DHMH Laboratories Administration Division of Drug Control:
The Division of Drug Control (DDC) is charged with enforcing the Controlled Dangerous Substance (CDS) regulations and assisting in the enforcement of Criminal Law Title 5 in Maryland.
All practitioners who administer, prescribe, or dispense any CDS must be registered under both state and federal Controlled Substance Acts. The latter is with the Drug Enforcement Administration (DEA) while the State registration is with the Division of Drug Control.
Practitioners, before applying for CDS registration must have a license from the appropriate Maryland Board licensing them to practice their profession.
DDC issues CDS registrations to manufacturers, distributors, prescribers and dispensers of Controlled Dangerous Substances (CDS). DDC conducts inspections, audits, investigations. DDC issues CDS registrations to Establishments and Practitioners to manufacture, distribute, dispense, administer, import, export and analyze CDS. Conducts inspections, audits, investigations and assists in enforcement of Criminal Law Title 5. The Division of Drug Control is under the umbrella of the Laboratories Administration.
The Division registers approximately 32, 000 practitioners and establishments to legally manufacture, distribute, dispense or otherwise handle controlled dangerous substances in Maryland. Registration is on a 24-month cycle renewable during the month the registration certificate expires. In order to be registered with the Drug Enforcement Administration in Maryland, a person must obtain and retain a controlled dangerous substance registration from the Division of Drug Control. Registration certificates must be maintained at the registered location. Practitioners who stock and dispense controlled substances at several locations must obtain a registration for each address, and changes in location must notify both the federal and state agencies.
Toward these ends, the Division's inspectors, who are licensed to practice pharmacy in Maryland, perform (CDS) inspections for compliance with CDS regulations of each pharmacy in Maryland. In addition to pharmacy inspections, the Division performs inspections at Nursing Homes, Assisted Living Facilities, Veterinary Clinics, Ambulatory/Surgical Centers, Dispensing Practitioners Offices, Research Laboratories, and any other facility handling CDS. Even though Drug Control performs inspections and investigations for the Board of Pharmacy, the Division is independent from the Board and the inspections and investigations are impartial in both appearance and fact.
Routine inspections sometimes lead to investigations of either the pharmacists or prescribing practitioners. Observation of unusual prescribing practices can lead to an investigation of either the practitioner or both the practitioner and pharmacist. DDC performs CDS investigations related to referrals from Boards of Pharmacy, Physicians, Nursing and other health care related Boards. DDC also investigates complaints from pharmacists, physicians and other health care professionals and general public. DDC also coordinates investigations with Office of Health Care Quality (OHCQ), Alcohol and Drug Abuse Administration (ADAA), Medicaid Pharmacy Program, Office of the Inspector General. DDC also investigates complaints from State and County police, Drug Enforcement Administration (DEA) and from other federal agencies; FBI, FDA and Health and Human Services (HHS).
Investigations of prescribers and pharmacists can be initiated from a number of sources. Other practitioners or pharmacists can notify the Division with concerns. The practitioner's board or the Board of Pharmacy may request an investigation or survey.
The Division is charged with the security and accountability of methadone in narcotic treatment programs. Inspectors audit the methadone routinely to determine accountability and examine each program's procedures from ordering, to storage, to dispensing of the methadone. Drug Control's expertise in administering and dispensing medicines has led to an advisory role in the administration and dispensing of methadone.
The Division is a source of information and expertise concerning CDS. A drug inspector is on duty each weekday from 8:00 a.m. to 4:30 p.m. to answer questions from the public, practitioners and pharmacists and can be reached at 410-764-2890. Practitioners often telephone to report and ask advice regarding fraudulent prescriptions and other triggers of illegitimate practice.
The Division has a number of diverse roles and fields of expertise. If we can be of any service, please telephone us at 410-764-2890 or fax us at 410-358-1793.