§ 1735.2. Compounding Limitations and Requirements; Self-Assessment.
16 CA ADC § 1735.2BARCLAYS OFFICIAL CALIFORNIA CODE OF REGULATIONS
16 CCR § 1735.2
§ 1735.2. Compounding Limitations and Requirements; Self-Assessment.
(a) Except as specified in (b) and (c), no drug preparation shall be compounded prior to receipt by a pharmacy of a valid prescription for an individual patient where the prescriber has approved use of a compounded drug preparation either orally or in writing. Where approval is given orally, that approval shall be noted on the prescription prior to compounding.
(b) A pharmacy may prepare and store a limited quantity of a compounded drug preparation in advance of receipt of a patient-specific prescription where and solely in such quantity as is necessary to ensure continuity of care for an identified population of patients of the pharmacy based on a documented history of prescriptions for that patient population.
(c) A “reasonable quantity” that may be furnished to a prescriber for office use by the prescriber as authorized by Business and Professions Code section 4052, subdivision (a)(1), means that amount of compounded drug preparation that:
(1) Is ordered by the prescriber or the prescriber's agent using a purchase order or other documentation received by the pharmacy prior to furnishing that lists the number of patients seen or to be seen in the prescriber's office for whom the drug is needed or anticipated, and the quantity for each patient that is sufficient for office administration; and
(2) Is delivered to the prescriber's office and signed for by the prescriber or the prescriber's agent; and
(3) Is sufficient for administration or application to patients solely in the prescriber's office, or for furnishing of not more than a 120-hour supply for veterinary medical practices, solely to the prescriber's own veterinary patients seen as part of regular treatment in the prescriber's office, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing; and
(4) That the pharmacist has a credible basis for concluding it is a reasonable quantity for office use considering the intended use of the compounded medication and the nature of the prescriber's practice; and
(5) With regard to any individual prescriber to whom the pharmacy furnishes, and with regard to all prescribers to whom the pharmacy furnishes, is an amount which the pharmacy is capable of compounding in compliance with pharmaceutical standards for integrity, potency, quality and strength of the compounded drug preparation; and
(6) Does not exceed an amount the pharmacy can reasonably and safely compound.
(d) No pharmacy or pharmacist shall compound a drug preparation that:
(1) Is classified by the FDA as demonstrably difficult to compound;
(2) Appears on an FDA list of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective; or
(3) Is a copy or essentially a copy of one or more commercially available drug products, unless that drug product appears on an ASHP (American Society of Health-System Pharmacists) or FDA list of drugs that are in short supply at the time of compounding and at the time of dispense, and the compounding of that drug preparation is justified by a specific, documented medical need made known to the pharmacist prior to compounding. The pharmacy shall retain a copy of the documentation of the shortage and the specific medical need in the pharmacy records for three years from the date of receipt of the documentation.
(e) A drug preparation shall not be compounded until the pharmacy has first prepared a written master formula document that includes at least the following elements:
(1) Active ingredients to be used.
(2) Equipment to be used.
(3) The maximum allowable beyond use date for the preparation, and the rationale or reference source justifying its determination.
(4) Inactive ingredients to be used.
(5) Specific and essential compounding steps used to prepare the drug.
(6) Quality reviews required at each step in preparation of the drug.
(7) Post-compounding process or procedures required, if any.
(8) Instructions for storage and handling of the compounded drug preparation.
(f) Where a pharmacy does not routinely compound a particular drug preparation, the master formula record for that preparation may be recorded on the prescription document itself.
(g) The pharmacist performing or supervising compounding is responsible for the integrity, potency, quality, and labeled strength of a compounded drug preparation until the beyond use date indicated on the label, so long as label instructions for storage and handling are followed after the preparation is dispensed.
(h) All chemicals, bulk drug substances, drug products, and other components used for drug compounding shall be stored and used according to compendia and other applicable requirements to maintain their integrity, potency, quality, and labeled strength.
(i) Every compounded drug preparation shall be given a beyond use date representing the date or date and time beyond which the compounded drug preparation should not be used, stored, transported or administered, and determined based on the professional judgment of the pharmacist performing or supervising the compounding.
(1) For non-sterile compounded drug preparation(s), the beyond use date shall not exceed any of the following:
(A) the shortest expiration date or beyond use date of any ingredient in the compounded drug preparation,
(B) the chemical stability of any one ingredient in the compounded drug preparation,
(C) the chemical stability of the combination of all ingredients in the compounded drug preparation,
(D) for non-aqueous formulations, 180 days or an extended date established by the pharmacist's research, analysis, and documentation,
(E) for water-containing oral formulations, 14 days or an extended date established by the pharmacist's research, analysis, and documentation, and
(F) for water-containing topical/dermal and mucosal liquid and semisolid formulations, 30 days or an extended date established by the pharmacist's research, analysis, and documentation.
(G) A pharmacist, using his or her professional judgment may establish an extended date as provided in (D), (E), and (F), if the pharmacist researches by consulting and applying drug-specific and general stability documentation and literature; analyzes such documentation and literature as well as the other factors set forth in this subdivision; and maintains documentation of the research, analysis and conclusion. The factors the pharmacist must analyze include:
(i) the nature of the drug and its degradation mechanism,
(ii) the dosage form and its components,
(iii) the potential for microbial proliferation in the preparation,
(iv) the container in which it is packaged,
(v) the expected storage conditions, and
(vi) the intended duration of therapy.
Documentation of the pharmacist's research and analysis supporting an extension must be maintained in a readily retrievable format as part of the master formula.
(2) For sterile compounded drug preparations, the beyond use date shall not exceed any of the following:
(A) The shortest expiration date or beyond use date of any ingredient in the sterile compounded drug product preparation,
(B) The chemical stability of any one ingredient in the sterile compounded drug preparation,
(C) The chemical stability of the combination of all ingredients in the sterile compounded drug preparation, and
(D) The beyond use date assigned for sterility in section 1751.8.
(3) For sterile compounded drug preparations, extension of a beyond use date is only allowable when supported by the following:
(A) Method Suitability Test,
(B) Container Closure Integrity Test, and
(C) Stability Studies
(4) In addition to the requirements of paragraph three (3), the drugs or compounded drug preparations tested and studied shall be identical in ingredients, specific and essential compounding steps, quality reviews, and packaging as the finished drug or compounded drug preparation.
(5) Shorter dating than set forth in this subdivision may be used if it is deemed appropriate in the professional judgment of the responsible pharmacist.
(j) The pharmacist performing or supervising compounding is responsible for the proper preparation, labeling, storage, and delivery of the compounded drug preparation.
(k) Prior to allowing any drug product preparation to be compounded in a pharmacy, the pharmacist-in-charge shall complete a self-assessment for compounding pharmacies developed by the board (Incorporated by reference is “Community Pharmacy & Hospital Outpatient Pharmacy Compounding Self-Assessment” Form 17M-39 Rev. 02/12.) as required by Section 1715 of Title 16, Division 17, of the California Code of Regulations. That form contains a first section applicable to all compounding, and a second section applicable to sterile injectable compounding. The first section must be completed by the pharmacist-in-charge before any compounding is performed in the pharmacy. The second section must be completed by the pharmacist-in-charge before any sterile compounding is performed in the pharmacy. The applicable sections of the self-assessment shall subsequently be completed before July 1 of each odd-numbered year, within 30 days of the start date of a new pharmacist-in-charge or change of location, and within 30 days of the issuance of a new pharmacy license. The primary purpose of the self-assessment is to promote compliance through self-examination and education.
(l) Packages of ingredients, both active and inactive, that lack a supplier's expiration date are subject to the following limitations:
(1) such ingredients cannot be used for any non-sterile compounded drug preparation more than three (3) years after the date of receipt by the pharmacy.
(2) such ingredients cannot be used for any sterile compounded drug preparation more than one (1) year after the date of receipt by the pharmacy.
Note: Authority cited: Sections 4005 and 4127, Business and Professions Code. Reference: Sections 4005, 4029, 4036, 4037, 4051, 4052 and 4127, Business and Professions Code.
1. New section filed 1-6-2010; operative 7-6-2010 (Register 2010, No. 2).
2. Amendment of section heading, subsection (j) and Note filed 9-19-2011; operative 10-19-2011 (Register 2011, No. 38).
3. New subsections (d)(2)-(3), repealer of former subsection (d)(6), subsection renumbering and amendment of subsection (j) filed 2-6-2013; operative 4-1-2013 (Register 2013, No. 6).
4. Amendment filed 9-13-2016; operative 1-1-2017 (Register 2016, No. 38).
5. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) filed 12-19-2017 as an emergency; operative 12-19-2017 (Register 2017, No. 51). A Certificate of Compliance must be transmitted to OAL by 6-18-2018 or emergency language will be repealed by operation of law on the following day.
6. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) refiled 6-18-2018 as an emergency; operative 6-18-2018 (Register 2018, No. 25). A Certificate of Compliance must be transmitted to OAL by 9-17-2018 or emergency language will be repealed by operation of law on the following day.
7. Amendment of subsections (i)(1)(B) and (i)(1)(D)-(F), new subsections (i)(1)(G)-(i)(1)(G)(vi) and amendment of subsection (i)(3) refiled 9-17-2018 as an emergency; operative 9-17-2018 (Register 2018, No. 38). A Certificate of Compliance must be transmitted to OAL by 12-17-2018 or emergency language will be repealed by operation of law on the following day.
8. Certificate of Compliance as to 9-17-2018 order, including nonsubstantive amendments to subsection (i)(5) and Note, transmitted to OAL 12-14-2018 and filed 1-30-2019 (Register 2019, No. 5).
This database is current through 6/4/21 Register 2021, No. 23
16 CCR § 1735.2, 16 CA ADC § 1735.2
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