D.C. Mun. Regs. tit. 22, r. 22-B1913

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B1913 - RECORDKEEPING

1913.1

The recordkeeping requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1913.2

A pharmacy shall maintain on a current basis a complete and accurate record of all prescription drugs and devices received, sold, compounded, dispensed, or otherwise disposed of by the pharmacy for a period of five (5) years.

1913.3

For purposes of this section, the requirement may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.

1913.4

A pharmacy shall keep a chronological record, for a period of five (5) years from the date of first dispensing, of each prescription that is filled or refilled including the following information:

(a) The name and address of the patient;

(b) The name and address of the prescriber and date prescribed;

(c) The name, strength, dosage form, and quantity of the drug prescribed, and quantity dispensed if different from the quantity prescribed;

(d) The name and manufacturer of the drug if it is a substitute or generic drug for the drug actually prescribed or filled initially;

(e) Directions for use;

(f) The date the prescription was compounded, dispensed, or refilled;

(g) The name or initials of the pharmacist responsible for final verification of the prescription order;

(h) The prescriber's Drug Enforcement Administration (DEA) number and District of Columbia Controlled Substances number when required by law or regulation;

(i) The expiration date of the drug dispensed;

(j) Any change or alteration made to the prescription dispensed based on contact with the practitioner to show a clear audit trail. This shall include, a change in quantity, directions, number of refills, or authorization to substitute a drug; and

(k) Any other information required by District of Columbia or federal law or regulations.

1913.5

The pharmacist performing the final verification of a prescription shall be identified on the prescription record by name or initial, and shall be fully responsible for the accuracy of the processing, compounding, and dispensing of the prescription order.

1913.6

A pharmacy shall put in place systems to assign a secure identification code to each pharmacist for use on verification records, or require manual signatures of pharmacists performing final verifications to ensure that only the actual verifying pharmacist can place his or her name or initials on the verification records.

1913.7

All prescriptions orders shall be maintained for a period of five (5) years from the date of first dispensing.

1913.8

Prescription orders for controlled substances in Schedules I and II shall be maintained in a file separate from all other records of the pharmacy.

1913.9

Prescription orders for controlled substance in Schedules III, IV, and V shall be maintained either in a separate prescription file or in such form that they are readily retrievable from the other prescription records of the pharmacy. They will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is marked in red ink in the lower right corner with the letter "C" no less than one-inch high and filed in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.

1913.9

All prescription orders shall be in compliance with requirements under this section, the Act and Title 21, C.F.R. Part 1306, where applicable.

1913.10

There shall be maintained in each pharmacy a bound volume, which shall be available for inspection by the Director, in which shall be recorded information required by federal or District of Columbia law or regulation concerning each sale of:

(a) Over-the-counter (OTC) Schedule V controlled substances;

(b) Hypodermic syringes, needles, or other medical devices which may be used in the administration of controlled substances;

(c) Gelatin capsules and glassine envelopes in quantities sufficient to indicate an intention to use such substances for the illegal distribution or dispensing of any controlled substance; and

(d) Diluents or adulterants, such as lactose or quinine, in quantities sufficient to indicate an intention to use such substances for the illegal distribution or dispensing of any controlled substance.

1913.11

A pharmacy shall maintain a patient record system in an automated data processing system or manual record system which shall provide for the immediate retrieval of patient information during the pharmacy's normal operating hours which may include:

(a) Full name of the patient for whom the drug is intended;

(b) Street address and telephone number of the patient;

(c) Patient's age or date of birth;

(d) Patient's gender, height and weight;

(e) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record during the (5) years immediately preceding the most recent entry showing the name of the drug, prescription number, name and strength of the drug, the quantity and date received, and the name of the practitioner;

(f) The pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug;

(g) Patient allergies, drug reactions, current medications and relevant prior medications including non-prescription medications and relevant devices, or medication conditions which are communicated by the patient or the patient's agent; and

(h) Any other information which the pharmacist, in his or her professional judgment, deems appropriate.

1913.12

A patient record shall be maintained for a period of not less than five (5) years from the date of the last entry in the profile record. This record may be a hard copy or a computerized form.

1913.13

Prescription records, patient records, and any other individually identifiable health care information shall be maintained, used, and disclosed only in a manner that protects the integrity and confidentiality of the information, and that is in compliance with the requirements of HIPPA, and all applicable federal and District of Columbia laws and regulations.

1913.14

Authorized agents of the Director shall have immediate and unimpeded access to all pharmacy patient records and the pharmacist-in-charge shall be responsible for informing their superiors.

D.C. Mun. Regs. tit. 22, r. 22-B1913

Final Rulemaking published at 38 DCR 6734, 6745 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008)