(1)Any compounding that is not permitted pursuant to the provisions of this chapter is considered manufacturing.
(2)The provisions of subsections (3) through (7) of this section apply to any person authorized to engage in the practice of non-sterile compounding, sterile compounding, and sterile prepackaging of drug products in or into Idaho but shall not apply to:
(a)The reconstitution of a non-sterile drug or sterile drug for immediate administration;
(b)The addition of a flavoring agent or coloring agent to a drug product, as long as the agent is therapeutically inert and in the minimum quantity necessary; or
(c)Product preparation of a non-sterile, non-hazardous drug according to the manufacturer’s FDA approved labeling.
(3)Any person engaging in compounding pursuant to this secti
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(1) Any compounding that is not permitted pursuant to the provisions of this chapter is considered manufacturing.
(2) The provisions of subsections (3) through (7) of this section apply to any person authorized to engage in the practice of non-sterile compounding, sterile compounding, and sterile prepackaging of drug products in or into Idaho but shall not apply to:
(a) The reconstitution of a non-sterile drug or sterile drug for immediate administration;
(b) The addition of a flavoring agent or coloring agent to a drug product, as long as the agent is therapeutically inert and in the minimum quantity necessary; or
(c) Product preparation of a non-sterile, non-hazardous drug according to the manufacturer’s FDA approved labeling.
(3) Any person engaging in compounding pursuant to this section shall:
(a) Obtain all active pharmaceutical ingredients from an FDA registered manufacturer;
(b) Unless the active pharmaceutical ingredient complies with the standards of an applicable USP-NF monograph, obtain a certificate of analysis for all active pharmaceutical ingredients procured for compounding and retained for a period of not less than three (3) years from the date the container is emptied, expired, returned, or disposed of. The certificate shall contain the product name, lot number, expiration date, and assay;
(c) Use equipment and utensils of suitable design and composition and that are cleaned, sanitized, or sterilized as appropriate prior to use; and
(d) Remove unknown or questionable products from stock and isolate such products for return, reclamation, or destruction.
(4) Compounding any drug products for human use that the FDA has identified as presenting demonstrable difficulties in compounding or has withdrawn or removed from the market is prohibited.
(5) A drug product that is commercially available may only be compounded if not compounded regularly or in inordinate amounts or if the commercial product is not reasonably available in the market in time to meet a patient’s needs.
(6) Limited quantities of a drug may be compounded or sterile prepackaged prior to receiving a valid prescription drug order based on a history of receiving valid prescription drug orders for the compounded or sterile prepackaged product.
(7) Policies and procedures for the compounding or sterile prepackaging of drug products shall ensure the safety, identity, strength, quality, and purity of the finished product. To meet this standard, licensees and registrants shall take into consideration the applicable provisions of USP chapters 795 and 797, and USP-NF chapters 1075 and 1160.