Are there federal or state regulations for recording keeping in pharmacies?

Yes – there are several federal and state regulations to be aware of regarding record keeping. These requirements typically fall into three categories:

• Detailed information that must be kept in a record.
• Record keeping practices.
• The length of time a record must be kept. 

Who oversees record keeping practices in pharmacies?

The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have legal authority over pharmacy records.

• FDA requirements largely pertain to labeling.
  • These requirements are largely found in the Food, Drug, and Cosmetic Act (FDCA).
• The FDA has also published a policy guide outlining the requirements for Computerized Prescription Recordkeeping.
  • Originally published in 1980, and continues to be the most relevant guide on the topic of compliance.

What types of documents are pharmacies required to keep?

Pharmacies are required to keep the following types of documents, however, additional requirements may apply.

• Prescription records.
• Medication inventory records for legend and over-the-counter medications.
• DEA Form222, or the electronic equivalent.
• Power of Attorney authorization to sign DEA Form 222.
• Reports of theft or significant loss - DEA Form 106.
• Reverse distributor records, or inventory of drugs surrendered for disposal DEA Form 41.
• Records of transfers between pharmacies and other providers.
• DEA registration certificate.
• State licensure documents
• Records required by HIPAA.
• Controlled substance inventory and sales reports.
• Precursor chemical purchases and sales (e.g., pseudoephedrine).
• Self-certification certificates.
• Required by the Combat Methamphetamine Epidemic Act of of 2005
• Third-party billing records.
• Prescriptions filled from foreign prescribers.
• Poison or exempt narcotic sales.

What types of filing systems are pharmacies required to keep?

Most records required to be kept by pharmacies relate to dispensing and inventory:

• Pharmacies are required to maintain either a “two-file” or “three file” system if they keep records in paper form.
  • An electronic or paperless system may also be acceptable.
• States may have additional requirements.

How do state requirements effect record storage and retrieval?

Regulations vary from state-to-state, however, they typically cover regulations regarding the length of time pharmacy records must be maintained and available for inspection by regulators.

• Most states mirror federal law, or extend the length of time that records must be maintained.

Are there other requirements on pharmacies to maintain records?

Typically contracts between pharmacies and health insurance companies or Prescription Benefit Management Companies (PBMs) prescribe requirements for records management.

• Medicare Part D contracts typically require ten years of record retention.

Are there options for pharmacies that do not have enough space to store these records on-site?

Pharmacies often contract with off-site records management companies, or rent space for off-site file storage. Privacy requirements, and requirements for having “readily retrievable records” must be considered when arranging for these services.

• Example: Some boards of pharmacy require a pharmacy to notify them of the intention to store records offsite, and pre-approval may be necessary.
• Depending upon the age of the records, the DEA may require the pharmacy to notify the agency prior to moving the records.