Is It Time to Purge? Understanding Record Retention Requirements

The majority of prescriptions filled by pharmacies are based off of an electronically-sent prescription, or “e-script” – 94% according to a 2021 Surescripts National Progress Report to be exact. However, physical hardcopies may still exist in the form of telephone orders, transfers, faxes and written hardcopies. In an effort to free up physical space, amongst other reasons, a common question PAAS National® analysts receive is in regard to how long pharmacies are obligated to retain physical hardcopies of prescriptions, in addition to other physical records. In essence, “PAAS, can I get rid of this yet?”.

Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!

Join today!

Unfortunately, there is not a straightforward answer. The pharmacy needs to consider a number of things in order to ensure they are in compliance.

Many regulations exist which impact how long records are maintained; inconveniently, they all differ. With that said, the pharmacy must maintain the records to accommodate the longest time period, relieving the pharmacy from memorizing specific regulations. According to 42 CFR §422.504(d) and 42 CFR §423.505(d), two federal regulations governing the CMS Medicare Part D Program, records must be retained for a period of ten (10) years in addition to the current contract year, which includes, but is not limited to, hardcopy prescriptions, signature logs, copay collection and invoices. Since Medicare Part D has the longest record retention requirement, it is PAAS’ recommendation to retain records for 11 years.

Pharmacies need to also consider in which format the records may be stored. As addressed above, electronic transmission is the primary origin of prescriptions. However, there still exists a fraction of prescriptions that pharmacies may have in a physical hardcopy form. It is common for states to have a requirement for hardcopies to be retained in their original form for a period of time before converting to an electronic format.

In the same vein as state-level original format requirements, the DEA has record retention requirements, including but not limited to controlled substance prescriptions, invoices, inventory counts. Controlled Substances must be kept in their original form for two (2) years from the written date. If a pharmacy opts to convert a physical hardcopy to an electronic copy thereafter, it needs to be an exact copy of the front and back of the prescription even if the back of the prescription is blank. 

In conclusion, PAAS urges members to be mindful of how they retain records, whether it is in electronic or physical format. In the case of software changes/crashes/etcetera, ensure there is a backup method to be able to access prescriptions (and other important documentation) in a “readily retrievable” manner. Regardless of the reason, pharmacies are still obligated to respond to audit requests.

PAAS Tips:

  • PAAS FWA/HIPAA Compliance Program members can refer to Section 4.3 of the Provider Manual to ensure that information conforms to your intended practices.
  • Medicaid record retention requirements may be more stringent than state regulations
  • For audit purposes, clinical notations must be retrievable for auditor’s review

Meredith Thiede, PharmD
Latest posts by Meredith Thiede, PharmD (see all)