Process ( Non-Hazardous and Hazardous Drug Compounding)

Question 1

Process

Answer 1

> Is the establishment and refinement of a master formulation record, which must include the template itself.

> It includes the verification of the formulation, its procedure, and all pre-, during-, and post- qualification and quantification related requirements and protocols.

> It includes the selection of:

• the appropriate environmental requirements, - preparatory techniques, equipment and devices,
• active pharmaceutical ingredients,
• chemical agents,
• pharmaceutical calculations,
• packaging and dispensing containers,
• establishment of a beyond-use date,
• storage and shipping requirements, and
• the establishment of a verification program for a compounded preparation.

Question 2

Process development

Answer 2

The steps you go through to establish a master formulation record

Question 3

Documentation of a master formulation record

Answer 3

All that is required:

> The formula ingredients
Technology used to prepare the medication,
Verification of the efficiency of the preparatory instructions,
Inspection and verification of the final preparation

Question 4

If a prescription arrives and you don’t have a MFR to match

Answer 4

Then one needs to be created.

For every compounding record, there must be a previously developed master formulation record.

Question 5

Process Development records.

Answer 5

Any documentation related to the development process should be kept and stored.

Question 6

Official MFR.

Answer 6

Once the process development phase is complete, the final documentation needs to be approved before it can be entered into the facility’s database

Question 7

MFR needs to be updated when»

Answer 7

> the pharmacy acquires a new mixing technology or
new beyond-use date information becomes available

Note: the required changes need to be written, documented, and approved.

Question 8

Responsibility of the compounding supervisor as relates to MFR

Answer 8

> ensure that master formulation records are developed, reviewed and updated, and that any personnel who actively compound follow the processes defined in these documents.

> ensure that each preparation has a master formulation record, and

> ensure that the MFR is referenced on the corresponding compounding records.

Question 9

Process Involves

Answer 9

Process involves the development, rehearsal, documentation, and final approval of the proposed Master Formulation Record

Question 10

Process Development & Workflow

Answer 10

Process, or process development, also refers to the efforts made to establish an efficient workflow in the designated compounding area(s).

As formulations are developed and practiced, the organization of the designated compounding area and direct workspace should be improved.

Question 11

Good workflow and efficient use of space

Answer 11

help minimize mistakes and cross contamination between ingredients, ingredients and devices, and finished and unfinished compounded preparations.

Question 12

Reusable and disposable accessories - Supply & Availability

Answer 12

should be in short supply and within arms’ reach of the workstation

Question 13

Chemicals - Supply & Availability

Answer 13

stored as overstock, away from the designated workstations

sealed at all times

Question 14

Frequently used excipient - Supply & Availability

Answer 14

short supply in the same designated area as reusable and disposable accessories

Question 15

Activities in compounding area

Answer 15

No other activities can be performed in the designated compounding area once compounding has commenced.

Question 16

Stock Formulation Records

Answer 16

documents that describe how to make an aliquot, concentrate, or triturate rather than a dispensable prescription

Question 17

Examples of Stock Formulations

Answer 17

> Powder blend aliquots (e.g., Liothyronine 1:1000 powder aliquot)
Powder-in-liquid aliquots and concentrates (e.g., Estradiol in oil concentrate)
Powder-in-semisolid aliquots and concentrates (e.g., Progesterone in cream concentrate)

Question 18

Stock Formulations

Answer 18

> prepared and kept as an ingredient in the pharmacy for use in multiple formulations and for different patients.
never directly dispensed to patients or sent to other facilities, as is.
kept in the original pharmacy and stored and used like other ingredients for compounding.
Aliquots, concentrates or triturates need to be labelled and packaged properly according to the SFR.
A beyond-use date also must be assigned. If an aliquot, concentrate or triturate is used in a MFR, they need to be linked so in the event of a recall, the ingredients and lot number of the original stock formulation can be retrieved.

Question 19

Safety benefits of stock formulations

Answer 19

> decrease chemical waste and increase efficiency,

> they also decrease the frequency in which personnel need to manipulate pure APIs.

> satisfy multiple prescriptions, instead of weighing pure API or making an aliquot each time.

Question 20

Labeling Requirements

Answer 20

• Pharmacy identification (e.g., name, address and telephone number of the compounder’s or dispenser’s pharmacy, as per
  regulatory requirements)
• Assigned internal identification number (e.g., barcode, prescription, order or lot number)
• Drug identification (e.g., active ingredient(s), activities or concentrations and amounts)
• Dosage form and route of administration
• Amount prepared or volume in each container
• Beyond-use date
• Indication that the preparation was compounded
• Details concerning mode of administration
• Any special handling instructions or precautions (e.g., if a product is an irritant)
• Any special precautions for disposal or destruction of the preparation
• Any special precautions related to drug storage
• All information that is required by provincial/territorial legislation and regulation regarding the labelling of medication but that could not be included on the main label

Question 21

Labelling Risks to Mitigate

Answer 21

> Processes need to be in place to ensure the correct label is on the correct preparation. “

> Special care also needs to be in place to ensure compounds that are in-process are not mixed-up or incorrectly identified during the compounding process.

Question 22

Reasons for Packaging type selection

Answer 22

> To facilitate patient compliance (e.g., ease of use and/or meter-dosed dispensing)
To protect the patient (or caregiver) and personnel from unintended exposure to the preparation
To protect the preparation from contamination and degradation (e.g., degradation from light and moisture)

Question 23

Packaging Risks to Mitigate

Answer 23

> check that it is clean and free of any traces of the contained preparation,

> check for any leaks or damages; this is especially important for hazardous compounds.

Question 24

Policies and procedures related to transport and delivery

Answer 24

> Storage conditions and shipping containers required during transportation
The use of temperature indicators during extreme weather
Safety precautions for the transporter
Directions for the return of expired, partially used or unused medications

Question 25

Hazardous materials must be shipped according to

Answer 25

information on the SDS and regulations of the transportation compan

Question 26

The beyond-use date (BUD) is

Answer 26

the date after which a compounded preparation must not be used, administered or stored, and is determined from the date the preparation was compounded.

Question 27

BUD documentation requirements in the MFR

Answer 27

BUDs must be determined for all compounded preparations and the criteria, rationale, and the sources used to establish BUDs must be in the MFR.

Question 28

BUDs should be assigned conservatively and the following criteria must be considered

Answer 28

• The nature of the drug and its degradation mechanism
• The dosage form and its components
• The potential for microbial growth in the preparation
• The container in which it is packaged
• The expected storage conditions
• The intended duration of therapy

Question 29

BUD:

For water-containing oral formulations

Answer 29

Not later than 14 days with storage at controlled cold temperatures

Question 30

BUD:

For water-containing topical/dermal, mucosal liquid and semi-solid formulations

Answer 30

Not later than 30 days

Question 31

For non–aqueous formulations

Answer 31

Not later than the time remaining until the earliest expiry date of any API
or 180 days, whichever is earlier

Question 32

Shorter BUD when

Answer 32

> if any ingredient (APIs, excipients, commercially manufactured or other compounded products) used to make a preparation has an expiry or BUD date less than the date assigned by the guidelines, then the shortest date determines the final BUD.

> any compound that is known to be susceptible to degradation must also be assigned a shorter BUD.

Question 33

BUD Validity

Answer 33

BUD to be valid, a preparation must also be free of microbial growth (e.g., mold) for the time indicated.

Water containing compounds are at a much higher risk of microbial proliferation and a suitable antimicrobial agent may need to be considered.

If it is not appropriate to add an antimicrobial agent to a susceptible compound, then the preparation should be stored in the refrigerator.