Hospitals and pharmacies are challenged to play a pivotal role in the nation's drug supply chain: dispensing medications to the public. Among the many regulations—state and federal—that govern the activities of dispensing medicine, are 3 critical laws pertaining to the safety and security of both the general public and industry professionals.
These laws pertain to: the security of the drug supply chain, the regulation and security of controlled substances, and the management of pharmaceutical hazardous waste—and are enforced by the FDA, DEA, and EPA.
FDA: The Drug Supply Chain Security Act (DSCSA)
Enacted in 2013, and enforced by the FDA, the DCSA ensures the safety and security of the US drug supply. It provides requirements and processes that pharmacies must follow in order to protect patients from receiving harmful or dangerous drugs.
By law, your pharmacy is required to do the following:
- Confirm licensing and registration. Confirm that the entities you work with are licensed or registered with the FDA.
- Store product tracing documentation. Drugs must be traced as they move through the supply chain. Therefore, for every prescription drug it receives, a pharmacy must store transaction information history, and a statement.
- Properly respond to suspect and illegitimate drugs. Establish and follow a process to investigate and handle suspect and illegitimate prescription drugs.
DEA: The Controlled Substance Act (CSA)
The handling, storage, and distribution of controlled substances in the custody of your pharmacy is regulated by the DEA and the Controlled Substances Act (CSA). The CSA provides regulations for controlled substances pertaining to:
Transfer & Disposal
Your pharmacy may hire an outside firm to help with inventory, packaging, transfer, or disposal of controlled substances in its custody.
In the unfortunate event of theft or significant loss of any controlled substance—such as an “in-transit loss” during shipment—your pharmacy must Notify DEA and Local Police; Complete DEA Form 106 (Report of Theft or Loss of Controlled Substances).
Your pharmacy must maintain complete, accurate, up-to-date records for every controlled substance purchased, received, stored, distributed, dispensed, disposed of, or otherwise passing through your pharmacy.
By law, your pharmacy must always maintain complete and accurate inventory records accounting for all controlled substances in your custody. Inventory records must be maintained for a minimum of 2 years, be readily available for inspection by the DEA, and must include the following:
- Initial inventory
- Biennial inventory (every two years)
- Newly scheduled controlled substance inventory
Your pharmacy may only dispense controlled substances upon receipt of a valid prescription from a licensed medical practitioner. Prescriptions must be signed and dated on the date issued and must include: the full name and address of both the patient and the practitioner; the practitioner's DEA number; along with the drug information—name, strength, dosage form, quantity prescribed, directions for use, and number of authorized refills.
To order a Schedule II controlled substance, an official DEA 222 order form must be used. This form is also required for each distribution, purchase, or transfer of a Schedule II controlled substance.
When dispensing prescriptions for controlled substances, your pharmacy must include a label on the package with: filling date for the prescription, pharmacy name/address, prescription serial number, patient and practitioner names, directions for use—as well as any cautionary statements as required by law under the FDA.
EPA: The Resource Conservation Recovery Act (RCRA)
Due to the discovery of pharmaceuticals in surface, ground, and drinking water sources around the country, there are rising concerns about the dangers of waste pharmaceuticals in the environment. As a result, there is a large responsibility—and an urgent need—for pharmacies and other participants in the drug supply chain, to properly manage and dispose of pharmaceutical waste.
Through the RCRA, the EPA regulates hazardous waste from the time the waste is created, all the way through transport, treatment, storage, and disposal. Following are the 6 important steps your pharmacy must follow in order to maintain compliance with EPA regulations:
- Identify. Identify each item of hazardous waste generated by your pharmacy.
- Count. Calculate the total weight of all hazardous waste that falls under the regulations of the RCRA.
- Notify. Large and Small Quantity Generators must notify the EPA or the applicable state agency of their production of hazardous waste.
- Manage. Manage the hazardous waste your pharmacy generates in accordance with the regulations for your generator category.
- Transport. All of the hazardous waste your pharmacy generates must be tracked from your pharmacy's location to the waste management facility that will ultimately dispose of it.
- Recycle - Treat - Dispose. Small and Large Quantity Generators are permitted to recycle hazardous waste on site without a permit as long as they comply with regulations regarding the accumulation of on-site waste.
To learn more, please visit www.pharmalogistics.com.