CDR RESOURCE CENTER

CDR Info – What every CDR needs to know!

Florida CDR (Certified Designated Representative) Info

What is a Florida Certified Designated Representative (CDR)?

The Florida Department of Business and Professional Regulation requires all prescription drug wholesale distributors and out-of-state prescription drug wholesale distributor permittees (this includes broker-only/virtual facilities) to designate one person to serve as the designated representative for each facility. This person must have an active certification from the State of Florida, Department of Business and Professional Regulation, as a Certified Designated Representative, be employed "full-time" in a managerial capacity and serve as CDR for only one facility at a time.

If a Certified Designated Representative leaves the employment of the facility for which they oversee, the facility has ONLY 10 days to replace that CDR employee. CDR Resource Center therefore recommends that prescription drug wholesale distributors employ more than one person at each facility with a CDR license.

How can the CDR Resource Center (CDRRC) help?

The Staff of the CDR Resource Center have knowledge and experience to help your business since they have worked both as:

A Florida State Inspector inspecting businesses that manufacture, store/distribute, purchase and sell prescription and over-the-counter drugs, devices and cosmetics; and
As a licensed Certified Designated Representatives in Florida with first-hand experience working as a CDR at a Prescription Drug Manufacturers and Wholesale Distributors.

The CDR Resource Center knows that the Certified Designated Representative exam is extremely difficult and that potential CDR candidates need help to prepare for the State of Florida CDR examination. We provide a masterfully designed fully automated learning and testing solution that simulates the extremely difficult State of Florida Certified Designated Representative examination.

In addition, CDR Resource Center provides one-on-one as well as classroom style training for groups. CDR Resource Center can train new CDRs, or to update CDRs with new regulations. With the passage of the Federal regulations, the Drug Supply Chain Security Act (DSCSA) also known as the Drug Quality and Security Act (DQSA), CDRRC also provides guidance in the transition from State to Federal compliance.

Requirements to become a Certified Designated Representative (CDR)

Individuals applying for this Florida Certified Designated Representative certification must:

Be at least 18 years of age and employed in a managerial position by the wholesale distributor, and actively involved in and aware of actual daily operations.
Have not less than 2 years of verifiable full-time work experience in a pharmacy licensed in this state or another state and was involved with Recordkeeping for prescription drugs, or have not less than 2 years of verifiable full-time managerial experience with a prescription drug wholesale distributor licensed in the United States.
Be physically present at the establishment during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.
Provide a personal information statement, including a set of fingerprints for a criminal extensive background check, to the Department as part of the application process.
Receive a passing score of at least 75 percent on an examination given by the Department regarding both State and Federal laws governing distribution of prescription drugs and the rules adopted by the Department governing the wholesale distribution of prescription drugs.
May serve as a designated representative for only one wholesale distributor at any one time.

Florida Department of Business and Professional Regulation Drugs, Devices and Cosmetics Program - CDR application (Click here to download)

Florida Department of Business and Professional Regulation Drugs, Devices and Cosmetics Program - Information Booklet for the Certified Designated Representative Laws and Rules Examination (Click here to download)

What does a CDR needs to know?

A Florida Certified Designated Representative (CDR) needs to be familiar with the applicable rules as presented in Florida Administrative Code (FAC 61N-1) and be up to date with the Florida Statutes of the Florida Legislature as contained in Florida Statues Title XXXIII (Regulation of Trade, Commerce, Investments, and Solicitations), Chapter 499 Part I (Drugs, Devices, Cosmetics, and Household Products) including:

499.001 - Florida Drug and Cosmetic Act; short title.
499.002 - Purpose, administration, and enforcement of and exemption from this part.
499.003 - Definitions of terms used in this part.
499.005 - Prohibited acts.
499.0051 - Criminal acts.
499.0054 - Advertising and labeling of drugs, devices, and cosmetics; exemptions.
499.006 - Adulterated drug or device.
499.007 - Misbranded drug or device.
499.008 - Adulterated cosmetics.
499.009 - Misbranded cosmetics.
499.01 - Permits.
499.012 - Permit application requirements.
499.01201 - Agency for Health Care Administration review and use of statute and rule violation or compliance data.
499.0121 - Storage and handling of prescription drugs; recordkeeping.
499.01211 - Drug Wholesale Distributor Advisory Council.
499.015 - Registration of drugs, devices, and cosmetics; issuance of certificates of free sale.
499.023 - New drugs; sale, manufacture, repackaging, distribution.
499.024 - Drug product classification.
499.025 - Drug products in finished, solid, oral dosage form; identification requirements.
499.028 - Drug samples or complimentary drugs; starter packs; permits to distribute.
499.029 - Cancer Drug Donation Program.
499.0295 - Experimental treatments for terminal conditions.
499.03 - Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.
499.032 - Phenylalanine; prescription required.
499.033 - Ephedrine; prescription required.
499.035 - Dimethyl sulfoxide (DMSO); labeling and advertising.
499.036 - Restrictions on sale of dextromethorphan.
499.039 - Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement.
499.04 - Fee authority.
499.041 - Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates.
499.05 - Rules.
499.051 - Inspections and investigations.
499.052 - Records of interstate shipment.
499.055 - Reports and dissemination of information by department.
499.057 - Expenses and salaries.
499.06 - Embargoing, detaining, or destroying article or processing equipment which is in violation of law or rule.
499.062 - Seizure and condemnation of drugs, devices, or cosmetics.
499.065 - Inspections; imminent danger.
499.066 - Penalties; remedies.
499.0661 - Cease and desist orders; removal of certain persons.
499.067 - Denial, suspension, or revocation of permit, certification, or registration.

61N-1.001 - General Regulations; Definitions
61N-1.006 - Drugs and Devices; Labeling Requirements
61N-1.007 - Compressed Medical Gases
61N-1.008 - Complimentary Human Prescription Drug Samples: Distribution and Disposal
61N-1.009 - Cosmetic Labeling Requirements
61N-1.010 - Requirements for Manufacturing Cosmetics
61N-1.011 - Wholesale Distribution of Prescription Drugs – Exceptions and Specific Distributions Authorized
61N-1.012 - Records of Drugs, Cosmetics and Devices
61N-1.013 - Prescription Drugs; Receipt, Storage and Security
61N-1.014 - Devices or Over-the-Counter Drugs; Storage and Receipt
61N-1.015 - Licensing, Application, Permitting
61N-1.016 - Product Registration
61N-1.017 - Certificates of Free Sale
61N-1.018 - Fees
61N-1.019 - Inspections, Investigations, Monitoring
61N-1.020 - Forms (Repealed)
61N-1.021 - Trade Secrets
61N-1.022 - Ether Applications; Licensing; Permitting; Records; Security; Distributing; Disposal
61N-1.023 - Restricted Prescription Drug Distributor Permits; Special Provisions
61N-1.024 - Administrative Enforcement
61N-1.025 - Certification Authority and Digital Signatures for Self-Authenticating Pedigree
61N-1.026 - Cancer Drug Donation Program
61N-1.027 - Distribution of Medical Oxygen for Emergency Use
61N-1.028 - Product tracking and Tracing – Definitions
61N-1.029 - Product Tracking and Tracing – Manufacturer Requirements
61N-1.030 - Product Tracking and Tracing – Wholesale Distributor Requirements
61N-1.031 - Product Tracking and Tracing – Dispenser Requirements
61N-1.032 - Product Tracking and Tracing – Repackager Requirements