FAQ | Pharmaceutical Categorization + Compliance

Yes. The DEA has expanded their acceptable methods of destruction for controlled substances as long as they meet the requirements of destruction. The controlled substance is officially “destroyed” when placed into the Secure a Drug container because it is rendered non-retrievable. For expired/unused controlled substances in inventory, the customer will need to follow specific DEA requirements for destruction. Requirements vary by state.

Daniels has utilized an independent source to test a representative sample of controlled substances. The results demonstrated 99.99% deactivation after 24 hours.

Secure a Drug does NOT replace witness wasting of controlled substances. You must still continue to witness waste these medications.

No. Secure a Drug can only accept Schedule II through Schedule V substances.

Secure a Drug containers are processed at a local Daniels facility or incinerated in accordance with appropriate state and federal regulations.

No. Secure a Drug will not render a pharmaceutical to be non-RCRA hazardous. Secure a Drug does not change the hazardous characteristics of RCRA substances. A “corrosive” waste is still hazardous if placed into Secure a Drug and needs to be treated accordingly.

Secure a Drug does not meet EPA standards for hazardous waste disposal (i.e., the waste is still considered RCRA hazardous). However, it can still be used as a means to render RCRA hazardous waste non-retrievable assuming that the user is properly disposing of the full Secure a Drug container as RCRA hazardous pharmaceutical waste with its unique hazardous waste profile.

Examples include:

• Chloral Hyrdrate
• Fentanyl Sublingual Spray
• Phenobarbital
• Testosterone Gels / Solutions
• Valium Injectables / Gels

Disposal requirements for controlled substances are regulated by the US Drug Enforcement Administration (DEA) and laid out in Title 21 Part 1317 of the US Code of Federal Regulations. This law provides explicit provisions depending on whether the disposer is a DEA registrant or non-registrant as well as destruction requirements and procedures for transferring controlled substances. While there is no requirement for a specific method of destruction, the law clarifies that all controlled substances must be rendered non-retrievable in order to prevent diversion of substances to illicit activity

According to 21 CFR 1300.05, “A controlled substance is considered “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.”

The DEA does not endorse or support any product, but instead requires that a product used to destroy controlled substances meets the definition of “non-retrievable.” Secure A Drug does meet this definition, in that it permanently alters the substance’s physical or chemical condition or state through irreversible means and thereby renders the substance unusable for all practical purposes, and it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue.

For expired/unused controlled substances, the registrant will need to complete a disposal log (DEA Form 41 – instructions here) and maintain that record onsite for at least two years. A copy of the DEA Form 41 can be found here. The registrant would complete a new form for each new Secure A Drug container. Official destruction of the drug occurs when it is wasted into the Secure A Drug because Secure A Drug renders the medication non-retrievable.

Be sure to check with your state board of pharmacy for local or state requirements in addition to those laid out by the DEA.