Chapter 03. Controlled Dangerous Substances

“Act” means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101—5-1101, Annotated Code of Maryland.

“Administrative probable cause” means a valid public interest, sufficient to justify an administrative warrant, allowing the inspection of the area, premises, or building to enforce this chapter.

“Agent” means a person who acts on behalf of the Department.

“Authorized provider” or “provider” means a:

“Board” means the Maryland Boards of Physicians, Podiatry, Dental Examiners, Nursing, and Veterinary Medicine.

“Chemical analysis” means the act of decomposing a substance into its constituent elements.

“Civil fine” means a fine assessed by the Department against an authorized provider, including establishments.

Commercial Container.

Controlled Premises.

“Department” means the Maryland Department of Health.

“Disciplinary action” includes but is not limited to a penalty, reprimand, restriction, suspension, or revocation of a license.

“Federal Act” means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

“Fee exempt” means an authorized provider that is required to register with the Department but is not required to pay the registration fee.

“In good standing” means having a professional license that is not subject to any form of sanction by the Board or Criminal Law.

“Inspector” means an officer or employee of the Department authorized by the Secretary to make inspections under the Act.

“Labeling” means all labels and other written, printed, or graphic matter on any controlled substance or any of its commercial containers or wrappers accompanying controlled substances.

“License” has the same meaning as State Government Article, §10-226, Annotated Code of Maryland.

Manufacture.

“Manufacturer” means a person who manufactures a drug or other substance under:

“Office of Controlled Substances Administration (OCSA)” refers to the division within the Maryland Department of Health responsible for administering the enforcement of Criminal Law Article, Title 5, Annotated Code of Maryland.

“Penalty” means monetary penalty, including but not limited to a fine.

“Person” means:

“Peyote” means the controlled substance in Schedule I under Criminal Law Article, §5-402, Annotated Code of Maryland. This schedule I listing does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church using peyote in this manner are exempt from registration.

“Pharmacist” means:

Prescription.

“Registration” means initial registration or subsequent re-registration with OCSA.

“Secretary” means the Secretary of the Maryland Department of Health.

“Sufficient application” means an application that is completed in full and has provided all of the information required by the Department.

Manufactures, distributes, dispenses, stores, and orders controlled substances;

Conducts research or instructional activities with controlled substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland;

Conducts research or instructional activities with a controlled substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland, with prior registration from the DEA;

Conducts a chemical analysis with controlled substances listed in any schedule;

Installs and maintains an automated dispensing machine containing controlled substances; or

Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church.

Apply for a registration certificate on a form made available by the Department to:

Have a professional license in good standing;

Be of good moral character;

Have no convictions for crimes of moral turpitude;

Be 18 years of age or older;

Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under Health-General Article, §21-2A-04.1, Annotated Code of Maryland; and

Except for researchers, have completed 2 continuing education credit hours:

The continuing education shall:

The continuing education shall pertain to the prescribing or dispensing of controlled substances.

Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education.

Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances.

Apply for a registration certificate on a form made available by the Department;

Obtain one registration for each separate place of business, professional practice, or location where controlled substances are:

Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances:

Submit a completed application made available by the Department;

Except for fee exempt applicants, pay the appropriate fee as set forth in Regulation .06 of this chapter;

Unless exempt from payment of a registration fee, apply for and obtain a registration certificate;

Provide an explanation for any not-applicable responses on the applications;

Notify the Department of any criminal convictions related to controlled substances;

Notify the Department of any actions taken on the applicant’s professional license;

Have the application and accompanying documents required for registration signed by the:

Provide additional documentation required by the Department pertinent to the registration, to:

May be determined invalid;

Will not be issued a refund, unless:

Will require a new application to be resubmitted.

May be determined invalid;

Will not be issued a refund, unless:

Will require a new renewal application to be submitted.

New registration certificate — $120;

Renewal registration certificate — $120;

Amend a registration certificate — $50;

Change of ownership fee — $144;

Duplicate registration certificate — $30; and

Reinstatement — $50.00.

Except for contractual positions, an employee of a hospital, clinic, institution, facility, or unit operated by a local or State government agency;

An agency, excluding a State agency and its employees, for which the State is responsible for payment of the fee, provided that the exemption is approved by the Secretary; or

A person included in 21 CFR §§1301.21.

The Secretary may not issue a credit towards or refund any registration fees to an applicant, including but not limited to, an applicant who:

The Secretary, or the Secretary’s designee, shall review the refund request and determine if a refund of any amount is appropriate.

A registration certificate expires on the date shown on the certificate.

The Secretary shall notify the registrant that the registration will expire not less than 30 days before the expiration date shown on the certificate.

A registration for which a sufficient application for renewal was submitted:

The failure to receive a renewal notice does not excuse a registrant from complying with this chapter.

A registrant whose registration has been surrendered in lieu of further investigation, revoked, suspended, or limited may not be eligible to request reinstatement for a:

To apply for reinstatement, a registrant shall:

Dies;

Discontinues business or professional practice in the State; or

Changes ownership, including when:

Notify the Secretary in writing;

Surrender the registrant’s current registration certificate; and

Legally transfer or dispose of any controlled substances relative to the registrant’s operation.

Notify the Secretary in writing at least 30 days before the change occurs;

Complete and submit a change of ownership application to the Department;

Pay the change-of-ownership fee in Regulation .06 of this chapter;

Surrender the registrant’s current registration certificate after the ownership change is finalized; and

Allow the Department to inspect the business or professional practice of the new owners.

Notify the Department at least 30 days before there is a change in the location of the registrant’s place of business or professional practice;

Apply to amend a current registration certificate; and

Pay the fee to amend a certificate in Regulation .06 of this chapter.

Any criminal convictions;

Any disciplinary actions taken against the registrant’s professional or occupational license; or

Any disciplinary actions taken against the registrant’s federal Drug Enforcement Agency registration.

Inspect the place of business or professional practice described in the application; and

Investigate the applicant to determine whether the applicant meets the requirements of this chapter.

A prescription for a controlled substance may be issued only by an authorized provider who is:

A prescription issued by an authorized provider may be communicated to a pharmacist by an employee or agent of the authorized provider.

A controlled substance prescription shall only be issued for a legitimate medical purpose by a provider.

A controlled substance prescription shall be issued by a provider in the usual course of the individual provider’s professional practice.

The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing provider.

A pharmacist has a corresponding responsibility to ensure, prior to dispensing, that a controlled substance prescription is issued for a legitimate medical purpose.

An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-501—5-505, Annotated Code of Maryland.

A prescription may not be issued in order for an individual provider to obtain controlled substances for supplying the individual provider for the purpose of general dispensing to patients.

May not be refilled more than 6 months after the date on which the prescription was issued;

May not be refilled more than five times; and

Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider.

The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription;

The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription;

The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and

The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation.

Each refilling of a prescription shall be documented on the:

The documentation shall indicate the:

Each refilling of a prescription shall:

A registrant in possession of legally obtained controlled substances deemed medical waste shall render the controlled substances irretrievable by disposing of:

Two licensed personnel shall keep Waste Destruction Logbooks and maintain the record for 2 years. The Destruction Log shall be readily available upon inspection.

The Office of Controlled Substances Administration shall authorize and instruct the registrant to dispose of the controlled substance in one of the following manners, provided complete records of the disposition are maintained by the registrant:

A registrant that has complied with 21 CFR §1304 is deemed to have complied with this section.

If a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge of the Federal Drug Enforcement Administration may authorize the registrant to dispose of these substances, in accordance with 21 CFR §1307.

List the controlled substance or substances which the registrant desires to dispose of on a drug destruction form provided by the Department;

Have two members of the professional staff, limited to an administrator, nurse, or pharmacist, destroy controlled drugs on premises;

Dispose per instructions given in §B of this regulation.

Forward a copy of the completed drug destruction form to the Office of Controlled Substances Administration within 10 days of destruction; and

Keep a copy of the drug disposal form on location for a period of 2 years.

Destroyed in the presence of an agent of the Office of Controlled Substances Administration or another authorized person or persons;

Disposed of by other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons; or

Impounded under Health-General Article, §21-1113, Annotated Code of Maryland.

Dispose of all controlled dangerous substances in accordance with Regulation .16 of this chapter; and

Return the controlled substances registration certificate to the Office of Controlled Substances Administration inspector at the time of the closing inspection.

A Change of Ownership requires the registrant to notify the Department in writing, Attention to the Office of Controlled Substances Administration.

The written notification shall be submitted:

The written notification must be received 14 days before the transfer occurs.

The Secretary has the authority to waive the 14-day time limitation in individual instances.

The written notification shall contain the following information:

Except for transfer denials by the Secretary, the registrant-transferor may distribute, without being registered to distribute, controlled substances in the registrant-transferor’s possession to the registrant-transferee in accordance with the following procedures, on the date of transfer of the controlled substances:

Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation.

Authority to make inspections is authorized in accordance with Criminal Law Article, §§5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following:

Entry.

Consent to Inspection of Financial Data, Sales Data Other than Shipment Data, or Pricing Data.

Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant.

Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, §5-804(d), Annotated Code of Maryland.

Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the authorized provider or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland.

A hearing may be ordered or granted by the Secretary, at the Secretary’s discretion, to permit any person against whom criminal or civil action is contemplated under the Controlled Dangerous Substances Act an opportunity to present the individual’s views and the individual’s proposals for bringing the individual’s alleged violations into compliance with the law. The hearing will also permit the individual to show cause why prosecution should not be instituted, or to present the individual’s views on the contemplated proceeding.

The rules of procedure for hearings before the Secretary of the Maryland Department of Health shall be governed by COMAR 10.01.03 and State Government Article, §§10-201—10-226, Annotated Code of Maryland.

Administrative Hearings. Procedures for administrative hearings shall be governed by the rules set forth in Criminal Law Article, §5-308, if applicable, Health-General Article, §2-207, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03.

The denial of an application;

The refusal to renew a registration;

Suspending a registration;

Revoking a registration;

Placing restrictions on a registration pursuant to Criminal Law Article, §5-307, Annotated Code of Maryland; or

Issuing a nonpublic advisory letter.

After a hearing pursuant to Criminal Law Article, §5-308, Annotated Code of Maryland, the Department may impose a monetary penalty against a controlled substance registration holder pursuant to Criminal Law Article, §5-908, Annotated Code of Maryland.

The monetary penalty may be imposed instead of or in addition to the:

The monetary penalty shall be paid within 30 calendar days of the order, unless the order specifies otherwise.

Until the imposed fine is paid, the registration may not be:

In its discretion, the Department may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management for collection.

Butalbital, Acetaminophen, caffeine C-III Fioricet®; and

Opium < or = 100mg per 100Gm or 100ml or not more than 5mg per dosage unit C-III.