Does your pharmacy compound non-sterile topical preparations such as diclofenac gel?

May 1, 2019

Existing pharmacies are required to comply with the first two priorities identified in the Standards for Pharmacy Compounding of Non-Sterile Preparations and the accompanying guidance document by January 1, 2020. New pharmacies must demonstrate full compliance prior to opening. In preparing for this deadline, you should complete a risk assessment for each active pharmaceutical ingredient (API) in the non-sterile compounds you prepare. Part of this risk assessment includes having a pharmacist review and approve the assigned beyond-use date (BUD) for each compound.

The BUD is the date after which a non-sterile compounded preparation should no longer be used. BUDs should be assigned conservatively. When assigning a BUD, compounders should consult the literature and documentation available about stability in general and on the specific stability of the API. When a manufactured drug is used as the API, information provided by the manufacturer may be used as a reference. The manufacturer’s expiry date for the drug should not be used as the BUD for the final preparation.

The nature of the ingredient used, the compounding method, degradation mechanisms, compatibility, dosage form, potential for microbial proliferation in the preparation, the container in which the preparation is packaged, the expected storage conditions, and the intended use and duration of therapy should all be considered, and the BUD assigned conservatively.

In the absence of any stability data for a drug or a specific non-sterile compounded preparation, compounding personnel must adhere to Table 4 in Section 6.1.1 of the Guidance Document for Pharmacy Compounding of Non-sterile Preparations.

Table 4 presents maximum BUDs recommended for non-sterile compounded preparations that are packaged in air-tight, light-resistant containers and stored at controlled room temperature, unless otherwise indicated. 

Beyond-use date (BUD) by type of formulation* 

  • Non-aqueous formulations: the BUD is not later than the time remaining until the earliest expiry date of any API or six months, whichever is earlier.
  • Water-containing oral formulations: the BUD is not later than 14 days with storage at controlled cold temperatures.
  • Water-containing topical/dermal, mucosal liquid, and semi-solid formulations (such as preparations for topical application, like creams, gels, etc.): the BUD is not later than 30 days.

*These maximum BUDs are recommended for non-sterile compounded drug preparations in the absence of stability information that is applicable to a specific drug or preparation. The BUD shall not be later than the expiration date on the container or any component.

Next steps

Review the BUDs assigned to your pharmacy’s commonly prepared topical creams and gels. For water-containing topical/dermal, mucosal liquid and semi-solid formulations, the assigned BUD must generally not be later than 30 days. “Water-containing” may refer both to preparations where water has been added as an ingredient, or where water is already inherently a component of the formulation (e.g., creams, gels, etc.). Assigning alternative BUD dates requires a critical appraisal of the literature and stability documentation that is applicable to the specific drug or preparation in question. 

References

United States Pharmacopeial Convention (USP). General chapter <795>: pharmaceutical compounding — nonsterile preparations. In: USP compounding compendium. Rockville, MD: USP; 2016.

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