All of us in health care are required to deal with a myriad of regulations from various governmental agencies. The primary regulatory agency for assisted living and skilled nursing facilities is The Department of Health Services.
Pharmacies are regulated and audited by the Arizona Board of Pharmacy, The Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). Often care facility staff are not intimately familiar with pharmacy regulations. Therefore, customers have often asked us to do things that might violate regulations from one or more of the agencies above. We really dislike saying no to customer requests. However, we cannot do something that places the pharmacy out of compliance. Here are some of the requests we have had from customers who are unaware they are violations of pharmacy regulations:
- A pharmacy cannot repackage medications that have been dispensed by another pharmacy. The Arizona Pharmacy Board specifically prohibits pharmacies from repackaging and relabeling a prescription that has been dispensed by a different pharmacy. Pharmacies are held accountable for ensuring that medications are purchased from legal, pedigreed sources and for ensuring that they are stored under the proper conditions. This cannot be done for drugs that were packaged by a previous pharmacy.
- Pharmacies are not allowed to re-dispense any drugs that have been returned from assisted living facilities. In Arizona pharmacies are not allowed to credit and reuse any medications that have been dispensed to assisted living facilities in anything other than the original manufacturer’s packaging. Pharmacy regulations for skilled nursing facilities are different and allow for the credit and reuse of whole unit-dose packages that were previously dispensed by the same pharmacy accepting the return.
- Pharmacies may not take back controlled substances. Facilities must make arrangements for destruction of unused controlled substances. Reverse distributors can provide containers for mail-in return or locked receptacles for periodic pick up.
- Pharmacies MUST have a signed hard copy for ALL controlled substance prescriptions. Faxed prescriptions for drugs in class CII are only allowed for patients in skilled nursing or under hospice care. Faxed prescriptions for drugs in classes III – V are allowed in assisted living if they were faxed by the doctor or his agent. The pharmacy must pick up the original hard copy of all prescriptions in classes II-V that were faxed from an assisted living facility.
These are just a few of the regulations affecting long term care pharmacies. I hope you find these helpful. From time to time, you may be offered one of these services by a pharmacy provider who may be ignorant of the regulations. Just because the pharmacy is ignorant does not make these any less of a violation.
Thank you for allowing us to service your pharmacy needs and for helping us remain compliant with the law.
Sincerely,
John Saliba, RPh., President