DEPARTMENT OF COMMUNITY HEALTH

                            DIRECTOR’S OFFICE

                        PHARMACY - GENERAL RULES

(By authority conferred on the director of the department of community health 
by sections 16145(3) and 17701 of 1978 PA 368, MCL 333.16145(3) and 333.17701 
et seq. and Executive Reorganization Order Nos. 1996-1, 1996-2, and  2003-01, 
being MCL 330.3101, 445.2001, and 445.2011)


                        PART 1. GENERAL PROVISIONS


R 338.471   Repealer.
  Rule 1. All rules and regulations previously adopted by the state  board of 
pharmacy, hereinafter referred to as the board, are hereby repealed  and  set 
aside.

  History:  1979 AC.


R 338.471a  Definitions.
  Rule 1a. As used in these rules:
  (a) "Accredited college or school of pharmacy" means a college  or   school 
of pharmacy that  is  accredited   by   the   accreditation    council    for 
pharmacy education, as provided in R 338.474(1)(a).
  (b) "Board" means the board of pharmacy.
  (c) "Code" means 1978 PA 368, MCL 333.1101.
  (d) "Department" means the department of community health.
  (e) "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 non-repudiation so that  the   signature  may  not  be 
rejected based on its validity.
  (f)  "Unconventional  internship"   means   an   educational   program   of 
professional and practical experience involving  those  pharmacy  or  related 
pharmaceutical experiences which, by practical, on-the-job training,  provide 
knowledge useful to  the  practice  of  the  profession  of pharmacy  without 
meeting all of the criteria of a conventional internship.

  History:  1980 AACS; 1986 AACS; 2007 AACS.


R 338.472  Prescription drugs and devices;  return  or  exchange  for  resale 
prohibited.
  Rule  2.  (1)  For  the  protection  of  the  public  health  and   safety, 
prescription drugs or devices which have been dispensed and which  have  left 
the control of the pharmacist shall not be returned or exchanged for resale.
  (2) Subrule (1) of this rule does not apply to a pharmacy    operated    by 
the department  of  corrections  or  under  contract  with  the   department
 of corrections or a county jail that has accepted a  prescription  drug  for 
resale or redispensing, as provided under section 17766d of the code.

  History:  1979 AC; 1980 AACS; 2007 AACS.


R 338.473   Intern licensure; eligibility; renewal; limitations.
  Rule 3. (1) An applicant for  a  pharmacy  intern  license  shall  submit a 
completed application on a form provided by the department,   together   with 
the requisite fee. In addition to meeting the requirements of the  code   and 
the administrative  rules  promulgated  pursuant   thereto,   an    applicant 
shall establish that  he  or  she  is  admitted  to  and  actively   enrolled 
in  a professional program of study within   an   accredited    college    or 
school  of pharmacy, as provided in R 338.474(1)(a).
  (2) An intern shall engage in  the  practice  of  pharmacy    only    under 
the supervision of a pharmacist preceptor as defined in section 17708(1)   of 
the code and only under the personal charge of a pharmacist.

  History:  1979 AC; 1980 AACS; 1990 AACS; 2007 AACS.


R 338.473a  Interns;   eligibility;   limited    license;     qualifications; 
supervision; notice of position change; duties;  professional  and  practical 
experience; denial, suspension, or revocation of license.
  Rule 3a. (1)  An  individual  is  eligible  for  intern  licensure  at  the 
beginning of the first professional year of study in an accredited college or 
school of pharmacy.
  (2) Upon application and  payment  of   appropriate   fees,    a    limited 
license shall be issued by  the  department  to  qualified  applicants.   The 
limited license shall remain active while the applicant is actively  pursuing 
a degree in an accredited  college  or  school  of   pharmacy    and    until 
licensure  as  a pharmacist or for not more than 1  year  from  the  date  of 
graduation from  such college or school of pharmacy, unless extended  by  the
 board  upon  written request of the intern.
  (3) An  intern  shall   complete   not   less   than   1,000    hours    of 
internship experience, 500 hours of which  shall  be  completed  during   the 
18  months immediately preceding the examination for  pharmacist  licensure.
An  intern working in Michigan shall hold an intern license in order to  earn 
the  hours of internship experience required in Michigan.  The minimum number
 of  hours of internship experience may be  satisfied  by   complying    with 
any  of  the following provisions:
  (a) Obtaining the minimum  number  of  hours  of  experience   under    the 
personal charge of a qualified, approved preceptor.
  (b)  Completing  a  board-approved,   structured    practical    experience 
program within the college or school of pharmacy curriculum.
  (c) Through a combination of subdivisions (a) and (b) of this subrule.
  (4) When eligible, a student shall apply for licensure as an intern.
  (5) Hours of internship experience shall be computed  from  the   date   of 
board certification as a licensed intern. In   computing   the    hours    of 
internship experience, all of the following provisions shall apply:
  (a) Experience shall  be   granted   only   upon   verification    by    an 
approved pharmacy preceptor or other person previously approved by the board.
  (b)  The  board  may   grant    internship     experience     gained     in 
unconventional internship programs. Up to 400 hours of internship  experience 
may be  granted for such unconventional education experiences.
  (c) A maximum of 40 hours of internship  experience  shall    be    granted 
per calendar week served by the intern.
  (d)  A  maximum  of  16  hours    of    non-college-sponsored    internship 
experience shall be granted per calendar week while the intern is a full-time 
student in a college or school of pharmacy, except during authorized vacation 
periods.
  (e) The board may  grant  credit  for  internship    experience    obtained 
through practice  as   an   intern   in   another   jurisdiction    if    the 
experience  was comparable to the minimum standards set forth in these rules.
  (f) The board may accept  experience  as   a   licensed    pharmacist    in 
another jurisdiction as the equivalent of internship experience.
  (6) An intern shall be supervised by an approved    pharmacist    preceptor 
and shall, at all times,  practice  only  under  the  personal  charge  of  a 
pharmacist.
The intern shall be responsible for verifying board approval of  his  or  her 
pharmacy preceptor.
  (7) Within 30 days, an intern also shall notify the board if he or  she  is 
no longer actively enrolled  in   a   pharmacy   degree   program    at    an 
accredited college or school of pharmacy.
  (8) Interns shall complete and submit such  forms  or   examinations,    or 
both, as deemed necessary by the board.
  (9) Interns shall receive professional and  practical  experience   in   at 
least all of the following areas:
  (a) Pharmacy administration and management.
  (b) Drug distribution, use, and control.
  (c) Legal requirements.
  (d) Providing health information services and advising patients.
  (e) Pharmacists' ethical and professional responsibilities.
  (f) Drug and product information.
  (10)  Interns  shall  keep  abreast  of  current  developments    in    the 
internship program and the pharmacy profession.
  (11) The board may deny, suspend, or revoke the license of an   intern   or 
may deny hours of internship for failure to comply with  pharmacy   law    or 
rules relating to pharmacy practice or internship.

  History:  1979 AC; 1980 AACS; 1986 AACS; 2007 AACS.


R 338.473b  Rescinded.

  History:  1979 AC; 1980 AACS; 1986 AACS.


R 338.473c   Preceptors;   approval;    qualifications;    duties;    denial, 
suspension, or revocation of preceptor approval.
  Rule 3c. (1) Before training an intern, a licensed   pharmacist   in   this 
state shall apply to the board for approval as a  preceptor.   A   pharmacist 
shall have at least  1  year  of  practice  before  being   approved   as   a 
preceptor.
  (2) There shall be not more than 2 interns per pharmacist on  duty  at  the 
same time. However, the approved preceptor is responsible  for  the   overall 
internship program at the pharmacy.
  (3) A preceptor is responsible for arranging the   intern's   training   in 
areas of practice as defined in R 338.473a(9).
  (4) A preceptor shall annually submit internship  training  affidavits   on 
forms provided by the board.
  (5) The preceptor shall  determine  the  degree   of   professional   skill 
possessed by the intern and shall develop a training  program   whereby   the 
intern will be able to improve upon and develop his or her  ability  in   the 
practice of pharmacy.
  (6) The preceptor shall allow sufficient time to instruct  the  intern   in 
the practice of pharmacy and to frequently review and discuss  his   or   her 
progress.
  (7) Upon completion of the intern training, the preceptor  under  whom  the 
training was obtained shall give the preceptor's opinion on  the  ability  of 
the intern to practice pharmacy without supervision.   If   the   preceptor's 
report is not satisfactory, the board may require  further  training   before 
allowing the intern to take the examination for licensure as  required  by  R 
338.474.
  (8) The board may deny, suspend, or revoke the  preceptor's  approval   for 
failure to properly supervise the intern during   the   internship   training 
program or for violation of the laws and rules relating to  the  practice  of 
pharmacy or the internship program.
  (9) The board may deny, suspend, or revoke the preceptor's  approval  of  a 
pharmacist who has been convicted of any violation of a  federal,  state,  or 
local law, ordinance, or rules relating  to  pharmacy   practice   within   5 
years of the application for approval as a preceptor.

  History:  1980 AACS; 1986 AACS.


R 338.473d   Graduates  of  a   non-accredited   college   or    school    of 
pharmacy; requirements; internship.
  Rule 3d. (1) An applicant who is a graduate of a  non-accredited    college 
or school of pharmacy may be granted  an  intern  license  to   comply   with 
the requirements  of  R  338.473a(3)  upon  making  application,  payment  of 
appropriate fees, and providing evidence  of  successful  completion  of  the 
Foreign Pharmacy Graduate  Examination  Committee    certification    program 
administered  by  the National   Association   of   Boards    of    Pharmacy, 
Foreign  Pharmacy  Graduate  Examination  Committee,  1600  Feehanville  Dr., 
Mount Prospect, IL 60056.
  (2) An intern license issued in accordance with this rule is   valid    for 
not more than 2 years from the date of issuance, unless  extended   by    the 
board upon written request by the intern.

  History:  1986 AACS; 2007 AACS.


R 338.474   Pharmacist licensure; eligibility; examination.
  Rule 4. (1) An applicant for  licensure  as  a  pharmacist  shall  submit a 
completed application on a form provided by the department,   together   with 
the appropriate fee. In addition to meeting the requirements of the code  and 
the administrative rules promulgated pursuant thereto, an   applicant   shall 
comply with all of the following requirements:
  (a) Have completed the  requirements  for  a  degree  in   pharmacy    from 
an accredited college or school of pharmacy education approved by the   board 
or successfully  completed  the  Foreign  Pharmacy    Graduate    Examination 
Committee certification program administered by the National  Association  of 
Boards  of Pharmacy, Foreign Pharmacy Graduate Examination  Committee,   1600 
Feehanville Dr., Mount Prospect, IL 60056.  The board adopts   by   reference 
the  standards of the Accreditation Council for  Pharmacy    Education,    20 
North  Clark  St., Suite 2500, Chicago, IL  60602.   The  standards  are  set 
forth in the  documents entitled "Standards and Guidelines for  Accreditation 
of  Professional  Degree Programs in Pharmacy", 8th edition,  January   1995; 
and,  the  "Accreditation  Standards  and  Guidelines  for  the  Professional 
Program in Pharmacy Leading  to the Doctor of Pharmacy Degree", adopted  June 
14, 1997, of  the  Accreditation Council for Pharmacy Education.   Copies  of 
the standards are available at  no  cost  from  the  Council's   website   at 
http://www.acpe-accredit.org/standards.
Copies of the guidelines also are available for inspection  and  distribution 
at cost from the Michigan Board of Pharmacy, Department of Community  Health, 
611 West Ottawa, P.O. Box 30670, Lansing, MI 48909.
  (b) Have completed a program of internship pursuant to these rules.
  (c) Pass a  jurisprudence  examination,  approved  by  the   board,   which 
measures an applicant's knowledge of the rules and regulations governing  the 
practice of pharmacy with a scaled score of not less than 75.
  (d)  Pass  an  examination,  approved  by  the  board,  which   measures an 
applicant's theoretical and practical  knowledge  of    pharmacy    with    a 
scaled score of not less than 75.
  (2) An applicant who has not achieved a  passing  score  on    either    of 
the examinations identified in subrule (1)(c)  and   (d)   of    this    rule 
after  6 attempts may be reexamined only after meeting the  requirements  set 
forth in R 338.474a.

  History:  1979 AC; 1980 AACS; 1988 AACS; 2007 AACS.


R 338.474a  Licensure; reexamination.
  Rule 4a. An applicant may take the examinations required by these rules  on 
6 separate occasions. An applicant who has not received a passing  score   on 
an examination after 6 attempts shall not take  the  examination  a   seventh 
or subsequent time, unless the applicant can demonstrate to the  board   that 
the applicant has complied with all of the following:
  (a) Has enrolled as a student in a pharmacy education   program    approved 
by the board.
  (b) Has taken courses which would provide a  thorough  review   of    those 
areas failed on the applicant's most recent examination.
  (c) Has  submitted  certification  to  the  board   from    the    pharmacy 
education institution that the courses have been satisfactorily completed.

  History:  1983 AACS; 2007 AACS.


R 338.475   Licensure by endorsement; examination.
  Rule 5.  An  applicant  for  licensure  by  endorsement  shall   submit   a 
completed application on a form provided by the department, together with the 
requisite fee.  In addition to meeting the requirements  of  the   code   and 
administrative rules promulgated pursuant thereto, an applicant shall satisfy
 both  of  the following requirements:
  (a)  Pass  an  examination,  approved  by  the  board,  which   measures an 
applicant's knowledge of the rules and regulations governing the practice  of 
pharmacy with a scaled score of not less than 75.
  (b) Satisfy those requirements in existence in this state at the  time   he 
or she was licensed in another state.

  History:  1979 AC; 1980 AACS; 1990 AACS; 2007 AACS.


R 338.476   Rescinded.

  History:  1979 AC; 1980 AACS; 1998-2000 AACS.


R 338.477   Pharmacy   licenses;   applications;    notice    of     changes; 
self-inspection reports.
  Rule 7.  (1)  Each separate pharmacy location where drugs  are     prepared 
or dispensed shall be licensed by the board under section 17741 of the code.
If multiple locations under the same  ownership  exist  at  a  single  street 
address and share a central inventory, then only 1 license is required.
  (2)  A licensee who is moving to a new location shall apply and be approved 
for a new license for each location  before  moving.   The  department  shall 
provide license applications.  A licensee shall pay  a  license  fee  to  the 
department for each new location.
  (3)  An applicant that is a partnership or  corporation  or  that  operates 
under an assumed name  shall  file,  with  its  application  for  a  pharmacy 
license,  certified  copies  of  its  partnership   certificates,   corporate 
articles, or assumed name certificate.  This requirement shall be  waived  if 
the application is for additional units and  the  additional  units  will  be 
under the same ownership.
  (4)  A partnership, corporation, or entity operating under an assumed  name 
shall provide the board with written notification of a change in any  of  the 
following entities:
  (a)  Partners.
  (b)  Stockholders.
  (c)  Officers.
  (d)  Members of the board of directors.
  (e)  The individual pharmacist who is designated as the  pharmacy  licensee 
of a licensed pharmacy.
A partnership or corporation shall notify the board within  30  days  of  the 
change.
A publicly held corporate pharmacy need not report changes in stockholders.
  (5)  A person who applies for a new pharmacy license or pharmacy relocation 
shall send an application and a completed  self-inspection  report  on  forms 
provided by the department.

  History:  1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.


R 338.477a  Application for license by governmental entity.
  Rule 7a. An application by a governmental entity for a   new   or   renewal 
pharmacy, drug manufacturer's, or wholesaler's license  shall  designate   an 
individual to be the licensee. That individual and the  pharmacist  on   duty 
are responsible for compliance with federal and state  laws  regulating   the 
distribution of drugs and the practice of pharmacy.

  History:  1979 AC.


R 338.477b  Requirements for relicensure.
  Rule 7b. (1)  An applicant for relicensure who has had a lapsed license for 
3 years or less under the provisions of section 16201(3) of the code  may  be 
relicensed upon compliance with both of the following requirements:
  (a)  Submission of a completed  application  on  a  form  provided  by  the 
department, together with the requisite fee.
  (b)  Submission of proof of completion of 30 hours of continuing  education 
that has been earned within  the  2-year  period  immediately  preceding  the 
application for relicensure.
  (2) An applicant for relicensure who has had a lapsed license for more than 
3 years under the provisions of sections  16201(4)  and  17733  of  the  code 
shall, in addition to the requirements set forth in subrule (1) of this rule, 
take and pass the board’s jurisprudence examination with a score of not  less 
than 75 and have been licensed and engaged in the  practice  of  pharmacy  in 
another state during the period that  the  applicant's  Michigan  license  is 
expired or complete a program of practical pharmacy experience  that  is  not 
less than 200 hours as follows:
  (a)  The individual shall practice under the personal charge of a currently 
licensed pharmacist.
  (b)  The individual shall notify the board, in writing, of the name of  the 
supervising pharmacist and the  name  and  address  of  the  pharmacy  before 
beginning the required practical experience.
  (c) When an applicant has completed the required practical experience,  the 
supervising pharmacist shall provide  the  board  with  verification  of  the 
applicant's completion of the experience.
  (3)  For purposes of subrule (2) of this rule, "completion of a program  of 
practical pharmacy experience" means professional and clinical instruction in 
at least all of the following areas:
  (a)  Pharmacy administration and management.
  (b)  Drug distribution, use, and control.
  (c)  Legal requirements.
  (d)  Providing health information services and advising patients.
  (e)  Pharmacist’s ethical and professional responsibilities.
  (f)  Drug and product information.
  (4)  For purposes of complying with the provisions of subrule (2)  of  this 
rule, an applicant may  be  granted  a  temporary,  nonrenewable  license  to 
complete the practical experience.

  History:  1980 AACS; 1986 AACS; 1998-2000 AACS.


R 338.478  "Person" defined.
  Rule 8.  The  word  "person,"  as  used  in  all   statutes,   rules,   and 
regulations relating to the profession of pharmacy, shall  be  construed   to 
include individuals, partnerships, firms,  corporations,  associations,   and 
governmental institutions.

  History:  1979 AC.


R 338.479   Prescription drug labeling.
  Rule 9. (1) All labeling of prescription drugs  shall   comply   with   the 
requirements of the code and the federal food, drug, and  cosmetic  act,   21 
U.S.C. S301 et seq.
  (2) All containers in which prescription medication  is   dispensed   shall 
bear  a  label  which  contains,  at  a  minimum,  all   of   the   following 
information:
  (a) Pharmacy name and address.
  (b) Prescription number.
  (c) Patient's name.
  (d) Date the prescription was most recently dispensed.
  (e) Prescriber's name.
  (f) Directions for use.
  (g) The name of the medication, unless the prescriber  indicates  "do   not 
label."
  (3) If a drug is  dispensed  that  is  not  the   brand   prescribed,   the 
purchaser shall be notified and the prescription label  shall  indicate  both 
the name of the brand prescribed and the name of the  brand   dispensed.   If 
the dispensed drug does not have a  brand  name,   the   prescription   label 
shall indicate the name of the brand prescribed followed   by   the   generic 
name of the  drug  dispensed  or  the  reference   "G.Eq.,"   "generic,"   or 
"generic equivalent"  in  the  case  of   multi-ingredient   products.   This 
subrule does not apply if the prescriber indicates "do not label."
  (4) If drug product selection takes place, the brand name or  the  name  of 
the manufacturer or supplier of the drug dispensed shall be  noted   on   the 
prescription.
  (5) This rule does not apply to inpatient medical  institution  service.

  History:  1979 AC; 1980 AACS.


R 338.479a  Prescription drug receipts.
  Rule 9a. (1) The purchaser of a prescription drug shall  receive,  at   the 
time the drug is delivered to the purchaser, a receipt which contains  all of 
the following information:
  (a) The brand name of the drug  dispensed,  if   applicable,   unless   the 
prescriber indicates "do not label."
  (b) The name of the manufacturer or supplier of the drug if the drug has no 
brand name, unless the prescriber indicates "do not label."
  (c) The strength of the drug,  if  significant,   unless   the   prescribed 
indicates "do not label."
  (d) The quantity dispensed, if applicable.
  (e) The name and address of the pharmacy.
  (f) The serial number of the prescription.
  (g) The date the prescription was most recently dispensed.
  (h) The name of the prescriber.
  (i) The name of the patient for whom the drug was prescribed.
  (j) The price for which the drug was sold to the purchaser.
  (2) Notwithstanding R 338.479, the information  mandated   in   this   rule 
shall appear on either the prescription label or on   a   combination   label 
and receipt.
  (3) For prescription services that are covered  by  a   third   party   pay 
contract, the price included in the receipt is the amount  actually  paid  by 
the patient.
  (4) A pharmacist shall retain a copy of the receipt for a  period   of   90 
days. The inclusion of the  information  required  in  this   rule   on   the 
written prescription form  and  the  retention  of   the   form   constitutes 
retaining a copy of the receipt. The physical presence  of  the  prescription 
form in the pharmacy constitutes compliance with the  requirement  of  having 
the name and address of the pharmacy on the form.
  (5) This rule does not apply to inpatient medical  institution  service.

  History:  1979 AC; 1980 AACS.


R 338.479b  Noncontrolled prescriptions.
  Rule 9b.  (1) A prescriber who issues a prescription for  a   noncontrolled 
legend drug shall date and sign the prescription and shall  ensure  that  the 
prescription contains all of the following information:
  (a)  The full name of the patient for whom the drug is being prescribed.
  (b)  The prescriber's printed name and address.
  (c)  The drug name and strength.
  (d)  The quantity prescribed.
  (e)  The directions for use.
  (f)  The number of refills authorized.
  (2)  A prescriber shall ensure that a prescription is legible and that  the 
information specified in subrule (1)(c)  to  (f)  of  this  rule  is  clearly 
separated.
  (3)  A prescriber shall not prescribe more than the following on a   single 
prescription form as applicable:
  (a)   For  a  prescription  prescribed  in  handwritten  form,  up  to    4 
prescription drug orders.
  (b)  For a prescription prescribed  on  a  computer-generated  form  or   a 
preprinted list or produced on a personal computer or  typewriter,  up  to  6 
prescription drug orders.
  (4)  A prescriber shall not add handwritten drugs to a preprinted form  and 
shall clearly designate which drugs are to be dispensed.
  (5)  A prescriber shall  not  prescribe  a  controlled  and   noncontrolled 
substance on the same prescription form.
  (6)  A prescription is valid for 1 year from the date the prescription  was 
issued.
  (7)  A prescriber  shall  clearly  indicate  the  total  number  of   drugs 
prescribed for each prescription.
  (8)   A   noncontrolled   substance   prescription   may   be   transmitted 
electronically from the prescriber to the pharmacy of the  patient's  choice, 
and shall  occur by utilizing a system that includes the following:
  (a) A combination of technical  security  measures  such  as,    but    not 
limited to, those listed in R 164.312 under Subpart C -  Security   Standards 
for  the Protection of Electronic Protected Health Information of 45 CFR Part 
164  that  implements  the   federal   Health   Insurance   Portability   and 
Accountability Act of 1996, to ensure all of the following:
  (i) Authentication of an individual who prescribes or dispenses.
  (ii) Technical non-repudiation.
  (iii) Content integrity.
  (iv) Confidentiality.
  (b)  An  electronic  signature  as  defined   in   R    338.471a(e).     An 
electronic  signature  is  valid  only  when  it  is   used   to    sign    a 
prescription  that  is transmitted electronically  from  a  prescriber  to  a 
pharmacy.
  (c) Appropriate security measures to invalidate a  prescription  if  either 
the electronic signature or prescription  record  to  which  it  is  attached
 or logically associated is altered or compromised following transmission  by 
the prescriber.  The electronic prescription may be reformatted   to   comply 
with industry standards provided that no data is added, deleted, or changed.
  (9) The electronic prescription shall meet any  other    requirements    of 
the federal Health Insurance Portability and Accountability Act.
  (10) The electronic prescription shall permit the  prescriber  to  instruct 
the pharmacist  to  dispense  a  brand  name  drug  product   provided   that 
the prescription includes both of the following:
  (i) The indication that  no  substitute  is  allowed,   such    as"dispense 
as written" or "DAW".
  (ii) The indication that no substitute is allowed  and  that  it    is    a 
unique element in the prescription.
  (11) If the prescription  is  transmitted  electronically,  the  prescriber 
shall generate and transmit the prescription in a  format   that    can    be 
read  and stored by a pharmacy in a retrievable  and  readable   form.    The 
electronic prescription shall identify the name of the pharmacy  intended  to 
receive  the transmission, and shall include the  information  identified  in 
subrule (1)  of this rule.
  (12) The electronic  prescription  shall  be  preserved  by   a    licensee 
or dispensing prescriber for not less than 5 years.   A  paper   version   of 
the electronic prescription shall be made available to an authorized agent of 
the board upon request.  A secured copy shall be retained for a minimum of  1 
year by the transaction service vendor  for  record-keeping   purposes    and 
shall  be shared only with the parties involved in the transaction except  as 
otherwise permitted by state or federal law.
  (13) An electronic signature that meets the requirements of this rule shall 
have the full force and effect of a handwritten signature  on  a  paper-based 
written prescription.
  (14) This rule does not apply to inpatient medical institutions.

  History:  1998-2000 AACS; 2000 AACS; 2007 AACS.


R 338.479c  Customized patient medication packages (CPMP).
  Rule 9c.  (1)  In place of dispensing 2 or more prescribed drug products in 
separate containers, a pharmacist may, with the consent of the  patient,  the 
patient’s caregiver, or a prescriber, provide a customized patient medication 
package (CPMP).  A CPMP is a package which is prepared by a pharmacist for  a 
specific patient and which contains 2 or more prescribed  solid  oral  dosage 
forms.  The CPMP is designed and labeled to indicate  the  day  and  time  or 
period of time that the contents within each CPMP are to be taken.
The person who dispenses  the  medication  shall   instruct  the  patient  or 
caregiver on the use of the CPMP.
  (2) If medication is dispensed  in  a  CPMP,  then  all  of  the  following 
conditions shall be met:
  (a)  Each CPMP shall bear a clearly readable label that states all  of  the 
following information:
  (i)  A serial number for the CPMP itself and a separate identifying  serial 
number for each of the prescription orders for  each  of  the  drug  products 
contained in the CPMP.
  (ii)  The name, strength, physical description, and total quantity of  each 
drug product contained in the CPMP.
  (iii)  The name of the prescriber for each drug product.
  (iv)  The directions for use and cautionary statements, if  any,  contained 
in the prescription order for each drug product in the CPMP.
  (v)  The date of the preparation of the CPMP.
  (vi)  An expiration date for the CPMP.  The date shall not  be  later  than 
the earliest manufacturer’s expiration date for any  medication  included  in 
the CPMP or 60 days after the date of dispensing.
  (vii)  The name, address, and telephone number of the dispenser.
  (viii)  Any other information, statements, or warnings required for any  of 
the drug products contained in the CPMP.
  (b)  A CPMP shall be accompanied by a patient package insert  in  case  any 
medication in the CPMP  is  required  to  be  dispensed  with  an  insert  as 
accompanying labeling.  Alternatively, required medication information may be 
incorporated by the pharmacist into a single educational insert that includes 
information regarding all of the medications in the CPMP.
  (c)  In the absence of more stringent packaging requirements for any of the 
drug products contained in the CPMP, each CPMP shall be  in  compliance  with 
the United States pharmacopeia (USP) and national formulary,  as  defined  in 
section 17706(2) of the code, for  moisture  permeation  requirements  for  a 
class b single- unit or unit-dose container.  Each container shall be  either 
not reclosable or so designed as to show evidence of having been opened.  All 
provisions of the poison prevention packaging  act,  as  defined  in  section 
17761(2) of the code, shall be complied with.
  (d)  When preparing a CPMP, the  dispenser  shall  take  into  account  any 
applicable compendial requirements or guidelines, the physical  and  chemical 
compatibility of the dosage forms  placed  within  each  container,  and  any 
therapeutic incompatibilities that may attend the simultaneous administration 
of the medications.
Medications shall not be dispensed in CPMP packaging in any of the  following 
situations:
  (i)  The USP monograph or official  labeling  requires  dispensing  in  the 
original container.
  (ii)  The drugs or dosage forms are incompatible with packaging  components 
or each other.
  (iii)   The  drugs  are  therapeutically  incompatible  when   administered 
simultaneously.
  (iv)  The drug products require special packaging.
  (e)   If  2  medications  have  physical  characteristics  that  make  them 
indistinguishable from each other, then the medication shall not be  packaged 
together in the same CPMP.
  (f)  Medications that have been dispensed in  CPMP  packaging  may  not  be 
returned to stock or dispensed  to  another  patient  when  returned  to  the 
pharmacy for any reason.
If a prescription for any drug contained in the CPMP is changed, then  a  new 
appropriately labeled CPMP shall be prepared for the patient.
  (g)  In addition to all  individual  prescription  filing  requirements,  a 
record of each CPMP dispensed shall be made and filed.   At  a  minimum  each 
record, shall contain all of the following information:
  (i)  The name and address of the patient.
  (ii)  The serial number of the prescription order  for  each  drug  product 
contained in the CPMP.
  (iii)  Information identifying or describing the  design,  characteristics, 
or specifications of the CPMP sufficient to allow subsequent  preparation  of 
an identical CPMP for the patient.
  (iv)  The date of preparation of the CPMP and the expiration date assigned.
  (v)  Any special labeling instructions.
  (vi)  The name or initials of the pharmacist who prepared the CPMP.

   History:  1998-2000 AACS.


R 338.480   Prescription records; nonapplicability to  inpatient  medical
  institution service.
  Rule 10. (1) A prescription shall be numbered, dated,  and   initialed   by 
the dispensing pharmacist  at  the  time  of  the  first   filling   at   the 
pharmacy.
  (2) If the drug that is dispensed is other than the brand prescribed  or if 
the prescription is written generically, the name of   the   manufacturer  or 
supplier of the drug dispensed shall be indicated on the  prescription.
  (3) This rule does not apply to inpatient medical  institution  service.

  History:  1979 AC; 1980 AACS; 1992 AACS.


R 338.480a  Prescription refill records;  manual  systems;  profile  systems; 
automated data processing  systems;  nonapplicability  to  inpatient  medical 
institution service; record confidentiality   and access.
  Rule 10a.  (1) A pharmacist shall record prescription refills using only  1 
of the systems described in subrule (2), (3), or (4)  of  this  rule  and  in 
compliance with the provisions of subrule (2), (3), or (4) of this  rule,  as 
applicable.
  (2)  A pharmacy may utilize a manual system of  recording  refills  if  the 
system is in compliance with both of the following criteria:
  (a)  The amount and date dispensed shall be entered on the prescription  in 
an orderly fashion and the dispensing pharmacist shall initial the entry.
If the pharmacist only initials and dates the  prescription,  then  the  full 
face amount of the prescription shall be deemed dispensed.
  (b)  If the drug that is dispensed is other than the brand prescribed or if 
the prescription is written generically, then the name of the manufacturer or 
supplier of the drug dispensed shall be indicated on the prescription.
  (3)  A pharmacy may utilize a uniform system of recording  refills  if  the 
system is in compliance with all of the following criteria:
  (a)  Records shall be created and maintained in written form.  All original 
and refill prescription  information  for  a  particular  prescription  shall 
appear on single documents  in  an  organized  format.   The  pharmacy  shall 
preserve the records for 5 years.  The records are subject to  inspection  by 
the board or its agents.
  (b)  All of the  following  information  for  each  prescription  shall  be 
entered on the record:
  (i)  The prescription number.
  (ii)  The patient's name and address.
  (iii)  The prescriber's name.
  (iv)  The prescriber's federal drug enforcement administration  number,  if 
appropriate.
  (v)  The number of refills authorized.
  (vi)  The "dispense as written" instructions, if indicated.
  (vii)  The name, strength, dosage form, and quantity of the drug prescribed 
and the drug  dispensed  originally  and  upon  each  refill.   If  the  drug 
dispensed is other than the  brand  prescribed  or  if  the  prescription  is 
written generically, then the name of the manufacturer  or  supplier  of  the 
drug dispensed shall be indicated.
  (viii)  The date of issuance of the prescription.
  (ix)  The date and identifying designation of the dispensing pharmacist for 
the original filling and for each refill.
  (c)  Prescription entries shall be made on  the  record  at  the  time  the 
prescription is first filled and at the time of each refill, except that  the 
format of the record may be organized so that information already entered  on 
the record may appear for a prescription or  refill  without  reentering  the 
information.  The dispensing pharmacist is responsible for  the  completeness 
and accuracy of the  entries  and  shall  initial  the  record  each  time  a 
prescription is filled or refilled.
  (d)  The information required by subdivision (b) of this subrule  shall  be 
entered on the record for all prescriptions filled at a  pharmacy,  including 
nonrefillable  prescriptions.   This  requirement  is  in  addition  to   the 
requirements set forth in R 338.480.
  (4)  A pharmacy may utilize a uniform automated data processing  system  of 
recording refills if the system is in compliance with all  of  the  following 
criteria:
  (a)  All information that is pertinent to a prescription shall  be  entered 
on the record, including all of the following information:
  (i)  The prescription number.
  (ii)  The patient's name and address.
  (iii)  The prescriber's name.
  (iv)  The prescriber's federal drug enforcement administration  number,  if 
appropriate.
  (v)  The number of refills authorized.
  (vi)  Whether the drug must be dispensed as written.
  (vii)  The name, strength, dosage form, and quantity of the drug prescribed 
and the drug  dispensed  originally  and  upon  each   refill.  If  the  drug 
dispensed is other than the  brand  prescribed  or  if  the  prescription  is 
written generically, then the name of the manufacturer  or  supplier  of  the 
drug dispensed shall be indicated.
  (viii)  The date of issuance of the prescription.
  (ix)  The date and identifying designation of the dispensing pharmacist for 
the original filling and for each refill.
  (b)  Prescription entries shall be made on  the  record  at  the  time  the 
prescription is first filled and at the time of each refill, except that  the 
format of the record may be organized so that information already entered  on 
the record may appear for a prescription or  refill  without  reentering  the 
information.  The dispensing pharmacist is responsible for  the  completeness 
and accuracy of the entries.  The pharmacy shall preserve the records on-site 
for 5 years.  The records are subject to  inspection  by  the  board  or  its 
agents.
A procedure shall be established to facilitate inspections.
  (c)  The required information shall  be  entered  on  the  record  for  all 
prescriptions filled at the pharmacy, including nonrefillable prescriptions.
This requirement is in addition to the requirements set forth in R 338.480.
  (d)   The  recording  system  shall  provide  adequate  safeguards  against 
improper manipulation, the alteration of records, and the loss of records.
  (e)  The recording system shall have the capability of producing a printout 
of all original and refilled prescription data, including a  prescription-by- 
prescription and refill-by-refill audit trial for any specified strength  and 
dosage form of a controlled substance by either brand or generic name  or  an 
audit  trail of controlled substance prescriptions written for  a  particular 
patient or by a particular practitioner.  A printout of  an  audit  trail  or 
other required information shall be made available to an authorized agent  of 
the board upon request.  The prescription data  shall  be  maintained  for  5 
years.  Data older than 16 months shall be provided within 72  hours  of  the 
time the request is first made by the agent.  Prescription data for the  most 
current 16 months shall be readily retrievable  on  site  and  available  for 
immediate review.
  (f)  If the automated data processing system is inoperative for any reason, 
then the pharmacist shall ensure that all refills are authorized and that the 
maximum  number  of  refills  is  not  exceeded.   When  the  automated  data 
processing system is restored to operation, the pharmacist  shall  enter  the 
information  regarding  prescriptions  filled   and   refilled   during   the 
inoperative period into the automated data processing system within 48 hours.
  (g)   A  pharmacy  shall  make  arrangements  with  the  supplier  of  data 
processing services or materials to assure that  the  pharmacy  continues  to 
have adequate  and  complete  prescription  and  dispensing  records  if  the 
relationship with the supplier terminates for any reason.  A  pharmacy  shall 
assure continuity in the maintenance of records.
  (h)  The automated data processing system shall  be  an  integrated  system 
that is capable of complying with all of the requirements of these rules.
  (5)  This rule does not apply to inpatient medical institution service.
  (6)  Records that are created under subrule (3) or (4)  of  this  rule  are 
subject to the same requirements regarding confidentiality  and  access  that 
apply to original prescriptions.

  History:  1992 AACS; 1998-2000 AACS.

R 338.481  Professional and technical equipment and supplies.
  Rule 11.  (1)   A  pharmacy  shall  be  equipped  with  necessary  drawers, 
shelves, storage cabinets, and prescription files.  A sink that has  hot  and 
cold running water and a refrigerator of reasonable capacity shall be in  the 
pharmacy department.
  (2)  A pharmacy shall have current editions or revisions  of  the  Michigan 
pharmacy laws and rules and not less  than  2  current  or  revised  pharmacy 
reference texts that pertain to  pharmacology,  drug  interactions,  or  drug 
composition.  A current electronic medium version of pharmacy reference texts 
meets the requirements of this subrule.
  (3)  A pharmacy shall have the necessary technical  equipment  to  compound 
and dispense prescription drugs.

  History:  1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.


R  338.482   Housing of pharmacy.
  Rule 12. (1) All professional and technical equipment  and   supplies   and 
prescription drugs  shall  be  housed  in  a   suitable,   well-lighted   and 
well-ventilated room or department with clean and  sanitary  surroundings.
  (2) All pharmacies shall have a prescription department  which  is  devoted 
primarily to the compounding  of  prescriptions  and   the   manufacture   of 
pharmaceutical preparations which occupies not less than 150  square  feet of 
space, and which includes a prescription counter that provides not less  than 
10 square feet of free working surface. If more than 1 pharmacist  is on duty 
at any one time, the free working space shall be increased by  not less  than 
4 square feet for each  additional  pharmacist.   The   prescription  counter 
shall be kept clean and orderly. The space behind  the  prescription  counter 
shall be sufficient to allow free movement  within  the  area  and  shall  be 
free of obstructions.
  (3) All pharmacies that occupy less than the entire area  of  the  premises 
owned, leased, used, or controlled by the licensee   shall   be   permanently 
enclosed by partitions from the floor to the ceiling. All partitions shall be 
of substantial construction and shall  be  securely  lockable  so  that drugs 
and devices that can only be sold by a pharmacist  are   unobtainable  during 
the absence of the pharmacist. Identification of this department by  the  use 
of the words "drug," "medicines," or "pharmacy" or by the use  of  a  similar 
term or combination of terms  shall  be  restricted  to  the  area   that  is 
registered by the board. The pharmacy department shall be  locked   when  the 
pharmacist is not in the establishment.

  History:  1979 AC; 1980 AACS.


R 338.483  Rescinded.

  History:  1979 AC; 1992 AACS.


R 338.484  Rescinded.

  History: 1979 AC.


                          ADMINISTRATIVE HEARINGS


R 338.485 - R 338.485y   Rescinded.

  History:  1979 AC; 1980 AACS.


R 338.486  "Medical institution" and "pharmacy  services"  defined;  pharmacy 
services in medical institutions.
 Rule 16.  (1)  As used in this rule:
  (a)  "Medical institution" means  a  hospital,  skilled  nursing  facility, 
county medical care facility, nursing home, or other 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.
  (2)  Pharmacy services  shall  be  directed  and  provided  by  a  licensed 
pharmacist.
  (3)  Pharmacy personnel who assist the pharmacist by  performing  delegated 
functions in the care of inpatients shall be supervised by a  pharmacist  who 
is on the premises of the medical institution.
  (4)  The pharmacist  who  directs  the  pharmacy  services  shall  develop, 
implement, supervise, and coordinate all of the services provided, including, 
at a minimum, all of the following:
  (a)  Dispensing medications in a form that minimizes additional preparation 
before administration to the patient, including the admixture of parenterals.
  (b)   Obtaining  the  prescriber's  original  medication  order,  a  direct 
carbonized copy, an electromechanical facsimile, or  other  electronic  order 
transmission.  Security measures shall be in  place  to  ensure  that  system 
access by unauthorized individuals is not allowed.
  (c)  Interpreting and reviewing  the  prescriber's  medication  orders  and 
communicating problems with these orders to the  physician  or  nurse  before 
administration of first doses.  If the interpretation and review will cause a 
medically unacceptable delay, then a limited number  of  medications  may  be 
stocked at the patient care areas for the administration of first doses.
These medications shall be provided in a manner  that  ensures  security  and 
immediate availability, such as sealed or secured medication kits, carts,  or 
treatment trays.
 A pharmacist shall routinely inspect the medications and, after  use,  shall 
verify the contents and replace the medications as necessary.
  (d)  Monitoring medication therapy to  promote  positive  patient  outcomes 
while   evaluating   clinically   significant   chemical   and    therapeutic 
incompatibilities.
  (e)   Establishing  the  specifications  for   the   procurement   of   all 
pharmaceuticals and related biologicals and chemicals approved for use in the 
medical institution.
  (f)  Periodically inspecting all areas in  the  medical  institution  where 
medications are stored to verify compliance with the standards for  the  safe 
use and storage of the medications.
  (g)  Maintaining proper security for all medications stored or kept  within 
the medical institution.
  (h)  Providing educational programs regarding medications  and  their  safe 
use.
  (i)  Providing a method by which medications can  be  obtained  during  the 
absence of a pharmacist in a medical institution where a  pharmacist  is  not 
available 24 hours a day.   The  method  shall  minimize  the  potential  for 
medication error.  During the absence of a  pharmacist,  the  services  of  a 
pharmacist shall be available on an on-call basis.  Only a limited number  of 
medications that are packaged in units of use shall be available.
The medications  shall  be  approved  and  reviewed  periodically  as  deemed 
necessary, but not less than once a year, by an appropriate interdisciplinary 
practitioner committee of the medical institution.  The medication  shall  be 
kept  in   a  securely  locked,  substantially  constructed  cabinet  or  its 
equivalent in an area of limited access in a  centralized  area  outside  the 
pharmacy.  Each medication shall be  labeled  to  include  the  name  of  the 
medication, the strength, the expiration date, if dated, and the lot number.
A written order and a proof of removal and use document shall be obtained for 
each medication united removed.  The order and document shall be reviewed  by 
the pharmacist within 48 hours of removing medication from the cabinet or its 
equivalent.  The pharmacist who directs  pharmacy  services  in  the  medical 
institution shall designate the practitioners who are permitted to remove the 
medication.  A pharmacist shall audit  the  storage  locations  as  often  as 
needed to guarantee control, but not less than once every 30 days.
  (5)  Upon recommendation of an interdisciplinary  practitioners  committee, 
the pharmacist who directs pharmacy services in the medical institution shall 
adopt written policies and procedures to promote safe  medication  practices, 
to conduct medication utilization review,  to  approve  medications  for  the 
medical institution's formulary or medication list, and to  promote  positive 
patient outcomes.  A pharmacist  shall  meet  with  the  committee  at  least 
quarterly to conduct assigned responsibilities.
  (6) A pharmacy shall ensure that every medication dispensed  is  identified 
with its name and strength labeled on the container in which it is  dispensed 
or on each  single  unit  package.   A  pharmacy  that  is  engaged  in  drug 
distribution to medical institutions which use  unit-of-use  packaging  shall 
place identification on the label of its package to allow the package  to  be 
readily traced.  The name of the patient and any identifying number shall  be 
labeled on the medication container.  The container  may  be  the  individual 
patients' assigned medication drawer.  The directions for use shall be on the 
label of the container if the directions  are  not  communicated  in  another 
effective manner.   If  the  medication  is  to  be  self-administered,  then 
directions for use shall be on the container.  The  preceding  provisions  of 
this subrule are minimum labeling standards only and do not  supersede  other 
applicable laws or rules.
  (7)  A pharmacist shall personally  supervise  the  destruction  of  unused 
portions of prescription medication, other than controlled  substances  under 
part 71 of the code, dispensed to patients. However, medications  in  single- 
unit packages and intravenous solutions which  are  designed  to  be  tamper- 
evident and which show  no  evidence  that  tampering  has  occurred  may  be 
returned to stock.  Medications that leave the  medical  institution  or  its 
legal affiliates may not be returned to stock for redispensing.
  (8)  The licensed pharmacist who directs pharmacy services in  the  medical 
institution shall make the policies, procedures, and written reports required 
by this rule available to the board of pharmacy, upon request.

  History:  1979 AC; 1980 AACS; 1998-2000 AACS.

R 338.487   Rescinded.

  History: 1979 AC.


R 338.488   Standard clinical thermometers.
  Rule 18. (1) In addition to meeting the standards approved by the  board in 
subrule (2) of this rule,  standard  clinical  thermometers   shall   be   in 
compliance in all respects with standards set forth in section  469  of   Act 
No. 328 of the Public Acts of 1931, as  amended,  being   S750.469   of   the 
Michigan Compiled Laws.
  (2) The board  approves  and  adopts  by  reference   the   standards   for 
manufacturing clinical thermometers approved by the  American   society   for 
testing and materials on August 29, 1986, and issued under the designation "E 
667-86." Copies of the standards may  be   obtained,   at   no   cost,   from 
either the Board of Pharmacy, P.O. Box 30018, Lansing,  Michigan  48909,   or 
the  American  Society  for  Testing  and  Materials,   1916   Race   Street, 
Philadelphia, Pennsylvania 19103.
  (3) To obtain certification, a manufacturer  shall   submit   a   completed 
application, on a form provided  by  the  department,   together   with   the 
requisite fee and 2  representative  samples  of  each  type   or   kind   of 
thermometer which the manufacturer desires to offer for sale in  Michigan.
The  manufacturer  shall  submit  additional   representative   samples    if 
requested by the board. If the board finds that the   samples   comply   with 
the requirements of this rule, the board shall   certify   the   thermometers 
for sale in Michigan and the department shall issue a  certification  to  the 
manufacturer.
  (4) Upon request, a manufacturer shall provide a  signed   guarantee   that 
the standard clinical thermometers  offered  for  sale   in   Michigan   were 
certified by the manufacturer to comply with subsection 469(2) of Act  No.
328 of the Public Acts of 1931,  as  amended,  being   S750.469(2)   of   the 
Michigan Compiled Laws, and this rule. A manufacturer  that   is   issued   a 
certification  by  the  board  shall  package    each    standard    clinical 
thermometer in a container that prominently displays  a   notification   that 
the thermometer meets the manufacturing standards approved by  the  board.
The notification shall be printed either on the  package   or   the   package 
insert.

  History:  1979 AC; 1982 AACS; 1988 AACS; 1990 AACS.


R 338.489  Automated devices.
  Rule 19. (1) An automated  device  means  a  device  designed    for    the 
specific purpose of selling, dispensing, or otherwise disposing of  any  drug 
or  device ordered by a prescription.
  (2) An automated device may be used only in the following locations:
  (a) A pharmacy.
  (b) A hospital.
  (c) A county medical care facility.
  (d) A hospice.
  (e) A nursing home.
  (f) Other skilled nursing facility as defined in 1978 PA 368, MCL 333.20109.
  (g) An office of a dispensing prescriber.
  (3) An automated  device   designed   for   the   specific    purpose    of 
selling, dispensing, or otherwise disposing   of   any   drug    or    device 
ordered  by  a prescription, as defined in the code,  and  located  within  a 
licensed  pharmacy shall be used only by a pharmacist or    other    pharmacy 
personnel  under  the personal charge of a pharmacist.
  (4)  If  an  automated  dispensing  device  is  used   in   a    dispensing 
prescriber's office, the  device   shall   be   used   only    to    dispense 
medications  to  the dispensing prescriber's  patients  and  only  under  the 
control of the dispensing prescriber.  A pharmacy shall not   own,   control, 
or  operate  an  automatic dispensing device  in  a  dispensing  prescriber's 
office.
  (a) If a dispensing prescriber 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 complies with R 338.3154.
  (b) A dispensing prescriber operating an automated  device  is  responsible 
for all medications that are stocked and stored in that  device  as  well  as 
removed from that device.
  (c) If 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  by  the dispensing  prescriber  for  review  by   an   agent   of 
the   board.     This  documentation  shall  include  at  least  all  of  the 
following information:
  (i) Manufacturer name and model.
  (ii)   Quality   assurance   policy    and    procedure    to     determine 
continued appropriate use and performance of the automated device.
  (iii) Policy and procedures  for  system  operation  that  addresses  at  a 
minimum all of the following:
  (A) Accuracy.
  (B) Patient confidentiality.
  (C) Access.
  (D) Data retention or archival records.
  (E) Downtime procedures.
  (F) Emergency procedures.
  (G) Medication security.
  (H) Quality assurance.
  (5) An  automated  device  that  is  to  be  used  for  the  furnishing  of 
medications for administration to registered patients  in    any    hospital, 
county  medical care facility, nursing home, hospice, or  any  other  skilled 
nursing  facility, as defined  in  1978  PA  368,  MCL  333.20109,  shall  be 
supplied and controlled by a pharmacy that is licensed and  located  in  this
 state.   The  use  of  an automated device  in  these  locations   is    not 
limited  to  the  provisions  of subrule (3) of this rule.  If  a  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 complies with  R  338.3154.
Each such device shall comply with all of the following provisions:
  (a) A  pharmacy  operating  an  automated  device  is    responsible    for 
all medications that are stocked and stored in that device   as    well    as 
removed from that device.
  (b) If 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  by  the pharmacy for review by an  agent  of  the   board.    The 
documentation  shall include at least all of the following information:
  (i) Name and address of the pharmacy responsible for the    operation    of 
the automated device.
  (ii) Name and address of the facility where the device is located.
  (iii) Manufacturer name and model number.
  (iv)  Quality  assurance  policy  and  procedure  to  determine   continued 
appropriate use and performance of the automated device.
  (v) Policy and procedures for system operation that address  at  a  minimum 
all of the following:
  (A) Accuracy.
  (B) Patient confidentiality.
  (C) Access.
  (D) Data retention or archival records.
  (E) Downtime procedures.
  (F) Emergency procedures.
  (G) Medication security.
  (H) Quality assurance.
  (I) Ability to provide on demand  to  an  agent  of  the  board   a    list 
of medications qualifying for emergency dose removal    without    pharmacist 
prior review of the prescription or medication order.
  (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 for 5 years by the  pharmacy   and    shall 
be retrievable on demand for review by an agent of the  board.   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 responsible for the    accuracy    of 
the medications to be stocked or restocked in the device.
  (7) 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.
  (e) The device is located in a dispensing prescriber's office.
  (8) A copy of all  policies  and  procedures  related  to  the  use  of  an 
automated device shall be maintained at  the  pharmacy  responsible  for  the
 device's specific location or at the dispensing prescriber's office and   be 
available for review by an agent of the board.

  History:  1979 AC; 1980 AACS; 2007 AACS.


R 338.490  Professional responsibility; "caregiver" defined.
  Rule 20.  (1)  A pharmacist has  a  professional  responsibility   for  the 
strength, quality,  purity,  and  the  labeling  of  all  drugs  and  devices 
dispensed under  a  prescription.   In  discharging  this  responsibility,  a 
pharmacist shall utilize only those drugs and devices that are obtained  from 
manufacturers and wholesale distributors licensed under section 17748 of  the 
code or from other lawful channels of distribution.
  (2)   A  pharmacist  shall  not  fill  a  prescription  order  if,  in  the 
pharmacist's professional judgment, any of the following provisions apply:
  (a)  The prescription appears to be improperly written.
  (b)  The prescription is susceptible to more than 1 interpretation.
  (c)  The pharmacist has reason to believe that the prescription could cause 
harm to the patient.
  (d)  The pharmacist has reason to believe that  the  prescription  will  be 
used for other than legitimate medical purposes.
  (3)  A prescription drug shall only be dispensed when the pharmacy is  open 
and under the personal charge of a pharmacist.
  (4)  To encourage intended, positive patient outcomes, a  pharmacist  shall 
communicate, to  the  patient  or  the  patient’s  caregiver,  necessary  and 
appropriate information regarding safe and effective medication  use  at  the 
time a prescription is dispensed.  As used in this subrule, "caregiver" means 
the parent, guardian, or other individual who has assumed responsibility  for 
providing a patient’s  care.   All  of  the  following  provisions  apply  to 
communicating medication safety and effectiveness information:
  (a)  The information shall be communicated orally  and  in  person,  except 
when the patient or patient’s caregiver is not at  the  pharmacy  or  when  a 
specific communication barrier  prohibits   oral  communication.   In  either 
situation, providing printed material designed to help the  patient  use  the 
medication safely and effectively satisfies the requirements of this subrule.
  (b)  The information shall be provided with each prescription  for  a  drug 
not previously prescribed for the patient.
  (c)  If the pharmacist deems  it  appropriate,  the  information  shall  be 
provided with prescription refills.
  (d)  The information shall be provided  if  requested  by  the  patient  or 
patient’s caregiver or agent for any prescription dispensed by the pharmacy.
This subrule does not require that a pharmacist  provide  consultation  if  a 
patient or a patient’s caregiver refuses consultation.  This subrule does not 
apply to prescriptions dispensed for administration to a  patient  while  the 
patient is in a medical institution.
  (5)  Pharmacist delegation  of  acts,  tasks,  or  functions  shall  be  in 
compliance with section 16215 of the code and under the  personal  charge  of 
the delegating pharmacist, except as provided in R 338.486(3).  A  pharmacist 
who delegates acts, tasks, or functions to a licensed  or  unlicensed  person 
shall do all of the following:
  (a)  Determine the knowledge and skill required to safely  and  competently 
complete the specific act, task, or function to be delegated.
  (b)  Before delegating an act, task, or function, make a determination that 
the  delegatee  has  the  necessary  knowledge  and  skills  to  safely   and 
competently complete the act, task, or function.
  (c)  Provide written procedures or protocols, or both, to  be  followed  by 
the delegatee in the performance of the delegated act, task, or function.
  (d)  Supervise and evaluate the performance of the delegatee.
  (e)  Provide remediation of the performance of the delegatee if indicated.
  (6)  A delegating pharmacist shall bear the ultimate responsibility for the 
performance  of  delegated  acts,  tasks,  and  functions  performed  by  the 
delegatee within the scope of the  delegation.

  History:  1979 AC; 1990 AACS; 1998-2000 AACS.


R  338.491, R  338.492   Rescinded.

  History: 1979 AC.


       PART 2. MANUFACTURING AND DISTRIBUTION OF PRESCRIPTION DRUGS


R 338.493a  Applicability; distributions by pharmacies; license requirements.
   Rule  23a.   (1)   These  rules  apply  to  a  manufacturer  or  wholesale 
distributor that is licensed to  do  business  in  this  state  on  or  after 
September 1, 1992, or that applies for a license to do business in this state 
on or after September 1, 1992.
  (2)  If the total number of dosage units of all prescription drugs that are 
distributed by a pharmacy to a person as defined in section 1106 of the code, 
during any consecutive 12-month period is more than 5% of the total number of 
dosage units of prescription drugs distributed and dispensed by the  pharmacy 
during the 12-month period, then the pharmacy is a wholesale  distributor  as 
defined in section 17709(2) of the code.
  (3)  If the total number of dosage units of all prescription drugs that are 
prepared or compounded by a pharmacy for resale, compounding,  or  dispensing 
by another person, as defined  in  section  1106  of  the  code,  during  any 
consecutive 12-month period is more than 5% of the  total  number  of  dosage 
units of prescription drugs prepared by  the  pharmacy  during  the  12-month 
period, then the pharmacy is a manufacturer as defined in section 17706(1) of 
the code.
  (4)  A manufacturer or wholesale distributor that distributes  prescription 
drugs in Michigan only from a location outside of  Michigan  shall  obtain  a 
license to do business in Michigan.  A manufacturer or wholesale  distributor 
that manufactures or distributes prescription drugs in  Michigan  from  1  or 
more locations in Michigan shall obtain a separate license for each  location 
in Michigan where prescription drugs are manufactured or distributed.

  History:  1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.


R  338.493b   Manufacturing practice; adoption by reference of  standards.
  Rule 23b. A  manufacturer  shall  maintain  the   building,   operate   the 
equipment, and administer the controls, records, and methods used for, and in 
connection  with,   the   manufacturing,   processing,   packing,   labeling, 
holding, and distributing of all prescription  drugs   in   conformity   with 
current good manufacturing practice pursuant to the criteria  set  forth   in 
the provisions of 21 C.F.R.  SS211.1  to  211.208,  (April  1,   1979).   The 
criteria set forth in the provisions of 21 C.F.R. SS211.1  to   211.208   are 
adopted in these rules by reference. Copies of the   adopted   material   are 
available from the Superintendent of Documents,  United   States   Government 
Printing Office, Washington, DC 20402,  at  a  cost  as  of   the   time   of 
adoption of these amendatory rules of $4.00 or from the  Board  of  Pharmacy, 
Department of Commerce, P.O. Box 30018, Lansing, Michigan 48909, at a cost as 
of the time of adoption of these amendatory rules of $4.00.

  History:  1979 AC; 1980 AACS; 1992 AACS.


R  338.493c   Wholesaling practice; minimum requirements.
  Rule 23c. A wholesale distributor shall maintain and comply  with  all   of 
the  following  minimum  standards  for  the  storage   and    handling    of 
prescription drugs and the establishment and  maintenance   of   prescription 
drug distribution records:
  (a) All facilities at which prescription drugs  are   stored,   warehoused, 
handled, held, offered, marketed, or displayed shall be  in  compliance  with 
all of the following provisions:
  (i) Be of a suitable  size  and  construction   to   facilitate   cleaning, 
maintenance, and proper operations.
  (ii) Have storage areas that are designed to  provide  adequate   lighting, 
ventilation, temperature,  sanitation,  humidity,   space,   equipment,   and 
security conditions.
  (iii) Have a quarantine area for the storage of  prescription  drugs  which 
are outdated, damaged, deteriorated, misbranded, or  adulterated   or   which 
are in immediate or sealed secondary containers that have been opened.
  (iv) Be maintained in a clean and orderly condition.
  (v) Be free from infestation by insects, rodents, birds,   or   vermin   of 
any kind.
  (b) All facilities that are used for wholesale drug  distribution  shall be
 secure  from  unauthorized   entry   as   specified   in    the    following 
provisions:
  (i) Access from outside the premises shall be kept to a  minimum   and   be 
well-controlled.  The  outside  perimeter  of  the    premises    shall    be 
well-lighted. Entry into areas where prescription drugs are  held  shall   be 
limited to authorized personnel.
  (ii) All facilities shall be equipped with an  alarm   system   to   detect 
entry after hours.
  (iii) All facilities shall be equipped with a security  system  that   will 
provide suitable protection against theft and  diversion.  When  appropriate, 
the security system shall provide protection against   theft   or   diversion 
that is facilitated or hidden by tampering with   computers   or   electronic 
records.
  (c) All prescription drugs shall be stored  at   appropriate   temperatures 
and under appropriate conditions in accordance with label requirements  or in 
accordance with requirements set forth  in  the  current   edition   of   the 
official compendium. If storage requirements are  not   established   for   a 
prescription drug, the drug may be held at controlled  room  temperature   to 
help ensure that its identity,  strength,  quality,  and   purity   are   not 
adversely affected. Appropriate manual,  electromechanical,   or   electronic 
temperature and humidity recording equipment, devices, or   logs   shall   be 
utilized to  document  the  proper  storage  of   prescription   drugs.   The 
recordkeeping requirements in  subdivision  (f)  of  this   rule   shall   be 
followed for all stored prescription drugs.
  (d) All  of  the  following  provisions  apply  to   the   examination   of 
materials:
  (i) Each outside shipping container  shall  be   visually   examined   upon 
receipt for the identity of the prescription drug products  and  to   prevent 
the acceptance of contaminated prescription drugs   or   prescription   drugs 
that are otherwise unfit  for  distribution.  This   examination   shall   be 
adequate  to  reveal  container  damage  that    would    suggest    possible 
contamination or other damages to the contents.
  (ii) Each outgoing shipment shall be carefully inspected  for  identity  of 
the prescription drug products and to ensure that  prescription  drugs   that 
have been damaged in storage or held under  improper   conditions   are   not 
delivered.
  (iii) The recordkeeping requirements in subdivision  (f)   of   this   rule 
shall be followed for all incoming and outgoing prescription drugs.
  (e) All of the following provisions  apply  to   returned,   damaged,   and 
outdated prescription drugs:
  (i)  Prescription  drugs  that  are   outdated,   damaged,    deteriorated, 
misbranded, or adulterated shall be quarantined  and   physically   separated 
from other prescription drugs until they  are  destroyed   or   returned   to 
their supplier.
  (ii) Any immediate or sealed outer or sealed secondary  containers  of  any 
prescription drugs that have been opened or used shall   be   identified   as 
such and the drugs shall be  quarantined  and   physically   separated   from 
other prescription drugs until they are either destroyed   or   returned   to 
the supplier.
  (iii) If the  conditions  under  which  a  prescription   drug   has   been 
returned cast doubt on the drug's safety, identity,  strength,  quality,   or 
purity, then the drug shall be destroyed  or  returned   to   the   supplier, 
unless examination, testing, or other investigation proves  that   the   drug 
meets appropriate standards of safety, identity,   strength,   quality,   and 
purity. In determining whether the conditions under which a  drug  has   been 
returned cast doubt on the drug's safety, identity,  strength,  quality,   or 
purity, the wholesale distributor  shall  consider   the   conditions   under 
which the drug has been held, stored, or  shipped  before   or   during   its 
return and the condition  of  the  drug  and  its   container,   carton,   or 
labeling as a result of storage or shipping.
  (iv) The recordkeeping requirements of  subdivision  (f)   of   this   rule 
shall be followed for all outdated, damaged,  deteriorated,  misbranded,   or 
adulterated prescription drugs.
  (f) All of the following provisions apply to recordkeeping:
  (i) Wholesale distributors shall establish and  maintain  inventories   and 
records of all transactions regarding  the  receipt   and   distribution   or 
other disposition of prescription drugs. These records shall  include  all of 
the following information:
  (a) The source of the drugs, including the name and  principal  address  of 
the seller or transferor, and the address of the location  from   which   the 
drugs were shipped.
  (b) The identity and quantity of the drugs received  and   distributed   or 
disposed of.
  (c) The dates of receipt and distribution or other   disposition   of   the 
drugs.
  (ii) Inventories and records shall be made available  for  inspection   and 
photocopying by authorized federal, state, or local  law  enforcement  agency 
officials for a period of 2 years after disposition of the drugs.
  (iii) Records which are described in this subdivision and which are kept at 
the inspection site or can be  immediately  retrieved  by  computer  or other
 electronic   means   shall   be   readily   available     for     authorized 
inspection during the retention  period.  Records  which  are   kept   at   a 
central location  apart  from  the  inspection  site  and   which   are   not 
electronically retrievable shall be made available for  inspection  within  2 
working days of a request by an authorized official of a  federal,  state, or 
local law enforcement agency.
  (g) Wholesale distributors shall  establish,  maintain,   and   adhere   to 
written policies and procedures, which shall be followed  for  the   receipt, 
security, storage, inventory,  and  distribution   of   prescription   drugs, 
including  policies  and  procedures  for   identifying,    recording,    and 
reporting losses or thefts and for correcting all errors and  inaccuracies in 
inventories. Wholesale drug   distributors   shall   include   all   of   the 
following procedures in their written policies and procedures:
  (i) A procedure whereby the oldest approved stock of  a  prescription  drug 
product is distributed first. The procedures  may   permit   deviation   from 
this requirement if the deviation is temporary and appropriate.
  (ii) A procedure to be followed for handling recalls  and  withdrawals   of 
prescription drugs. The procedure shall be adequate to  deal   with   recalls 
and withdrawals due to any of the following:
  (a)  Any  action  initiated  at  the  request  of  the   food   and    drug 
administration,  the  board,  or  other  federal,  state,   or   local    law 
enforcement agency or other government agency.
  (b) Any voluntary action by the  manufacturer  to   remove   defective   or 
potentially defective drugs from the market.
  (c) Any action  undertaken  to  promote  public  health   and   safety   by 
replacing existing merchandise with an improved  product   or   new   package 
design.
  (iii) A procedure to ensure that  wholesale   drug   distributors   prepare 
for, protect against, and handle, any  crisis  that   affects   security   or 
operation of any facility in the  event  of  strike,   fire,   flood,   other 
natural disaster,  or  other  situations  of  local,   state,   or   national 
emergency.
  (iv) A procedure to ensure that any outdated prescription  drugs  shall  be 
segregated from other drugs and either returned  to   the   manufacturer   or 
destroyed. This procedure shall provide for written  documentation   of   the 
disposition of outdated drugs. This documentation shall be maintained  for  2 
years after disposition of the outdated drugs.
  (h)  Wholesale  distributors  shall  establish  and   maintain   lists   of 
officers, directors, managers, and other persons  who  are   in   charge   of 
wholesale  drug  distribution,  storage,   and    handling,    including    a 
description of their duties and a summary of their qualifications.
  (i) Wholesale distributors shall operate in  compliance   with   applicable 
federal, state, and local laws and regulations and permit  representatives of
 the  board  and  other   authorized   federal,   state,   and   local    law 
enforcement officials to enter and inspect  their   premises   and   delivery 
vehicles and audit their  records  and  written   operating   procedures   at 
reasonable times and in a reasonable manner.
  (j) Wholesale distributors shall be subject to  the   provisions   of   any 
applicable federal, state, or local laws or  regulations   that   relate   to 
prescription drug product salvaging or reprocessing.
  (k) Each person employed in any prescription  drug  wholesale  distribution 
activity shall have education, training and experience, or any combination of 
education, training and   experience,   sufficient   for   that   person   to 
perform the assigned functions in such a manner as   to   provide   assurance 
that the drug product quality, safety and security will at   all   times   be 
maintained as required by law.

  History:  1979 AC; 1980 AACS; 1992 AACS.


R  338.493d   License    application;    manufacturers    and    wholesale
  distributors.
  Rule 23d. An application for a license as a   manufacturer   or   wholesale 
distributor shall be made on a form provided by the  department   and   shall 
contain all of the following information:
  (a) All names, addresses, and telephone numbers used by  the  applicant  in 
this state.
  (b) State of incorporation.
  (c) The kind of ownership or  operation,  such   as   individually   owned, 
partnership, association, cooperative, or corporation.
  (d) The name of the owner or operator,  including,  in  the   case   of   a 
partnership, the name of each partner and, in the case  of   a   corporation, 
the name and title of each corporation officer and director.
  (e) A partnership, corporation, or an applicant who   operates   under   an 
assumed name shall file certified copies of  its   partnership   certificate, 
corporate  articles,  or  assumed  name  certificate   with    its    initial 
application.
  (f) A brief description of the buildings in this state  that   are   owned, 
controlled, or used by the  applicant  in  connection  with,   or   for   the 
manufacture or wholesale distribution of, prescription drugs, the address, if 
different from that of the principal address of the applicant, at which  each 
building is located, and  an  indication  of  the   type   of   activity   or 
activities carried on in each building, such as any of the following:
  (i) The manufacture of active ingredients.
  (ii) Compounding.
  (iii) Packaging.
  (iv) Repackaging.
  (v) Operating a quality control laboratory.
  (vi) Recordkeeping and storage.
  (vii) Operating a sales office.
  (viii) Warehousing of ingredients.
  (ix) Warehousing of finished products for distribution.
  (g) An  applicant  for  a  manufacturer's  license   shall   also   furnish 
information as to the formula and name or names of  each  prescription   drug 
that is  supplied  or  distributed  under  the   manufacturer's   label.   An 
up-to-date catalog that contains information required  by  this   subdivision 
may be supplied for this purpose.

  History:  1979 AC; 1980 AACS; 1992 AACS.


R  338.493e   Rescinded.

  History:  1979 AC; 1980 AACS; 1992 AACS; 1998-2000 AACS.


R  338.493f   Inspection of applicants and licensees.
  Rule 23f. The board or a board inspector may enter,  at  reasonable  times, 
any building, place, or facility which  is  owned  or   controlled   by   any 
applicant for, or holder of, a license to  make  an   inspection   which   is 
reasonably  necessary  to  enable  the  board  to   determine   whether   the 
applicant possesses the necessary qualifications and   competence   for   the 
license sought or to determine whether a license holder is,  and  has   been, 
complying with the acts and rules enforced by the   board.   The   inspection 
shall be carried out in a reasonable manner and shall  concern  only  matters 
relevant to the applicant's or license holder's  manufacturing  or  wholesale 
distributing of drugs saleable on prescription only.  The  inspection   shall 
not extend to any of the following information:
  (a) Financial data.
  (b) Sales data other than shipment data.
  (c) Pricing data.
  (d) Personnel data other than data as to the  qualifications  of  personnel 
performing functions subject to the acts and rules enforced by the  board.
  (e) Research data.

  History:  1979 AC; 1980 AACS.


R  338.493g   Persons to whom drugs may be sold or distributed.
  Rule  23g.  With  respect  to  prescription  drugs,   a   manufacturer   or 
wholesale distributor shall only supply, distribute, sell,  offer  for  sale, 
barter, or otherwise transfer drugs to persons who  are   licensed   by   the 
board or to persons who are licensed to prescribe drugs in this state.

  History:  1979 AC;  1980 AACS; 1992 AACS.


R  338.493h  Rescinded.

  History:  1979 AC; 1980 AACS.


R  338.494  Rescinded.

  History:  1979 AC; 1982 AACS; 1988 AACS.


R  338.495   Rescinded.

  History:  1979 AC; 1988 AACS; 1998-2000 AACS.


R  338.496   Rescinded.

  History:  1979 AC; 1998-2000 AACS.


R  338.497   Assessment of fines.
  Rule 1. (1) When a fine has been designated as an available sanction for  a 
violation of section 16221 to section 16226 of the code, in  the   course  of 
assessing a fine, a board  shall  take  into  consideration   the   following 
factors without limitation:
  (a) The extent to which the licensee obtained financial  benefit  from  any 
conduct comprising part of the violation found by the board.
  (b) The willfulness of the conduct found to be  part   of   the   violation 
determined by the board.
  (c) The public harm, actual or potential, caused by the violation  found by 
the board.
  (d) The cost  incurred  in  investigating  and   proceeding   against   the 
licensee.
  (2) A fine shall not exceed the sum  of  $5,000.00   for   each   violation 
found to have been committed by the licensee.

  History:  1981 AACS.

         PART 3. MEDICATION DRUG BOX EXCHANGE PROGRAMS FOR HOSPICE


R  338.500   Hospice emergency drug box.
  Rule 30. (1) A pharmacy  that  establishes  a   medication   box   exchange 
program for hospice emergency care services rendered   in   patients'   homes 
pursuant to the provisions of section 17746 of the   code   shall   establish 
drug boxes that are in compliance with this rule.   Before   providing   drug 
boxes for a hospice emergency care system, the pharmacist  in  charge   shall 
assure that the hospice has developed policies and  procedures  that  require 
all of the following:
  (a) Maintenance by the hospice of a drug box exchange  log  that   accounts 
for the hospice's receipt of the boxes from the   pharmacy,   assignment   of 
the boxes to registered nurses or physicians' assistants,   and   return   of 
the boxes to the pharmacy for restocking.
  (b) A procedure to assure that the drug boxes  are   inspected   at   least 
weekly to determine if they have expired or have been opened.
  (c) Procedures for the storage and control of a drug  box   while   it   is 
assigned to,  and  being  used  by,  a  registered   nurse   or   physician's 
assistant.
  (d)  A  procedure  for  implementing  the   hospice   medical    director's 
responsibility for assuring that prescriptions for drugs  removed  from   the 
drug boxes are obtained from the attending physicians.
  (2) A pharmacy shall stock drug  boxes  for  a   hospice   emergency   care 
system in accordance with the policies and  procedures   developed   by   the 
hospice and approved by the hospice medical director.
  (3) The drugs contained in each drug box  shall  be   listed   inside   the 
front  cover  of  the  box.  Each  box  shall  be  equipped   with   only   1 
nonreuseable, tamper-evident seal or sealing system which is  a  color   that 
designates that the box has not  been  opened   and   several   nonreuseable, 
tamper-evident seals or sealing systems which are a  different   color   that 
designates that the box has been opened.
  (4) The drug boxes shall be numbered. A permanent  record   of   all   drug 
boxes shall be maintained at the pharmacy.
  (5) A label that contains all of  the  following   information   shall   be 
attached to the drug box so that it is visible from  the   outside   of   the 
box:
  (a) The name and address of the pharmacy.
  (b) The name and address of the hospice.
  (c) The name of the pharmacist who last inspected and  restocked  the  drug 
box.
  (d) The date the drug box was last restocked.
  (e) The date on which the drug box must be returned to  the  pharmacy   for 
the replacement of expired drugs.
  (f) The number of the drug box.
  (6) After the drug box has been  stocked  and   labeled,   the   pharmacist 
shall seal it with the nonreuseable, tamper-evident seal  or  sealing  system 
which is the color that designates that the box has not been opened.
  (7) The drug  boxes  shall  be  kept  in   a   substantially   constructed, 
securely locked storage compartment when not under the  direct   control   of 
the pharmacist, registered nurse,  or  physician's   assistant.   The   boxes 
shall be  stored  under  conditions  that  will   maintain   the   stability, 
integrity,  and  effectiveness  of  the  drugs.  Access   to   the    storage 
compartment shall be limited to individuals who are  authorized  to  dispense 
drugs from a drug box on the  order  of  an  attending   physician   or   the 
hospice medical director.
  (8) The drug box shall remain sealed at all times, except when  in  use.
The drug box shall only be opened by a  registered   nurse   or   physician's 
assistant on the order of an attending physician or the  medical  director of 
the hospice. All drugs removed from the  box   shall   be   recorded   on   a 
medication use form. After completing the form, the   registered   nurse   or 
physician's assistant shall place the form in the box  and   seal   the   box 
with a nonreuseable, tamper-evident seal or  sealing  system   which   is   a 
color that designates that the box has been opened.
  (9) Each drug box under the control of the pharmacy shall  be  examined  at 
least weekly to assure that the seal which designates that the  box  has  not 
been opened is still intact and the expiration date has not been exceeded.
If the expiration date has been exceeded or the box has  been   opened,   the 
box shall be returned to the  pharmacy.  When   written   prescriptions   are 
required, the prescriptions of the attending physician  or  hospice   medical 
director shall accompany the drug boxes that have  been   opened   when   the 
drug boxes are returned to the pharmacy.
  (10) The  pharmacy  shall  maintain  a  permanent  record   of   drug   box 
exchanges on a drug box exchange log. The record shall contain  all  of   the 
following information:
  (a) The number of the box.
  (b) The name of the hospice to which the box is released.
  (c) The date the box is released to the hospice.
  (d) The name and signature of the pharmacist who releases the  box  to  the 
hospice.
  (e) The expiration date assigned.
  (f) The date the box is returned to the pharmacy for restocking.
  (g) The name and signature of the pharmacist who received   the   box   for 
restocking.
  (11) Upon return of the drug box to the pharmacy,  the   pharmacist   shall 
reconcile the drugs dispensed from the drug box with  the  prescriptions   of 
the attending physician or medical director of the  hospice.  The  pharmacist 
shall note that the prescriptions were dispensed from the hospice drug box on 
the back of the prescriptions. The prescriptions shall be filed in  the  same 
manner as other prescriptions are maintained at the pharmacy.

  History:  1995 AACS.