New Requirement for Prescribing Compounded Drugs
(2) Medical records in which compounded medications are administered to a patient in an office setting must contain, at a minimum, the following information:
Important: Effective Monday, Sept. 9
New Requirement for Prescribing Compounded Drugs
Effective
September 9, 2013 any physician prescribing compounded drugs to a
patient MUST abide by the amended language in Rule 64B15-15.004
regarding patient records.
The Florida Board of Osteopathic Medicine has modified their medical records rule to include additional language regarding physicians prescribing compounded drugs.
The
Board of Osteopathic Medicine promulgated this rule not due to any new
laws, but because of the problems associated with the New England
Pharmacy's compounding drugs. These additional requirements will help
ensure patient safety, patient awareness, and patient protection.
64B15-15.004 Written Records; Minimum Content; Retention.
(1)
For the purpose of implementing the provisions of Section
459.015(1)(o), F.S., osteopathic physicians shall maintain written
legible records on each patient. Such written records shall contain, at a
minimum, the following information about the patient:
(a) Patient histories;
(b) Examination results;
(c) Test results;
(d) Records of drugs prescribed, dispensed or administered;
(e) Reports of consultations; and
(f) Reports of hospitalizations.
(2) Medical records in which compounded medications are administered to a patient in an office setting must contain, at a minimum, the following information:
(a) The name and concentration of medication administered;
(b) The lot number of the medication administered;
(c) The expiration date of the medication administered;
(d) The name of the compounding pharmacy or manufacturer;
(e) The site of administration on the patient;
(f) The amount of medication administered; and
(g) The date medication administered.
(3)
Whenever patient records are released or transferred, the osteopathic
physician releasing or transferring the records shall maintain either
the original records or copies thereof and a notation shall be made in
the retained records indicating to whom the records were released or
transferred. However, whenever patient records are released or
transferred directly to another Florida licensed physician, or licensed
health care provider it is sufficient for the releasing or transferring
osteopathic physician to maintain a listing of each patient whose
records have been so released or transferred which listing also includes
the physician or licensed health care provider to whom such records
were released or transferred. Such listing shall be maintained for a
period of five (5) years.
(4)
In order that the patients may have meaningful access to their records
pursuant to Section 456.058, F.S., an osteopathic physician shall
maintain the written record of a patient for a period of at least five
(5) years from the date the patient was last examined or treated by the
osteopathic physician. However, upon the death of the osteopathic
physician, the provisions of Rule 64B15-15.001, F.A.C., are controlling.
Rulemaking
Authority 459.005 FS. Law Implemented 456.058, 459.015(1)(o) FS.
History-New 11-30-94, Amended 10-25-95, Formerly 59W-15.004, Amended
12-22-97, 9-9-13.
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