Pharmacy compounding - Importance, Non sterile compounding and Sterile compounding, Regulations of US Pharmacoepia, Compounded Products For any suggestions and questions regarding this ppt please comment below.

1. Pharmacy Compounding
“Meeting Unique Physician and Patient
Needs”
Romit K. Subba
B.Pharmacy, Final Year

2. • Compounding is the method of preparing customized
medications to help meet unique practitioner and patient needs.
• Compounding includes the preparation, mixing, assembling,
packaging or labeling of a drug in response to a prescription
written by a licensed practitioner.

3. • Compounding pharmacists focus on providing innovative patient
care. This may involve compounding eye drops in a sterile lab,
preparing medications for animals, or providing bio-identical hormone
replacement therapy.
• Also known as a problem-solver, a compounding pharmacist’s ultimate
goal in preparing customized medications is to help the practitioner
and patient achieve a more positive therapeutic outcome.

4. Why to Compound?
• Pediatric patients requiring diluted adult strengths of drugs.
• Patients needing an oral solution or suspension of a
product that is only available in another form.
• Patients with sensitivity to dyes, preservatives, or flavoring
agents found in commercial formulations.
• Dermatological formulations with fortified (strengthened)
or diluted concentrations of commercially available
products.
• Specialized dosages for therapeutic drug monitoring.
• Care for hospice patients in pain management.

5. Related USP Chapters
-USP has developed standards to enhance patient safety and
protect pharmacists from litigation.
• Chapter 795 - called Pharmaceutical Compounding -
Nonsterile Preparations
• Chapter 797- called Pharmaceutical Compounding - Sterile
Preparations,
• Other Chapters
Containers 661
Good Compounding Practices 1075
Pharmaceutical Stability 1150
Pharmaceutical Dosage Forms 1151
*Chapters numbered below 1000 are legally enforceable by the FDA.

6. Non-sterile Compounding
• Used in the preparation of commercially unavailable drug
formulations from bulk ingredients in the community
pharmacy.
• Environment: General Facility Requirements:
– Adequate storage and space
– Appropriately maintained equipment
– High cleanliness
– Free of dust
– Must have an eyewash station
– Physically separate from the dispensing pharmacy

7. • Quality of ingredients:- only USP or National Formulary
(NF) pharmaceutical-grade.
• Sources for Bulk Ingredients: The source for ingredients
depends on cost, quality, and purity of product.
• Bulk ingredients are typically stored in tight, light resistant
containers at room temp.
• The technician should check expiration dates, the source of
the ingredients, and the NDC number
• Controlled substance inventory must be in locked storage
accessible only to the pharmacist.

8. • Beyond-use dates- Used for compounded preparations
only and are generally in the order off “days” or “months.”
– Refrigerated aqueous solution or suspension has a
beyond-use dating of 14-30 days.
– Solids, like tablets and capsules and non-aqueous
solutions have a beyond-use date of 6 months or less.
– All other formulations have a 30-day beyond-use date
or duration of therapy, whichever date is earlier.

9. • Non-sterile Compounding Attire:
– Clean protective clothing
– Hairnet
– Long lab coat
– Disposable gloves
– Eye goggles
– Masks
– Double gowning
– Hand washing – liquid antimicrobial soap, minimum of
15 seconds

10. Equipment for Weighing,
Measuring, and Compounding
• Measuring: Balance, weights, weighing containers,
volumetric glassware (graduates, pipettes, flasks,
syringes).
• Mixing: Beakers, Conical flasks, spatulas, funnels, sieves,
mortar and pestle.
• Molding: Hot plates, suppository molds, capsule shells,
ointment slabs.
• Packaging: Prescription bottles, capsule vials, suppository
boxes, ointment jars.

11. • Compounded capsules: Medications formulated in capsules enable
the patient to get the exact dosage needed, while avoiding unwanted
dyes and fillers.
• Cellulose capsules are available, and are dye-free
• Oral liquid: Preparing medications in a liquid form allows the patient
who can’t swallow pills to get the appropriate medicine in a vast range
of flavors, such as tutti-frutti or vanilla butternut.

12. • Medicated Lollipops:
Local effects: Anesthetic ♦ Antifungal ♦ Antiviral ♦ Anti-inflammatory
Saliva stimulant ♦ Healing agents
Systemic effects:Anti-anxiety ♦ Antipyretic, Analgesic – Narcotic or
Non-narcotic
Troches RDT

13. Suppositories Nasal and otic preparations
• Rectal rocket: Designed to get the drug(s) to the site of action
• Holds drug(s) at sight of action for an extended period of time (air
vent included)
• Anti-inflammatory agents • Anesthetic agents
• Steroidal agents

14. • Topical Preparation:
Transdermal gels and creams are specially prepared
emulsions that penetrate the skin and get medications into
the bloodstream quickly
• Effective dosage form for the patient who can’t swallow
• May be used for systemic or local effects
• Other topical dosage forms include lip balms, sprays,
foams, and more!

15. The Compounding Process
• Each step of the compounding process is checked by the
pharmacist and technician.
• Selecting Medication Containers:
– Tablets and capsules should be stored in amber-colored
vials to protect the product from light.
– Ointments and creams may be placed in white ointment
jars.
– Suppositories and pellets may be dispensed in
cardboard boxes.

16. Key Formulation Skills
Weights and measures
-During compounding, ingredients will need to be either weighed or
measured and the accuracy of the compounder’s technique will have a
great bearing on the accuracy and efficacy of the final product.
Weighing:
-Use of SI system based around gram
-For weights less than 1 mg, the units of the weight are usually written in
full (for example 1 nanogram rather than 1 ng, or 3.4 micrograms
rather than 3.4 mg)
-All balances have different accuracies, precisions and tolerances and it is
important that the correct balance is used for a particular weighing
task.
For example, a balance designed to weigh 5 kg to an accuracy of 0.01
kg (10 g) is not going to be suitable to weigh 200mg (0.2 g).

17. Measuring:
-Two perspectives: First, concern with the ability to accurately measure the
components of a prescription preparation. Secondly, concern with how the
patient will measure and deliver an accurate dose of a liquid medication.
-There are two main types of vessel used within pharmacy for measuring
liquids:
* Graduates * syringes *Pipettes
Graduates
-Graduates are used for measuring and transferring liquids in a manner that is less
precise than with a pipette. When appropriately used, graduates may be used to
measure and deliver volumes over 1 ml of most liquids with an acceptable
level of accuracy. As a general rule, a graduate should be used which has a
capacity equal to or just exceeding the volume to be measured.
PTBN:
-Meniscus
-Pouring viscous liquid
Cylindrical Conical

18. Syringes:
-1mL syringes have been used to measure graduated volumes less than 1
ml, and 5mL syringes to measure graduated volumes up to 5 ml. It
must be remembered that although their use is commonplace, syringes
are less accurate than pipettes.
Pipettes:
Pipettes are recommended for the delivery of all volumes <5 ml and are
required for delivering volumes <1 ml (in the absence of an
appropriate syringe). There are two basic types of pipettes, single
volume or Graduated multi volume pipettes.

19. Labeling and Cleanup
• The compounded preparation must be labeled with all
information for the consumer as required by state and
federal governments.
• The label should include:
– Beyond-use date,
– Lot number,
– Date of compounding
• Equipment should be cleaned and properly stored after use.
• Hazardous chemicals should be disposed of in a proper
manner.

20. Sterile compounding
-USP Chapter <797> deals with sterile compounding.
– CSP – compounded sterile preparation
– The intent is to prevent harm and fatality resulting from
 microbial contamination
 excessive bacterial endotoxins
 large errors in the strength of correct ingredients
 and the presence of incorrect ingredients.

21. Risk Level Classifications of
Compounded Sterile Products
• Risk level classifications are divided up into low, medium, and high
depending on how much manipulation to the admixture is involved
1.Low-risk level:- All aseptic manipulations within class 100
environment using only sterile ingredients and devices
- Only single transfers used & Measuring/mixing no more than 3
products
E.g.: Manually prepared TPN with three ingredients, Single patient
doses
2.Medium-risk level: Multiple individual doses of sterile products are
combined to prepare a product that will be administered to multiple
patients or the same patients on multiple occasions
E.g..: TPN prepared by a compounder

22. 3.High level risk:- Sterile products compounded from non-sterile
ingredients or use of a non-sterile device prior to terminal sterilization
E..g.: TPN for terminal sterilization by final filtration, Mixing or
measuring in non-sterile devices

23. Environment Controls
• Primary engineering controls:
-USP requires that all sterile compounding regardless of
risk level be done in an ISO Class 5 environment. (fewer
than 100 airborne particles large than .5 microns per cubic
foot )
This is maintained in a Horizontal Laminar Airflow
Workbench, a suitable Biological Safety Cabinet or a
suitable Compounding Aseptic Isolator.

24. Horizontal LAF Vertical LAF

25. • Secondary engineering controls:
Buffer area :- Area immediately surrounding the work
bench. Area where primary engineering control is
physically located. Should not contain any drains or sinks.
Ante area:- Space beyond the buffer area where hand
sanitizing and gowning occurs. It includes hands free
faucets and air dryers or low-shedding towels.
- Low and medium risk preparations may be compounded in
facilities where there is no physical separation between the
ante area and the buffer area, High risk preparations
require an anteroom separate from the buffer room.

28. Beyond Use Dating

29. End-Product Evaluation
• End-product evaluation is the final inspection made by the
pharmacist before the product is allowed to leave the
pharmacy.
• It includes an inspection for leaks, cloudiness, particulate
matter, color, solution volume, and container integrity.
• The pharmacist also verifies compounding accuracy with
respect to the correct ingredients and quantities.
• This check of the technician’s work is an important step in
ensuring that only quality products are sent for patient use.