vs. ) CASE NO. 86-3029
PREM N. TANDON, M.D., )
Respondent. )
Pursuant to notice, final hearing in the above-styled action was held on February 29, 1988, in Orlando, Florida, before Robert E. Meale, Hearing Officer of the Division of Administrative Hearings.
For Respondent: Prem N. Tandon, pro se
On July 11, 1986, Petitioner filed an Administrative Complaint against Respondent. The Administrative Complaint alleged that Respondent failed to register his two medical offices with the federal Drug Enforcement Administration; failed to store controlled substances in a secure location; failed to maintain biennial inventories of drugs and records showing the receipt and disposal of controlled substances; maintained unlabeled, mislabeled, and returned prescriptions and outdated legend drugs in his office stock; and made or filed a false report or intentionally or negligently failed to file a report or record required by state or federal law.
On July 29, 1986, Respondent filed an Election of Rights in which he disputed the factual allegations and requested a formal hearing.
At the hearing, Petitioner's Motion for Official Recognition dated January 23, 1987, was granted. Petitioner called two witnesses and offered into evidence 11 exhibits. All were admitted into evidence. Respondent called three witnesses, including himself, and offered into evidence one exhibit. All were admitted.
The transcript was filed on March 14, 1988. Petitioner filed a proposed recommended order. Treatment accorded the proposed findings is detailed in the Appendix.
Respondent is and at all material times has been a licensed physician in the State of Florida. He holds license number ME 0029977.
On August 7, 1984, Flo-Nita Spanogle and Mary Willis, investigators of Petitioner, conducted an inspection of Respondent's medical office at 5705 Hansel Avenue, Orlando, Florida. The following day, Ms. Spanogle inspected Respondent's medical office at 201 Hilda Street, Suite 38, Kissimmee, Florida.
Respondent had not registered the Orlando or the Kissimmee office with the Drug Enforcement Administration. The Orlando office had only been open for about one week. However, the registration certificate for Respondent's previous Orlando office states clearly on the bottom in capital letters: "This certificate is not transferable on change of ownership, control, location, or business activity."
Respondent maintained no biennial record of his stock of controlled substances and had no separate records of the receipt and disposal of controlled substances. Respondent maintained patient records that contained, among other things, copies of all prescriptions. Respondent never charged patients for drugs dispensed from his office.
Ms. Spanogle found in the Orlando office about 20 containers of controlled substances. The only Schedule III controlled substances were six 1/2-ounce bottles of Hycomine, two Tylenol 3 tablets, two Fiorinal 2 tablets, 12 Fiorinal #3 tablets, and 18 tablets of Vicodin consisting of the remainder of an original prescription of 30 tablets issued by Respondent to Grady Lebbit on June
4, 1984. The remaining controlled substances were listed in Schedules IV and V. Those found in significant quantities were: 80 tablets of Valium (5 mg dosage),
70 tablets of Valium (10 mg dosage), 71 tablets of Valium (2 mg dosage), 40 capsules of Valrelease (15 mg dosage), 60 tablets of Xanex (0.25 mg dosage), 60 tablets of Xanex (0.3 mg dosage), 66 tablets of Dalmane (15 mg dosage), 42 tablets of Dalmane (30 mg dosage), 25 tablets of Limbitrol (varying dosages),
140 tablets of Equagesic (no reported dosage), 23 tablets of Halcion (0.25 ng dosage), five one-ounce bottles of Donnagel PG, and nine one-ounce bottles of Actifed with codeine. With the exception of the Vicodin, the controlled substances described in this paragraph were kept in the office for the purpose of dispensing to patients.
Ms. Spanogle discovered in the Kissimmee office only one controlled substance, Valrelease, which is a time-release form of Valium. The total quantity consisted of only three physician's samples, each containing a single
15 mg dose. There is no evidence that the Valrelease was in the Kissimmee office for the purpose of dispensing to patients.
None of the above-described controlled substances was kept in a securely locked, substantially constructed cabinet. The controlled substances kept in Orlando were in an unlocked room that was behind the receptionist.
Ms. Spanogle confiscated from Respondent's Orlando office numerous legend drugs because they were kept in unmarked or unlabeled containers or bore
labels that indicated that their expiration date had passed. With the exception of 18 tablets of Vicodin, none of these drugs was a controlled substance. These drugs were either office stock maintained by Respondent for the purpose of dispensing to his patients or were returned prescriptions from various of Respondent's patients. There was no evidence that Respondent dispensed drugs to other patients from the returned prescriptions.
Ms. Spanogle seized the following Orlando office' stock: 297 capsules of Tetracycline contained in an unmarked ziplock plastic bag, eight one- and two-ounce bottles of Kwell lotion either unmarked or marked only with the name "Kwell," 16 tablets of Pyridium (100 mg dosage) with a label bearing an
expiration date of February, 1981, 42 tablets of Catapres (0.3 mg dosage) with a label bearing only the drug name and dosage, 111 tablets of folic acid (1 mg dosage) with a label bearing only the drug name, 5 1/2 tablets of Inderal (40 mg dosage) with a label bearing only the drug name, five tablets of Sorbitrate Sublingual with a label bearing only the drug name, eight tablets of Urobiotic (250 mg dosage) with a label bearing only the drug name and dosage, nine tablets of Microdantin (100 mg dosage) with a label bearing only the drug name, 24 tablets of Dilantin (100 mg dosage) with a label bearing only the drug name, 62 tablets of Donnatal (30 mg dosage) with a label bearing only the drug name, 10 tablets of Orinase (250 mg dosage) with a label bearing only the drug name, and three tablets of Microdantin (200 mg dosage) with a label bearing only the drug name.
Ms. Spanogle seized from the Orlando office 15 vials of returned prescriptions of legend drugs. None of these was a controlled substance except for a vial containing 18 tablets of Vicodin. All but two of the prescriptions had originally been written by Dr. Tandon. None of the vials, which were the original vials supplied to the patient from the pharmacy, bore a lot number or expiration date. There is no evidence that the returned prescriptions were kept for the purpose of dispensing to patients.
Ms. Spanogle destroyed the three physician's samples of Valrelease, as well as three outdated legend drugs found in the office stock of the Kissimmee office. The outdated legend drugs, which were found in a refrigerator in the office, consisted of unreported quantities of Metromycin with an expiration date of April, 1984, Mycostatin vaginal tablets with an expiration date of October 1, 1980, and Permapen Isoject with an expiration date of January 8, 1984.
On two occasions prior to the inspection, Respondent had written a prescription for an ampule of Demerol, which Respondent then administered to a patient during an office visit. Demerol is a Schedule II controlled substance.
A legend drug is a drug that may be dispensed only by prescription. A controlled substance is a legend drug that is subject to additional regulation due to its potential for creating dependence. Controlled substances listed in Schedule I have the greatest potential for producing dependence. Controlled substances listed in Schedule V have the least potential for producing dependence.
A legend drug whose expiration date has passed no longer bears the manufacturer's guaranty as to strength.
Lot numbers of legend drugs are used to identify drugs that have been recalled by the manufacturer.
Respondent was previously disciplined by Petitioner. By Final Order dated February 27, 1984, Petitioner found Respondent guilty of violating Section 458.331(1)(r), Florida Statutes, by unlawfully prescribing legend drugs to himself. The drugs in that case were Nembutal and Ritalin, which are Schedule II controlled substances. Petitioner imposed an administrative fine of $200 and placed Respondent on probation for a period of one month. He successfully completed the probationary period.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and the subject matter. Sections 120.57(1) and 455.225(4), Florida Statutes. Petitioner has jurisdiction over the licensing of physicians. Section 458.311, Florida Statutes.
Discipline against a license may be imposed if a physician "fail[s] to perform any statutory or legal obligation placed upon a licensed physician." Section 458.331(1)(g), Florida Statutes. Discipline against a license may be imposed if a physician "mak[es] or fil[es] a report which the licensee knows to be false [or] intentionally or negligently fail[s] to file a report or record required by state or federal law. Such reports or records shall include only those which are signed in the capacity as a licensed physician." Section 458.331(1)(h), Florida Statutes.
Petitioner must prove the allegations of the Administrative Complaint by clear and convincing evidence. Ferris v. Turlington, 510 So.2d 292 (Fla. 1987).
Failure to Register
A separate registration is required, under federal law, for each principal place of professional practice at "one general physical location where controlled substances are ... dispensed by a person." Title 21, Code of Federal Regulations, Section 1301.23(a). No unregistered person may engage in any activity for which registration is required until his application for registration is granted. Title 21, Code of Federal Regulations, Section 1301.31(a).
However, no separate registration is required for an office used by a practitioner registered at another location if, at such office, controlled substances are prescribed but neither administered or otherwise dispensed as a regular part of the professional practice of that practitioner and if no supplies of controlled substances are maintained at such office. Title 21, Code of Federal Regulations, Section 1301.23(b)(3).
Respondent is guilty of failing to register the Orlando office with the Drug Enforcement Administration. He was practicing at this office in direct violation of the law, as well as the clear language on the bottom of the face of the certificate.
Respondent is not guilty of failing to register the Kissimmee office with the Drug Enforcement Administration. The evidence did not establish that Respondent administered or dispensed controlled substances from the Kissimmee office. Under federal law, he could prescribe controlled substances from the Kissimmee office without registering it as long as "no supplies of controlled substances" were "maintained" there. The three sample containers of Valrelease found in the Kissimmee office do not satisfy the regulatory criteria set forth
above. There was no evidence of any other controlled substances being maintained in the Kissimmee office.
Controlled Substances in Unsecured Location
Controlled substances must, under federal law, be "stored in a securely locked, substantially constructed cabinet." Title 21, Code of Federal Regulations, Section 1301.75(b).
The controlled substances were kept in the Orlando office in violation of federal law. Although Respondent had recently moved into this office, he was already seeing patients. Proper storage of controlled substances is as much a precondition to seeing patients as is arranging for utility service.
Failure to Maintain Inventory and Records
Every two years, a person involved in the "dispensing" of controlled substances must "make a complete and accurate record of controlled substances on hand." Section 893.07(1)(a), Florida Statutes. "Dispense" means the "transfer of possession of one or more doses of a medicinal drug by a ... licensed practitioner to the ultimate consumer..." Section 893.02(6), Florida Statutes. The same requirement exists under federal law. Title 21, Code of Federal Regulations, Section 1304.13.
A person involved in the dispensing of controlled substances must also "maintain, on a current basis, a complete and accurate record of each substance
... received, sold ... or otherwise disposed of by him, except that this subsection shall not require the maintenance of a perpetual inventory." Section 893.07(1)(b), Florida Statutes.
The record of receipt of controlled substances must show the date of receipt, the name and address of the transferor, and the kind and quantity of controlled substances received. Section 893.07(2), Florida Statutes. The record of disposal of controlled substances must show the date of sale, administration, or dispensing, the name and address of the transferee, and the kind and quantity of controlled substances disposed of. Section 893.07(3), Florida Statutes. "Administration" means the "direct application of a controlled substance, whether by injection... or any other means, to the body of a person ..." Section 893.02(1), Florida Statutes.
The biennial inventory and records of receipt and disposal must be maintained "[s]eparately from all other records of the registrant, or, [a]lternatively, in the case of Schedule III, IV, or V controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant." Section 893.07(4), Florida Statutes. In either case, the records must be kept for two years. Id. The same requirements are imposed under federal law. Title 21, Code of Federal Regulations, Section 1304.04(g).
A person may show compliance with Section 893.07(1) by showing "[c]ompliance with the provisions of federal law pertaining to the keeping of records of controlled substances..." Section 893.07(1), Florida Statutes.
Under federal law, a registrant is "not required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled
substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered." Title 21, Code of Federal Regulations, Section 1304.03(d).
Respondent did not charge his patients for drugs dispensed from his office stock. He therefore was exempt from the federal record-keeping requirements and thereby satisfied state record-keeping requirements as well.
Maintaining Unlabeled and Outdated Drugs
In its Proposed Recommended Order, Petitioner withdrew its allegations that Respondent maintained adulterated drugs in his office stock, in violation of Section 499.006, Florida Statutes.
Petitioner's proof of unlabeled and outdated drugs is based on asserted violations of Section 499.907, Florida Statutes, and Rule 10D-45.039, Florida Administrative Code. These are detailed provisions requiring much analysis to determine the extent of their applicability to the subject facts. These statutory and regulatory provisions were omitted from Petitioner's Notion for Official Recognition and Administrative Complaint, except that the Administrative Complaint referred to a violation of Chapter 499. Rule 10D-
45.039 may provide no basis for discipline because of the failure of Petitioner to refer to the rule in its Administrative Complaint or Motion for Official Recognition. See, e.g., Poirier v. Department of Health and Rehabilitative Services, 351 So.2d 50 (Fla. 1st DCA 1977). The single reference to Chapter 499 is also insufficient to apprise Respondent of the nature of this portion of the charges against him. See, e.g., Mobley v. State, 143 So.2d 821 (Fla. 1962).
Assuming, arguendo, that Petitioner's reference in the Administrative Complaint to Chapter 499 has sufficiently apprised Respondent of the nature of this portion of the charges against him, Petitioner has failed to prove by clear and convincing evidence that Respondent is guilty of a violation of this provision. Under Section 499.007, a drug is deemed to be misbranded when its labeling is false or misleading or under certain other conditions not relevant here. Section 499.007, Florida Statutes. There was no evidence of such practices by Respondent in this case.
Failure to File Report or Record
There was no evidence that Respondent negligently or intentionally failed to file a report or record required by law. The biennial inventory and records of receipt and disposal, which Petitioner asserts that Respondent failed to file, were required to be maintained, not "filed."
Disciplinary Guidelines
The failure to perform a legal obligation results in discipline ranging from a reprimand to revocation and an administrative fine ranging from
$250 to $5000. Rule 21M-20.001(2)(g), Florida Administrative Code. Applicable aggravating circumstances in this case are the number of violations and Respondent's recent disciplining with respect to his handling of controlled substances. Applicable mitigating circumstances are that there was no evidence that Respondent's patients were exposed to harm as a result of the violations, Respondent has not previously committed the same offenses, and Respondent enjoyed no pecuniary gain from the offenses.
RECOMMENDED that a Final Order be entered finding Respondent guilty of failing to register his Orlando office with the Drug Enforcement Administration and failing to store controlled substances in a securely locked, substantially constructed cabinet; but finding Respondent not guilty of failing to maintain biennial inventories of controlled substances failing to keep records of receipt and disposal of controlled substances, failing to register his Kissimmee office with the Drug Enforcement Administration, making or filing a false report or intentionally or negligently failing to file a report or record required by state or federal law, and unlawfully maintaining unlabeled, mislabeled, misbranded, outdated and returned legend drugs, including controlled substances, in his office or dispensing stock.
In light of Respondent's previous discipline and Petitioner's disciplinary guidelines, it is further recommended that an administrative fine of $1500 be assessed against Respondent, which fine shall be paid within 30 days of the day that the Final Order imposing same becomes final.
DONE and ORDERED this 4th day of April, 1988, in Tallahassee, Florida.
ROBERT E. MEALE
Filed with the Clerk of the Division of Administrative Hearings this 4th day of April, 1988.
APPENDIX TO RECOMMENDED ORDER, CASE NO. 86-3029
1-2, 4-5. Adopted, except that Respondent was previously found guilty of prescribing to himself Ritalin and Nembutal.
3. Rejected as unnecessary and unsupported by the evidence. Petitioner's Exhibit 4 is a certified copy of Respondent's statement that he earned six hours' credit, under continuing education, required to dispense drugs. Without more, this statement alone is not sufficient to establish registration.
7. Rejected as unnecessary.
8-16. Adopted, except that there was no evidence that the Vicodin, which, unlike the other controlled substances, was a returned prescription, was maintained for dispensing purposes.
17,20. Rejected as unnecessary. 18-19,21. Adopted in substance.
27. Rejected as unnecessary. 28-32. Adopted.
Stephanie Daniels, Esquire William O'Neil, Esquire Senior Attorney General Counsel
130 North Monroe Street 130 North Monroe Street Tallahassee, Florida 32399-0750 Tallahassee, Florida 32399-0750
Prem N. Tandon 5705 Hansel Avenue
