DATE: November 15, 2012
TO: Pharmacists and pharmacies licensed by the Minnesota Board of Pharmacy
FROM: Cody Wiberg, Executive Director, Minnesota Board of Pharmacy
Given the recent tragic events surrounding the distribution of contaminated products to
Minnesota health care providers, I am sending this reminder memo to all pharmacists and
pharmacies licensed by the Board.
The Minnesota Board of Pharmacy frequently receives questions and complaints about the sale
of drug products to physicians and clinics for office-use. The most common question is whether
or not pharmacies can fill a prescription that is not written for a specific patient but is instead
written out for “office use”. The short answer is no, they can’t.
Minnesota Statutes §151.01, subd. 16 defines “prescription” as: “a signed written order, or an
oral order reduced to writing, given by a practitioner licensed to prescribe drugs for patients in
the course of the practitioner's practice, issued for an individual patient and containing the
following: the date of issue, name and address of the patient, name and quantity of the drug
prescribed, directions for use, and the name and address of the prescriber”. (Emphasis added).
Clearly, by law, a practitioner cannot issue a prescription without specifying an individual
patient. Thus, if a physician writes out an order on a prescription pad (or as part of an electronic
prescription or chart order) that is “for office use”, the order is not a legally valid prescription.
A pharmacy is allowed to sell prescription drugs to a physician or clinic pursuant to a wholesale
transaction, but only if it is licensed by the Minnesota Board of Pharmacy as a wholesaler. In
such cases, the pharmacy must follow all applicable state and federal laws and rules concerning
the wholesaling of drug products. However, drugs prepared by a compounding pharmacy
cannot be supplied to a physician or clinic as part of a wholesale transaction unless certain
other conditions are met, as described below
Another question the Board receives is whether or not pharmacies can provide “compounded
drugs” to physicians, clinics and other healthcare providers or facilities for office-use. The
answer is, again, no. Minnesota Rules 6800.3300 requires compounding to be done pursuant to
United States Pharmacopeia (USP) Chapters 795 or 797 standards, as appropriate. USP
Chapter 795 notes that compounding is differentiated from manufacturing by the existence of a
“practitioner-patient-compounder relationship”. When a drug product is prepared for office-use
and a specific patient is not named, no such relationship exists – since the pharmacist has no
idea who the drug will be administered to at the time he or she is preparing it.
Preparing a drug for sale to a physician or clinic for office use, when a prescription has not been
issued for a specific patient in advance of the distribution of the drug, is not compounding.
Instead, the preparation of the product would be considered manufacturing and the sale would
be a wholesale transaction. That being the case, the pharmacy would need to be licensed by
the Board as a wholesaler and a manufacturer and would need to follow good manufacturing
procedures. The pharmacy would also need to be registered by the Food and Drug
Administration as a manufacturer or would have to supply the Board with a letter from the FDA
stating that registration with that agency is not required. A non-residential pharmacy would also
need to be licensed as a wholesaler and a manufacturer by the state in which it is located.
The definition of manufacturing in M.S. §151.01, subd. 14 is: “The term manufacturing except in the case of bulk compounding, prepackaging or
extemporaneous compounding within a pharmacy, means and includes the production,
quality control and standardization by mechanical, physical, chemical, or pharmaceutical
means, packing, repacking, tableting, encapssulating, labeling, relabeling, filling or by any
other process, of all drugs, medicines, chemicals, or poisons, without exception, for
medicinal purposes”. (internal quotation marks omitted).
Bulk compounding is the preparation by a pharmacy of a supply of a compounded drug product
that is sufficient to meet its short-term anticipated need for the filling of prescriptions. It is not
the preparation of bulk amounts of a drug product that can be sold for office use.
Extemporaneous compounding is the preparation of a drug product upon receipt of a
prescription for a specific patient. Note that the prescription must be received prior to the
shipment of the drug product to the patient (or to a practitioner that will use it in the care of the
patient). Shipping a drug to a practitioner for office use and having the practitioner send back a
prescription right before or after the drug is used for a patient is not acceptable because no
practitioner-patient-compounder relationship truly exists in those circumstances.
Unless certain conditions are met, pharmacies in other states cannot legally supply Minnesota
patients or practitioners with compounded drugs. Minnesota Statutes §151.19, subd. 2 requires
any non-residential pharmacy that dispenses medications for Minnesota residents and mails,
ships, or delivers prescription medications into this state to be licensed by this Board. A
pharmacy license issued to a nonresidential pharmacy would allow it to dispense drugs to
Minnesota residents only pursuant to a prescription for an individual patient. The laws and rules
mentioned above concerning compounding, wholesaling and manufacturing apply to
nonresidential pharmacies licensed by the Board.
In addition to state laws and rules, there are federal considerations as well. The U.S. Food and
Drug Administration has issued a Compliance Policy Guide for compounding. The Guide
includes the following language: “when the scope and nature of a pharmacy's activities raise the
kinds of concerns normally associated with a drug manufacturer and result in significant
violations of the new drug, adulteration, or misbranding provisions of the Act, FDA has
determined that it should seriously consider enforcement action. In determining whether to
initiate such an action, the Agency will consider whether the pharmacy engages in any of the
following acts . . . (c)ompounding drugs for third parties who resell to individual patients or
offering compounded drug products at wholesale to other state licensed persons or commercial
entities for resale” and “(f)ailing to operate in conformance with applicable state law regulating
the practice of pharmacy”. The full CPG can be found at:
Before purchasing any drug products from a company, pharmacists and pharmacies would be
well advised to verify the company’s licensure status. That can be done using the licensure
verification page on the Board's Web site at:
Do not purchase drugs at wholesale from any entity that is not licensed by the Board as a drug
wholesaler. Do not purchase any “compounded” products at wholesale from any company that
is not also licensed as a manufacturer.
Note that pharmacies can distribute small quantities of commercially manufactured products to
other pharmacies without obtaining a wholesale license – but only to alleviate temporary
source found here