Term
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Definition
| combine, mix, alter a drug |
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Term
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Definition
1. Not available commercially
2. Avoid certain ingredients
3. Flavor
4. Drug Shortage |
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Term
| What 3 organization are involved in quality ingredients? |
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Definition
1. USP
2. NF (Nat. Form)
3. FCC (Food Chem. Codex) |
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Term
| All ingredients should meet these 3 reqs |
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Definition
1. manufactured in n FDA approve facility
2. Exp date
3. batch number |
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Term
| 3 things that cannot be compounded |
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Definition
1. Drugs removed from market
2. large quantities of comm. avail drug
3. drugs with demonstratable differences |
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Term
| Compounding pharmacists are regulated by __________ while manufacturers are regulated by _______ |
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Definition
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Term
| Fed law 21 U.S.C 353a says compounded drugs can be exempt from what three reqs if certain conditions are met? |
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Definition
1. cGMP
2. Labeling
3. Approval |
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Term
| What conditions must be met to be exempt from the reqs described in U.S.C. 353a |
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Definition
1. for patient with rx
2. liscense pharmacists
3. quality ingredients
4. cannot be drug removed from mkt
5. no comm copies
6. no demonstratabel diffs
7. state has mou with fda |
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Term
| Drug quality and security act of 2013 |
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Definition
response to necc
Title 1 compounding quality act
title 2 supply chain sec. act |
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Term
| Reqs if voluntarily registering as an outsourcing fac. with fda |
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Definition
1. reports every 6 mo
2. subject to inspection |
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Term
| advantages if voluntarily registering as an outsourcing fac. with fda |
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Definition
exempt from:
1.label reqs
2. filling NDA/ADA
3. drug tracing (title 2)
4. rx not required |
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Term
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Definition
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Term
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Definition
| Good compounding Practices; use in addition to 795 |
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Term
| Would the FDA take action if vet or pharm compounded product for animals with bulk drug subst? |
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Definition
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Term
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Definition
1. no bulk drugs
2. withdraw time req
3. list of prohibited drugs |
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Term
| Who else has good compounding procdures aside from usp? |
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Definition
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Term
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Definition
dissolve in solvent
evaporate
fine crystal product |
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Term
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Definition
| mix powder with small amount of non-soluble liquid |
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Term
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Definition
| final product has lower boiling point than ingredients |
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Term
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Definition
used in creams and ointments;
a liquid that is:
- viscous
- low surface tension |
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Term
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Definition
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Term
| What is more accurate conical or cylindrical? |
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Definition
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Term
| grad cyls are measured at the _________ of the meniscus while syringes are measured at the ______ of the plunger |
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Definition
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Term
Beyond used dates of:
1. Non-aqueous
2. aqueous oral
3. aqueous topical |
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Definition
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Term
| 5 pieces of record keeping |
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Definition
1. Master Formulation
2. Compounding record
3. SOP
4. MSDS
5. Animal compounding |
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Term
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Definition
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Term
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Definition
covert desired active ing. amount to grains subtract resulting answer from 7 to determine cap size
-3 = 000
-2 = 00
-1 or 0 = 0 |
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Term
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Definition
subtract capsule size from 6
multiple ans X 65 to convert from grains
answer = cap capacity in mg |
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Term
|
Definition
semi-solid prep.
Ext. or Mucous memb. app.
<20% w/w solids
Soften at body temp |
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Term
|
Definition
Semisolid prep.
Cosmetically aesthetically appealing
o-in-w or w-in-o emulsion |
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Term
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Definition
Internal listed first
Ex: o-in-w = int. oil; ext. water |
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Term
|
Definition
Semisolid
Contains: suspension, particle, or organic molecule that is inpenetrated by liquid |
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Term
|
Definition
| water , alcohol, gelling agnt |
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Term
|
Definition
| hydro gel + hydrocarbon base |
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Term
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Definition
| extensive cross-linking/entanglement when dissolved/dispersed in a liquid |
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Term
|
Definition
Protect
Hydrate
Medication vehicle |
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Term
|
Definition
no penetration
not for liquid ingredients
not water-washable
ex: Vaseline |
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Term
| Absorption base - anhydrous |
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Definition
absorbs water
penetrates one layer, but poor drug release
not water washable
hydrophobic drugs |
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Term
| Absorption base - w-in-oil |
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Definition
multi-layer penetration
contains water
absorbs water (microbial growth-30d BUD)
Good drug release
Ex: Cream |
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Term
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Definition
Contains water(microbial - 30d BUD)
Absorbs water
fair-good drug release
can dry out |
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Term
|
Definition
Can be IRRITATING
Stability problems with hydrolysis drugs
Good drug release |
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Term
| Can you change the base if it is specified in the Rx? |
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Definition
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Term
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Definition
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Term
|
Definition
Two phase
Particles
Transdermal useage |
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Term
| T/F try to use an ingredient in the recipe as a levigating agent |
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Definition
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Term
| Rectal supp. phys desscription |
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Definition
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Term
| Vag supp. psy description |
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Definition
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Term
|
Definition
5mm diameter
Male: 4g
Female: 2g |
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Term
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Definition
non-toxic/irritating
multi-drug-compatiability
Stable storeage
Dissolves/melt when placed |
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Term
| T/F Cocoa butter supp base should only be used rectally |
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Definition
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Term
| How to store cocoa butter |
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Definition
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Term
| T/F Polyethylene glycol supp base is mostly used for vag |
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Definition
| T; causes urge to poop if put rectally |
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Term
| T/F PEG supp base can be used for hydrophilic and phobic drugs |
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Definition
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Term
| PEG supp base is incompatible with |
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Definition
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Term
| Glyceerinated gelatin supp bases are commonly used for _____________ supp |
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Definition
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Term
| How are glycerinated gelatin bases stored? |
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Definition
|
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Term
| two methods of making supp and lozenges? |
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Definition
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Term
| When using a Mfg dosage form in compounding BUD is: |
|
Definition
which ever comes first:
< 25% of MFG exp or 6mo ...30 days if aqueous |
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Term
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Definition
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Term
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Definition
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Term
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Definition
sugar or syrup base
heat and molds needed to make
Ex: lolipop |
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Term
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Definition
Fatty base
can also be hand molded |
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Term
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Definition
glycerinated/gelatin base
time intensive to make |
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Term
|
Definition
Prolonged contact with tissue needed
difficulty swallowing typical dosage
local and systemic effects |
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