If your pharmacy has been vandalized or looted in the recent riots that have affected many cities and towns across the country, depending on the issue, there may be a number of notifications that the pharmacy is required to make as it relates to the Drug Enforcement Administration “DEA,” and Pharmacy Benefit Managers (“PBMs”).
In addition to the practical challenges, looting requires that a pharmacy take particular action. Where looters have stolen or destroyed the pharmacy’s DEA Form 222s beyond use, a pharmacy should contact the DEA’s registration unit on the website linked below. The link informs pharmacies how to obtain expedited replacement of DEA Form 222s. For theft or loss of controlled substances, 21 CFR §1301.76(b) requires that the registrant inform their DEA Division Office, in writing, within one business day of the discovery. With respect to meeting the “in writing” requirement, a registrant can simply send an email to the DEA point of contact for that State as indicated in the link below. In addition, the registrant is required to submit a DEA Form 106 as a report of theft or loss of controlled substances either online or by sending the form to the local DEA field office. DEA registrants should also perform an internal reconciliation of controlled substances inventory to determine the quantities of controlled substances lost or stolen and make the requisite report on a DEA Form 106 as soon as possible. Following these steps will provide protection against subsequent audits or investigations.
Finally, if a pharmacy has been seriously damaged/destroyed during the civil unrest, and the pharmacy is looking to open a temporary pharmacy at the same physical registered address (i.e. temporary structure at the address’s parking lot) it is permissible to operate a temporary pharmacy at the same registered address under the same DEA number that was issued to the damaged/destroyed pharmacy under certain conditions. Additionally, the temporary structure is required to comply with all regulatory requirements applicable to registered pharmacies. If a temporary pharmacy is set up, it is suggested that the pharmacy informs the local DEA field office of the new security measures in place at the pharmacy’s temporary location. Specifically, with respect to controlled substances stored or dispensed in the temporary structure, the security measures must comply with 21 CFR §1301.71 and 21 CFR §1301.75(b). If the damaged/destroyed pharmacy has temporarily moved to a different physical address, the pharmacy is required to update the address on the DEA registration to indicate the new physical location. Additionally, registrants need to ensure that applicable state and local law in their state permits this type of transfer. It is also recommended that the pharmacy contact the local DEA field office for assistance in record-keeping and security requirements for the new address of the temporary pharmacy as well. As with temporary structures at the same address, a pharmacy with a temporary location at a new address is required to comply with all regulatory requirements applicable to registered pharmacies, including security control requirements.
In addition to some of the DEA notifications required in the scenarios described above, it is important that pharmacies contact their state pharmacy board for additional guidance and be aware that there may be additional PBM reporting requirements such as change of address notifications within a certain number of days.
How Frier Levitt Can Help
For pharmacy owners looking for assistance on how to proceed if their pharmacy was damaged/destroyed by the civil unrest, Frier Levitt is willing to evaluate the pharmacy’s needs and assist on a pro bono basis. Contact us today for more information.
For more information on this issue, please visit the DEA’s website : https://www.deadiversion.usdoj.gov/faq/civil_unrest.htm