IDAPA 27 - BOARD OF PHARMACY

27.01.01 - RULES OF THE IDAHO STATE BOARD OF PHARMACY

DOCKET NO. 27-0101-1301

NOTICE OF RULEMAKING - ADOPTION OF PENDING

EFFECTIVE DATE: This rule has been adopted by the agency and is now pending review by the 2014 Idaho State Legislature for final approval. The pending rule becomes final and effective at the conclusion of the legislative session, unless the rule is approved, rejected, amended or modified by concurrent resolution in accordance with Section 67-5224 and 67-5291, Idaho Code. If the pending rule is acted on by concurrent resolution, the rule becomes final and effective upon adoption of the concurrent resolution or upon the date specified in the concurrent resolution.

AUTHORITY: In compliance with Section 67-5224, Idaho Code, notice is hereby given that this agency has adopted a pending rule. The action is authorized pursuant to Section 54-1717, Idaho Code.

DESCRIPTIVE SUMMARY: The following is a concise explanatory statement of the reasons for adopting the pending rule and a statement of any change between the text of the proposed rule and the text of the pending rule with an explanation of the reasons for the change:

The text of the pending rule has been amended in accordance with Section 67-5227, Idaho Code. Only those sections that have changes that differ from the proposed text are printed in this bulletin. The original text of the proposed rule published in the October 2, 2013 Idaho Administrative Bulletin, Vol. 13-10, pages 374 through 386.

In addition to non-substantive changes, such as changes to improve grammar, condense language, and clarify confusing language, these changes rename a subsection, add an exception to the definition of compounding, and expand who may initial certain documents.

FEE SUMMARY: The following is a specific description of the fee or charge imposed or increased. None.

FISCAL IMPACT: The following is a specific description, if applicable, of any negative fiscal impact on the state general fund greater than ten thousand dollars ($10,000) during the fiscal year:

The Board envisions requesting about ten thousand dollars ($10,000) to send the Board's inspectors to sterile compounding training.

ASSISTANCE ON TECHNICAL QUESTIONS: For assistance on technical questions concerning this pending rule, contact Mark Johnston, Executive Director, at (208) 334-2356.

DATED this 1st day of November, 2013.

Mark Johnston, R.Ph.
Executive Director
Board of Pharmacy
1199 W. Shoreline Ln., Ste. 303
P. O. Box 83720
Boise, ID 83720-0067
Telephone: (208) 334-2356
FAX: (208) 334-3536

DOCKET NO. 27-0101-1301 - ADOPTION OF PENDING RULE

Substantive changes have been made to the pending rule.

Italicized red text that is double underscored is new text that has been added to the pending rule.

Only those sections or subsections that have changed from the original proposed text are printed in this Bulletin following this notice.

The text of the proposed rule was published in the Idaho Administrative Bulletin, Volume 13-10, October 2, 2013, pages 367 through 373.

This rule has been adopted as a pending rule by the Agency and is now awaiting review and final approval by the 2014 Idaho State Legislature.

FOLLOWING IS THE AMENDED TEXT OF THE PENDING RULE FOR DOCKET NO. 27-0101-1301

239. COMPOUNDING DRUG PRODUCTS.

02. General Compounding Standards. ( )

[Paragraph 239.02.a.]

a. Certificate of Analysis. A COA issued by a firm located in the United States must be obtained for all active ingredients procured for compounding and retained for a period of not less than three (3) years from the date the container is emptied. If a COA is not available from the vendor, one must be procured from a laboratory located in the United States. COAs are not required if the active ingredient utilized is designated USP-NF. If the product is not designated as USP-NF, then the following minimum information is required on the COA: ( )

[Paragraph 239.02.d.]

d. Disposing Compromised Drugs. When the correct identity, purity, strength, and sterility of ingredients and components cannot be confirmed (in cases of, for example, unlabeled syringes, opened ampules, punctured stoppers of vials and bags, and containers of ingredients with incomplete labeling) or when the ingredients and components do not possess the expected appearance, aroma, and texture, they must be disposed of immediately. ( )

03. Scope of Practice. A pharmacist may compound a drug product in the usual course of professional practice for an individual patient pursuant to an established prescriber/patient/pharmacist relationship and a valid prescription drug order. ( )

[Paragraph 239.03.b. - proposed text deleted]

b. Anticipatory Compounding. A pharmacist may compound limited quantities of a drug product prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders generated solely within an established pharmacist/patient/prescriber relationship. ( )

[Paragraph 239.03.e.]

e. Exceptions. Compounding does not include reconstituting of a nonsterile drug or a sterile drug for immediate administration or the addition of a flavoring agent to a drug product. ( )

[Subsection 239.04 - entire subsection being reprinted]

04. Drug Compounding Controls. ( )

a. Policies and Procedures. In consideration of the applicable provisions of USP 795 concerning pharmacy compounding of non-sterile preparations, USP 797 concerning sterile preparations, Chapter 1075 of the USP-NF concerning good compounding practices, and Chapter 1160 of the USP-NF concerning pharmaceutical calculations, policies and procedures for the compounding or sterile prepackaging of drug products must ensure the safety, identity, strength, quality, and purity of the finished product, and must include any of the following that are applicable to the scope of compounding being performed: ( )

i. Appropriate packaging, handling, transport, and storage requirements; ( )

ii. Accuracy and precision of calculations, measurements, and weighing; ( )

iii. Determining ingredient identity, quality, and purity; ( )

iv. Labeling accuracy and completeness; ( )

v. Beyond use date assignment; ( )

vi. Auditing for deficiencies, including routine environmental sampling, quality and accuracy testing, and maintaining inspection and testing records; ( )

vii. Maintaining environmental quality control; ( )

viii. Safe limits and ranges for strength of ingredients, pH, bacterial endotoxins, and particulate matter; and ( )

b. Accuracy. Components, including but not limited to, bulk drug substances, used in the compounding or sterile prepackaging of drug products must be accurately weighed, measured, or subdivided, as appropriate. The amount of each active ingredient contained within a compounded drug product must not vary from the labeled potency by more than the drug product's acceptable potency range listed in the USP-NF monograph for that product. If USP-NF does not publish a range for a particular drug product, the active ingredients must not contain less than ninety percent (90%) and not more than one hundred ten percent (110%) of the potency stated on the label. If any drug potency analysis is conducted, records must be maintained in a readily retrievable manner. ( )

c. Non-Patient Specific Records. Except for drug products that are being compounded for direct administration, a production record of drug products compounded or sterile prepackaged for office use or prepared in anticipation of receiving prescription drug orders, solely as permitted herein, must be prepared and kept for each drug product prepared, including: ( )

i. Production date; ( )

ii. Beyond use date; ( )

iii. List and quantity of each ingredient; ( )

iv. Internal control or serial number; and ( )

v. Initials or unique identifier of all persons involved in the process or the compounder responsible for the accuracy of these processes. ( )

d. Labeling. The label affixed to the container of a compounded or sterile prepackaged drug product that is: ( )

i. Dispensed must comply with the standard prescription drug labeling requirements. ( )

ii. Distributed in the absence of a patient specific prescription drug order, solely as permitted herein, must contain the following information: ( )

(1) The name of each drug included; ( )

(2) The strength or concentration of each drug included; ( )

(3) If applicable, the name and concentration of the base or diluents; ( )

(4) If applicable, the dosage form or route of administration; ( )

(5) The total quantity of the drug product; ( )

(6) The expiration or beyond use date; ( )

(7) The initials or unique identifier of the compounder responsible for the accuracy of the drug product; ( )

(8) The statement "not for resale;" and ( )

(9) Handling, storage or drug specific instructions, cautionary information, and warnings as required or deemed appropriate for proper use and patient safety. ( )