Midterm Flashcards
what are the two types of compounding?
community and hospital
what are the dosage forms found in community pharmacy?
non-parenterals
- solid
-liquid
- semi solids
what are solid dosage forms? which are more popular?
powders and capsules
capsules
what are liquid dosage forms?
solutions and suspensions
what are semi solid dosage forms? which are not used often?
ointments and suppositories
suppositories
What are the dosage forms found in hospital pharmacy?
parenteral
- iv
-mEq
-TPN
-radiopharmaceuticals
non parenteral
the practice of profession of pharmacy is defined as…
the preparing, compounding, preserving, or the dispensing of drugs, medicines, and therapeutic substances on the basis of prescriptions or other legal authorities
a “one man” show is aka
extemporaneous compounding
what are the differences between compounding and manufacturing?
- specific physician patient pharmacist relationship
- small quantity prepared
- condition of sale is different (in compounding its limited to specific prescription order, and manufacturing is for public at large)
T or F compounding is legal and there are no restrictions
F, legal but are restrictions
What are the legal restrictions of extemporaneous compounding? (7)
- one CANNOT compound commercial products
- prescription for compounding must be UNSOLICITED
- compounding of prescription is necessary
- composed product CANNOT be commercially available
- compounded product must be SUBSTANTIALLY DIFFERENT from the commercial product (no capsules if tablet dosage form is available)
-DO NOT compound for physicians office - one can compound a product prior to receiving prescription, but ONLY in limited quantity, and based on history of receiving prescriptions
T or F can a pharmacy advertise their compounding services?
T - legal for a pharmacist to advertise its compounding service (Was not in the past)
Who are authorized prescribers?
physicians, midwives, optometrists, veterinarians, dentists, nurse practitioners, podiatrists
What are some things to consider for the stability of compounding preparations?
primary packaging
sterility
stability criteria and beyond use dating
what are some things to consider for the facilities for compounding?
space
cross contamination
sterile preparations
water for hand and equipment washing
water for non sterile products
water for sterile products
Pharmacy area designated for compounding should have adequate _______ for orderly placement of equipment and materials to prevent mix up between ingredients, containers, labels, in process materials and finished preparations
SPACE
the compounding area should be designed, arranged, used, and maintained to prevent adventitious __________
cross contamination
compounding areas for ____________ should be separate and distinct from the compounding area for non sterile preparation
sterile preparations
for washing hands and equipment, use a ___ which meets the standards prescribed in Environmental Protection Agencys National Primary Drinking Water Regulation s(40 CFR Part 14)
portable water
___________ must be used when formulations indicate the inclusion of water and must be used for rinsing equipment and utensils
purified water
_____ ____ is used for injections as well as _____ _____
sterile water, bacteriostatic water
the ___________ part deals essentially with weights and balances, prescription balances, and volumetric apparatus
equipment
the equipment should be of ____ ___ and _______ for compounding
appropriate design and size
the equipment should be ____,_______,___, and ____ at appropriate intervals to ensure the accuracy and reliability of their performance
inspected, cleaned, maintained and validated
T or F 5 ml equipment is suitable for 1 ml injection
False
the USP defines stability as the extent to which a preparation retains, within specified limits, and throughout its period of storage and use, ____________________ that it possessed at the time of compounding
the same properties and characteristics
stability allows for what percentage of error
5 % officially
we allow up to 10%
90-100 but preferrably 95-105%
what are the types of stability?
chemical, physical, microbiological, therapeutic, toxicological
what is chemical stability?
each active ingredient retains its chemical integrity and labeled potency within the specified limits
what is physical stability?
the original physical properties including appearance, palatability, uniformity, dissolution, and suspendibility are retained
what is microbiological stability?
sterility or resistance to microbial growth is retained according to the specific requirement.
antimicrobial agents that are present retain effectiveness within the specified limits
what is therapeutic stability?
the therapeutic effect remains unchanged
what is toxicological stability?
there is no increase in toxicity occuring
Does color change affect stability? why?
yes, because although the potency of the drug is the same, the plasma profile and solubility changes which affects stabiliy
what is freezing point?
0 C or 32 F
T or F USP requires that compounded preparations should be packaged in containers which meet USP standards
T
the container is that which holds _____________ and is or may be in _______ contact with the compounded preparation
the compounded preparation, direct
T or F the closure is not part of the container
F
what are the four types of containers?
Light resistant containers
well closed containers
tight containers
hermetic containers
what color are light resistant containers?
amber
What are well closed containers made of?
plastic only
What are tight containers made of? they are the same color as ___________
plastic or glass
light resistant - amber
What range is freezer temp?
-25 to -10 C
-13 to 14 F
What range is cold temp?
2 and 8 C
36 and 46 F
What range is cool temp?
8 and 15 C
46 and 59 F
What range is room temp?
the temp in the prevailing working area
What range is controlled room temp?
20-25 C
68-77 F
What range is warm?
30-40C
86-104 F
What range is excessive heat?
above 40 C
above 104 F
What range is protect from freezing temp?
above 0 c
above 32 C
what range is refrigerator temp?
2-8 C
36-46 F
transfer of a viscous solution is _________ 100%, such as a _________
never, syrup
where do we store parenterals?
glass containers, because interaction with plastics
do we qs viscous or non viscous solutions?
non viscous only
how many ml in 1 fl oz?
29.57 ml
30 ml
the USP uses the term beyond use date as the date
after which a compounded preparation should not be used
the beyond use date is determined from
the date the preparation is compounded
What is the beyond use date for non aqueous formulations?
not later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier
what is the beyond use date for water containing oral formulations?
suspensions
not later than 14 days when stored at controlled cold temperatures
what is the beyond use date for water containing topical/dermal and mucosal liquid and semisolid formulations?
not later than 30 days
Chapter 1075 of the USP classifies pharmaceutical compounding into how many categories?
7
what is the reason for the classification of compounding?
the intent is to provide the compounding personnel an understanding when different forms of preparations are compoundedW
what category describes non sterile compounding?
category 1/2
what categories deal with compounding of sterile products and risk levels associated with them?
categories 3,4,5
What categories in compounding deal with radio pharmaceuticals and veterinary compounding?
category 6,7
What category is non sterile complex?
2
what category is non sterile simple?
1
What is an example of non sterile simple category of compounding?
mixing of two or more commercial products
what is an example of non sterile complex category of compounding?
compounding with the bulk drug substances oe when calculations are required
What are some reference resources for compounding?
US pharmacopeia / National Formulary
FDA regulations of hospital compounding
state regulations of compounding
national association of boards of pharmacy NABP
Can a pharmacy compound a product prior to receiving a prescription for it?
yes but only a small amount of the drug and has a history of compounding with a patient
Can a pharmacy compound drugs that were withdrawn or removed for the market for safety reasons?
no, we need to follow fda (phase 1-3 clinical trial is needed)
is it permissible for a practitioner to post date on a prescription for a controlled substance in lieu of issuing such a prescription n the date it is due?
No, it is generally not permissible for a practitioner to post-date a prescription for a controlled substance. Prescriptions should be dated on the day they are issued. Post-dating can lead to potential legal issues and is against the regulations governing controlled substances.
can a pharmacy compound drugs from bulk active ingredients that have never been approved for marketing in the USA?
In the U.S., pharmacies can compound drugs from bulk active ingredients that have not been approved for marketing, but there are specific regulations that apply. According to the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), compounding must comply with the following: quality standards, patient specific needs, state regulations, or risk of harm
can a pharmacy advertise its compounding services?
YES, but not the product itself
Can a pharmacy use commercial scale manufacturing equipment for compounding drug products?
small scale, not large, so no
