CHAPTER

 3:  Current  Good  Manufacturing   • Quality  control   –   regulatory   process   through   w/c  
Practices  &  Current  Good  Compounding   industry   measures   actual   quality   performance,  
Practices   compares  it  w/  standards  
  • Quality   control   unit   –   an   organizational   element  
Standards   for   Current   Good   Manufacturing   designated  by  a  firm  to  be  responsibilities  
• Quarantine  –  an  area  that  is  marked  set  aside  for  
Practice  
the  holding  of  components  prior  to  acceptance  
• cGMP   or   GMP   regulations   are   established   by  
• Representative  sample  –  a  sample  that  accurately  
FDA   to   ensure   that   minimum   standards   are   portrays  the  whole  
met  for  drug  product  quality  in  the  US   • Reprocessing   –   activity   where   the   finished  
• first   GMP   regulations   were   promulgated   in   product  is  recycled  
1963   under   Kefauver-­‐Harris   Drug   • Strength  –  concentration  of  drug  substance  
Amendments   • Verified   –   signed   by   a   second   individual   or  
• established   requirements   for   all   aspects   of   recorded  by  automated  equipment  
pharmaceutical  manufacture   • Validation   -­‐     documented   evidence     (equipment,  
• apply  to  domestic  &  foreign  suppliers   software,   controls   )   that   a   system   does   what   is  
purpose  to  do    
• ensure  compliance  by  inspecting  facilities  &  
• Process   validation   –   documented   evidence   (  
production    
sterilization)  
Code  of  Federal  Regulations  (CFR)  
• Validation   protocol   –   prospective   experimental  
• contains   requirements   for   the   CGMP   for   plan  to  produce  documented  evidence  
Finished  Pharmaceuticals    
• additional   cGMP   requirements   for   biologic   Organization  and  Personnel  
products   • Sections   of   regulation   that   deals   with   the  
• medicated  articles   responsibility   of   quality   control   unit,  
• medical  devices   employees  &  consultants    
common  terms   • QCU   –   have   the   authority   &   responsibility    
• active   ingredient   /   active   pharmaceutical   for   all   functions   that   may   affect   product  
ingredient   –   intended   to   furnish   pharmacologic   quality  
activity  /  direct  effect  in  the  body  
• Accept   /   reject   product   components,  
• batch   –   specific   quantity   of   a   drug   of   uniform  
product  specs.  Packaging,  labeling    
specified   quality   produced   accor.   To   a   single  
manufacturing  order   Buildings  and  Facilities  
• Batchwise   control   –   the   use   of   validated   in   • Design,   structural   features,   &   functional  
process  sampling  &  testing  methods   aspects  of  buildings  and  facilities  
• Certification   –   documented   testimony   by   • Water   quality,   security,   materials   used   for  
qualified  authorities   floors,   lighting,   quarantine   areas,   storage  
• Compliance   –   determination   through   inspection   areas,  temp,  ventilation,  etc.    
of  the  extent  to  w/c  it  is  in  acting  w/  standards  &   Equipment  
practice  
• Each   equipment   must   be   of   appropriate  
• Component   –   any   ingredient   used   in   the  
design  &  size  to  facilitate  (cleaning,  intended  
manufacture  of  a  drug  product  
use,  &  maintenance)    
• Drug   product   –   a   finished   form   that   contains  
Control  of  Components,  Containers,  Closures  
active   drug   &   inactive   ingredients;   form   that  
dose  not  contain  an  active  ingredient  (placebo)   • Written   procedures   describing   the   receipt,  
• Inactive  ingredient   -­‐     any   component   other   than   identification,   storage,   handling,   sampling,  
active  ingredient   approval   of   drug   components   must   be  
• Lot  –  a  batch  /  any  portion  of  a  batch  w/  uniform   maintained  
specified  quality     • Chemicals,   containers,   closures   must   meet  
• Lot   /   control   /   batch   number   –   any   distinctive   the  exact  specs.  Established  
combination   from   w/c   the   complete   history   of   • Each  lot  must  be  logged  in  w//  the  purchase  
manufacture  of  a  product  may  be  determined  
no.,  bill  of  lading,  name  &  supplier  info,  etc.  
• Master   record   –   record   w/   formulation,  
Production  &  process  controls  
specification,   manufacturing   procedures,   quality  
assurance  &  labeling  
• Written   procedures   are   required   to   ensure  
• Quality   assurance   –   provision   to   all   concerned   that   products   have   the   correct   identity,  
evidence  needed  to  establish  confidence   strength,  quality  &  purity  
• Quality  audit  –  documented  activity  performed  in   • Procedures,   process   &   equipment  
accordance   w/   established   procedures   to   verify   validation,   sample   testing,   time   &   date   of  
compliance  &  ensure  safety   operation,  product  ingredients  &  equipment    
 
 In-­‐process  controls  -­‐    two  types    
•  
o those   performed   by   production   Holding  &  Distribution  
personnel   at   the   time   of   operation   to   • Finished   products   must   be   stored   under  
ensure   that   the   machinery   is   producing   conditions  that  do  not  affect  product  quality  
output   w/in   control   limits   (tablet   size,   until  released  by  the  QCU  
hardness)   Laboratory  Controls  
o those   performed   by   quality   control   •  Are   requirements   for   the   establishment   of  
laboratory   personnel   to   ensure   &   conformance   to   written   specs,   standards,  
compliance  w/  all  product  specifications   sampling  plans,  test  procedures  
(  tablet  content  ,  dissolution  )   • Provisions   for   sample   size,   test   intervals,  
  sample   storage,   stability   testing   &   special  
Packaging  &  Labeling  Control   testing  for  certain  dosage  forms  
• written   procedures   are   required   for   the   Records  &  Reports  
receipt,   identification,   storage,   handling,   • Production,   control,   &   distribution   records  
sampling   &   testing   ,   issuance   of   label   must  be  maintained  for  at  least  a  year  ff  the  
materials   expiration  date  
• strength,   dosage   form,   &   quantity   of   • Production,   control,   packaging,   labeling   &  
content-­‐must   be   stored   separately   w/   distribution   accomplished   &   approved   by  
identification   QCU  
• all  materials  must  be  withheld  for  use  in  the   Returned  &  Salvaged  Drug  Products  
packaging   &   labeling   of   product   until   • Returned  products  (from  wholesalers)  must  
approved  by  QCU   be  identified  by  lot  number  
• there   must   be   dedication   of   labeling   &   • Salvaged  products  must  meet  specifications  
packaging  lines  to  each  different  strength  of   • Records  for  returned  products  must  include  
each  diff.  drug  product   date   &   reasons,   procedures   employed   for  
• use   of   appro.   Electronic   equipment   for   holding,  testing,  &  product’s  disposition  
100%  examination  for  correct  labeling     Information  Technology  &  Automation    
• must   contain   expiration   date   &   production   • Not  part  of  CGMP  
batch  /  lot  number   • Effective   deployment   of   info.   Technologies  
o Expiration  Dating   can   enhance   pharmaceutical   process  
-­‐   to   assure   that   drug   product   meets   development,   production   efficiencies,  
applicable  standards  of  identity,  strength,  quality   product  quality  &  regulatory  compliance  
&  purity  at  the  time  of  use   • These   integrated   systems   support   GMP  
-­‐   exempt   from   these   are   homeopathic  
compliance,   process   validation,   resource  
drugs,   allergenic   extracts     &   investigational  
management  &  cost  control  
drugs   (meet   the   standards   during   clinical  
studies)   • Laboratory   robotics   –   provides   automation  
o Tamper-­‐Evident  Packaging     in   sample   preparation,   handling,   wet  
-­‐ (nov.5,1982)   FDA   published   chemistry  procedures,  lab.  Process  controls;  
regulations   on   tamper-­‐resistant   product  handling  –  sampling,  analysis,  tablet  
packaging  in  the  Federal  Register   content  uniformity  &  dissolution  
-­‐ promulgated   after   criminal   tampering    
w/   OTC   drugs   (Cyanide   was   placed   in   Additional  cGMP  Regulatory  Requiremnts  
acetaminophen  capsules)    
-­‐ improve   security   &   assure   safety   &  
Active   Pharmaceutical   Ingredients   &  
effectiveness  
Pharmaceutical  Excipients  
-­‐ all   OTC   drugs   (for   retail   sale)   are  
required;   except:   dentifrices,   • Manufacture   of   APIs   comes   under   aegis   of  
dermatological,  insulin,  throat  lozenges   cGMP  regulations  
-­‐ exemption  from  Tamper-­‐Evident  Rule  –   • Guide   to   the   Inspection   of   Bulk  
distributed   drugs   to   hospitals,   nursing   Pharmaceutical   Chemicals   –   identifies   the  
homes   &   health   care   clinics   for   inspection   program   for   manufacture   of  
institutional  use   chem.  Components  to  assure  standards  
-­‐ “tamper-­‐evident  package”  –  one  having   • Compliance   w/   cGMPs   is   a   critical   part   of  
1/more   indicators/barriers   to   entry,   if  
FDA’s   preapproval   inspection   program   for  
missing   can   reasonably   be   expected   to  
NDA  &  ANDA  
provide   evidence   that   tampering   has  
occurred   • Application  of  Regulation  includes:  
  o Specifications  &  analytical  method  
o Critical  chemical  reaction  steps  
 o Handling   of   chem.   Intermediates   &   Current  Good  Compounding  Practices  
solvents   • Reasons   for   the   increase   in   preparing  
o Effect  of  scale-­‐up  of  chem.  Batches   patient-­‐specific  medications:  
o Quality  of  water  systems   o Many   dosage   strengths   are   not  
o Analytical  methods  to  detect  impurities  
commercially  available  
o Stability   studies   of   bulk   pharmaceutical  
o Dosage   forms   (suppositories,   oral   liquids,  
chemical  
topicals)  are  not  commercially  available  
 
o Many   patients   are   allergic   to   excipients   in  
Clinical  Trial  Materials  
commercially  available  products  
• Must  be  produced  in  conformance  w/  cGMP   o Children’s   medications   must   be   prepared  
regulations;   as  liquids  &  flavored  
•  applies   to   APIs&   investigational   drug   o Some   medications   are   not   stable   &  
products   suitable  to  be  manufactured  
• during   pre-­‐clinical   testing   (Phase   1   &   2)   o Many   physicians   desire   to   deliver  
regulatory   requirements   are   applied   w/   products  in  innovative  ways  
flexibility   o Most   products   are   not   available   for  
• Phase  3  –  meet  all  regulatory  requirements,   veterinary  patients  
process   optimization   is   demonstrated   to   o Home   health   care   resulted   in   many  
FDA   by   production   of   at   least   1/10   of   a   community  pharmacies  
commercial-­‐size  batch     o Hospice   care   has   now   resulted   in   new  
  approaches  to  pain  management  
Biologics   o Pharmacists   can   compound   many   drugs  
that   are   reported   in   the   literature   but   not  
• Nature   of   blood,   bacterial,   viral   products  
yet  manufactured  
requires  specific  additional  mandates  
USP-­‐NF  
 
• Chapters   related   to   compounding   were  
Medical  Devices  
developed  in  1996  
• Follow   a   path   for   FDA   approval   that  
• First   of   the   compounding   monographs  
resembles  pharmaceuticals  
became  official  in  1998  
• Clinical   investigation,   adverse   events  
National  Association  of  Boards  of  Pharmacy  
reports  
• “The   Good   Compounding   Practices  
• Intraocular  lenses,  hearing  aids,  intrauterine  
Applicable   to   State-­‐Licensed   Pharmacists”  
devices,   cardiac   pacemakers,   catheters,  
developed   by   the   Nat.   Assoc.   of   Boards   of  
dental  xray,  surgical  gloves,  etc.    
Pharmacy  discuss  8  recommendation  
 
o Subpart  A:  General  Provisions      
Noncompliance  w/  cGMP  Regulations  
-­‐ provides  2  important  definitions  
• Noncompliance   during   premarket   approval  
-­‐ Compounding   –   means   the   prep.   Of  
inspection  =  delay  of  approval    
components   into   a   drug   product   (a)   as  
• In   worst   cases   FDA   removes   violative   the   result   of   a   Practitioner’s   Rx   Drug  
products,   withdraw   approval   &   restrict   Order,  or  (b)  for  the  purpose  of,  research,  
further  application   teaching,  &  chemical  analysis  and  not  for  
  sale  /  dispensing  
cGMP   Requirements   for   Manufacturing   in   -­‐ Manufacturing   –  means   the   production,  
Pharmacists   prep.,   propagation,   conversion,   /  
• Includes   hospital   pharmacies,   chain   processing  of  a  Drug  or  Device  
pharmacy,   indiv.   Pharmacists   for   o Subpart  B:  Organization  &  Personnel  
distribution   to   retailers   (that   repackage   -­‐ Responsibilities   of   pharmacist   &  
drug  products)   personnel  engaged  in  compounding  
o Subpart  C:  Drug  Compounding  Facilities  
• Pharmaceutical  manufacturing  -­‐     large   scale  
-­‐ Special   attention   is   required   for  
production  of  drugs  for  distribution  /  sale  
radiopharmaceuticals   &   products  
• Compounding   -­‐     professional   prep.   Of   requiring  special  precautions  
prescriptions  for  specific  patients   o Subpart  D:  Equipment  
• Affirmed   by   provision   in   Food   &   Drug   -­‐ Must  be  of  appropriate  design  &  size  
Administration  Modernization  Act  (1997)   o Subpart   E:   Control   of   Components   and  
  Drug  Product  Containers  &  Closures  
  -­‐ Packaging  requirements  
   
   
 o Subpart  F:  Drug  Compounding  Controls   o HERMETIC  CONTAINER  
-­‐ Written   procedures   to   ensure   the   -­‐
Impervious   to   air   or   any   other   gas  
products’  identity,  strength,    &  quality   under   ordinary   of   customary  
o Subpart   G:   Labeling   Control   of   Excess   conditions  
Products  &  Records  &  Reports   o STERILE  HERMETIC  CONTAINER  
  -­‐ Holds   preparations   intended   for  
Packaging,   Labeling,   &   Storage   of   injection   or   parenteral  
Pharmaceuticals   administration  
• Standards  for  packaging  are  contained  in  the   o SINGLE-­‐DOSE  CONTAINER  
cGMP   section   of   the   Code   of   Federal   -­‐ Holds  a  quantity  of  drug  intended  for  
Regulations;   USP-­‐NF;   &   FDA’s   Guideline   for   a  single  use  &  cannot  be  resealed  
Submitting  Documentation  for  Packaging  for   -­‐ Include   fusion-­‐sealed   ampuls   &   pre-­‐
Human  Drugs  &  Biologics   filled  syringes  &  cartridges  
• During   initial   stages   of   clinical   o MULTIPLE-­‐DOSE  CONTAINER  (vials)  
investigations,   packaging   must   be   shown   for   -­‐ Hermetic   container   that   permits  
adequate  drug  stability   withdrawal   of   successive   portions   of  
• During   final   stages,   physical   &   chemical   the   contents   w/o   changing   the  
characteristics   of   the   container   must   be   strength   or   endangering   the   quality  
developed  to  ensure  drug’s  stability     of  the  remaining  portion    
  • Tablets,   capsules,   oral   liquids   may   be  
Containers   packaged  in  single-­‐unit  or  multiple-­‐units  
• among  the  qualities  tested  are:   • Single-­‐unit  package  =  UNIT-­‐DOSE  PACKAGE  
o physicochemical  prop   o  Many  find  single-­‐unit  packages  convenient  
o light  transmission  for  glass  /  plastic   and  sanitary;  
o drug  compatibility   o positive  identification  of  dosage  unit  
o leaching  /  migration   o reduction  of  medication  errors  
o vapor  transmission  for  plastics   • Many  hospitals  with  unit-­‐dose  systems  
o moisture  barrier   strip-­‐package  oral  solids  
o toxicity  for  plastics  
o Seals  solid  dosage  forms  into  4-­‐sided  
o valve,   actuator,   metered   dose,   particle   size,  
pouches  &  imprints  dose  identification  
spray  charac.,  leaks  for  aerosols  
o sterility  &  permeation  for  parenteral  
on  each  package  (50  pcs  per  minute)  
o drug  stability   o Foil,  paper,  plastic,  cellophane  
• (according   to   USP)   –   container   is   “that   w/c   o Clear  plastic  or  aluminum  blister  wells  (most  
popular  method  of  SUP)  
HOLDS  the  article  and  is  or  may  be  in  direct  
contact  w/  the  article”   • Oral  liquids  –  may  be  dispensed  in  single  
units  in  paper,  plastic  or  foil  cups  
• Immediate  container   –   that   w/w   is   in   direct  
o Hospitals  –  disposable  plastic  oral  
with  the  article  AT  ALL  TIMES  
syringes  (for  children’s  use)  
• Closure  –  part  of  the  container  
• Light-­‐resistant  containers  
• Must   not   interact   physically   or   chemically  
o Good  quality  of  amber  glass  or  a  light-­‐
with  the  drug  &  alter  its  strength  &  purity  
resistant  opaque  plastic  
• USP  classifies  containers  
o Ultraviolet  absorbers  –  may  be  added  to  
o WELL-­‐CLOSED  CONTAINER  
plastic  to  decrease  the  transmission  of  
-­‐ It   protects   the   contents   from  
short  UV  rays  
extraneous   solids   and   from   loss   of  
o must  meet  USP  standards  that  define  the  
the   article   under   ordinary  
limit  of  light  transmission  at  any  
conditions   of   handling,   shipment   &  
wavelength  bet.  290-­‐450  nm.  
storage  
o Coextruded  two-­‐layer  high-­‐density  
o TIGHT  CONTAINER  
polyethylene  bottle    
-­‐ Protects   the   contents   from  
-­‐ recent  innovation  in  plastic;  
contamination   by   extraneous  
-­‐ inner  layer  of  black  polyeth.  &  outer  
liquids,   solids,   vapor;   from   loss   of   white  polyeht.  
article;   from   efflorescence,   -­‐ Provides  light  resistance  &  moisture  
deliquescence  or  evaporation  under   protection  (tablets  &  capsules)  
ordinary  /  customary  conditions;      
   
   
   
   o Amounts  &  type  of  plasticizers,  filler,  
• Glass  (glass  types)   lubricants,  pigments,  increase  in  temp.  &  
o TYPE  I  –  Highly  resistant  borosilicate  glass;     Pressure  
  most  resistant   • Moisture  can  damage  the  stability  of  the  
o TYPE  II  –  treated  soda  lime  glass   product  
o TYPE  III  –  soda  lime  glass   o Pharmaceutical  adjuncts    
o TYPE  NP  –  general  purpose  soda  lime  glass   -­‐  Diluents,  binders  &  disintegrating  
o Type  I-­‐III  =  parenteral  products   agents  (in  tablets)  are  affected  by  
Degree  of  water  attack  is  determined  by  
o moisture  
the  amount  of  alkali  released  from  glass   -­‐ carbohydrates;  natural  /  synthetic  
• Contemporary  plastic  packaging     gums;  HYGROSCOPICITY  
o Modern  compact-­‐type  container  used  for   o aspirin,  nitroglycerin    
oral  contraceptives   • Developed  high-­‐barrier  packaging  
o Plastic  bags  for  IV  fluids,  ointment  tubes,   o Provide  added  protection  
plastic  film-­‐protected  suppositories   o Meets  the  drug  requirements  by  
o The  widespread  use  arose  from:   International  Committee  on  
-­‐ Advantage  in  lightness  of  weight  &  
Harmonization  
resistant  to  impact  (reduces  
-­‐ Testing  of  packaged  prod.  For  a  min.  
transportation  costs  &  container  
of  12  months  at  25C  at  60%  humidity    
damage)  
• Desiccant  protectants  (silica  gels)  are  
-­‐ Versatility  in  container  design  
-­‐ Consumer  preference  for  plastic   added  for  protection  against  moisture  
squeeze  bottles  (  ophthalmic,  sprays,   • Greater  degree  of  degradation  when  placed  
lotions)     in  plastic  than  in  glass  (because  of  being  
-­‐ Popularity  of  blister  packaging  &  unit-­‐ constantly  exposed  to  oxygen  from  the  
dose  dispensing   replenished  sir  supply  entering  container)  
o The  placement  of  other  functional  grps.   o Liquid  pharmaceuticals  packaged  in  
On  the  chain  of  polyethylene  or  added   permeable  plastic  may  lose  drug  molecules  
to  polymers  can  give  alterations  to  the   or  solvent  
final  plastic  material   • Leaching  –  term  used  to  describe  the  
-­‐
Polyethylene  terephthalate  (PET)   movement  of  components  of  a  container  
-­‐
Amorphous  polyethylene  terephthalate   into  the  contents  
glycol  (APET)   o  Polymer  additives  –  cpds  leached  from  
-­‐ Polyethylene  terephthalate  glycol   plastic  containers  (  plasticizers,  stabilizers,  
(PETG)   antioxidants  )  
-­‐ APET  &  PETG  have  excellent   o occurs  predominantly  when  liquids  or  
transparency  and  luster  &  can  be   semisolids  are  packaged  in  plastic  
sterilized  w/  gamma  radiation   o may  be  influenced  by  temp.,  excess  
o Problems  encountered:   agitation  of  filled  container,  solubilizing  
-­‐ Permeability  to    atmospheric  oxygen  &   effect  of  liquid  
moisture  vapor   o leached  material  poses  a  health  hazard  
-­‐ Leaching  of  constituents  of  container  to   • Sorption  –  term  used  to  indicate  the  binding  
internal  contents   of  molecules  to  polymer  materials,  includes  
-­‐ Absorption  of  drugs  from  container’s   both  adsorption  and  absorption  
contents   o Occurs  through  chem  /  phy.  Means  due  to  
-­‐ Transmission  of  light   chemical  structure  of  the  solute  molecules  
-­‐ Alteration  of  container  upon  storage   &  polymer  
o Agents  added  to  alter  the  properties  of   o The  pH  may  influence  the  sorption  
plastic:   tendency  of  a  particular  solute  
-­‐ Plasticizer;  stabilizer;  antioxidants   o Plastic  materials  w/  polar  grp.  Are  prone  to  
-­‐ Antistatic  agents;  antifungal;  colorants   sorption  
• Permeability  –  process  of  soln  &  diffusion,   o Depends  on  penetration  or  diffusion  of  a  
with  the  penetrant  dissolving  in  plastic  on   solute  into  plastic;  or  solvent  
one  side  &  diffusing  on  the  other   o May  be  initiated  by  the  adsorption  of  a  
o Should  not  be  confused  w/  POROSITY  in   solute  to  the  inner  surface  of  a  plastic  
w/c  minute  holes  or  cracks  allow  gas  or   o Methylparaben  –  may  be  sorbed  to  some  
moisture  vapor  to  move  directly   type  of  plastics;  ê  concentration  &  potency  
• Permeability  of  a  plastic  is  a  function  of    
 
several  factors  including:  
 
o The  nature  of  polymer  
 
Child-­‐Resistant  &  Adult-­‐Senior  Use  Packaging   Over  the  Counter  Labeling  
• US  Consumer  Product  Safety  Commission   • FDA  now  require  standard  format  for  OTC  
(1972)  through  Consumer  Prod.  Safety  Act   labeling    
o To  protect  against  unreasonable  risks   • “drug  facts”  must  appear:  
of  injuries  assoc.  w/  consumer   o product’s  active  ingredient  &  amount  
products   o purpose  of  product  
o indications  
o Regulate  sales  &  manufacture   o specific  warnings  
o All  legend  drugs  for  oral  use  must  be   o dosage  instructions  
dispensed  having  a  child-­‐resistant   o product’s  inactive  ingredients  
closure      
-­‐ Difficult  for  children  under  5  yrs  to   Dietary  Supplement  Labeling  
open  or  obtain  a  harmful  amount;  not   • products  intended  to  supplement  the  diet  
difficult  for  normal  adults  to  use   that  bear  one  /  more  of  the  ff:  
o Exemptions  include  certain  cardiac   o vitamin  
drugs  (SL  tab  of  nitroglycerin)  for   o mineral  
patient’s  immediate  access;  OTC  drugs   o herb  /  botanical  
o amino  acid  
for  one  package  size    
o dietary  substance  
-­‐  “Package  not  child-­‐resistant”   o concentrate,  metabolite,  constituent  
o 4  basic  designs   • Dietary  Supplement  Health  Education  Act  
-­‐ align  the  arrows   o Manufacturers  are  permitted  to  make  
-­‐ press  down  &  turn  
label  claims  
-­‐ squeeze  &  turn  
o Disallows  disease  claims  that  it  cures  &  
-­‐ latch  top    
prevent  a  disease  
 
• USP  Dietary  Supplements  Compendium  
Compliance  Packaging  
• misunderstanding  of  schedule  
o A  collection  of  standards  designed  to  
• confusion  –  multiple  medications   assist  dietary  supplement  
• forgetfulness   manufacturers  in  providing  quality  
• discontinuation  -­‐  feeling  of  well-­‐being   products  
• Pharmacists  &  manufacturers  devised   o Contains  quality  specifications  
techniques,  reminder  aids,  compliance   o General  &  regulatory  information  
packages  &  devices    
• Oral  contraceptive  compact  –  earliest   Storage  
packages  developed     • Cold:  any  temp  not  exceeding  8°C  (46F);  
• Methylprednisolone  “dose  pack”   Refrigerator:  2°C  -­‐  8°C  (36  F-­‐  46  F);          
  Freezer:  -­‐25°C  to  -­‐10°C  (-­‐13  F  to  14  F)  
Labeling   • Cool:  temp.  between  8°C  –  15°C  (46  –  59  F)  
• Accor.  To  federal  regulations;  labeling   • Room  temperature:  temp  prevailing  in  
includes  labels  on  containers;    inserts;   working  area,  20°C  –  25°C  (68  F  –  77  F)  and  
company  literature,  ads,  brochures,   from  15°C  –  30°C  (59  F  –  86  F)  
booklets,  exhibits,  film  strips,  etc.  related  to   • Warm:  30°C  –  40°C  (86  F  –  104  F)  
the  product   • Excessive  Heat:  above  40°C  (104  F)  
  • Protection  from  freezing  
Manufacturer’s  Label    
• Nonprop.  Name     Package  insert   Transportation  
• Manufacturer     Storage  instruction   • Stability  protection  during  transportation  
• Amount  of  each  drug   NDC  identification  
• Temperature  &  humidity  variation  
• Dosage  form     Lot  number  
• Net  amount  of  drug   Expiration  date  
 
• “Rx  only”     Schedule  
 
Prescription  Label    
• Name  &  address  of  pharmacy  
• Serial  no.  of  prescription  
• Date  of  prescription  /  filling  
• Name  of  prescriber  &  patient  
• Directions  for  use  
• **address  of  pt.  
• name  of  dispensing  pharmacist  
• Drug’s  name,  strength  &  information