CGCP

THE NEED FOR CGCP

 Many patients need drug dosages or strengths and dosage forms that are not
commercially available
 Many patients are allergic to excipients in commercially available products

 Some medications are not very stable

 Many drugs are reported in the literature but are not manufactured yet

 Many physicians deliver products in innovative ways

 Most products are not available for veterinary patients and must be compounded

 Home health care and treatment

COMPOUNDING VS MANUFACTURING

 Compounding is the act of preparing, mixing, assembling, packaging,

and/or labeling a drug or device as the result of a practitioner’s
prescription drug order
 Manufacturing is the production, preparation, propagation, conversion,
and/or processing of a drug or device, either directly or indirectly,
through extraction from substances of natural origin or chemical or
biological synthesis
TYPES OF DF FREQUENTLY COMPOUNDED
1. Simple
a. Topical creams, ointments, lotions,
gels e.g. steroids, hormones, coal tar,
cholestyramine
b. Oral liquids (solutions, suspensions,
emulsions, mixtures, elixirs),
tinctures e.g. omeprazole suspension
c. Capsules, tablets, powders e.g.
ethinylestradiol capsules
d. Suppositories, pessaries e.g.
paracetamol, clotrimazole
2. Complex
a. Parenterals e.g. morphine, clonidine
b. Ingredients with a safety hazard e.g.
cytotoxics, hormones
c. Single unit micro-dose (<25 mg of drug
or no more than 25% w/v of a dosage
form), e.g. naltrexone
d. Modified-release dosage forms e.g.
levothyroxine (T4)
e. Progesterone capsules
f. Ophthalmic preparations e.g.
phenylephrine, tropicamide, ciprofloxacin
REQUIREMENTS
I. COMPOUNDING FACILITY AND EQUIPMENT

 Designated area with adequate space

 Proper maintenance, cleanliness, and use of all

equipment
II. PERSONNEL
 Personnel authorized by the responsible pharmacist - vicinity of the drug-compounding
operation
 Personnel with illness or open lesion is excluded from direct contact compounding
materials and container components
 Duties of pharmacists
 Inspect and approve or reject
 Prepare and review all compounding records

 Qualifications of pharmacists
 Education, training, and proficiency

 Attire
 Protective apparel
HLI COMPOUNDING AREA
GRAN 1 – PMS, GLATT FLUID BED DRYER
III. INGREDIENT STANDARD

 USP Chapter 795 states that “The pharmacist is responsible

for compounding preparations of acceptable strength, quality,
and purity with appropriate packaging and labeling in
accordance with good pharmacy practices, official standards,
and relevant scientific data and information.”
III. INGREDIENT STANDARD CONT’N
IV. COMPOUNDING PROCESS

 Preparatory:

1. Judge the suitability of the prescription in terms of its safety and

intended use and the dose for the patient.
2. Perform the calculations to determine the quantities of the ingredients
needed.
IV. COMPOUNDING PROCESS

 Preparatory:

3. Select the proper equipment.

4. Wear the proper attire.
5. Clean the compounding area and the equipment
6. Assemble all the necessary materials and ingredients to compound and
package the prescription.
IV. COMPOUNDING PROCESS CONT’N

 Compounding:

7. Compounding the prescription according to the formulary

record or the prescription, using techniques according to the
art and science of pharmacy
 IV. COMPOUNDING PROCESS CONT’N

 Final Check”

8. Checks the weight variation, adequacy of mixing, clarity, odor, color,

consistency, and pH.
9. Enter the information in the compounding log.

10.Label the prescription.

 IV. COMPOUNDING PROCESS CONT’N
 Sign-Off:
11. Sign and date the prescription, affirming that all of the indicated
procedures were carried out to ensure uniformity, identity, strength,
quantity, and purity.
 Cleanup:
12. Clean and store all equipment.
13. Clean the compounding area.
VI. PACKAGING, STORAGE, AND LABELING
 Packaging

1. According to the specifications in USP/NF

2. Selection of a container depends on the physical and chemical

properties
 Plastic containers have become increasingly popular because they are less
expensive and lighter in weight than glass
VI. PACKAGING, STORAGE, AND LABELING
 Storage:
1. Chemicals should be stored according to either the manufacturers’
directions or the appropriate USP/NF monographs
2. Use tightly closed, light-resistant containers at room temperature
3. Chemicals should be stored off the floor
4. Temperatures of the storage areas, including refrigerators and freezers,
should be monitored and recorded at least weekly
VI. PACKAGING, STORAGE, AND LABELING
 Labeling:

1. Labeling information includes:

a. Generic or chemical names
b. Strength or quantity
c. Pharmacy lot number
d. Beyond-use date
e. Any special storage requirements
STABILITY AND BEYOND-USE DATE

 Stability is “extent to which a dosage form retains, within specified limits and
throughout its period of storage and use, the same properties and characteristics that
it possessed at the time of its preparation.” (Usp 34/nf 29)
 Discard-after or beyond-use date
o Is the date after which a compounded preparation should be discarded
o Cannot exceed the expiration date of any of its components
DISPOSING OF EXPIRED CHEMICALS AND
MEDICATIONS

 Pharmacists must comply with

all pertinent state and federal
regulations
 Philippines:
 DOH’s Health Care Waste
Management Manual