Updated Dispense in Original Container Chart

Medications that are required to be dispensed in their original container continue to appear in audits. Billing for a quantity that is not divisible by the full bottle size is a red flag to the PBM and, unfortunately, easily recoupable. Many of these products are sensitive to light/moisture or have only been studied under storage in their original container; thus, removing them from the original package may cause stability and potency issues. Product labeling can be obtained from the FDA’s DailyMed website, which was referenced by PAAS National® to update the Dispense in Original Container chart under the Tools & Aids section of the PAAS member portal.

For example, PAAS analysts have seen an increase in

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questions regarding Truvada® for HIV post-exposure prophylaxis (PEP). Prescribers are issuing scripts for 28 days to follow the PEP treatment guidelines by the CDC, but one of the drugs included in the CDC 28-day PEP treatment regimen is Truvada®, which comes in 30-count bottles with labeling to “dispense only in original container.” PAAS cannot recommend dispensing outside of FDA guidelines and advises the pharmacy to obtain authorization from the prescriber to dispense the full bottle.

Additionally, pharmacies dispensing to nursing homes or providing medication packaging to patients in the retail pharmacy setting must also follow the FDA guidelines to dispense in the original container.

PAAS Tips:

  • Print and display a copy of the PAAS National® Dispense in Original Container chart near the billing station
  • Place labels on the shelf by products required to be dispensed in their original container
  • Only bill these products for quantities divisible by the full bottle size to decrease audit risk
  • If necessary, contact the prescriber for authorization to change the prescribed quantity to facilitate dispensing in the original container and document the change with a clinical note
  • Contact PAAS with concerns or for further clarifications
Sara Hathaway, PharmD
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