INSTRUCTIONS FOR PODIATRISTS WITH PERMIT TO DISPENSE PRESCRIPTION DRUGS
A Permit to Dispense Prescription Drugs from the Maryland Board of Podiatry allows a podiatrist to dispense prescription drugs to a patient only when the pharmacy is not conveniently available to the patient, as determined by the patient. If prescriptions will be dispensed in more than one location or by more than one podiatrist, a separate dispensing permit is required for each. Dispensing Permits are valid only at the location identified on the Permit.
When you apply and receive the dispensing permit, you CERTIFY THAT YOU:
A. Are thoroughly familiar with the statutes and regulations which govern podiatrist dispensing of prescription drugs, including Health Occupations Article §§12-102, 12-505, and 12-604, Annotated Code of Maryland and Code of Maryland Regulations (COMAR) 10.13.01, 10.19.03.04, .10.19.03.05, and 10.19.03.07.
B. Have read and understood the following information sheet for podiatrists who are dispensing drugs.
C. Will comply with the dispensing requirements set forth in COMAR 10.13.01, Regulations .01--.06 and the above referenced statutes and regulations.
D. Understand that you must follow the requirements listed in COMAR 10.13.01.04 regarding dispensing, labeling, record keeping, and patient notifications in order to receive and maintain a permit to dispense.
Failure to comply with these requirements or other conditions included in the laws and regulations may be considered a violation of the Maryland Podiatry Act, Maryland Code Annotated Health Occupation Article, §16-101 et. seq.
Information Sheet for Podiatrists Who Want to Dispense Prescription Drugs
Who needs a dispensing permit? If a podiatrist wants to dispense medication to his/her own patients (i.e., give a prescription drug to a patient to take at a later time), the podiatrist must:
- Obtain a dispensing permit from the Board of Podiatry, OR
- • Be treating a patient and dispensing medication in a nonprofit health facility, a local or state health department facility, a health center operating on the campus of an institution of higher education, or a clinic dealing primarily with workers compensation cases.
A licensed podiatrist in Maryland may prescribe (write or issue an order for medication) and/or administer (give to patient for immediate consumption) prescription drugs without a dispensing permit. A podiatrist may also dispense drug samples and starter doses (for a period of 72 hours or less) of drugs without a permit.
Restrictions on Dispensing
A podiatrist is required to:
- Dispense prescription drugs to his or her own patients only;
- Issue a written prescription to each patient;
- Be physically present on the premises when the prescription is filled;
- Personally perform a final check of the prescription to verify patient name, medication, and labeling before the prescription is provided to the patient; and
- Take the written prescription back from the patient and file it in the prescription file.
A podiatrist is required to:
- Post a sign stating that prescription drugs may be purchased by the patient if a pharmacy is not conveniently available to the patient.
- Post a sign or distribute written instructions with each prescription explaining the process for resolving incorrectly filled prescriptions.
Label for Prescriptions Must Include:
- Name and Address of Prescriber/Dispenser,
- Patient's Name,
- Name, strength, quantity of the drug,
- Date dispensed,
- Directions for use,
- Expiration date (one year from date of dispensing or a shorter period as determined by the prescriber or as indicated on the original container),
- Special handling or storage instruction,
- For controlled drugs, the statement "CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
Child Resistant Containers
- All prescriptions must be dispensed in child resistant containers unless the prescription requires or the patient specifically requests noncompliant packaging.
Other Important Information for Podiatrists who Dispense Drugs Patient Record
- Insert a form in the chart of each patient to whom drugs are dispensed, indicating
- A pharmacy is not conveniently available to the patient, and
- The determination of "conveniently available" has been made solely by the patient;
- Patient must sign form when drugs are first dispensed to the patient.
- Each time a drug is dispensed to the patient, a notation must be inserted into the patient's medical record.
Record Keeping for Dispensing Medications
- Maintain complete record of all receipts, invoices, and dispensing transactions for all prescription drugs and controlled dangerous substances (CDS).
- Maintain a separate file for CDS Schedule II prescriptions; all other prescriptions may be placed into one other file.
- All written prescriptions must be kept for 5 years.
- Make sure that the quantity and strength of the drug prescribed (i.e., written on the prescription and in the patient's medical record) match the amount dispensed and that the notation of dispensing in the patient record also matches
We recommend that you maintain a separate dispensing log book in the drug room. The log should include the following information:
- The date the drug was dispensed;
- The patient's full name;
- The drug name, strength, and dosage;
- The quantity dispensed;
- The name and initials of the dispensing podiatrist performing the [mal check.
Inventory of Controlled Dangerous Substances (CDS)
The licensed podiatrist shall take an inventory of all stocks of CDS on hand on the first day he/she engages is dispensing any CDS and every 2 years thereafter. If no CDS are on hand at the initial inventory, a zero inventory should be recorded. The inventory record must be kept at the location specified on the DEA registration certificate. The inventory record shall be kept for a period of 2 years, and must include the following:
- Podiatrist's name, address, and Drug Enforcement Administration registration number;
- Date and time the inventory (i.e., opening or close of business); and
- Signature of the person taking the inventory.
Storage of Medications:
- Maintain room temperature between 59°F and 86° F.
- Maintain refrigerator temperature between 36°F and 46° F.
- Secure all prescription drugs.
- Limit access to CDS to personnel authorized by the physician.
- Establish effective controls and procedures to guard against theft and unlawful diversion of CDS.
- Notify the Drug Enforcement Administration, local police and the Maryland Division of Drug Control upon discovery of significant loss of CDS.
Disposal of expired prescription drugs and CDS
- All expired and unused prescription drugs and CDS shall be separated from useable stock.
- Expired drugs must be disposed in accordance with applicable State and federal laws and regulations