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Compounded and repackaged products must not be manipulated

November 13, 2019
Community pharmacies must consider compounds prepared by compounding and repackaging pharmacies as “finished” products.

ACP pharmacy practice consultants (PPCs) have noticed some Alberta pharmacies are pursuing agreements, or are reviewing existing agreements, with compounding and repackaging pharmacies to meet the needs of their patients while being compliant with the non-sterile compounding standards. It is important that pharmacists and pharmacy technicians understand the limitations of compounding and repackaging agreements.

“Some pharmacies have planned or questioned changing, manipulating, adding, and/or diluting either concentrated or common products that compounding and repackaging pharmacies prepare,” said Tyler Watson, PPC based in Edmonton. “Then, the pharmacies plan to adjust a prescription pursuant to the order they actually receive from a particular patient. ACP has been asked whether it is acceptable to further adjust products they receive from a compounding and repackaging pharmacy.”

The answer is, NO.

The ACP Compounding and Repackaging Pharmacy Agreement states the following in section 2.4:

2.4 Nothing in this Agreement allows the Compounding and Repackaging Pharmacy to compound or repackage a drug for or on behalf of the Community Pharmacy unless the Community Pharmacy:

  1. holds a valid prescription for a patient for that drug; or
  2. has a reasonable expectation of receiving a valid prescription for a patient for that drug in the immediate future.

Because a compound may only be prepared pursuant to a specific prescription for an individual or in anticipation of a prescription for that compound, the community pharmacy that receives the compounded product must consider it the “finished” product. If an appropriate patient assessment took place in the community pharmacy and the product was appropriately assessed by the compounding and repackaging pharmacy, the product should be considered ready to dispense without further manipulation.

“Any adjustment or manipulation to that product by the community pharmacy could negatively impact the integrity, quality, stability, and sterility of that compound,” said Tyler. “To do so is not only in contravention of the regulations, but also could result in an inferior product being dispensed.”

The requirements for compounding in a pharmacy, in general, are less stringent than they are for manufacturing. For that reason, compounds are not appropriate to be used as ingredients in other compounds.

“Something that’s been prepared in one pharmacy, then opened and re-compounded in another pharmacy, just adds more risk for that final product,” said Tyler.

Simply put, “compounding a compound” may result in a poor-quality product and this adds another level of risk to your patient.

Tyler advises pharmacies that either have, or plan to have, compounding and repackaging agreements to reach out to their providers to confirm expectations and responsibilities of both parties. It should be clear that the compounding and repackaging pharmacy is only preparing compounds pursuant to prescriptions and that the community pharmacy will dispense the product without any further alterations.

ACP’s Standards for the Operation of Licensed Pharmacies require pharmacies to ensure they are in a position to provide compounding services to their patients. That could mean reaching an agreement with a compounding and repackaging pharmacy, reviewing an existing compounding and repackaging agreement, or investing in your pharmacy’s policies, procedures, training, infrastructure, and equipment to provide the services on your own. It’s up to you to determine what works best for your pharmacy and, ultimately, your patients.

NOTE: This article was updated on May 18, 2022, to link to new versions of the compounding and repackaging agreement form.