Or. Admin. Code § 855-045-0270

Current through Register Vol. 63, No. 11, November 1, 2024

Section 855-045-0270 - Records

(1) All records must be maintained in written or electronic format, stored in an organized manner, retained for a minimum of three years and be made readily available for inspection by the Board. Records must be stored onsite for at least one year and then may be stored in a secure off-site location if then retrievable within three business days. Required records include, but are not limited to:

(a) Standard operating procedures, including documented annual review;

(b) Personnel training according to the type of compounding performed, including competency assessment, and qualification records, including corrective actions for any failures, including gloved fingertip and thumb sampling test and aseptic manipulation validation. The pharmacy must maintain a training record for each person, including temporary personnel, who compound preparations. At a minimum, the record must contain:

(A) Name and signature of the person receiving the training;

(B) Documentation of initial and continuing competency evaluation, to include dates and results of required elements outlined in the outlet's policies and procedures; and

(C) Name and signature of the pharmacist who is designated as responsible for validation of the completion of all training.

(c) Engineering and environmental control records, including equipment, calibration, certification, environmental air and surface monitoring procedures and results, as well as documentation of any corrective actions taken; and

(d) Cleaning and disinfecting of all compounding areas and equipment.

(2) Master formulation records, including as appropriate:

(a) The name, strength and dosage form of the preparation;

(b) Physical description of the final preparation;

(c) Ingredient identities and amounts;

(d) Complete instructions for preparing the product, including equipment, supplies, and a description of the compounding steps;

(e) Calculations needed to determine and verify quantities of components and doses of ingredients;

(f) Compatibility and stability information, including references;

(g) Beyond-use date (BUD) assignment and storage requirements, including reference source;

(h) Sterilization method utilized, when applicable. Methods include steam, dry heat, radiation and filtration;

(i) Quality control procedures and expected results; and

(j) Appropriate ancillary instructions, such as storage instructions or cautionary statements, including hazardous drug warning labels where appropriate.

(3) Each compounded product must be documented and the unique compounding record must include, but is not limited to, the following:

(a) Drug name, strength, and dosage form of the preparation;

(b) Physical description of the final preparation, when dispensed to a patient for self-administration;

(c) Master formulation record reference for the preparation, when applicable;

(d) Quantity prepared;

(e) Date and time prepared;

(f) Pharmacy unique lot number;

(g) Name, quantity, and manufacturers' lot numbers and expiration dates for all ingredients used to prepare compounded product, to include the name of the base, diluent, or primary excipient;

(h) Beyond-use date;

(i) Pharmacist documented verification of order accuracy;

(j) Identity of all personnel involved in each step of the process;

(k) Documentation of the proper weight and measurement of each ingredient;

(l) Pharmacist documented verification of compounded product accuracy including the correct formula, calculations, and the correct measurements and drugs used;

(m) Total quantity compounded;

(n) Beyond-use date assignment and storage requirements, including reference source, if differs from master formulation record;

(o) Documentation of any quality control issue and any adverse reaction or preparation problem, including those reported by the patient, caregiver, or other person, to include corrective actions for any failure;

(p) Records of dispensing or transfer of all compounded preparations; and

(q) Any other information required by the pharmacy's policies and procedures.

Or. Admin. Code § 855-045-0270

BP 2-2008, f. & cert. ef. 2-20-08; BP 12-2019, amend filed 12/20/2019, effective 12/20/2019

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155