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.
Added to NAC by Bd. of
Pharmacy by R032-02, eff. 5-31-2002; A by R035-06, 9-18-2008; A by
R100-23A,
eff. 6/10/2024
