Iowa Board of Pharmacy Reminder That All Iowa Pharmacies Respond to the Following Survey

Compounding Survey
The Board has requested that all Iowa pharmacies respond
to the following survey. Responses may be sent via e-mail to
terry.witkowski@iowa.gov. Please respond by July1. Are you compounding prescription or over-the-counter
(OTC) drugs at your pharmacy?
2. If you are engaged in compounding, what type of compounding
is being done (eg, sterile, nonsterile, OTC)?
3. Does your pharmacy ship compounded products to
other states?
4. Are your pharmacists, technicians, or the pharmacy
itself accredited?
5. If accredited, what is the name of the accrediting body?
6. Are all compounds dispensed pursuant to a patientspecific
prescription?
7. If compounds are distributed for “office use,” what is the
percentage of total compounded prescription volume?
8. Does your pharmacy have a separate compounding
area within the prescription department? If so, please
describe.
9. Are you compounding any commercially available
products? If so, what products are being produced and
in what quantities?
10. Does your pharmacy document and track adverse drug
events associated with compounded drug products?

quoted from Iowa Board of Pharmacy June 2013 Newsletter

Iowa Board of Pharmacy Clarification on Compounded Preparations

Clarification on Compounded
Preparations
Iowa Board of Pharmacy Subrule 657 IAC 20.3(1) allows
the compounding of a commercially available product only if
it is necessary to meet the unique medical need of a patient.
The complete text of that subrule is provided below. Pursuant
to 657 IAC 20.2, all compounding, regardless of the type
of product, is to be done pursuant to a prescription and the
prescription must be based on a valid pharmacist/patient/prescriber
relationship. Subrule 657 IAC 20.3(4) allows for the
preparation of non-patient-specific products for “office use” if
the product is administered to an individual patient by the prescribing
practitioner in a professional practice setting. Subrule
657 IAC 20.3(4) also allows a pharmacy to prepare and sell
to a hospital pharmacy a compounded drug product prepared
pursuant to a prescriber’s authorization for administration to a
specific patient. Iowa law and rules have never allowed a pharmacy
to prepare and sell to a hospital pharmacy compounded
preparations in the absence of a prescription. Such activity is
considered manufacturing. This would include the preparation
of sterile products such as outsourced compounded solutions,
IVs, or injectables.
657 Iowa Administrative Code – 20.3(1) Compounding
commercially available product. Based on the
existence of a pharmacist/patient/prescriber relationship
and the presentation of a valid prescription,
pharmacists may compound, for an individual patient,
drug products that are commercially available in the
marketplace, if the compounded product is changed
to produce for that patient a significant difference, as f
authorized by the prescriber, between the compounded
drug and the comparable commercially available drug
product, or if use of the compounded product is in the
best interest of the patient. “Significant difference”
would include the removal of a dye for a medical reason
such as an allergic reaction. When a compounded
product is to be dispensed in place of a commercially
available product, the prescriber and patient shall
be informed that the product will be compounded

quoted from Iowa Board of Pharmacy June 2013 Newsletter

Kentucky Board of Pharmacy Issues a Reminder About Compounding Issues

Compounding Issues
In line with FDA’s statement, pharmacists are reminded that 20 CSR
2220-2.200(9) provides:
Compounding of drug products that are commercially available
in the marketplace or that are essentially copies of commercially
available Federal [Food and] Drug Administration (FDA) approved
drug products is prohibited. There shall be sufficient
documentation within the prescription record of the pharmacy
of the specific medical need for a particular variation of a commercially
available compound.

quoted from Kentucky Board of Pharmacy June 2013 Newsletter

Kentucky Board of Pharmacy Hires a New Pharmacy and Drug Inspector

New Pharmacy and Drug Inspector
Amanda Harding, RPh, began working as a pharmacy and drug
inspector for the Board on May 1, 2013. She is a 2008 graduate of the
University of South Carolina College of Pharmacy. Amanda’s pharmacy
background consists primarily of working in community pharmacy. She
was a pharmacy manager for Walgreens from 2009 to 2013. She is a
resident of Louisville, KY, and will be inspecting Louisville and some
surrounding counties.

quoted from Kentucky Board of Pharmacy June 2013 Newsletter

New Mexico Board of Pharmacy Proposed Changes to Compounding Rules

During the April 18-19, 2013, New Mexico Board of Pharmacy
meeting, three regulation changes were made. One of  these
regulation changes is discussed below and relates to compounding

16.19.30.9 NMAC – Compounding of Nonsterile Pharmaceuticals;
Operational Standards. This regulation revision
states that a pharmacy may no longer compound for a prescriber’s
office use. The wording allowing for office use compounding
was removed from the regulation. A compounded
medication may be sold by a pharmacy by prescription only.
The labeled compounded product is sold after receipt of a
valid prescription is issued to a specific patient.
All Board regulation changes are heard in open session
during Board meetings. Links to the proposed changes are
available online. Go to the Board Web site and click on the
agenda for the Board meeting. There you will find a link to
a proposed regulation change. Public and professional comments
are welcome. Please submit comments to the Board
through written correspondence at least 15 days prior to the
Board meeting, or you may appear in person to express your
opinion.

quoted from New Mexico Board of Pharmacy June 2013 Newsletter