Have you received an administrative complaint against your pharmacy license for making a prescription drug with an ingredient contrary to statute or dispensing or distributing a legend drug other than in the course of the professional practice of pharmacy? If you have, it is very important that you contact an experienced health care attorney to go over the charges. These charges are serious and can have a negative impact on your license and your ability to practice as a pharmacist in Florida.

The Law

The law states that disciplinary action can be taken against your license if you compound or furnish a prescription using ingredients different from those prescribed by other statutes. A separate statute states that is a violation of law to dispense, distribute, or compound a legend drug other than in the professional practice of pharmacy. Violations of both these statutes lead to the same actions taken in the disciplinary guidelines. Florida law on point here are Florida Statutes 465.016(1)(g) and (i). Those statutes say in particular:

(1) The following acts constitute grounds for denial of a license or disciplinary action, as specified in s. 456.072(2):

(g) Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in s.465.019(6) or s. 465.025.

(i) Compounding, dispensing, or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interests of the patient and is not in the course of the professional practice of pharmacy.

Using an ingredient or article different from any manner prescribed in those other statutes in the compounding or furnishing of a prescription is a violation. Interesting to note here as well is that it is legally presumed that the compounding, dispensing, or distributing of legend drugs in excess or in inappropriate quantity is not in the course of the professional practice of medicine. These statutes are most likely together in that using an ingredient in a manner not prescribed by other statutes would be considered not in the course of the professional practice of pharmacy. If you have had complaints made against your license for violation of this statute, you should contact an experienced health care attorney immediately to go over your options. There can be severe repercussions for you if you wait.

Penalties

There are a range of actions that can be taken against you should the Board of Pharmacy decide to take disciplinary action against you. The penalties you could face are found in the Disciplinary Guidelines for the Board of Pharmacy, particularly in Rule 64B16-30.001 in the Florida Administrative Code. The rule states the following for disciplinary guidelines for violation of the statute:

At a minimum, for a violation of the statute, you could face a $250 fine for no ingestion or harm caused or $500 fine for ingestion. You would have to complete an approved continuing education course in prevention of medication errors of no less than eight hours. The fines get stiffer on the maximum level, especially if violations of this statute keep happening. You could face a $500 fine if no ingestion or harm occurred or $1,000 fine if ingestion did occur. You would also have to go through the approve continuing education course and be subject to two years of probation. At worst, your license could be revoked. This is very serious. You should also be aware that these are guidelines that the board should follow in handing out discipline, but are not set in stone, and can be accompanied by other penalties or deviated from. These penalties can be found in Florida Statute 456.072(2), which you should review with your health care attorney.

Aggravating/Mitigating Circumstances

The board hearing your case can take into account various factors that could affect the discipline you receive. These factors are called aggravating and mitigating circumstances. Aggravating circumstances are factors that can hurt your case. If aggravating circumstances are proven you could face harsher penalties. Mitigating circumstances are factors that can help your case. If mitigating circumstances are proven you could face lesser penalties. These factors can also be found in rule 64B16-30.001 in the Florida Administrative Code. If either side can prove with clear and convincing evidence the aggravating or mitigating circumstances, the discipline you face could be altered by the board. Here are the factors:

(a) Aggravating circumstances; circumstances which may justify deviating from the above set forth disciplinary guidelines and cause the enhancement of a penalty beyond the maximum level of discipline in the guidelines shall include but not be limited to the following:

1. History of previous violations of the practice act and the rules promulgated thereto.
2. In the case of negligent acts, the magnitude and scope of the damage or potential damage inflicted upon the patient or the general public by the licensee’s misfeasance.
3. Evidence of violation of professional practice acts in other jurisdictions wherein the licensee has been disciplined by the appropriate regulatory authority.
4. Harm occurred.

(b) Mitigating circumstances; circumstances which may justify deviating from the above set forth disciplinary guidelines and cause the lessening of a penalty beyond the minimum level of discipline in the guidelines shall include but not be limited to the following:

1. In cases of negligent acts, the minor nature of the damage or potential damage to the patient’s or the public’s health, safety, and welfare resulting from the licensee’s misfeasance.
2. Lack of previous disciplinary history in this or any other jurisdiction wherein the licensee practices his profession.
3. Restitution of any monetary damage suffered by the patient.
4. The licensee’s professional standing among his peers.
5. Steps already taken by the licensee to insure the non-occurrence of similar violations in the future, including continuing education.
6. The degree of financial hardship incurred by a licensee as a result of the imposition of fines or the suspension of his practice.

The board can take into account any of these factors, or other factors, in your hearing. The board can deviate from the standard disciplinary guidelines if they find that any of these aggravating or mitigating circumstances exist. These are very important factors that you should discuss with your health care attorney.

Conclusion

If you are a licensed health care professional in Florida and have received an administrative complaint for violation of the statutes, you are probably concerned about how this may affect your license.  To set up a FREE no obligation consultation with Jeff Howell contact the law firm of Howell, Buchan & Strong, Attorneys at Law at 850-877-7776.  We represent licensed health care professionals and facilities statewide, including out of state clients who are concerned about the status of their Florida license