NAC639.757. Preparation and sale of compounded drugs by pharmacy or pharmacist: License as manufacturer not required under certain circumstances; unsafe or ineffective drug; restrictions on sale.

     1. A pharmacy or pharmacist is not required to obtain a license as a manufacturer to compound drugs if:

     (a) The compounded drugs are prepared in a quantity that is:

          (1) Necessary to fill a prescription or chart order; or

          (2) Reasonably necessary to fill future prescriptions or chart orders based upon the previous history of practitioners and patients who regularly use the pharmacy;

     (b) The compounded drugs are not sold or otherwise provided by the pharmacy or pharmacist to any person other than the ultimate user of the drugs, the agent of the ultimate user of the drugs or a practitioner who will be administering the drugs to a patient;

     (c) The compounded drugs are dispensed pursuant to a prescription or chart order;

     (d) Except as otherwise provided in paragraph (e) and subsection 2, the active ingredients used to compound the drugs:

          (1) Have a monograph in and meet or exceed the standards of the United States Pharmacopoeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670;

          (2) Have been components of drugs approved by the Food and Drug Administration; or

          (3) Are authorized to be used in pharmacy compounding pursuant to 21 U.S.C. § 353a(b)(1) or the regulations adopted pursuant thereto; and

     (e) Except as otherwise provided in subsection 2, for an active ingredient used to compound the drugs that does not have a monograph in the United States Pharmacopoeia - National Formulary, as adopted by reference in paragraph (c) of subsection 1 of NAC 639.670, the active ingredient is:

          (1) Prepared by a manufacturer or distributed by a distributor registered with the Food and Drug Administration;

          (2) Accompanied by a certificate of analysis provided by the manufacturer or distributor of the ingredient; and

          (3) Prepared to a grade that, at a minimum, satisfies the requirements set forth in:

               (I) The Food Chemicals Codex, as adopted by reference in paragraph (d) of subsection 1 of NAC 639.670; or

               (II) Reagent Chemicals: Specifications and Procedures, as adopted by reference in paragraph (e) of subsection 1 of NAC 639.670, if the active ingredient is a certified analytical reagent, is for use in high pressure liquid chromatography, is for use in spectrophotometric applications or is a primary standard grade for use in standard solutions for analytical purposes.

     2. In compounding a drug product, a pharmacy or pharmacist may use an active ingredient that does not satisfy the requirements of paragraphs (d) and (e) of subsection 1 if the pharmacy or pharmacist establishes the purity and safety of the ingredient by reasonable means, satisfactory to the Board, which include, without limitation, analysis of the lot in which the ingredient was packaged, the reputation of the manufacturer of the ingredient and the reliability of the source of the ingredient. A pharmacy shall make and maintain a record of the means that the pharmacy relied upon in determining that an ingredient was pure and safe pursuant to this subsection.

     3. Except as otherwise provided in this subsection, a pharmacy or pharmacist shall not compound a drug that has been withdrawn or removed from the market because the drug was found to be unsafe or ineffective. A pharmacy or pharmacist may compound a drug for veterinary use that has been withdrawn or removed from the market because the drug was found to be unsafe or ineffective for use in humans if the drug remains available for veterinary use.

     4. A pharmacy shall not sell or otherwise provide a compounded drug to a retail pharmacy or a practitioner, except that a pharmacy may sell or otherwise provide a compounded drug to:

     (a) A practitioner who will be administering the drug to a patient; or

     (b) A practitioner or another pharmacy if the compounded drug is:

          (1) A highly concentrated drug product that is not commercially available; or

          (2) Needed to fill a particular prescription or chart order in the possession of the receiving pharmacy at the time the receiving pharmacy orders the compounded drug from the compounding pharmacy.

     5. The quantity of a compounded drug that is sold or otherwise provided to a practitioner or pharmacy pursuant to subsection 4 must not exceed the amount necessary for the practitioner or pharmacy to serve the present needs of the patients of the practitioner or pharmacy.

     (Added to NAC by Bd. of Pharmacy by R032-02, eff. 5-31-2002; A by R035-06, 9-18-2008)