Chapter 12. Impoundment and Disposal of Drugs and Prescription Records
Regulation .01 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Authorized prescriber” means:
(a)
A licensed dentist, licensed physician, licensed podiatrist, licensed veterinarian, or to the extent permitted under Health Occupations Article, §8-601, Annotated Code of Maryland, certified nurse midwife;
(b)
A certified nurse practitioner to the extent permitted under Health Occupations Article, §8-508, Annotated Code of Maryland; or
(c)
Another individual authorized by law to prescribe prescription or nonprescription drugs or devices.
(2)
“Board” means a health occupation licensing board:
(a)
Authorized to issue a permit, license, or certificate under Health Occupations Article, Annotated Code of Maryland; and
(b)
That has regulatory authority over the permit holder or authorized prescriber who is responsible for the drugs or prescription records subject to impoundment.
(3)
“Department” means the Maryland Department of Health, or its authorized agent.
(4)
“Drug” means a prescription drug or device or a nonprescription drug, as defined in Health-General Article, §21-1113(a), Annotated Code of Maryland.
(5)
“Impoundment order” means an order issued by the Department to impound drugs or prescription records in accordance with Health-General Article, §21-1113, Annotated Code of Maryland, and this chapter.
(6)
“Permit holder” means a holder of, or applicant for:
(a)
A pharmacy permit, manufacturer's permit, or distributor's permit issued by the State Board of Pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland; or
(b)
A dispensing permit issued by the board under the authority of Health Occupations Article, §12-102(c)(2), Annotated Code of Maryland.
(7)
“Prescription records” means records maintained by a permit holder or authorized prescriber which identify a patient and any medical information relating to that patient.
(8)
“Transfer” means the release of impounded drugs or prescription records by the department to a transferee.
(9)
“Transferee” means a permit holder or authorized prescriber to whom impounded drugs or prescription records are transferred in accordance with this chapter.
Regulation .02 Requirements for an Impoundment Order.LinkCopy Citation
A.
The Department may issue an impoundment order if:
(1)
A permit holder's permit or authorized prescriber's license has expired or has been revoked or suspended;
(2)
An application for a permit or license has been denied;
(3)
A board has:
(a)
Determined that the permit holder or authorized prescriber failed to comply with a board order, letter of surrender, or law regarding the disposition of drugs or prescription records; and
(b)
Requested that the Department impound the drugs or prescription records;
(4)
The drugs pose an imminent threat to the public health, safety, or welfare; or
(5)
The confidentiality of the prescription records is in imminent danger of being compromised.
B.
The Department may issue an impoundment order based on:
(1)
On-site observation by a law enforcement official, the Department, or other regulatory official of drugs that pose imminent danger to the public health, safety, or welfare;
(2)
On-site observation by a law enforcement official, the Department, or other regulatory official that the confidentiality of prescription records is in imminent danger of being compromised;
(3)
Investigation by the Department or law enforcement authority sufficient to prove that drugs are posing an imminent danger to the public health, safety, or welfare, or that the confidentiality of prescription records is in imminent danger of being compromised; or
(4)
Review of the board's licensing records that indicate the permit holder or authorized prescriber does not have the licensing or permit authority to possess drugs or prescription records.
C.
Before execution of an impoundment order issued in accordance with Health-General Article, §21-1113(c)(1), Annotated Code of Maryland, the Department shall:
(1)
Attempt to serve written notice of the impoundment on the permit holder or authorized prescriber by certified mail at the last known address in the board's licensing files; and
(2)
Provide the permit holder or authorized prescriber with an opportunity to:
(a)
Avoid impoundment by allowing the permit holder or authorized prescriber to dispose of the drugs or prescription records in a manner acceptable to the Department;
(b)
Review the nature, type, and amount of information upon which the Department issued the impoundment order; and
(c)
Avoid impoundment by providing the Department with information upon which the Department could reasonably conclude that the impoundment is not warranted.
D.
Notice of Order of Impoundment.
(1)
If the Department issues an impoundment order in accordance with Health-General Article, §21-1113(c)(2), Annotated Code of Maryland, the Department shall attempt to contact the permit holder or authorized prescriber at the last known address or telephone number contained in the board's licensing files before executing the impoundment order.
(2)
Posting.
(a)
If the Department is unsuccessful in contacting the permit holder or authorized prescriber before the execution of the impoundment order, the Department shall post the impoundment order in a conspicuous place at the site of the drugs or prescription records.
(b)
The posted impoundment order shall contain information regarding:
(i)
The location of the impounded drugs or prescription records; and
(ii)
An individual to contact for further information.
Regulation .03 Disposition of Impounded Drugs or Prescription Records.LinkCopy Citation
A.
If the Department executes an impoundment order against a permit holder or authorized prescriber, the Department shall:
(1)
Arrange for the drugs or prescription records to be kept in a secure location;
(2)
Ensure that any location which stores impounded drugs provides the necessary temperature controls and equipment to properly maintain the drugs; and
(3)
Provide the permit holder or authorized prescriber with a list of all drugs and prescription records impounded.
B.
Reclamation or Transfer.
(1)
The permit holder or authorized prescriber may petition the Department to reclaim or transfer the impounded drugs or prescription records within 30 days of the date of the impoundment order.
(2)
In order to reclaim or receive a transfer of impounded drugs or prescription records, the permit holder, authorized prescriber, or transferee shall demonstrate:
(a)
Capability to maintain the impounded drugs or prescription records in compliance with all relevant State and federal laws;
(b)
Applicable licensing or permit authority to obtain possession of the impounded drugs or prescription records; and
(c)
If the impounded drugs or prescription records are to be transferred to a transferee, the existence of an express written agreement between the permit holder or authorized prescriber and the transferee, permitting the Department to release the impounded drugs or prescription records to the transferee.
(3)
If the Department grants a petition to reclaim or transfer impounded drugs or prescription records, the petitioner shall arrange for the removal and transport of the impounded drugs or prescription records.
(4)
Notice of Denial.
(a)
If the Department denies a petition to reclaim or transfer impounded drugs or prescription records, the Department may destroy or transfer the impounded drugs or prescription records in accordance with §C(2) of this regulation at least 15 days after the Department has attempted to serve notice by certified mail at the last known address of the permit holder or authorized prescriber.
(b)
The notice shall indicate that the Department:
(i)
Has denied the petition; and
(ii)
Intends to destroy or transfer the impounded drugs or prescription records.
C.
Disposition of Drugs or Prescription Records if No Petition is Filed.
(1)
If the permit holder or authorized prescriber has not petitioned the Department within 30 days as provided in §B of this regulation, the Department may destroy or transfer the impounded drugs or prescription records.
(2)
The Department shall destroy or transfer:
(a)
Impounded drugs in accordance with all relevant State and federal laws, including Health-General Article, §21-1113(i), Annotated Code of Maryland; and
(b)
Prescription records in accordance with Health-General Article, §§4-403 and 21-1113(i), Annotated Code of Maryland.
D.
Reimbursement.
(1)
The permit holder or authorized prescriber shall reimburse the Department for the reasonable expenses relating to the collection, storage, and disposition of impounded drugs or prescription records.
(2)
The Department may require that the permit holder or authorized prescriber provide advance reimbursement to the Department as a precondition to granting a petition to reclaim or transfer impounded drugs or prescription records.
Chapter annotations
Authority: Health-General Article, §21-1113, Annotated Code of Maryland
History: Effective date: June 24, 2002 (29:12 Md. R. 927)