HEARING

NOTICE OF PUBLIC HEARING - BOARD OF PHARMACY

TUESDAY, JULY 23, 2013 - 1:30 P.M.

The Michigan Department of Licensing and Regulatory Affairs will hold a public hearing on Tuesday, July 23, 2013, starting at 1:30 p.m. at the following address:

Ottawa Building - Conference Room UL#3 611 W. Ottawa Street - Lansing, Michigan

The public hearing is being held to receive comments on the following proposed rules:

• General Rules (ORR #2012-095): Proposed amendments will affect rules for intern eligibility, examination information, limited licenses, licensure eligibility, relicensure requirements, prescription drug receipts, records, labeling, housing, etc.

• Controlled Substances (ORR #2012-096): Proposed rules will update the various controlled substance schedules.

• Animal Euthanasia and Sedation (ORR #2012-097): New rules will be added to comply with Public Act 451 of 2006.

These rules are being promulgated by the director of the Department of Licensing and Regulatory Affairs by sections 7201, 7216, 7333(8), 16145(2), 16145(3), 17722(a), 17737, and 17767 of 1978 PA 368, being MCL 333.7201, 333.7216, 333.7333(8), 333.16145(2), 333.16145(3), 333.17722(a), 333.17737, and 333.17767, and Executive Reorganization Order Nos. 1996-1, 1996-2, 2003-01, and 2011-4, being MCL 330.3101, 445.2001, 445.2011, MCL 445.2030. These rules are proposed to take effect immediately upon filing with the Secretary of State, unless specified otherwise in the rules.

Comments on the proposed rules may be presented in person at the public hearing. Written comments may be submitted at the time of presentation and will also be accepted until 5:00 p.m. on July 29, 2013, at the following address or e-mail address:

Michigan Department of Licensing and Regulatory Affairs
Bureau of Health Care Services - Board of Pharmacy Rules Public Hearing
PO Box 30670; Lansing, MI 48909-8170
Attention: Norene Lind: E-mail address: lindn@michigan.gov

Copies of the proposed rules may be obtained by sending a request to the e-mail address listed above. Electronic copies may also be obtained at the following link: http://www7.dleg.state.mi.us/orr/Rules.aspx?type=dept&id=LR. Simply locate the ORR number associated with the rules above, and click on "Revision Text" to view the draft rules.

All hearings are conducted in compliance with the 1990 Americans with Disabilities Act. Hearings are held in buildings that accommodate individuals with disabilities, and accessible parking is available. An individual who requires accommodations in order to participate in a hearing should call Shellayne Grimes at (517) 335-1341 to make the necessary arrangements. To ensure availability of the accommodation, please call at least 1 week in advance of the public hearing.