DEPARTMENT OF COMMUNITY HEALTH

                              DIRECTOR'S OFFICE

                       PHARMACY - CONTROLLED SUBSTANCES

(By authority conferred on the director of the department of community health 
by sections 16145(3) and 7301 of 1978 PA 368 MCL 333.16145(3) and 333.7301 et 
seq. and Executive Reorganization Order Numbers 1996-1,  1996-2  and  2003-1, 
MCL 330.3101, 445.2001 and 445.2011)


                        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   3.88 
grams or less.
  (c) "Department" means the department of community health.
  (d) "Electronic signature"  means  an  electronic   sound,    symbol,    or 
process attached to or logically associated with a  record  and  executed  or 
adopted  by a person with the intent  to  sign  the  record.   An  electronic 
signature also 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   may    not 
be  rejected  based  on  its validity.

  History:  1979 AC; 1992 AACS; 2002 AACS; 2004 AACS.


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) "Michigan automated prescription system  (maps)  claim  form"  means  a 
form, to be determined by the  department,  that  is  in  the   format    and 
includes  the information as specified by the american society for automation
 in  pharmacy (asap) and contains the information specified in R 338.3162b.
  (d) "National drug code number (ndc)" means a  number    that    identifies 
the labeler/vendor, product, and package  size  and  is  assigned   to   each 
drug product listed under section 510, registration  of  producers  of  drugs
 and devices, of the federal food, drug, and cosmetic act.
  (e) "Officer" means a state, county, or local law    enforcement    officer 
who has a duty to enforce the laws of this state.
  (f) "Patient identifier" includes all of the following information  about a 
patient:
  (i)  Full name.
  (ii) Address, including zip code.
  (iii) Date of birth.
  (iv) Any 1 of the following:
  (A) A Michigan driver's license number.
  (B) An identification number  obtained  from   a    photo    identification 
card issued by the state of Michigan.
  (C) The number zero.  Zeroes  shall  be  entered  as   the   identification 
number, if the positive identification presented by  the  patient   or    the 
patient's agent or caregiver does not include a  license   number    or    an 
identification number, as  listed  in  subparagraphs  (A)  and  (B)  of  this 
paragraph.
  (g)  "Positive  identification"  means  identification   that   includes  a 
photograph of an individual in addition  to  his  or  her  date  of  birth.
Positive identification shall include an  identification  card  issued  by  a 
governmental agency, provided the identification card meets the  requirements 
of this rule.
  (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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2003 AACS; 2004 AACS;
2007 AACS.


R 338.3104   Definitions; R, S.
  Rule 4. As used in these rules:
  (a) "Readily retrievable" means a record which is kept  in  such  a  manner 
that it can be separated from all other records within 48  hours    and    in 
which  a listed controlled  substance  shall  be  marked  with  an  asterisk, 
redlined, or in some other manner be visually identifiable apart  from    the 
other  substances listed in the record.
  (b) "Scientific investigator" means a person, other than a  physician,  who 
is licensed to conduct research  with  a  controlled  substance   listed   in 
schedules 1 to 5.
  (c) "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 R 338. 3101.  Stamped signatures are not  valid 
for any controlled substance prescription.
  (d)  "Substance"  means  a  controlled  substance  unless    the    context 
indicates otherwise.

  History:  1979 AC; 1992 AACS; 2003 AACS.


R 338.3108    Terms defined in act.
  Rule 8. Terms defined in the act have the same  meanings   when   used   in 
these rules.

  History: 1992 AACS.


R 338.3109    Rescission.
  Rule 9. Rules 14, 21, and 22 of the board,  being  R  338.484,   R  338.491 
and R 338.492 of the Michigan Administrative Code and  appearing   on   pages 
2880 and 2885 of the 1963 Annual Supplement of the Code, are rescinded.

  History:  1979 AC.


                         PART 2. SCHEDULES


R 338.3111    Schedule 1; opiates.
  Rule 11. Unless specifically excepted, the  following   opiates   including 
their isomers, esters, ethers, salts, and salts of   isomers,   esters,   and 
ethers, when the existence of such isomers, esters, ethers,  and   salts   is 
possible  within  the  specific  chemical  designation,   are   included   in 
schedule 1:
  (a) Acetyl-alpha-methylfentanyl.
  (b) Acetylmethadol.
  (c) Allylprodine.
  (d) Alphacetylmethadol, except  levo-alphacetylmethadol   also   known   as 
levo-alpha-acetylmethadol, levomethadyl acetate, or LAAM.
  (e) Alphameprodine.
  (f) Alphamethadol.
  (g) Alpha-methylfentanyl.
  (h) Alpha-methylthiofentanyl.
  (i) Benzethidine.
  (j) Betacetylmethadol.
  (k) Beta-hydroxyfentanyl.
  (l) Beta-hydroxy-3-methylfentanyl.
  (m) Betameprodine.
  (n) Betamethadol.
  (o) Betaprodine.
  (p) Clonitazene.
  (q) Dextromoramide.
  (r) Diampromide.
  (s) Diethylthiambutene.
  (t) Difenoxin.
  (u) Dimenoxadol.
  (v) Dimepheptanol.
  (w) Dimethylthiambutene.
  (x) Dioxaphetyl butyrate.
  (y) Dipipanone.
  (z) Ethylmethylthiambutene.
  (aa) Etonitazene.
  (bb) Etoxeridine.
  (cc) Furethidine.
  (dd) Hydroxypethidine.
  (ee) Ketobemidone.
  (ff) Levomoramide.
  (gg) Levophenacylmorphan.
  (hh) MPPP(1-methyl-4-phenyl-4-propionoxypiperidine).
  (ii)                       3-methylfentanyl(n-(3-methyl-1-2-phenylethyl)-4- 
piperidyl)-n-phenylpropanamide).
  (jj) 3-Methylthiofentanyl.
  (kk) Morpheridine.
  (ll) Noracymethadol.
  (mm) Norlevorphanol.
  (nn) Normethadone.
  (oo) Noripipanone.
  (pp) Para-fluorofentanyl.
  (qq) PEPAP(1-(2-phenethyl)-4-phenyl-4-acetoxypiperidine.
  (rr) Phenadoxone.
  (ss) Phenampromide.
  (tt) Phenomorphan.
  (uu) Phenoperidine.
  (vv) Piritramide.
  (ww) Proheptazine.
  (xx) Properidine.
  (yy) Propiram.
  (zz) Racemoramide.
  (aaa) Thiofentanyl.
  (bbb) Tilidine.
  (ccc) Trimeperidine.

  History:  1979 AC; 1982 AACS; 1985 AACS; 1986 AACS; 1988 AACS; 1995 AACS.


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

  History:  1979 AC.


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.
  (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.

  History:  1979 AC; 1986 AACS; 1988 AACS; 1994 AACS; 2002 AACS.


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.

  History:  1988 AACS; 2002 AACS.


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)Δ1cis 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)Δ6cis  or  trans  tetrahydrocannabinol  and 
their optical isomers.
  (c)Δ3,4cis 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.


  History:  1979 AC; 1986 AACS.


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-5-phenyl-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.

  History:  1988 AACS; 1994 AACS; 2002 AACS.


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.

  History:  1979 AC; 1986 AACS; 1994 AACS.


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.

  History:  1979 AC; 1985 AACS; 1988 AACS; 1995 AACS; 2002 AACS.


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.

  History:  1979 AC; 1992 AACS.


R 338.3119    Schedule 2; depressants.
  Rule 19. 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 2:
  (a) Amobarbital.
  (b) Glutethimide.
  (c) Pentobarbital.
  (d) Phencyclidine.
  (e) Secobarbital.
  (f)  Any  compound,  mixture,  or   preparation   containing   amobarbital, 
secobarbital, pentobarbital, or  any  salt  thereof   in   combination   with 
itself, one another, or 1 or more other controlled substances.

  History:  1979 AC; 1986 AACS; 1992 AACS.


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.

  History:  1986 AACS; 1994 AACS; 2002 AACS.


R 338.3119b   Schedule 2; immediate precursors.
  Rule 19b. Unless specifically  excepted  or  unless   listed   in   another 
schedule, any material, compound, mixture, or   preparation   that   contains 
any quantity of the following substances:
  (a) Immediate precursor to amphetamine and methamphetamine:
  Phenylacetone
  Some trade or other names:
  Phenyl-2-propanone;
  P2P;
  Benzyl methyl ketone;
  Methyl benzyl ketone.
  (b) Immediate precursors to phencyclidine (PCP):
  (i) 1-phenylcyclohexylamine.
  (ii) 1-Piperidinocyclohexanecarbonitrile (PCC).

  History:  1994 AACS.


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:
Chlorhexadol.
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.
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.
  (7) Buprenorphine is included in schedule 3.

  History:  1979 AC; 1982 AACS; 1988 AACS; 1992 AACS; 2002 AACS; 2007 AACS.


R 338.3121    Schedule 3; narcotic drugs.
  Rule 21. Unless specifically excepted, any material,  compound,  mixture or 
preparation containing limited   quantities   of   any   of   the   following 
narcotic drugs or any salts thereof is included in schedule 3:
  (a) Not more than 1.8 grams of codeine per 100 milliliters  and  not   more 
than 90 milligrams per dosage unit when combined with an  equal  or   greater 
quantity of an isoquinoline alkaloid of opium.
  (b) Not more than 1.8 grams of codeine per 100 milliliters  and  not   more 
than 90 milligrams per dosage unit, with 1 or more  active   ingredients   in 
recognized therapeutic amounts.
  (c) Not more than 300 milligrams of dihydrocodeinone  per  100  milliliters 
and not more than 15 milligrams  per  dosage  unit,  with   a   fourfold   or 
greater quantity of an isoquinoline alkaloid of opium.
  (d) Not more than 300 milligrams of dihydrocodeinone  per  100  milliliters 
and not more than 15 milligrams per dosage unit, with one  or   more   active 
nonnarcotic ingredients.
  (e) Not more than 1.8 grams of dihydrocodeine per   100   milliliters   and 
not more than 90 milligrams per  dosage  unit,  with  1   or   more   active, 
nonnarcotic ingredients in recognized therapeutic amounts.
  (f) Not more than 300 milligrams of ethylmorphine   per   100   milliliters 
and not more than 15 milligrams per dosage unit, with 1   or   more   active, 
nonnarcotic ingredients in recognized therapeutic amounts.
  (g) Not more than 500 milligrams of opium per 100 milliliters  or  per  100 
grams and not more than 25 milligrams per dosage  unit,  with   1   or   more 
active, nonnarcotic ingredients in recognized therapeutic amounts.
  (h) Not more than 50 milligrams of morphine per 100  milliliters   or   per 
100 grams and not more than 2.5 milligrams per dosage unit, with  1  or  more 
active,  nonnarcotic  ingredients  in   recognized    therapeutic    amounts, 
including paregoric.

  History:  1979 AC.


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.

  History: 2002 AACS.


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) Methenolone.
  (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.

  History:  1992 AACS; 1994 AACS.


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:
Cathine ((+)-norpseudoephedrine).
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.

  History:  1979 AACS; 1982 AACS; 1984 AACS; 1985 AACS; 1988 AACS; 1992 AACS;
1994 AACS; 2002 AACS; 2007 AACS.


R 338.3125   Schedule 5; narcotics added to nonnarcotic compounds.
  Rule 25. (1)  Schedule  5  includes  the  drug  pregabalin   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.

  History:  1979 AC; 1985 AACS; 1994 AACS; 2002 AACS; 2007 AACS.


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.

  History: 2002 AACS.


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.

  History:  1979 AC; 1992 AACS; 2002 AACS.


R 338.3129    Excepted components.
  Rule 29. A compound, mixture, or preparation which contains a depressant or 
stimulant substance, which is of  a  similar  quantitative  composition shown 
in federal regulations as an excepted compound, or which contains   a  lesser 
quantity of a controlled substance or other substances which do  not  have  a 
stimulant,  depressant,   or   hallucinogenic   effect,    and    which    is 
restricted by law to dispensing  by  prescription  is   excepted   from   the 
provisions of sections 7212, 7214,  7216,  7218,  and  7220  of  the  act.
Compliance with the federal law concerning an excepted  compound  is   deemed 
compliance with this rule.

  History:  1979 AC; 1992 AACS.


                            PART 3. LICENSES

R 338.3131   Rescinded.

  History:  1979 AC; 1992 AACS; 1997 AACS.


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   free   of   charge   via   the    Internet    at    web-site 
http://www.gpoaccess.gov.   Printed copies may be  purchased  by  mail  order 
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 $24.00 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 Community Health, Bureau of Health Professions, 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  the  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, stored, or dispensed by a licensee.
  (3) If a principal place of business or professional   practice    consists 
of multiple locations,  then  each  location  shall   obtain    a    separate 
controlled  substance   license     if     controlled     substances      are 
received,   stored, administered, or dispensed at that location.
  (4) A prescriber or practitioner who holds a controlled  substance  license 
to prescribe, administer, or dispense controlled substances  at  a  principal 
place of business or professional practice consisting of multiple   locations 
shall not be required to obtain a separate controlled substance  license  for
 each physical location of the principal place of  business  or  professional 
practice if the prescriber or practitioner only prescribes at the location.
  (5) A pharmacist who holds a controlled substance  license   may   dispense 
from any licensed pharmacy.
  (6) A separate controlled substances license is required, as provided  in R 
338.3154(4), when controlled substances are stored in an   automated   device 
and the automated device is not located at  the   same   address    as    the 
pharmacy responsible for the device.

  History:  1979 AC; 1992 AACS; 2002 AACS; 2004 AACS; 2007 AACS.


R 338.3133   Rescinded.

  History:  1979 AC; 1992 AACS; 2002 AACS.


R 338.3134   Rescinded.

  History:  1979 AC; 1992 AACS; 2002 AACS.


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.

  History:  1979 AC; 1992 AACS; 2002 AACS.


R 338.3137   Waiver of license requirement.
  Rule 37. (1) The requirement of licensure is waived   for   the   following 
persons in the circumstances described in this rule:
  (a) An officer or employee of the drug  enforcement  administration   while 
engaged in the course of official duties.
  (b) An officer of the United States customs service while  engaged  in  the 
course of official duties.
  (c)  An  officer  or  employee  of  the  United  States   food   and   drug 
administration while engaged in the course of official duties.
  (d) A federal officer who is lawfully engaged in the   enforcement   of   a 
federal law relating to controlled substances, drugs, or customs  and  who is 
duly authorized to possess controlled  substances  in  the  course  of   that 
person's official duties.
  (e) An officer or employee of the state  of  Michigan,   or   a   political 
subdivision or agency thereof, who is engaged  in  the   enforcement   of   a 
state or local law relating to  controlled  substances  and   who   is   duly 
authorized to possess controlled substances in the course  of  that  person's 
duties.
  (2) An official who is exempted from licensure by this   rule   may,   when 
acting  in  the  course  of  that  person's  official   duties,   possess   a 
controlled substance and may transfer a controlled substance  to  any   other 
official who is also exempted by this rule and who is acting in the course of 
that person's official duties.
  (3) An official who is exempted by this rule may   procure   a   controlled 
substance in the course of a criminal investigation  involving   the   person 
from whom the substance was procured or in the course  of  an  administrative 
inspection or investigation.

  History:  1979 AC; 1992 AACS.


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.

  History:  1981 AACS; 2002 AACS.


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.

  History:  1981 AACS; 2002 AACS.


                             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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS.


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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS.


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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS.


                              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.

  History:  1979 AC; 1982 AACS; 2002 AACS.


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.

  History:  1979 AC; 1992 AACS; 2002 AACS.


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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS.


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.

  History:  1980 AACS; 1992 AACS; 2002 AACS.


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 338.3125.  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 338.3125 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.
  (e) Subrule 3 of this rule does not apply to automated dispensing devices.
  (4) 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.
When patient medication is stocked  in  an  automated  device,  the  pharmacy 
responsible for the device shall obtain an  additional  controlled  substance 
license for each  hospital,  county  medical  care  facility,  nursing  home, 
hospice, or other skilled nursing facility as defined in  1978  PA  368,  MCL 
333.20109, when the pharmacy is not  located  at  the  same  address  as  the 
facility and controlled substances are dispensed from the automated device.
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.
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:
Prevention of unauthorized access or use.
Compliance with any applicable federal and state regulations.
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  responsible   for    the 
device 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 April 11, 2003.
  (viii) Additional information as the pharmacist 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  provided  in  R 
338.486(4)(i).
  (b) The system is being used in place of an emergency kit as provided  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  provided  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 review by  an  agent   of 
the board.
  (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 pharmacy responsible for the device 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.

  History:  1979 AC; 1980 AACS; 1992 AACS; 2002 AACS; 2007 AACS.


            PART 6. DISPENSING AND ADMINISTERING PRESCRIPTIONS PRESCRIPTIONS


R 338.3161   Controlled substance 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    drug     enforcement     administration     (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) A written prescription for a controlled substance in schedules  2  to 5 
shall be written legibly with ink or an indelible pencil, or prepared using a 
printer and shall be signed by the prescriber.
  (3) An agent of  the  prescriber  may  prepare  a  prescription   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.
  (6)   A   prescriber   shall   not   prescribe     a     controlled     and 
noncontrolled substance on the same prescription form.

  History:  1979 AC; 1992 AACS; 1994 AACS; 2002 AACS; 2003 AACS; 2007 AACS.


R 338.3162   Dispensing by pharmacists; delivery of controlled substances.
  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) A pharmacist shall require positive  identification   of    individuals 
to whom controlled substances are dispensed or delivered when the  individual 
is not known to the pharmacist or pharmacy employees.  The following  provide 
for waiver of this requirement:
  (a) When positive identification is not available and a  pharmacist,    who 
in exercising his or her professional  judgment,  determines  that  a   delay 
in dispensing the controlled substance may be detrimental to a patient.
  (b) Subdivision (a) of this subrule does not exempt a    pharmacist    from 
the  requirement  to  submit  a  patient  identifier,   as   defined   in   R 
338.3102(1)(f).
  (3)  The  dispensing  pharmacist  and  pharmacy   are    responsible    for 
compliance with this rule.
  (4) 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.
  (5) 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:
The information required by R 338.3161.
The transmitting agent's identity.
The individual who received the prescription at the pharmacy.
  (6)  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.

  History:  1979 AC; 1993 AACS; 2002 AACS; 2003 AACS; 2007 AACS.


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.

  History:  1993 AACS; 2002 AACS.


R 338.3162b  Electronic system  for  monitoring  schedules  2,  3,  4,  and 5 
controlled substances.
  Rule  62b.  (1)  A  pharmacist,  dispensing  prescriber,  and  veterinarian 
licensed under Part 177 who dispenses  a  prescription  drug  which   is    a 
controlled substance listed in schedules 2 to 5 or a pharmacy licensed by the 
state that dispenses in this state or dispenses to an address in this state a 
controlled substance listed in  schedules  2  to  5  shall  report   to   the 
department  or  the department's contractor by means of an  electronic   data 
transmittal  process the following information for  each  prescription  of  a
 schedules  2  to  5 controlled substance prescription dispensed:
  (a) The  patient  identifier,  as  defined  in  R   338.3102(1)(f).     The 
following apply:
  (i) An identification number, as specified  in   R    338.3102(1)(f)(iv)(A) 
or (B), is not required for patients under the age of 16.
  (ii) If the patient is under 16 years of age, zeroes shall  be  entered  as 
the identification number.
  (iii) If the patient  is  an  animal,  positive  identification   of    the 
animal's owner that meets the requirements of R 338.3102(1)(f)(iv).
  (b) The name of the controlled substance dispensed.
  (c) The metric quantity of the controlled substance dispensed.
  (d) The   national   drug   code   number   (ndc)   of    the    controlled 
substance dispensed.
  (e) The date of issue of the prescription.
  (f)The date of dispensing.
  (g)The estimated days of supply of the controlled substance dispensed.
  (h) The prescription number assigned by the dispenser.
  (i)The dea  registration  number  of  the  prescriber  and  the  dispensing 
pharmacy.
  (j) The Michigan license number of the dispensing pharmacy.
  (2) A pharmacist, dispensing prescriber, or  veterinarian    may    presume 
that the patient identification information provided by  a  patient   or    a 
patient's representative is correct.

  History: 2003 AACS; 2007 AACS.


R 338.3162c  Format for electronic transmission of data; waiver.
  Rule 62c. (1) A  pharmacist,  dispensing  prescriber,    or    veterinarian 
who dispenses a prescription drug which  is  a  controlled  substance  listed
 in schedules 2 to 5 shall transmit the data, as specified under R 338.3162b,
 by electronic media or  other  means  as  approved  by  the  department   or 
the department's contractor.
  (2) The data shall be  transmitted  in  the  format  established   by   the 
american society for automation  in  pharmacy    (asap)    telecommunications 
format  for controlled substances.
  (3)  A  pharmacist,   dispensing   prescriber,    or    veterinarian    who 
dispenses controlled substances and who  does   not   have    an    automated 
record-keeping system capable of producing an electronic report in the format 
established by subrule (2) of this rule may request a waiver from  electronic 
reporting.  The request shall be made in writing to the department.
  (4) A pharmacist, dispensing prescriber, or veterinarian may  be  granted a 
waiver, if he or she demonstrates an inability to report  as  required  by  R 
338.3162b and he or  she  agrees  in  writing  to  report  the  data   to the 
department or the department's contractor  by  submitting  a  completed  maps 
claim form as defined in  R  338.3102(c)  or  transmitting   data   via    an 
internet web portal that is provided by the Department or  the   Department's 
contractor for this purpose.

  History: 2003 AACS; 2007 AACS.


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 twice monthly, by the first calendar day and the  15th   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 15th 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 
twice  monthly  by the first calendar day and the 15th 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  15th 
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  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.

  History: 2003 AACS; 2007 AACS.


R 338.3162e   Exemption from reporting requirements.
  Rule 62e. A pharmacist,  dispensing  prescriber,  or   veterinarian   shall 
be exempt from the reporting requirements under the following circumstances:
  (a) When a controlled substance in  schedules  2  to  5   is   administered 
directly to a patient.
  (b) When a controlled substance in schedules 2  to  5  is  dispensed   from 
a health facility or  agency  licensed  under  article  17  of  the  act   by 
a dispensing prescriber in a quantity adequate to treat a patient   for   not 
more than 48 hours.

  History: 2003 AACS.


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.

  History:  1979 AC; 2002 AACS.


R 338.3164     Emergency  dispensing   of   schedule   2   substances;   oral 
prescriptions.
  Rule 64. A  pharmacist  may  dispense  a  controlled  substance  listed  in 
schedule 2 in case of an emergency in which all of the  following  conditions 
are met:
  (a) The prescriber advises the pharmacist of the following:
  (i) Immediate administration of the controlled substance    is    necessary 
for proper treatment of the intended ultimate user.
  (ii)   Appropriate   alternative    treatment    is     not      available, 
including administration of a drug that is not a controlled substance under
 schedule 2.
  (iii) It is not reasonably possible  for  the  prescriber  to   provide   a 
written prescription to be presented to the person dispensing  the  substance
 before the dispensing.
  (iv) The quantity  prescribed  and  dispensed  is  limited  to  the  amount 
adequate to treat the patient during the emergency period and pursuant  to  a
 written prescription.
  (b) The  prescription  shall  be  immediately  reduced  to    writing    by 
the pharmacist and shall contain all  information  that  is  required  to  be 
contained in a prescription under provisions of R 338.3161,  except  for  the 
prescriber's signature.
  (c) If the  prescriber  is  not  known  to  the  pharmacist,    then    the 
pharmacist shall  make  a  reasonable  effort  to  determine  that  the  oral 
authorization  came from a prescriber by returning the  prescriber's    call, 
using  the  telephone number listed in the telephone directory   and    other 
good  faith  efforts  to assure the prescriber's identity.

  History:  1979 AC; 2003 AACS. 


R 338.3165     Emergency   dispensing   of     schedule     2     substances; 
written prescriptions.
  Rule 65. Within 7 days after authorizing an emergency oral prescription  of 
a controlled substance listed in schedule 2, the prescriber   shall    reduce 
the prescription  to  writing  and  have  recorded  on   the   prescription's 
face "Authorization for Emergency Dispensing" and the date of the oral order.
 The written prescription shall be delivered to the pharmacist   in    person 
or  by mail within 7 days after  the  oral  prescription  is   issued.   Upon 
receipt,  the dispensing pharmacist shall attach  this  prescription  to  the 
oral order  which earlier had  been  reduced  to  writing.   The   pharmacist 
shall  notify  the department of consumer and industry  services    if    the 
prescriber  fails  to deliver a written  prescription  to  him  or  her.  The 
failure of a pharmacist  to notify  the  department   if    the    prescriber 
fails  to  deliver  a   written prescription voids the authority conferred by 
this rule to dispense without a written prescription of a prescriber.

  History:  1979 AC; 1992 AACS; 2003 AACS.


R 338.3166    Partial dispensing of schedule 2 substances.
  Rule 66.  (1)  A  pharmacist  may   partially   dispense    a    controlled 
substance listed in schedule 2 if he or she is  unable  to  supply  the  full
 quantity called for in a written or emergency oral prescription  and  he  or 
she makes  a notation of the quantity supplied on the  face  of  the  written 
prescription  or written record of the emergency  oral   prescription.    The 
remainder  of  the prescription may be  dispensed  within  72   hours   after 
the  first  partial dispensing.  If the remainder  of  the  prescription   is 
not  or  cannot  be dispensed within the 72 hours, the  pharmacist  shall  so 
notify the prescriber.
A further quantity shall not be dispensed beyond the 72 hours without  a  new 
prescription.
  (2) Prescriptions for schedule 2 controlled substances that   are   written 
for a patient in long-term care facilities  or  for  a   patient    with    a 
medical diagnosis that  documents  a  terminal  illness  may  be  filled   in 
partial quantities, including individual  dosage  units.   For  each  partial 
filling, the dispensing pharmacist  shall  record,  on  the  back   of    the 
prescription  or  on another   appropriate   record   that    is    uniformly 
maintained   and   readily retrievable, all of the following information:
  (a) Date of the partial filling.
  (b) Quantity dispensed.
  (c) Remaining quantity authorized to be dispensed.
  (d) Identification of the dispensing pharmacist.
The total quantity of schedule  2  controlled  substances  dispensed  in  all 
partial fillings shall not  be  more  than  the  total  quantity  prescribed.
Schedule 2 prescriptions for a patient in a long-term care facility or for  a 
patient with a medical diagnosis that documents a terminal illness  shall  be 
valid for a period of not more than  60  days  from  the  issue  date  unless 
terminated at  an  earlier  date  by  the  discontinuance  of  medication.  A 
pharmacist shall record on the prescription whether the patient is terminally 
ill or is a long-term care facility patient.

  History:  1979 AC; 1992 AACS; 1994 AACS; 2003 AACS. 


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 met:
  (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 are distributed at retail
 to  the  same purchaser in any single 48-hour period.
  (c) The purchaser is at least 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) If a pharmacist dispenses a controlled substance listed  in    schedule 
5, then he or she shall affix  to  the  container  in  which  the   substance 
is dispensed a label that shows the date, his or her own name, and  the  name 
and address of the place of practice in which the substance is dispensed.
  (3) The  pharmacist  shall  maintain  a  record  of  the   dispensing    of 
controlled substances listed in schedule 5.  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.

  History:  1979 AC; 1982 AACS; 2002 AACS; 2003 AACS.


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  prescription's  date  of 
issuance 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 met:
  (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.

  History:  1979 AC; 2002 AACS; 2003 AACS.


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.

  History:  1979 AC; 2002 AACS.


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.

  History:  1979 AC; 2002 AACS.


                           PART 7. DISTRIBUTIONS


R 338.3181    Distributions by dispensers.
  Rule 81. (1) A dispenser who  is  not  licensed  as   a   distributor   may 
distribute a controlled substance to another dispenser for  the  purpose   of 
general dispensing to  his  or  her  patients  if  all   of   the   following 
conditions are satisfied:
  (a) The receiving dispenser is licensed to dispense the substance.
  (b) The distribution is recorded by the  distributing   dispenser   and   a 
receipt record is maintained by the receiving dispenser.
  (c) An order form for substances listed in schedules 1 and 2 is used.
  (d) The total number  of  dosage  units  of   all   controlled   substances 
distributed by the distributing dispenser during the   12-month   period   in 
which the dispenser is licensed is not more than 5% of the  total  number  of 
all dosage units distributed and dispensed during the 12-month period.
  (2) If the dispenser has reason to believe  that  the   total   number   of 
dosage units which will be distributed by him or her pursuant  to  this  rule 
will be more than 5% of the total number of dosage units  of  all  controlled 
substances distributed and dispensed by him or  her   during   the   12-month 
period, the dispenser shall obtain  a  license   to   distribute   controlled 
substances.

  History:  1979 AC; 1992 AACS.


R 338.3182    Distribution of aqueous and oleaginous solutions.
  Rule 82. (1) A pharmacist who is licensed to   dispense   may   distribute, 
without being licensed to  distribute,  to  a   licensed   practitioner,   an 
aqueous or oleaginous solution, in a quantity of not more than  1  ounce   at 
any one  time,  which  contains  a  narcotic  controlled   substance   in   a 
proportion that is not more than 20% of the complete solution and which is to 
be used by the practitioner in the  course  of  his   or   her   professional 
practice for administration to a patient. The pharmacist  shall  maintain   a 
written record that contains all of the following information:
  (a) The date of the transaction.
  (b) The name, form, and quantity of the substance.
  (c) The name, address, and license number of  the   pharmacist   or   other 
licensed person.
  (d) The name, address, and license number of the practitioner.
  (2) In the case of a controlled substance listed in schedules 1  or  2,  an 
order form shall be used and maintained  as  the  written   record   of   the 
transaction.

  History:  1979 AC; 1992 AACS.


R 338.3183    Distribution to suppliers.
  Rule 83. (1) A person who is lawfully  in  possession   of   a   controlled 
substance that is listed in any  schedule  may   distribute   the   substance 
without being licensed to distribute to the person from  whom   he   or   she 
obtained the substance or to the manufacturer of the  substance.  The  person 
who is in possession of the substance shall maintain a  written  record  that 
contains all of the following information:
  (a) The date of the transaction.
  (b) The name, form, and quantity of the substance.
  (c) The name, address, and license number, if any,  of   the   person   who 
makes the distribution.
  (d) The name, address, and license number, if known, of  the  supplier   or 
manufacturer.
  (2) In the case of a controlled substance listed in schedules 1  or  2,  an 
order form shall be used and maintained  as  the  written   record   of   the 
transaction.

  History:  1979 AC; 1992 AACS.


R 338.3185    Discontinuances and transfers.
  Rule 85. A licensee  who  wants  to  discontinue   or   transfer   business 
activities or a professional practice altogether or only  with   respect   to 
controlled substances shall return his or her  DEA   registration   and   any 
unexecuted order forms in his or her possession to   the   drug   enforcement 
administration. The administrator's  license  shall  be   returned   to   the 
administrator.  The  transfer  of  controlled  substances   is   subject   to 
approval by  the  drug  enforcement  administration   or   administrator   in 
accordance with the provisions of 21 C.F.R. S300.

  History:  1979 AC; 1992 AACS.


R 338.3186    Use of order forms and invoices.
  Rule 86. An order form shall be used to distribute  schedule  2  substances 
and an invoice shall be used to distribute schedules 3  to  5  substances.
The order form may be executed only by a practitioner who  is   licensed   to 
prescribe or dispense controlled substances.

  History:  1979 AC; 1992 AACS.


              PART 8. ADMINISTRATIVE AND DISCIPLINARY PROCEDURE


R 338.3191 - 338.3198a    Rescinded.

  History:  1979 AC; 1980 AACS; 1996 AACS.


R 338.3199 - 338.3199q    Rescinded.

  History:  1979 AC; 1980 AACS; 1997 AACS.