Chapter 11

1. Bulk Repackaging and Non–
Sterile Compounding
Chapter 11
1

2. 2
Proper Packaging and Repackaging
Procedures
1. Explain the need for packaging products in
the appropriate type and size of container.
2. List the steps in the bulk repackaging of
medications.
3. List five reasons pharmacies often repackage
bulk medications into unit dose packages.
4. Describe the proper handling of medications
during bulk repackaging.
5. Demonstrate how to complete a repacking
logbook with the necessary information.
Lesson 11.1

3. 3
Proper Packaging and Repackaging
Procedures
6. Explain the importance of the accurate
labeling of pharmaceuticals.
7. Explain the calculations used to determine
the beyond-use date when repackaging.
8. List the common reasons for using unit dose
medications.
9. Describe the types of containers used for
repackaged and compounded medications.
10.Name three advantages of blister card
packaging.
Lesson 11.1

4. Introduction
• Bulk repackaging medication is common in the
hospital pharmacy
▫ This is a technician duty in most settings
• Compounding non-sterile products is common
in the community pharmacy
• Bulk repackaging is also called unit dosing
4

5. Unit Dose Medications
• Using these saves a lot of money
• Creates an inventory for automatic dispensing
systems
• It is easier to deliver one dose at a time
▫ Nurses can ensure that the exact amounts are
given to each patient
▫ Even liquids can be divided into single 15- to 30-
mL dose cups to allow the nurse to dispense just
the correct amount for a single dose.
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6. 6

7. Importance of Correct Packaging
• Bulk containers have up to 1000 doses per
container
▫ 100-count doses can be packaged into single doses
 Easier for dispensing single doses to patients
• Containers: Unit dose (UD), single dose, bubble
pack (blister card), dispensing machines
• Can be done manually or by means of an
automated system, transferring medications
from a manufacturer’s original container to
another type of container before the need arises
to dispense a prescriber’s order.
7

8. Steps for Repackaging
• Package one dose at a time; done in a specific
work area
• Labels must have all required information
▫ Label requirements include the proprietary and
nonproprietary names, dosage form, strength,
strength of an individual dose, total contents
delivered, beyond-use date, and lot number.
▫ See Table 11-1 (p. 237) for repackaging guidelines.
8

9. Steps for Repackaging
• All medications must be checked
• All equipment must be in good condition and
clean
• Containers must be correct size
• All necessary information must be logged
9

10. Reasons for Bulk Repackaging
• Drugs that cannot be bought from manufacturer
• Cost of unit dosing may be cheaper (Why?)
• Speed and efficiency increased
• Individual labels result in decrease in errors
• Can be put back in stock if not used
10

11. Unit Dose Medication Containers
• Strip pack (unit dose pack)
• Liquid cups
• Blister card/bubble pack (punch cards)
▫ May contain one or more doses of medication
• Applicators
• Syringes
• Foil cups
• Plastic suppository shells
11

12. 12

13. Bulk Repackaging Techniques
• Non-sterile technique:
▫ Lab coat
▫ Hair tied back
▫ Hands washed
▫ Gloves if the tablets or capsules will be touched
▫ Pill counting tray and spatula if the tablets will be
dispensed from the tray
▫ *Always prepare medication one at a time to avoid
cross-contamination in the packaging process*
13

14. Bulk Repackaging Techniques (Cont.)
• Keep equipment clean and in good working
order
• Maintain records
• Have enough packages and labels ready for use
• Calculate accurate beyond-use date
• Record on documentation
▫ It is important to be accurate in record keeping in
case there is a recall on the bulk products used
14

15. Documentation
• Dosage forms that are repackaged: Tablets,
capsules, liquids
• Unit dose labels: Computer generated to save
time and reduce errors
• Technician determines amount needed,
calculates expiration date, documents
components, generates labels, loads medication
15

16. Documentation (Cont.)
• Date the drug is repackaged: Date, month, year
• Drug name: Both generic and brand name
• Dosage form and manufacturer
• Manufacturer's lot number and expiration date:
Located on label or bottom of bottle; located
with lot number
• Pharmacy lot number, beyond-use date,
technician initial
16

17. Labeling/Checking Bulk Repackaged
Medications
• Dosage forms that are repackaged: Tablets,
capsules, liquids
• Unit dose labels: Computer generated
• Technician determines amount needed,
calculates expiration date, documents
components, generates labels, loads medication
17

18. Storage and Stability
• Expiration date given by manufacturer and FDA
• Beyond-use dates (BUD) given to repackaged
products is done by using USP <795>
18

19. Repackage Guideline
• Items repackaged for use in a hospital or for a
specific patient’s use cannot be mass produced.
• Only drug manufacturing companies following
FDA guidelines may mass produce medications
19

20. Beyond-Use Date
• Different from expiration date
• Calculated by pharmacy when
repackaging/compounding medications
• Solid/liquid: One year from repackage date or
expiration date of ingredient, whichever is
less
• Manufacture's expiration: Exact amount of
time drug is usable
▫ Once a bulk bottle is opened and the
medication is repackaged, the manufacturer’s
expiration date may no longer be valid.
20

21. Blister Cards
• Blister cards may contain one or more doses of
medication and are usually used for long-term
care medications.
• The medications prescribed by a physician are
put into individual pockets in a card that holds a
month’s worth of medication. Morning doses
and the night doses can be placed in different
cards, and each dose is put in an individual
pocket.
21

22. 22

23. Blister Cards
• Advantages to using:
▫ Makes compliance easier for patients in taking their
medication correctly
▫ Allows timely monitoring by health care team members
▫ The unsteady hands of an elderly patient can get one tablet
from the card without spilling the entire contents of a bottle
or touching the other tablets in the card
▫ If a dose is changed (often the case with long-term care
patients due to their chronic or multiple disease states), the
remaining uncontaminated medications in the card can be
returned and reused
▫ The card is a visible way to easily identify missed doses and
to aid the patient in medication compliance
23

24. 24

25. 25
Equipment Used and Storage for
Compounded Medications
11. Define non-sterile compounding.
12. List the common reasons patients need compounded
medications.
13. Explain the important considerations in the storage and
stability of compounded products.
14. Describe the equipment used in compounding drugs.
15. Differentiate between the types of scales used to weigh
compounds.
16. Demonstrate how to complete a compounding sheet with
the necessary information.
17. Demonstrate compounding procedures.
18. Describe the types of dosage forms compounded for
animal use.
Lesson 11.2

26. Non–Sterile Compounding: History
• Medicinal mixtures using plants, animals, and
minerals dates back 4000 years
• In 1820, 80% of prescriptions in the first U.S.
pharmacopoeia were compounds
• Premade dosages do not necessarily treat
everyone, are not always commercially available
▫ Pediatric doses, hospice patients
26

27. Use of Non–Sterile Compounding
• Non–sterile compounding: Done in vertical
hood or on clean work surface as stated in USP
<795>
• Common items: Creams, ointments, oral
suspensions
• Less common: Capsules, suppositories, syringe
27

28. Reasons for Compounding
• No longer manufactured
• Patients may be allergic to something in a drug
• Specialized dosage/strength for specific patients
• Increased patient compliance
• Patient unable to ingest normal dosage form
• Medication requires flavorings
28

29. Equipment Used in Compounding
• Personal protective equipment: Gloves, goggles,
gown, hair cover, lab coat, mask, shoe covers
• Measuring devices: Graduated cylinders,
syringes, pipettes, electronic filling machines
▫ Measuring liquids requires reading a meniscus
• Mixing equipment: Mortar and pestle
29

30. Weighing Equipment
• Weighing equipment: Scales, electronic balances
▫ Class A balance – Minimum of 120 mg, Sensitivity
6mg or less
 Torsion balance
 Pan balances such as the class A balance are
standard in pharmacies.
 Weights are placed on right side using
tweezers/forceps
▫ Class II – Analytical or digital – 100 g
 The digital balances are common and can weigh
heavier amounts.
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31. 31

32. Weighing Techniques
• Pharmacy balances are sensitive
▫ Airflow: Keep to minimum
▫ Glass lid cuts air currents
• Spatula: Used to pick up small amounts; lightly
tapping to flick few granules at a time
• Compounding: Time-consuming, accuracy
important
32

33. Additional Supplies
• Mold forms: Metal and rubber
• Excipients =?
• Emollients =?
• Flavorings: Added to mask bad taste of
ingredients
33

34. Completing a Compounding Sheet
• Clean countertops and other surfaces
• Dispose of all cleaning products as soon as
cleaning is complete
• Damp mop the floor
• Check off each activity as it is completed for each
room
• Prepare cleaning solutions on the day of use
34

35. Measuring Liquids
• Liquids: There are simple steps to ensure proper
volume
▫ Water molecules will cling to sides of container
▫ Have liquid at eye level
▫ Read at bottom of liquid line (meniscus)
 Liquids can have a concave (U-shaped) meniscus, no meniscus, or a
convex (domed) meniscus. The meniscus shape depends on the liquid
and the container material.
 Read the bottom of a convex meniscus and the top of a convex
meniscus.
 The liquids used in the pharmacy will almost always have a concave
meniscus.
35

36. Measuring Liquids
• For maximum accuracy in measuring liquids,
use the 20% rule
▫ 50mL graduated cylinder x 20%= 10mL
 10mL is the smallest accurate amount a 50mL
graduated cylinder can measure
36

37. Meniscus
37

38. Preparing Solutions
• Solutions comprise:
▫ Solvent (larger part)
▫ Solute (ingredient used in solvent)
• Measure carefully and mix thoroughly
• Solubility will dictate the type of dosage form
that needs to be prepared
• Reconstitution of premade oral suspensions may
be done away from the compounding area
38

39. Solids: Tablets, Capsules, and
Lozenges
• Molds are used for forming these types of oral
dosage forms
• Molded tablets disintegrate quickly when they come
into contact with moisture
• Tablets or lozenges can be made one at a time or in
multiple doses
• Lozenges: Normally made with flavors to enhance
their taste and sugar
▫ Hard
▫ Soft
▫ Chewable
39

40. Semisolids: Ointments, Sticks and
Suppositories
• Medication sticks
▫ Applied directly to a site on the body that needs
treatment
• Ointment: Hydrophobic base
▫ Petroleum jelly mixed with drug
▫ Jars or tubes
• Hard sticks and soft sticks
• Suppositories: Oleaginous bases, water-soluble
bases, glycerinated gelatins
40

41. Terms
• Hydrophobic compounds do not dissolve in
water. Can you break the word hydrophobic
down into its two root words?
▫ Examples- ointments, oleagnious bases
• How about hydrophilic, which means “water
soluble”?
• Suspensions have both hydrophilic and
hydrophobic ingredients, so they must be shaken
before use.
41

42. Packaging
• Containers must:
▫ Be appropriate size
▫ Protect contents
▫ Have childproof caps (not for jars and syringes)
▫ Have appropriate labels
▫ Common auxiliary labels placed on medication
containers:
 Suspensions: Shake well
 Ophthalmic: For the eye
42

43. Storage and Stability of Compounded
Drugs
• Consider stability of any additives
• Factors affecting stability:
▫ Amount of light and air
▫ Temperature
▫ pH alters longevity
• Solid forms have longer shelf life than liquid
forms
▫ It is easier for a liquid product to degrade or for its
components to separate
43

44. Documentation
• Documentation of records under quality
assurance of FDA guidelines
• Compounding record (CR): Log
• Formulation record (FR): Recipe
44

45. Documentation
• Date prepared; name of ingredients;
manufacturer of each ingredient; lot number and
expiration date of each ingredient [including
sterile water]; amount or weight of each
ingredient; dosage form of each ingredient;
pharmacy lot number assigned; pharmacy
expiration date assigned; date dispensed;
patient’s name and medical record number
• In addition, a step-by-step recipe is required, and
both the pharmacist and the technician must
initial the records.
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46. Safety
• Documentation: Safety Data Sheets (SDSs)
• All chemicals should be stored inside cabinets
or behind shelf brackets to avoid spillage
• Method of cleaning and disposing of agents or
any equipment used depends on the type of
agents used
• SDSs contain emergency contact information
in case of spillage or contact.
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47. Professionalism and Quality Control
• Appearance is important
▫ Great care must be taken when topping off jars of
creams and ointments.
• Packaging affects medication inside and
compliance
▫ Many medications can degrade with ultraviolet
(UV) light exposure; therefore, they must be
placed in amber-colored containers to protect the
medication.
• Follow all storage and labeling guidelines
47

48. Veterinary Medications
• Dosage in a form that avoids stress on the
animal
• Medication may be mixed into a treat
▫ Sticks to administer antibiotics to the inside of the
ear
▫ Liquids poured onto pet food
• Flavorings
▫ Bacon
▫ Tuna
48

49. Compounding Calculations
• The final product may need to be prepared in a
different strength or volume than what the
recipe lists
▫ Standard formulas are provided by agencies such
as Professional Compounding Centers of America
(PCCA).
• Pharmacist or technician will need to perform
calculations to attain the correct weights and/or
volumes for the final product
49