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CONTROLLED SUBSTANCE OVERVIEW: AUTHORIZED USE
The registrant/licensee is responsible for managing the controlled substances in accordance with the requirements of the regulations including inventory, record keeping and security provisions. Authorized agents of the registrant/licensee may engage in approved activities under the direction of the registrant/licensee. These activities must be delegated by the licensee/registrant to the authorized agent in writing. Lab employees can be considered authorized agents of the person with an active State of Michigan license and DEA registration if they are acting in the usual course of their business or employment and with proper screening and authorization by the registrant. The registrant/licensee must screen all authorized agents. Each authorized agent must complete a copy of the Employee Questionnaire for Employees Who Will Have Access to Substances Regulated by the US Drug Enforcement Agency.
- Authorized agents must follow all state and federal regulation governing controlled substances.
- Authorized agent access to controlled substances should be kept to a minimum.
- A current list of authorized agents with access to controlled substances should be maintained. A form that can be used for this purpose can be found in the Controlled Substances section of the EHS web site.
- Only the registrant/licensee and authorized agents are allowed access to the storage cabinet where controlled substances are stored.
- Only the registrant/licensee or an authorized agent is allowed to reconcile controlled substance shipments from outside vendors into the general inventory.
- If authorized agents are to administer controlled substances, that responsibility must be delegated to them in writing.
- All responsibilities delegated to authorized agents must be documented. This includes conducting inventories, receiving packages, having access to the storage location, administering drugs, etc. This documentation must be kept up to date.
State law and federal regulations provide limitations on who can be an authorized agent.
MI R 338.3145
Rule 45. (1) The following individuals shall not be employed or otherwise utilized, with or without compensation, by a person who is licensed by the administrator pursuant to section 7303, 17711, or 17748 of the act in any manner or capacity that allows the individuals access to controlled substances:
- An individual who the licensee knows, or should reasonably know, to be a substance abuser as defined in section 6107 of the act. This subdivision does not apply to a licensee enrolled in the health professional recovery program under a current monitoring agreement.
- An individual whose controlled substance license is suspended, revoked, or denied.
- An individual whose license issued by this state or another state is under suspension or revoked in this state or another state for a violations that involves controlled substances.
- An individual who has been convicted of a crime that involves controlled substances and who is currently under sentence for that conviction.
21 CFR 1301.90
It is the position of DEA that the obtaining of certain information by non-practitioners is vital to fairly assess the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity, essential to overall controlled substance security. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry. It is, therefore, assumed that the following questions will become part of an employer’s comprehensive employee screening program:
Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court martial.) If the answer is yes, furnish details of conviction, offense, location, date and sentence.
Question. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details.