STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )

)

Petitioner, )

)

vs. ) CASE NO. 86-4207

)

GEORGE SALAZAR, JR., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was held in this cause on February 10, 1987, in Tampa, Florida, before Diane A. Grubbs, a Hearing Officer with the Division of Administrative Hearings.

APPEARANCES

For Petitioner: David E. Bryant, Esquire

1107 East Jackson Street, Suite 104

Tampa, Florida 33602

For Respondent: George Salazar, Jr., pro se

4332 South Manhattan

Tampa, Florida 33611

ISSUE

Whether respondent committed the acts alleged in the Administrative Complaint, and, if so, whether respondent's license should be revoked or suspended, or whether other discipline should be imposed.

BACKGROUND

On October 8, 1986, petitioner filed an Administrative Complaint against the respondent. The complaint alleged that at all times material to the complaint respondent was a licensed pharmacist in the State of Florida and was prescription department manager for Interbay Discount Drugs in Tampa, Florida.

Count One of the complaint alleged that respondent dispensed Robitussin AC,

2 oz., a Schedule V controlled substance, to Vester McDaniel on October 14 and 15, 1985, and on December 3 and 4, 1985, and that such sales violated Section 893.08(3)(c), Florida Statutes, in that the total quantity of Robitussin AC sold within the 48 hour period exceeded 120 milligrams of codeine. Based on the foregoing allegations, respondent was charged with violating Section 465.016(1)(e), Florida Statutes, which permits a pharmacist to be disciplined for violating any of the provisions of Chapter 893.

Count Two of the complaint alleged that between the dates of November 1984, and April 1986, the respondent sold exempt narcotics, primarily Robitussin AC, a

Schedule V controlled substance, to Vester McDaniel on numerous specified occasions; that due to the length of time respondent sold the exempt narcotics and the proximity of the dates on which the respondent sold the narcotics, respondent knew or should have known that the narcotics were not being sold in good faith as a medicine; and that respondent, therefore, violated Section 893.08(3)(b), Florida Statutes, by selling a Schedule V controlled substance not in good faith as a medicine. Based on the foregoing allegations, respondent was charged in Count Two with violating Section 465.016(1)(e), Florida Statutes.

Count Three alleged that respondent dispensed Novahistine DH, 2 oz., to Cynthia D. Anderson twice on the same day, April 14, 1986; that Novahistine DH is a Schedule V controlled substance; that the total quantity of Novahistine DH sold exceeded 120 milligrams of codeine within 48 hours; and therefore respondent was in violation of Section 893.08(3)(c), Florida Statutes, and thus subject to discipline pursuant to Section 465.016(1)(e), Florida Statutes.

Count Four alleged that between February 24, 1984, and April 23, 1986, respondent sold exempt narcotics, primarily Novahistine DH, to Cynthia D. Anderson on numerous specified occasions, and that due to the length of time respondent sold the exempt narcotics and the proximity of the dates on which the respondent sold the narcotics respondent knew or should have known that the narcotics were being sold not in good faith as a medicine. Based on the foregoing allegations, respondent was charged with violating Section 465.016(1)(e), in that selling a Schedule V controlled substance not in good faith is in violation of Section 893.08(3)(b), Florida Statutes.

On October 22, 1986, the respondent disputed the factual allegations contained in the Administrative Complaint and requested a formal hearing pursuant to section 120.57(1), Florida Statutes. On October 31, 1986, the matter was referred to the Division of Administrative Hearings for further proceedings.

At the hearing the petitioner presented the testimony of Beth Christie, an investigation specialist with the Department of Professional Regulation, and Ronald A. Moss, who was accepted as an expert witness in pharmacology.

Petitioner's exhibits 1-5 were admitted into evidence. The respondent testified on his own behalf. No exhibits were introduced into evidence by the respondent.

The parties filed proposed findings of fact and conclusions of law. 1/ A ruling on each of the proposed findings of fact has been made in the Appendix to this Order.

FINDINGS OF FACT

1. Respondent is a licensed pharmacist in the State of Florida, having been issued license number 005517, and was so licensed at all times material to the Administrative Complaint. The respondent is engaged in the practice of pharmacy at Interbay Discount Drugs, 4332 South Manhattan, Tampa, Florida, where he is the proprietor and the sole pharmacist.

   
   

2. On April 23, 1986, Ms. Beth Christie, investigation specialist for the Department of Professional Regulation, conducted a pharmacy inspection of Interbay Discount Drugs. During the pharmacy inspection, Ms. Christie reviewed certain documents, including the Certified Exempt Narcotic Record of Retail Sales maintained by Interbay Discount Drugs. This record, or log, is required to be maintained by a pharmacist to reflect the pharmacist's dispensing of Schedule V drugs. The log must show to whom the Schedule V drug was dispensed,

   the date it was dispensed, and identify the dispensing pharmacist. The log is used to ensure that certain amounts of exempt drugs are not dispensed to the same customer within a 48-hour period. Since respondent was the sole pharmacist at Interbay Drugs, all the log entries are followed by his initials.

   
   

3. Ms. Christie initially reviewed the log while conducting her inspection at Interbay Discount Drugs. She noticed the same names appearing over and over again throughout the log which covered approximately a two-year period. Subsequently, Ms. Christie reviewed the log more extensively and prepared a patient profile for Cynthia D. Anderson and Vester L. McDaniel based on the information contained in the log. The patient profiles contained the date the drug was dispensed to the patient, the drug dispensed, and the quantity.

   
   

4. The patient profile revealed that Vester L. McDaniel received Robitussin AC, 2 oz., on the following dates in the 1 1/2-year period from November 30, 1984, through April 21, 1986:

   
   

   11-30-84	04-25-85	08-20-85	11-21-85	02-08-86
   12-04-84	04-27-85	08-22-85	11-23-85	02-10-86
   12-11-84	05-02-85	08-24-85	11-26-85	02-12-86
   12-15-84	05-07-85	08-27-85	11-30-85	02-14-86
   12-20-84	05-11-85	08-29-85	12-03-85	02-17-86
   12-22-84	05-16-85	09-02-85	12-04-85	02-18-86
   12-27-84	05-21-85	09-05-85	12-07-85	02-21-86
   12-31-84	05-25-85	09-07-85	12-10-85	02-24-86
   01-05-85	05-27-85	09-10-85	12-12-85	02-26-86
   01-10-85	05-29-85	09-12-85	12-14-85	02-28-86
   01-15-85	06-03-85	09-14-85	12-17-85	03-03-86
   01-22-85	06-07-85	09-17-85	12-19-85	03-10-86
   01-29-85	06-11-85	09-21-85	12-21-85	03-12-86
   02-02-85	06-15-85	09-26-85	12-23-85	03-14-86
   02-06-85	06-18-85	10-01-85	12-26-85	03-17-86
   02-09-85	06-22-85	10-03-85	12-28-85	03-19-86
   02-12-85	06-28-85	10-08-85	12-31-85	03-21-86
   02-16-85	07-02-85	10-10-85	01-02-86	03-24-86
   02-18-85	07-06-85	10-12-85	01-04-86	03-26-86
   02-21-85	07-09-85	10-14-85	01-06-86	03-28-86
   02-23-85	07-13-85	10-15-85	01-08-86	03-31-86
   02-26-85	07-16-85	10-22-85	01-11-86	04-02-86
   03-01-85	07-18-85	10-24-85	01-14-86	04-04-86
   03-05-85	07-20-85	10-26-85	01-16-86	04-06-86
   03-08-85	07-23-85	10-29-85	01-18-86	04-09-86
   03-14-85	07-30-85	10-31-85	01-20-86	04-11-86
   03-18-85	08-01-85	11-02-85	01-22-86	04-14-86
   03-23-85	08-03-85	11-05-85	01-24-86	04-17-86
   04-04-85	08-06-85	11-07-85	01-27-86	04-19-86
   04-06-85	08-08-85	11-09-85	01-29-86	04-21-86
   04-10-85	08-10-85	11-14-85	01-31-86
   04-18-85	08-13-85	11-16-85	02-03-86
   04-20-85	08-17-85	11-19-85	02-06-86

   
   

   In addition to the above, Mr. McDaniel received Terpin Hydrate with Codeine on September 19, 1985, and November 12, 1985.

   
   

5. The record reveals that Mr. McDaniel received Robitussin AC, 2 oz., on October 14 and 15, 1985, and on December 3 and 4, 1985. The quantity of codeine contained in the Robitussin AC dispensed to Mr. McDaniel by respondent within

   the 48-hour period from 10-14-85 to 10-15-85 and the 48-hour period from 12-3-85 to 12-4-85 exceeded 120 milligrams.

   
   

6. The patient profile of Cynthia D. Anderson revealed that Ms. Anderson received Robitussin AC, 2 oz. on February 24, 1984, and received Novahistine DH,

   2 oz., on the following dates in the 2-year period from April 14, 1984, to April 23, 1986:

   
   

   	04-25-85	09-04-85	12-09-85	02-21-86
   04-14-84	04-29-85	09-06-85	12-11-85	02-24-86
   04-20-84	06-29-85	09-09-85	12-13-85	02-26-86
   05-04-84	07-02-85	09-11-85	12-16-85	02-28-86
   07-31-84	07-06-85	09-13-85	12-21-85	03-03-86
   08-23-84	07-09-85	09-16-85	12-23-85	03-05-86
   09-05-84	07-11-85	09-18-85	12-30-85	03-07-86
   09-08-84	07-13-85	09-20-85	01-01-86	03-10-86
   10-11-84	07-15-85	09-23-85	01-03-86	03-12-86
   10-13-84	07-17-85	09-30-85	01-07-86	03-14-86
   10-16-84	07-22-85	10-02-85	01-10-86	03-17-86
   10-23-84	07-24-85	10-04-85	01-13-86	03-19-86
   11-01-84	07-26-85	10-07-85	01-14-86	03-21-86
   11-15-84	07-29-85	10-09-85	01-16-86	03-24-86
   11-17-84	07-31-85	10-11-85	01-20-86	03-26-86
   12-07-84	08-02-85	10-15-85	01-22-86	03-28-86
   12-27-84	08-07-85	10-17-85	01-24-86	03-31-86
   01-28-85	08-09-85	10-21-85	01-27-86	04-02-86
   01-30-85	08-12-85	10-23-85	01-29-86	04-04-86
   02-06-85	08-14-85	10-25-85	01-31-86	04-06-86
   02-12-85	08-16-85	10-29-85	02-03-86	04-08-86
   02-15-85	08-20-85	10-31-85	02-05-86	04-10-86
   02-18-85	08-22-85	11-18-85	02-07-86	04-14-86
   02-21-85	08-24-85	11-22-85	02-10-86	04-14-86
   04-06-85	08-26-85	11-27-85	02-12-86	04-18-86
   04-09-85	08-28-85	12-02-85	02-14-86	04-21-86
   04-11-85	08-30-85	12-04-85	02-17-86	04-23-86
   04-23-85	09-02-85	12-06-85	02-19-86

   
   

7. As the above shows, respondent dispensed Novahistine DH, 2 oz., to Ms. Anderson twice on April 14, 1986. 2/ The quantity of codeine contained in the Novahistine DH dispensed to Ms. Anderson on April 14, 1986, exceeded 120 milligrams.

   
   

8. Ms. Christie asked respondent about the repeated dispensing of Robitusin AC and Novahistine DH to Mr. McDaniel and Ms. Anderson, and respondent stated that both complained of a chronic cough. However, Ms. Christie observed Ms. Anderson, who happened to purchase Novahistine DH while Ms. Christie was performing her inspection, and Ms. Anderson did not cough at all while she was in the store. Respondent also told Ms. Christie that he continued to provide the drugs to Ms. Anderson and Mr. McDaniel because "they were regular customers and purchased other items in his store [and] it would be awkward for him to refuse to sell the exempt narcotics to them." [T-30]

   
   

9. Codeine is a very potent narcotic, and it can be addictive. Approximately 60 milligrams of codeine are contained in one ounce of Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine. Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine, in two ounce quantities, are Schedule V controlled substances. No more than two ounces of these drugs can be dispensed

   by a pharmacist to the same person within a 48-hour period without a prescription.

   
   

10. Although Robitusin AC, Novahistine DH, and Terpin Hydrate with Codeine are cough depressants, there are much better things for people with chronic coughs than cough depressants that contain narcotics.

    
    

11. A pharmacist who is presented with a request for Robitusin AC, 2 oz., by the same customer every two or three days should be very concerned and cautious. First, the pharmacist should be concerned about the health of the customer. A chronic coughing problem over a period of time should be treated professionally by a physician, not a pharmacist. A pharmacist should advise the customer to see a physician and refuse to sell the customer any more of the drug. Second, the pharmacist should be cautious because of the potential for abuse of the drug. It would be prudent for a pharmacist to refuse to dispense the drug after about three requests within a short period of time. To dispense Robitusin AC regularly over a two-year period cannot be considered dispensing the drug in good faith as a medicine. Any pharmacist dispensing the drug in good faith as a medicine would cease such regular dispensing of the drug long before two years had elapsed.

    
    

12. The dispensing of Robitusin AC, 2 oz., and Terpin Hydrate with Codeine to Mr. McDaniel from November 30, 1984, to April 21, 1986, was not in good faith as a medicine.

    
    

13. Novahistine DH is a essentially the same drug as Robitusin AC but made by a different company. The dispensing of Novahistine DH to Ms. Anderson from April 14, 1984, to April 23, 1986, was not in good faith as a medicine.

    
    

14. Respondent admitted that he used poor judgement in dispensing the drugs to Mr. McDaniel and Ms. Anderson, but he denied that he dispensed the drugs not in good faith as a medicine. Mr. McDaniel was a heavy smoker and had a chronic cough. Respondent stated that he was just not aware that Mr. McDaniel had been receiving Robitusin AC for the period of time that he had. Respondent stated that Ms. Anderson had a family history of chronic bronchitis and respondent felt the medication was needed. Respondent also stated that he did not sell more than two ounces of either Robitusin AC or Novahistine DH to Ms. Anderson or Mr. McDaniel within a 48-hour period, although he admitted that his log reflected that such had occurred. Respondent contended that the customers had written in the wrong dates.

    
    

    CONCLUSIONS OF LAW

    
    

15. The Division of Administrative Hearings has jurisdiction over the subject matter and of the parties to this action. Section 120.57(1), Florida Statutes.

    
    

16. Section 469.016(2) provides that when the Board of Pharmacy finds any person guilty of any of the grounds set forth in Section 469.016(1), Florida Statutes, the Board may revoke or suspend his license, impose an administrative fine not to exceed $1,000 for each count, issue a reprimand, or place the pharmacist on probation. Section 465.016(1)(e), Florida Statutes, provides that a violation of Chapter 893 is a ground for discipline.

    
    

17. Section 893.08(3), Florida Statutes, provides that any compound, mixture or preparation described in Schedule V may be distributed at retail by a registered pharmacist without a prescription. However, Section 893.08(3) places

    certain limitations on those sales. Section 893.08(3)(c) provides that "[t]he total quantity of controlled substance listed in Schedule V which may be sold to any one purchaser within a given 48-hour period shall not exceed 120 milligrams of codeine.

    
    

18. The facts in this case revealed that on two occasions respondent sold Mr. McDaniel Robitusin AC which exceeded 120 milligrams of codeine within a 48- hour period. The evidence also showed that respondent sold Ms. Anderson Novahistine DH which exceeded 120 milligrams of codeine within a 48-hour period. Respondent therefore violated Section 893.08(3)(c), Florida Statutes, and thus is subject to discipline pursuant to Section 465.016(1)(e), Florida Statutes, as alleged in counts one and three of the Administrative Complaint.

    
    

19. Section 893.08(3)(b), Florida Statutes, imposes another condition on the sale of a Schedule V compound by a registered pharmacist. It provides that "[s]uch compounds, mixtures, and preparations shall be sold by the pharmacist in good faith as a medicine and not for the purpose of evading the provisions of this chapter." Although there was no evidence that the respondent was attempting to evade the provisions of Chapter 893 in his sale of Schedule V substances to Ms. Anderson and Mr. McDaniel, the regularity of the sales and the length of time over which the sales were made established that the Schedule V substances were not sold in good faith as a medicine. Therefore, respondent violated Section 893.08(3)(b), Florida Statutes, and is subject to discipline pursuant to Section 465.016(1)(e), Florida Statutes, as alleged in counts two and four of the Administrative Complaint.

RECOMMENDATION

Based upon the foregoing findings of fact and conclusions of law it is RECOMMENDED that the Board of Pharmacy enter a final order finding

respondent committed those acts set forth in Counts I, II, III, and IV of the Administrative Complaint, imposing an administrative fine of $200 for each of the four counts, for a total fine of $800, and placing the respondent on probation for a period of one year under such terms and conditions as the Board may deem appropriate.

DONE and ORDERED this 17th day of April 1987, in Tallahassee, Florida.

DIANE A. GRUBBS

Hearing Officer

Division of Administrative Hearings The Oakland Building

2009 Apalachee Parkway

Tallahassee, Florida 32301

(904)488-9675

Filed with the Clerk of the Division of Administrative Hearings this 17th day of April 1987.

ENDNOTES

1/ Respondent's letter dated March 22, 1987, has been treated as respondent's proposed findings of fact. However, the portion of the letter referring to a record that was not admitted into evidence was stricken.

2/ The record also shows that respondent dispensed Novahistine DH to Ms. Anderson on consecutive days in January, 1986; however, the charges do not relate to those dates.

APPENDIX

(Case No. 86-4207)

RULINGS ON PETITIONER'S PROPOSED FINDINGS OF FACT:

1-2. Accepted, paragraph 1.

3-5. Accepted, paragraph 3.

6. Rejected as not a finding of fact since it only relates testimony; however, substance of testimony accepted in paragraph 3.

7-8. Accepted, paragraph 4 and 5.

1. Rejected as it is a conclusion of law.

2. Accepted, paragraph 5.

3. Accepted, paragraph 4 except there were 164 sales.

4. Accepted, paragraph 6, 7.

13-15. Rejected as it is merely a recitation of testimony (paragraphs 6 and 7).

16-19. Rejected as recitation of testimony, (paragraph 8 addresses substance).

20. Rejected as irrelevant; however, Mr. Moss recognized as an expert in "Background" section.

21-48. Rejected as findings of fact. These paragraphs merely recite the witness testimony

RULINGS OF RESPONDENT'S FINDINGS OF FACT:

1. Rejected, not finding of fact.

2. Accepted that respondent denied selling 4 or of the drugs in question within a 48-hour period and explained evidence of such sales in log as writing the wrong date in paragraph 14. However, reject as a finding that such sales were not made within a 48-hour period, since the log is the best evidence of when the sales were made.

3. Accepted generally in paragraph 14; however, the evidence of regular sales of the drugs over a two-year period established that the drugs were not sold in good faith as a medicine notwithstanding respondent's personal belief that he was selling the drugs in good faith.

4. Rejected as irrelevant and not supported by competent substantial evidence.

5-6. Not findings of fact.

COPIES FURNISHED:

David E. Bryant, Esquire Suite 104

1107 East Jackson Street Tampa, Florida 33602

George Salazar, Jr.

4332 South Manhattan

Tampa, Florida 33611

Rod Presnell, Executive Director Department of Professional Regulation

130 North Monroe Street Tallahassee, Florida 32301

=================================================================

AGENCY FINAL ORDER

=================================================================

STATE OF FLORIDA

DEPARTMENT OF PROFESSIONAL REGULATION BOARD OF PHARMACY

DEPARTMENT OF PROFESSIONAL REGULATION, BOARD OF PHARMACY,

Petitioner,

vs. CASE NO. 86-4207

GEORGE SALAZAR, JR.,

Respondent.

/

FINAL ORDER

THIS CAUSE CAME on to be heard before the Florida State Board of Pharmacy at a regularly scheduled meeting held in Jacksonville, Florida on June 24, 1987.

The Florida Board of Pharmacy of the Department of Professional Regulation, after determining that no exceptions has been filed with respect to the Recommended Order entered in this case by Diane A. Grubbs, Hearing Officer.

Division of Administrative Hearings, on April 1, 1987, and after reviewing the complete record accompanying the Recommended Order, and being otherwise fully advised in the premises, hereby accepts the Findings of Fact, Conclusions of Law and Recommended Penalty contained in the Recommended Order, with the condition of probation being that Respondent's Class V Sales should be audited during aid inspection to be performed during the year of probation by the Department of Professional Regulation at Respondent's expense. Said Recommended Order is hereby declared to be and this Order becomes the Final Order of the Board of Pharmacy.

DONE and ORDERED this 23rd day of July, 1987, by the Florida Board of Pharmacy.

C. ROD PRESNELL EXECUTIVE DIRECTOR

COPIES FURNISHED TO:

George Salazar, Jr., William Furlow, Esquire

Docket for Case No: 86-004207

Orders for Case No: 86-004207