“New Drug” under Florida Statute 499.03(1)
The attorneys at the Sammis Law Firm in Tampa, FL, represent individuals charged with possession of a new drug without a prescription (charge code DRUG9876) under Florida Statute Section 499.03(1), which is charged as a second degree misdemeanor. We also represent the owners of convenient stores charged with the felony offense of possession with intent to sell, of any habit-forming, toxic, harmful or new drug subject to Florida Statute Section 499.003(32), or prescription drug as defined in s. 499.003(40) (charge code DRUG9877). Related charges include dispensing medicinal drugs without being licensed as a pharmacist or otherwise having the authority to do so (charge code DRUG9880).
In many of these prosecutions for the felony offense under Florida Statute 499.03(1), the undercover officers will conduct sting operations by posing as a customer who enters the convenient store for the purposes of purchasing the new drug prohibited under Florida law. In Hillsborough County, FL, the undercover officers will attempt to purchase the new drug on three different occasions before seeking a “search warrant.” A few days later (sometimes weeks or months later) the law enforcement officers will return to the convenient store to execute the search warrant in order to seize any of these new drugs from behind the counter and bring additional charges against the convenient store, the owner of the convenient store, or an employee at the convenient store.
In many of these cases, the convenient store owner and the employee at the store has no idea that the package contains a forbidden substance. Sometimes a local and reputable distributor will supply the product to the convenient store and even the distributor doesn’t know that the product contains a forbidden substance under s. 499.003(32) or s. 499.003(40). One of the most common drugs being targeted by law enforcement officers conducting these undercover sting operations is any form of sildenafil which is often packaged as a novelty idea or male enhancement substance.
Administrative Complaint by DBRP
Our clients who own a convenient store might also receive correspondence from the Florida Division of Alcoholic Beverages and Tobacco. The letter will inform you that the DBPR is taking legal action against their (beverage/tobacco) license in the Form of an Administrative Complaint. You only have 21 days after receiving the letter to request a FORMAL hearing to contest issues that you want to dispute.
Contact the attorneys at the Sammis Law Firm about preserving your rights under Florida’s Administrative Procedures Act, Chapter 120, Florida Statutes, to request the formal hearing. The failure to respond appropriately may result in the revocation of your license. You can seek judicial review of a Final Agency Action under Section 120.68, Florida Statute.
If you were charged or arrested for any criminal offense related to the sale or possession of a new drug listed under 499.003(32) or s. 499.003(40) then contact an experienced criminal defense attorney at the Sammis Law Firm.
We fight drug charges, including cases involving a new legend drug, throughout Tampa, Hillsborough County, and the surrounding areas including Hernando County, Pasco County, Pinellas County, Manatee County, and Polk County, Florida. Call us today for a free consultation to discuss your case at (813) 250-0500.
Call (813) 250-0500 to discuss your case today.
The Prescription Defense for New Drugs
Often called the “prescription defense,” it is not a crime to possesses or sell such a drug if the drug was obtained by a valid prescription of a practitioner licensed by law to prescribe the drug.
Additionally, this crime does not apply to the delivery of such drugs to persons included in any of the classes named in this subsection, or to the agents or employees of such persons, for use in the usual course of their businesses or practices or in the performance of their official duties, as the case may be; nor does this section apply to the possession of such drugs by those persons or their agents or employees for such use.
Exceptions and Exemptions to the Possession of a New Drug
For crimes charged under Florida Statute Section 499.03(1), the crime does not occur if the substance is possessed by any of the following:
- An officer or employee of a federal, state, or local government;
- A person that holds a valid permit issued by the department pursuant to this part which authorizes that person to possess prescription drugs;
- A licensed hospital or other institution that procures such drugs for lawful administration or dispensing by practitioners;
- A qualified person who uses prescription drugs for lawful research, teaching, or testing, and not for resale;
- A licensed practitioner authorized by law to prescribe prescription drugs or any person under the licensed practitioner’s supervision while acting within the scope of the licensed practitioner’s practice; or
- A licensed pharmacist or any person under the licensed pharmacist’s supervision while acting within the scope of the licensed pharmacist’s practice.
Presumptions under the Possession of Sale of New Drug Statute
In many of these cases, the prosecution has absolutely no evidence that the person charged actually knew that the substance possessed was illegal. Although likely unconstitutional as applied to most of these cases, the statutory scheme for possession of a new drug also contains a legal presumption that constitutes “prima facie evidence” that the possession is unlawful if the “drug is not properly labeled to indicate that possession is by a valid prescription of a practitioner licensed by law to prescribe such drug.”
That statutory presumption essentially takes away the knowledge requirement because the very fact that the substance is NOT labeled correctly is the reason an innocent person might come into possession of the substance without KNOWING that it is forbidden under Florida law.
Penalties for Possession of a New Drug under Florida Statute 499.03(1)
The crime of possession of a new drug or a new legend drug can be charged as either a second-degree misdemeanor or a third-degree felony.
A violation of Florida Statute 499.03(1) is a misdemeanor of the second degree, punishable by up to 60 days in jail and a $500 fine. The offense can be charged as a felony, however, if it is alleged that the possession was with the intent to sell, dispense, or deliver. A third-degree felony is punishable by up to 5 years in Florida State Prison and a $5,000 fine. is a
In fact, Florida Statute 499.03(4) expressly provides that the Florida Department of Law Enforcement may adopt rules regarding persons engaged in lawful teaching, research, or testing who possess prescription drugs and may issue letters of exemption to facilitate the lawful possession of prescription drugs under this § 499.03(1).
Definition of a “New Drug” under Section 499.003(32)
Under Section 499.003(32)(a), the term “new drug” is defined as any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of that drug; or
(b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under certain conditions, has been recognized for use under such conditions, but which drug has not, other than in those investigations, been used to a material extent or for a material time under such conditions…..
Definition of a “Prescription Drug” under Section 499.003(32)
Under Section 499.003(40), the Florida legislature defined the term “prescription drug” to mean a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by s. 503(b) of the federal act or s. 465.003(8), s. 499.007(13), subsection (31), or subsection (47), except that an active pharmaceutical ingredient is a prescription drug only if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs.
Action by DBPR Against a Beverage/Tobacco Licence
In these cases, if you own a convenience store then you might also receive correspondence from the Florida Division of Alcoholic Beverages and Tobacco. The letter from DBPR will tell you that legal action is being taken against your (beverage/tobacco) license in the Form of an Administrative Complaint.
After you receive this notice you should immediately retain an attorney to help you request a formal hearing to contest the legal action. You only have 21 days after receiving the letter to request a FORMAL hearing to contest issues that you want to dispute.
Contact the attorneys at the Sammis Law Firm about preserving your rights under Florida’s Administrative Procedures Act, Chapter 120, Florida Statutes, to request the formal hearing. The failure to respond appropriately may result in the revocation of your license. The Division has jurisdiction over these matters pursuant to Section 561.02, Florida Statutes.
In many of these cases, an attorney for the Office of General Counsel, working on behalf of the Department of Business and Professional Regulation, Division of Alcoholic Beverages and Tobacco (“Division”) will call your attorney about entering into a consent agreement. The attorney for the DBPR will draft a “consent order” pursuant to the consent proceedings authorized by Section 120.57(4), Florida Statute.
The stipulated facts will show that following an investigation, the Division filed charges against you (or your agent, officer, servant or employee) alleging violations of section 499.03(1), Florida Statutes, within section 561.29(1)(a), Florida Statutes, for unlawfully on its licensed premises possessing, or possessing with the intent to sell, dispense or deliver, drugs that require a prescription which were not obtained by a valid prescription; and alleging a violation of section 465.015(2)(b), Florida Statute, within section 561.29(1)(a), for unlawfully on its licensed premises, dispensing medicinal drugs without being licensed as a pharmacist in the State of Florida.
The consent order allows you and the Division to resolve the pending administrative proceeding without any further administrative or judicial proceedings which might otherwise be available. The order is a stipulation and agreement to resolve the dispute under terms that might include any or all of the following:
- You must waive all causes of action, civil or otherwise, against the Division and its employees;
- The Division waives all administrative causes of action against you and your employees arising out of the facts and circumstances that were subject of the above-referenced case.
- Nothing in the consent order shall be construed to constitute an admission or finding of guilt with respect to any alleged violations of Florida law.
- You shall forfeit any and all evidence seized by the Division in conjunction with this case.
- You shall pay a two hundred and fifty dollars ($250.00) civil penalty within thirty (30) days of the filing date of this consent order.
- Payments and/or records shall be sent to: Division of Alcohol Beverages and Tobacco, Bureau of Enforcement, 1313 Tampa St., Park Trammel Bldg. #702, Tampa, FL, 33602.
- You shall submit your State of Florida Alcohol Beverage License No. BEV________, for cancellation within thirty (30) days from the filing date of this Consent Order.
- You agree that if you do not submit an application for cancellation of your license within thirty (30) days then you shall be deemed to have failed to fully comply with the terms of this Consent Order, and the State of Florida Alcohol Beverage License shall be subject to immediate revocation.
- The consent order, if fully complied with, shall not prejudice you from obtaining or holding an interest in the State of Florida Beverage License or in any State of Florida Tobacco Permit.
- Should you obtain another license or permit after the cancellation of the current license, you shall henceforth refrain from possessing, selling or delivering any amount of contraband prescription drugs on its licensed premises.
- Should you obtain another license or permit after the cancellation of the current license, you shall henceforth refrain from dispensing medicinal drugs without being licensed as a pharmacist in the State of Florida.
- Should you obtain another license or permit after the cancellation of the current license, you shall henceforth refrain from possessing or possessing with the intent to sell, dispense, or deliver, drugs that require a prescription which were obtained with a valid prescription.
Section 499.003(32)(a) for the Definition of a New Drug – The definitions of terms used in the Florida Drug and Cosmetic Act can be found in Florida Statute Section 499.003. Visit the Online Sunshine, the official website of the Florida legislature to learn more about the statutory language in Title XXXIII of the Regulation of Trade, Commerce, Investments, and Solicitations under Chapter 499 of the Florida Drug and Cosmetic Act. Find Florida’s definition of “new drug” and “prescription drug.”
New Legend Drug – Legend drug are prescription drugs that are approved by the U.S. Food and Drug Administration (FDA). Legend drugs not yet approved by the FDA are sometimes called a “new legend drug.” Under both state and federal law, these drugs can be dispensed to the public only with a valid prescription issued by a licensed physician or other licensed provider. Legend drugs in the United States can include a controlled substance or narcotic. Other types of legend drugs include non-narcotic drugs authorized by medical practitioners, optometrists, veterinarians, and dentists.
This article was last updated on Wednesday, October 10, 2018.