The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Health Policy
BILL: SB 668
INTRODUCER: Senator Burgess
SUBJECT: Storage and Disposal of Prescription Drugs and Sharps
DATE: March 10, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Pre-meeting
2. AHS
3. FP
I. Summary:
SB 668 exempts establishments
1
that store, warehouse, or hold certain prescription drugs or
certain controlled substances solely for the purpose of destruction, from security, storage, and
handling requirements of the Florida Drug and Cosmetic Act in s. 499.0121, F.S. Instead, under
the bill, such establishments must only secure the establishment, maintain specified records of
drug locations, and comply with federal law. As a result, such establishments would no longer
need to obtain a Restricted Rx Drug Distributor – Destruction permit from the Department of
Business and Professional Regulation (DBPR).
The bill also requires the Department of Health (DOH), in partnership with the Department of
Environmental Protection (DEP), to conduct a study of the safe collection and proper disposal of
sharps used by individuals to self-administer prescription drugs at home. The DOH and the DEP
would be required to submit a report on their findings with recommendations to the Governor
and Legislature by July 1, 2026. The DOH and the DEP may contract with private entities and
work with counties and municipalities that wish to participate in the study.
For the 2025-2026 fiscal year, the bill provides a nonrecurring appropriation of $200,000 to the
DOH and the DEP from the Solid Waste Management Trust Fund to conduct the study and
submit the report.
The bill provides an effective date of July 1, 2025.
11
Section 499.003(18), F.S. “Establishment” means a place of business which is at one general physical location and may
extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under
common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an
intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit,
floor, or building must be identified in the most recent permit application.
REVISED: BILL: 668 Page 2
II. Present Situation:
Federal Food and Drug Laws
The federal Food, Drug, and Cosmetic Act (FD&C Act), codified in Title 21 of the United States
Code, provides the foundation for the regulation of food, drugs, medical devices, and cosmetics.
Enacted in 1938 and administered by the Food and Drug Administration (FDA), the FD&C Act
establishes the legal structure for ensuring the safety, efficacy, and security of drugs and medical
products.
2
Over time, the FD&C Act has been amended to address emerging public health challenges,
including drug abuse and environmental concerns. One of the most significant expansions came
with the Controlled Substances Act (CSA) of 1970, which established a legal framework for
regulating potentially addictive or dangerous drugs, including their classification (scheduling),
distribution, and disposal.
3
While the FDA plays a crucial role in drug approval and safety monitoring, the Drug
Enforcement Administration (DEA) is the primary agency responsible for enforcing the CSA.
The DEA regulates the manufacturing, distribution, prescribing, and disposal of controlled
substances, ensuring that these drugs are used for legitimate medical purposes while preventing
diversion, abuse, and environmental harm.
Disposal of Controlled Substances under 21 C.F.R Part 1317
The DEA has developed regulations to enforce the CSA, such as 21 C.F.R Part 1317. This
regulation establishes the federal regulatory framework for the disposal of controlled substances,
ensuring that these substances are handled securely, preventing diversion, misuse, and
environmental harm. The regulation is structured into three distinct subparts – Subpart A,
Subpart B, and Subpart C – each governing different aspects of controlled substance disposal.
Subpart A applies to DEA registrants, including manufacturers, distributors, reverse distributors,
researchers, hospitals, and pharmacies, which are entities authorized to handle controlled
substances for commercial, medical, or research purposes. This subpart requires registrants to
ensure that controlled substances are disposed of in a way that renders them non-retrievable,
preventing any possibility of misuse or recovery. To achieve this, disposal methods such as
incineration or chemical destruction must be employed in accordance with DEA regulations and
environmental laws. Additionally, under Subpart A, registrants must maintain comprehensive
logs documenting how, when, and by whom the substances were destroyed.
Subpart B, in contrast, addresses the disposal of controlled substances by ultimate users,
referring to individuals who legally possess prescribed controlled substances for personal
medical use. Recognizing the risks posed by unused, expired, or unwanted prescription
medications, including substance abuse, accidental ingestion, and environmental pollution, this
2
U.S. Food & Drug Administration, Part II: 1938, Food, Drug, Cosmetic Act (last updated Nov. 27, 2018), available at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/Sharps/
default.htm, (last visited Mar. 9, 2025).
3
United States Drug Enforcement Administration, The Controlled Substances Act, available at: https://www.dea.gov/drug-
information/csa (last visited Mar. 9, 2025). BILL: 668 Page 3
section provides safe disposal options for the public. DEA-registered collectors, which may
include pharmacies, hospitals, and law enforcement agencies, are authorized to facilitate disposal
through three primary methods of collection:
• Collection receptacles – These are secure, tamper-resistant containers placed in authorized
locations, such as pharmacies or hospitals, where individuals can deposit unused or expired
medications. The design and placement of these receptacles must ensure that collected
substances are protected from unauthorized access.
• Mail-back programs – Registered collectors may offer prepaid, pre-addressed packages that
allow individuals to send controlled substances to an authorized disposal facility. This
method provides convenience while maintaining security, as the packaging must be designed
to prevent unauthorized retrieval.
• Take-back events – Law enforcement agencies, often in collaboration with other
organizations, may conduct periodic collection events to allow the public to safely dispose of
controlled substances. These events must be carefully managed to ensure the secure handling
and transportation of the collected substances.
These collection systems are designed to prevent unauthorized access while allowing for
convenient disposal by the general public. Unlike registrants under Subpart A, ultimate users are
not required to maintain records. A crucial aspect of the regulation pertains to the security and
management of collected substances. Once a controlled substance has been deposited in a
collection receptacle or received through a mail-back program, it may not be retrieved or resold.
Collectors are responsible for ensuring that all substances are rendered non-retrievable, meaning
they must be destroyed in a manner that prevents their use, recovery, or reconstruction. Disposal
methods must comply with federal, state, and local environmental regulations to minimize
ecological impact.
A key distinction between Subpart A and Subpart B is the level of security and procedural
responsibility imposed on the parties involved. Subpart A requires strict internal handling,
documentation, and supervision by DEA registrants, ensuring that controlled substances in
commercial and medical settings are never improperly diverted. Subpart B, on the other hand,
shifts the focus to public accessibility, establishing a safe framework for individuals to dispose of
their medications without contributing to public health risks or environmental hazards.
Subpart C further expands the regulatory scope by governing the role of reverse distributors and
law enforcement agencies in controlled substance disposal. Reverse distributors are specialized
DEA-registered entities that manage the collection, return, and destruction of controlled
substances on behalf of manufacturers, wholesalers, and pharmacies. This subpart specifies the
procedural and security measures required when transferring controlled substances to reverse
distributors for final disposal. It also includes provisions for law enforcement agencies, which
play a critical role in community disposal initiatives, such as drug take-back programs. Subpart C
ensures that when controlled substances are transferred to a reverse distributor or law
enforcement agency, they are properly documented and securely destroyed, reinforcing DEA
oversight and accountability.
Together, the three subparts of 21 C.F.R Part 1317 are designed to create a comprehensive
disposal framework that addresses the needs of both regulated industry stakeholders and the
general public. BILL: 668 Page 4
Prescription Drug Distribution Laws and Regulation in Florida
The Florida Drug and Cosmetic Act is codified in ch. 499, F.S. The purpose of the Act is to
safeguard public health by preventing fraud, adulteration, misbranding, and false advertising in
the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics
within the state.
4
The Act assigns the responsibility of regulating its provisions to the DBPR.
5
The DBPR conducts regular inspections and investigations to monitor compliance.
6
Violations
can result in fines, civil penalties, injunctions, product seizures, or referrals for criminal
prosecution.
7
Entities engaged in the manufacturing, repackaging, or distribution of prescription drugs,
medical gases, active pharmaceutical ingredients, medical devices, and cosmetics are required to
obtain appropriate permits from the DBPR.
8
Prescription Drug Wholesale Distribution and Establishments
All prescription drug wholesale distributors in the state of Florida are required to comply with
the storage and recordkeeping standards found in s. 499.0121, F.S., and rules adopted thereunder.
These standards apply to all prescription drugs in the possession of the distributors.
These standards, among other things, require permitted establishments to be of suitable size and
construction, secure from unauthorized entry and equipped with a security system with a well-lit
perimeter, free from infestation, and have provisions to store drugs at appropriate temperatures.
Furthermore, records must be maintained with the following information: the address of the
source of the drug, the date the drug was received, and the date and method of disposition of the
drug.
Rule 61N-1.023, F.A.C., was promulgated in 1996, and last amended in 2001, to implement the
requirements of s. 499.0121, F.S.
Rule 61N-1.023(4), F.A.C., sets out the specific requirements for Restricted Rx Drug Distributor
Destruction permits. This rule exempts destruction permittees from temperature storage
requirements, establishes that quantities of drugs may be recorded as estimates for destruction
purposes, and mandates the creation of a Certificate of Destruction to memorialize the weight of
the drugs destroyed, the method of destruction, and the time, date, and location of the
destruction.
Pharmacy Regulation in Florida
While the Florida Drug and Cosmetic Act addresses the broader spectrum of drug and cosmetic
regulation, the practice of pharmacy is specifically governed by the Florida Pharmacy Act,
detailed in ch. 465, F.S. The Florida Board of Pharmacy, operating under the Department of
4
Section 499.002(1), F.S.
5
Section 499.002(2), F.S.
6
Section 499.051, F.S.
7
Sections 499.062 and 499.066, F.S.
8
Section 499.001, F.S. BILL: 668 Page 5
Health, is responsible for the licensure, monitoring, and education of pharmacy professionals.
The Board ensures that pharmacists, pharmacy interns, and pharmacy technicians meet the
necessary qualifications and adhere to established standards.
Controlled Substances in Florida Law
Chapter 893, F.S., is known as the Drug Abuse Prevention and Control Act. The Act aligns with
federal law to manage the manufacture, distribution, prescribing, and dispensing of substances
that have potential for abuse or dependency. Florida imposes strict penalties for violations related
to controlled substances, including unauthorized possession, distribution, or trafficking. Penalties
vary based on the substance’s schedule and the offense’s nature, ranging from fines to significant
prison sentences.
Schedules of Controlled Substances
Section 893.03, F.S., categorizes controlled substances into five schedules (I-V) based on their
potential for abuse, accepted medical use, and safety considerations:
• Schedule I: Substances with a high potential for abuse, no accepted medical use in the United
States, and a lack of accepted safety under medical supervision. Examples include heroin and
cannabis.
9
• Schedule II: Substances with a high potential for abuse, accepted medical uses with severe
restrictions, and a risk of severe psychological or physical dependence. Examples include
oxycodone and methamphetamine.
10
• Schedule III: Substances with a lower potential for abuse than Schedules I and II, accepted
medical uses, and moderate to low risk of dependence. Examples include anabolic steroids
and products containing less than 90 milligrams of codeine per dosage unit.
11
• Schedule IV: Substances with a low potential for abuse relative to Schedule III, accepted
medical uses, and limited risk of dependence. Examples include alprazolam (Xanax) and
diazepam (Valium).
12
• Schedule V: Substances with a low potential for abuse relative to Schedule IV, accepted
medical uses, and limited risk of dependence. These often include preparations containing
limited quantities of certain narcotics, such as cough preparations with less than 200
milligrams of codeine per 100 milliliters.
13
Regulations on the Prescribing and Dispensing of Controlled Substances
Over time, Florida has enacted multiple laws to mitigate misuse and improve patient safety in the
prescribing and dispensing controlled substances. The following requirements are of note:
• Health care practitioners authorized to prescribe controlled substances must complete a
board-approved two-hour continuing education course on prescribing these substances.
14
This course must be taken with each licensure renewal.
15
9
Section 893.03(1), F.S.
10
Section 893.03(2), F.S.
11
Section 893.03(3), F.S.
12
Section 893.03(4), F.S.
13
Section 893.03(5), F.S.
14
Section 456.0301, F.S.
15
Id. BILL: 668 Page 6
• Prescriptions for controlled substances must include detailed information such as the
patient’s full name and address, the prescriber’s full name, address, and federal controlled
substance registry number, the drug name, strength, quantity, and usage directions.
16
Schedule II substances require a written or electronic prescription and cannot be refilled.
17
• For acute pain, prescriptions for Schedule II opioids are limited to a three-day supply, with a
seven-day supply permissible under specific conditions documented by the prescriber.
18
• Pharmacists must verify the validity of prescriptions for controlled substances before
dispensing. They are required to report dispensed controlled substances to the Prescription
Drug Monitoring Program (PDMP), known as E-FORCSE, no later than the close of the next
business day.
19
Safe Sharps Disposal
Improperly discarded sharps pose a serious risk for injury and infection to sanitation workers and
the community. For purposes of biomedical waste, the term “sharps” mean those biomedical
wastes which as a result of their physical characteristics are capable of puncturing, lacerating, or
otherwise breaking the skin when handled.
20
Examples of sharps include:
• Needles: hollow needles used to inject drugs or medications under the skin.
• Syringes: devices used to inject medication into or withdraw fluid from the body.
• Lancets, also called finger stick devices: instruments with a short, two-edged blade used to
get drops of blood for testing.
• Auto injectors: includes epinephrine and insulin pens or syringes with pre-filled fluid
medication designed to be self-injected into the body.
• Infusion sets: tubing systems with a needle used to deliver drugs to the body.
• Connection needles/set: needles that connect to a tube used to transfer fluids in and out of the
body.
21
Used needles and other sharps pose a dangerous risk to people and animals if not properly
disposed of, as they can spread disease and cause injury. The most common infections are
Hepatitis B (HBV), Hepatitis C (HCV), and HIV.
22
16
Section 893.04(1)(c), F.S.
17
Section 893.04(1)(f), F.S.
18
Section 456.44(5), F.S.
19
Section 893.055, F.S. See also Florida Dep’t of Health, E-FORCSE, available at: https://www.floridahealth.gov/statistics-
and-data/e-forcse/ (last visited Mar. 9, 2025).
20
Section 381.0098(d), F.S.
21
United States Food and Drug Administration, Safely Using Sharps (last updated Nov. 11, 2021), available at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/Sharps/
default.htm, (last visited Mar. 9, 2025).
22
Id. BILL: 668 Page 7
The FDA recommends a two-step process for properly disposing of used needles and other
sharps:
23
Step 1: Place all needles and other sharps in a sharps disposal container immediately after they
have been used. This will reduce the risk of needle sticks, cuts, and punctures from loose sharps.
Sharps disposal containers should be kept out of reach of children and pets.
Overfilling a sharps disposal container increases the risk of accidental needle-stick injury. When
your sharps disposal container is about three-quarters (3/4) full, follow your community
guidelines for getting rid of the container (Step 2, below). DO NOT reuse sharps disposal
containers.
Step 2: Dispose of used sharps disposal containers according to your community guidelines.
Sharps disposal guidelines and programs vary depending on where you live. Check with your
local trash removal services or health department to see which of the following disposal methods
are available in your area:
• Drop Box or Supervised Collection Sites
You may be able to drop off your sharps disposal containers at appropriate chosen collection
sites, such as doctors' offices, hospitals, pharmacies, health departments, medical waste
facilities, and police or fire stations. Services may be free or have a nominal fee.
• Household Hazardous Waste Collection Sites
You may be able to drop off your sharps disposal containers at local public household
hazardous waste collection sites. These are sites that also commonly accept hazardous
materials such as household cleaners, paints and motor oil.
• Mail-Back Programs
You may be able to mail certain FDA-cleared sharps disposal containers to a collection site
for proper disposal, usually for a fee. Fees vary, depending on the size of the container.
Follow the container manufacturer's instructions because mail-back programs may have
specific requirements on how to label sharps disposal containers.
• Residential Special Waste Pick-Up Services
Your community may provide special waste pick-up services that send trained special waste
handlers to collect sharps disposal containers from your home. These services are typically
fee-based and many have special requirements for the types of containers they will collect.
Some programs require customers to call and request pick-ups, while others offer regular
pick-up schedules.
24
Many Florida counties and municipalities have their own sharps disposal programs through their
respective county health departments
25
with strategically located sites where residents can drop
23
U.S. Food and Drug Administration, Best Way to Get Rid of Used Needles and Other Sharps, available at:
https://www.fda.gov/medical-devices/safely-using-sharps-needles-and-syringes-home-work-and-travel/best-way-get-rid-
used-needles-and-other-sharps (last visited Mar. 9, 2025).
24
Id.
25
Florida Department of Health, Needle Collection Programs, available at: https://www.floridahealth.gov/Environmental-
Health/biomedical-waste/needle-collection-programs.html (last visited Mar. 9, 2025). BILL: 668 Page 8
off a container filled with needles and at many sites receive a new container at minimal or no
cost.
26
III. Effect of Proposed Changes:
Section 1 of the bill requires the DOH, in partnership with the DEP, to conduct a study of the
safe collection and proper disposal of sharps used by individuals to self-administer prescription
drugs in home settings. The bill requires the departments to assess the risk of using sharps in
home settings to patients, health care professionals, caregivers, family members, and waste
industry workers. The study must consider the safeness of sharps disposal by mail and sharps
disposal at drop-off locations in both rural and urban environments. The bill authorizes the
departments to contract with private entities and work with counties or municipalities that wish
to participate in the study. The bill requires the departments to submit a report on their findings
with recommendations to the Governor, President of the Senate, and Speaker of the House of
Representatives by July 1, 2026.
Section 2 of the bill amends s. 499.0121, F.S., to create a new subsection (1), which establishes
an exemption from requirements of this section, except for new subsection (7), for schedule IV
and schedule V controlled substance and non-scheduled prescription drugs; or prescription drugs
collected under a program authorized by 21 C.F.R. s. 1317, Subpart B, relating to the “Disposal
of Controlled Substances Collected from Ultimate Users and Other Non-Registrants;” which are
stored, warehoused, or held solely for the purpose of destruction.
A new subsection (7) is created to provide that establishments that store, warehouse, or hold
schedule IV and schedule V controlled substance and non-scheduled prescription drugs; or
prescription drugs collected under a program authorized by 21 C.F.R. s. 1317, Subpart B, solely
for the purpose of destruction, shall only be required to:
• Secure the establishment that is used for activities related to destruction against:
o Unauthorized entry; or
o Unauthorized access to the prescription drugs when establishment personnel are not
present.
• Record the address at which the prescription drugs were destroyed and maintain either:
o Records of the address of the location from which the prescription drugs were collected
and a formulary or description of that location’s prescription drugs; or
o Documentation that the prescription drugs were collected under a program authorized by
21 C.F.R. s. 1317, Subpart B.
• Operate in compliance with applicable federal laws and regulations.
The use of the word “only” would limit the rulemaking authority of the DBPR. The first
paragraph of s. 499.0121, F.S., authorizes DBPR to adopt rules to implement this section as
necessary to protect the public health, safety, and welfare. Such rules must include, but are not
limited to, requirements for the storage and handling of prescription drugs and for the
establishment and maintenance of prescription drug distribution records. While DBPR may adopt
rules relating to new subsection (7), it may not burden such establishments with any additional
26
Florida Dep’t of Health, Home Management of Sharps, available at: https://www.floridahealth.gov/Environmental-
Health/biomedical-waste/home-management-of-sharps.html (last visited Mar. 9, 2025). BILL: 668 Page 9
requirements, because of the bill’s use of the word “only.” Existing additional requirements in
rule and the requirement to obtain the appropriate Restricted Rx Drug Distributor Permits from
the DBPR, would no longer apply to such establishments.
Sections 3-10 of the bill amend ss. 465.022, 499.003, 499.0051, 499.01, 499.012, 499.01201,
499.05, and 499.067, F.S., respectively, to conform cross-references to changes made to
s. 499.0121, F.S., in section 2 of the bill.
Section 11 of the bill provides an effective date of July 1, 2025.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
Section 6, Article III of the State Constitution requires every law to “embrace but one
subject and matter properly connected therewith, and the subject shall be briefly
expressed in the title.” The subject as expressed in the title circumscribes the one subject
to which the act must relate. SB 668 is titled “An act relating to storage and disposal of
prescription drugs and sharps,” but the disposal of sharps in a home setting and the
storage and disposal of prescription drugs by permitted prescription drug establishments
are two different types of disposal regulated by different state agencies for different
safety purposes. While the bill does regard the subject of disposal, it is unclear whether a
court would find that the bill embraces “but one subject” or two.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None. BILL: 668 Page 10
C. Government Sector Impact:
The bill provides, for the 2025-2026 fiscal year, that the nonrecurring sum of $200,000
from the Solid Waste Management Trust Fund is appropriated to the DOH and the DEP
to implement the study and submit the report on the safe collection and proper disposal of
sharps used by individuals to self-administer prescription drugs in the home.
The bill is likely to have an indeterminate operational impact on DBPR staff. The DBPR
may need to amend rules adopted under s. 499.0121, F.S., including Rule 61N-1.023,
F.A.C., to conform to changes made to that section by section 2 of bill, which could
temporarily result in an increased workload. The exemption created by section 2 of the
bill may result in a decreased workload for DBPR staff as they may no longer issue as
many Restricted Prescription Drug Distributor Permits.
VI. Technical Deficiencies:
It is unclear which prescription drugs and controlled substances are intended to be captured by
the exceptions created in lines 78-81 and in lines 186-192 of the bill. Section 893.03, F.S., is the
schedule of controlled substances while 21 C.F.R. s. 1317, subpart B pertains solely to controlled
substances. An amendment should be considered to clarify the intent of section 2 of the bill.
VII. Related Issues:
It is unclear whether the bill is appropriating dollars to the DOH or the DEP since the bill’s
language seeks to make a single appropriation to two departments jointly.
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 499.0121, 465.022,
499.003, 499.0051, 499.01, 499.012, 499.01201, 499.05, and 499.067.
IX. Additional Information:
A. Committee Substitute – Statement of Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
None.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.