What are the differences between USP , , and ?

795> is for non-sterile preparations is for general sterile preparations is for hazardous drugs and chemotherapy

Lecture #1 - Intro Flashcards by HILLARY FU

What are is non-sterile compounding?

Mixing 2 manufactured products
Diluting a liquid
Adding a flavor
Preparation of an ointment, solution, etc.

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What is sterile compounding?

IV admixtures

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What is the purpose for compounding?

Provide individualized patient care
Unavailable dose or dosage form (ie. adjust strength)
Allergies to manufactured product (ie. reformulation)
Child or pet friendly (ie. unable to swallow)
Flavoring for palatability
Combination to make a final product

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Is adding flavoring to a conventionally manufactured product considered compounding?

Yes, flavoring may destabilize the product and affect BUD

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What is the BUD if flavoring is added to a manufactured product that DOES NOT contain a preservative?

14 days refrigerated

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What is the BUD if flavoring is added to a manufactured product that CONTAINS a preservative?

35 days under controlled room temp or refrigerated

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How many categories of compounding are there?

7 categories → 2 non-sterile, 3 sterile, 2 other misc

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What are the different categories of NON-STERILE compounding?

Category 1 - simple: mixing commercial products
Category 2 - complex: bulk drug or calc required (ie. using concentrated stock soln)

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What are the different categories of STERILE compounding?

Category 3 - Risk Level 1 = LOW (simple: 2-3 ingredients)
Category 4 - Risk Level 2 = MEDIUM (> 3 ingredients mixed)
Category 5 - Risk Level 3 = HIGH (complex: 1 or more non-sterile equipment or ingredient)

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What are the other different categories of compounding?

Category 6 - Radiopharmaceuticals
Category 7 - Veterinary

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What is the difference between USP and NF?

NF = National Formulary : contains excipient monographs
USP = U.S. Pharmacopeia : contains monographs for drugs, preparations, ingredients, and supplements

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What are General Chapters in USP-NF?

Description of tests and procedures referred to in monographs

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What are General Notices in USP-NF?

Provides definitions for terms used in monographs and info necessary to understand the monograph

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What are the differences between USP <795>, <797>, and <800>?

<795> is for non-sterile preparations
<797> is for general sterile preparations
<800> is for hazardous drugs and chemotherapy

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What are the USP <795> standards for compounding NON-STERILE medications? Why is it needed?

Reduce risks of contamination, infection, or incorrect dosing
-Accepted variability of +/- 10% of labeled strength
-Nasal sprays/irrigations are non-sterile preparations
-Gloves must be worn
-Clean before sanitizing (use lab-grade detergents designed to not leave residues)

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What are some legal restrictions on compounding?

Necessary compounding
Product can be compounded PRIOR to receiving Rx, BUT in limited quantities and based on history of receiving Rx
Only for individual patient

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What is the difference between compounding and manufacturing?

Compounding = creation of drug product that is not commercially available to meet unique needs of a patient
Manufacturing = producing a drug by extraction of substances

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What facilities are considered for the compounding environment?

Space (ie. air, light, temp, humidity)
Separate space for sterile preparation
Measures to prevent cross contamination
Water

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What are the different types of water used in compounding environment?

Portable Water = hand/equipment washing
Purified Water = non-sterile
Water for Injection / Bacteriostatic water (contains preservatives) = sterile

What factors need to be considered for compounding equipment?

Comply with USP standards (ie. design, size)
Material doesn’t absorb or react w/ ingredients
Equipment is inspected, cleaned, and maintained

What are the major NON-STERILE compounding equipment?

Mortar and pestle
Spatulas
Beakers
Graduated cylinder
Conical graduated cylinder

What is the purpose of using a beaker vs. graduated cylinder vs. conical graduate?

Beaker = mixing things together
Graduated cylinder = measuring volumes of NON-VISCOUS liquids
Conical graduate = measuring VISCOUS liquids and allows mixing of 2-faced systems

What is the minimum volume measurable for a graduated cylinder?

20% of the graduated cylinder volume

What are the types of stability?

Chemical, physical, microbiological, therapeutic, toxicological

Define the criteria for Chemical stability.

Chemical = API retains chemical INTEGRITY and labeled POTENCY

Define the criteria for Physical stability.

Physical = appearance, suspendability, uniformity, dissolution, palatability are retained

Define the criteria for Microbiological stability.

Microbiological = sterility + antimicrobial agent effectiveness is retained

Define the criteria for Therapeutic stability.

Therapeutic = unchanged therapeutic effect

Define the criteria for Toxicological stability.

Toxicological = no increase in toxicity

What are some antimicrobial preservatives?

-Benz -Cresol -Parabens -Cet Thimerosal, thymol, sorbic acid

What is the purpose of packaging?

Ensure stability of product throughout shelf life (protection) Convenience + compliance of product storage until consumption Identification Aesthetics

What is a packaging system?

Sum of components + materials that contain and protect the product

What are the different components in a packaging system?

Primary = direct contact w/ drug Secondary = direct contact w/ primary and provides additional protection Tertiary = direct contact w/ secondary Ancillary = contact w/ tertiary during transportation or storage of the product (ie. pallets, shrink wrap, bubble wrap) Associated = drug delivery utensil but is not stored w/ product for its entire shelf life (ie. spoons, syringes, applicators)

What is Tamper-Evident packaging? What is it used for?

Accessing requires obvious destruction of the seal Sterile OPHTHALMIC or OTIC use OTC drugs for sale

What is Reclosable packaging?

Capable of being reclosed w/ similar degree of security and dispense contents w/o loss of security (ie. child-resistance)

What is Non-Reclosable packaging?

Cannot be closed again (ie. blisters, sachets, strips)

What is Multi-dose container?

Holds sterile medication for PARENTERAL administration that meets ANTIMICROBIAL effectiveness testing

What is Single-dose container?

Holds sterile medication for PARENTERAL administration that is NOT REQUIRED to meet antimicrobial effectiveness testing

What is the BUD for a Multi-dose container?

28 days

What is a Hermetic container?

Impervious to air or any gas

What is a Tight container?

Protection from contamination from EFFLORESCENCE (lose water from exposure to air), DELIQUESCENCE (absorbs moisture from environment), evaporation

What is a Light-resistant container?

Protects product against effects of light

What factors affect package selection?

-Product (physical + chemical properties of API/excipients) -Market (pt, nurse, doctor) -Distribution system (retail or wholesale) -Manufacturing facilities

What is the difference between BUD and Expiration Date?

BUD = date after which a compounded preparation can't be used Expiration Date = date set my manufacturer at which they can't guarantee strength or safety of a drug

Can the BUD be exceeded?

Yes, with supporting and valid scientific stability info

How do you assign appropriate BUD for a compounded NON-STERILE product?

Contains NO water = 6 months Contains water + Oral = 14 days refrigerated Contained water + NO oral = 30 days