DHMH Laboratories Administration Division of Drug Control:
The Division of Drug Control is a small unit of nine people under the Laboratory Administration. The Division is charged with enforcing parts of the Food, Drug and Cosmetic Act and the Controlled Dangerous Substance regulations. All four inspectors and deputy chief are licensed to practice pharmacy in Maryland and possess diverse backgrounds and expertise in various aspects of pharmacy.
The Division's inspectors perform a routine inspection to Controlled Dangerous Substances (CDS) of each pharmacy in Maryland. This inspection consists of two parts. One part of the inspection concerns pharmacy practice and the other compliance with controlled dangerous substance regulations. Inspection reports are sent to the Board of Pharmacy for their perusal and any action deemed appropriate. 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. The pharmacist has corresponding liability for the prescriptions he or she fills. Observation of a large number of apparent forged prescriptions being filled at the pharmacy or large purchases of schedule drugs may result in an audit and/or investigation of the pharmacist. Information regarding a practitioner is turned over to the practitioner's board and the pharmacist to the Board of Pharmacy.
Investigations of prescribers and pharmacists can be initiated from a number of sources. Other practitioners or pharmacists can call the Division with concerns. The practitioner's board or the Board of Pharmacy may request an investigation or survey. The Division works with the Drug Enforcement Administration and police and may conduct a joint investigation.
The Division is responsible for parts of the Food, Drug and Cosmetic Act. As a result, the Division has conducted various types of investigations independently or with the Food and Drug Administration. For example, the Division investigated local beauty supply shops selling non-corrective contact lenses.
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. However, Drug Control's expertise in administering and dispensing medicines has led to an advisory role in the administration and dispensing of methadone. The Division initiated a program whereby take home doses of methadone are recalled by the program nurse and new take home doses substituted. The original take home doses are taken to the State's pharmaceutical chemistry laboratory for assay. The narcotic treatment program directors have credited this program with decreasing diversion by detecting those patients who sell their methadone or drink their methadone before the appropriate time.
The Division registers approximately 30, 000 practitioners and establishments to legally manufacture, distribute, dispense or otherwise handle controlled dangerous substances in Maryland. Registration will be on a 24-month cycle renewable during the month the registration certificates 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 Drug Control.
The Division is a source of information and expertise concerning controlled dangerous substances. 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. Practitioners often telephone to report and ask advice regarding forged prescription or illicit prescriptions being telephoned into a pharmacy using their name. Particularly troublesome to the practitioners is when a trusted employee is telephoning in prescriptions to a pharmacy without the practitioner's permission or forging the practitioner's signature on a prescription blank. Pharmacists have similar questions about employee theft of drugs, people trying to telephone in illicit prescriptions, and the passing of forged prescriptions.
Expertise of the Division is made available to practitioners from all over the world at the Johns Hopkins School of Public Health regarding control of scheduled drugs in the United States and a class at the University Of Maryland School Of Pharmacy on how to recognize and what to do about forged prescriptions.
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.
Controlled Dangerous Substance (CDS) Registration : 410-764-2890
- Administrative Specialist :
- Administrative Staff:
- Renee McCray
- Tiffany Lovett
Pharmacy Inspection Team: 410-764-2890
- Fred Evans R.Ph.
- Howard Minster R.Ph.
- Jim Polek R.Ph.
- Peter Smith R.Ph.