e. Discussion Regarding “Batches”
Background
Board regulations related to compounding are found in Title 16 of the California Code of
Regulations, Article 4.5 (all compounding) and Article 7 (related to sterile injectable
compounding). On April 1, 2013, regulation changes went into effect that apply to
compounding definitions, expiration dating, recordkeeping requirements, and labeling of
cytotoxic agents. During this rulemaking, the board was asked what the board’s definition of
“batch” is, and what requirements apply to batching – but these topics were not included
within the scope of the regulation change.
The committee considered the following references as part of its discussion.
Existing Board Regulation
§ 1751.7. Sterile Injectable Compounding Quality Assurance and Process Validation.
(c) Batch-produced sterile injectable drug products compounded from one or more
non-sterile ingredients shall be subject to documented end product testing for sterility and
pyrogens and shall be quarantined until the end product testing confirms sterility and
acceptable levels of pyrogens.
(d) Batch-produced sterile to sterile transfers shall be subject to periodic testing through
process validation for sterility as determined by the pharmacist-in-charge and described in
the written policies and procedures.
United States Pharmacopeial Convention (USP)
“Batch” – More than 25 units
1
American Society of Health System Pharmacists (ASHP)
Excerpt:
Risk Level 2.
Risk level 2 sterile products exhibit characteristic 1, 2, or 3, stated below. All risk level 2
products should be prepared with sterile equipment, sterile ingredients and solutions, and
sterile contact surfaces for the final product and with closed-system transfer methods.
1 American Society of Health-System Pharmacists. ASHP Guidelines on Quality Assurance
for Pharmacy-Prepared Sterile Products. Am J Health-Syst Pharm. 2000; 57:1150-69.
Available at http://www.ashp.org
Risk level 2 includes the following:
1. Products stored beyond 7 days under refrigeration, stored beyond 30 days frozen, or
administered beyond 28 hours after preparation and storage at room temperature.
2. Batch-prepared products without preservatives (e.g., epidural products) that are
intended for use by more than one patient. (Note: Batch-prepared products without
preservatives that will be administered to multiple patients carry a greater risk to the
patients than products prepared for a single patient because of the potential effect of
inaccurate ingredients or product contamination on the health and well-being of a
larger patient group.)
3. Products compounded by complex or numerous manipulations of sterile ingredients
obtained from licensed manufacturers in a sterile container or reservoir obtained from a
licensed manufacturer by using closed-system aseptic transfer; for example, TPN
solutions prepared with an automated compounder. (Note: So many risks have been
associated with automated compounding of TPN solutions that its complexity requires
risk level 2 procedures.)
Discussion
There were no comments from the board or from the public.
quoted from here
Background
Board regulations related to compounding are found in Title 16 of the California Code of
Regulations, Article 4.5 (all compounding) and Article 7 (related to sterile injectable
compounding). On April 1, 2013, regulation changes went into effect that apply to
compounding definitions, expiration dating, recordkeeping requirements, and labeling of
cytotoxic agents. During this rulemaking, the board was asked what the board’s definition of
“batch” is, and what requirements apply to batching – but these topics were not included
within the scope of the regulation change.
The committee considered the following references as part of its discussion.
Existing Board Regulation
§ 1751.7. Sterile Injectable Compounding Quality Assurance and Process Validation.
(c) Batch-produced sterile injectable drug products compounded from one or more
non-sterile ingredients shall be subject to documented end product testing for sterility and
pyrogens and shall be quarantined until the end product testing confirms sterility and
acceptable levels of pyrogens.
(d) Batch-produced sterile to sterile transfers shall be subject to periodic testing through
process validation for sterility as determined by the pharmacist-in-charge and described in
the written policies and procedures.
United States Pharmacopeial Convention (USP)
“Batch” – More than 25 units
1
American Society of Health System Pharmacists (ASHP)
Excerpt:
Risk Level 2.
Risk level 2 sterile products exhibit characteristic 1, 2, or 3, stated below. All risk level 2
products should be prepared with sterile equipment, sterile ingredients and solutions, and
sterile contact surfaces for the final product and with closed-system transfer methods.
1 American Society of Health-System Pharmacists. ASHP Guidelines on Quality Assurance
for Pharmacy-Prepared Sterile Products. Am J Health-Syst Pharm. 2000; 57:1150-69.
Available at http://www.ashp.org
Risk level 2 includes the following:
1. Products stored beyond 7 days under refrigeration, stored beyond 30 days frozen, or
administered beyond 28 hours after preparation and storage at room temperature.
2. Batch-prepared products without preservatives (e.g., epidural products) that are
intended for use by more than one patient. (Note: Batch-prepared products without
preservatives that will be administered to multiple patients carry a greater risk to the
patients than products prepared for a single patient because of the potential effect of
inaccurate ingredients or product contamination on the health and well-being of a
larger patient group.)
3. Products compounded by complex or numerous manipulations of sterile ingredients
obtained from licensed manufacturers in a sterile container or reservoir obtained from a
licensed manufacturer by using closed-system aseptic transfer; for example, TPN
solutions prepared with an automated compounder. (Note: So many risks have been
associated with automated compounding of TPN solutions that its complexity requires
risk level 2 procedures.)
Discussion
There were no comments from the board or from the public.
quoted from here
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