Welcome to the Drugs, Devices, and Cosmetics Program (formerly known as Statewide Pharmaceutical Services)

The Drugs, Devices, and Cosmetics Program is responsible for enforcing Florida's Drug and Cosmetic Act, Chapter 499, F.S.  The purpose of this act is to safeguard the health of the public and protect the public from injury by product use and merchandising deceit involving drugs, devices and cosmetics, as well as false and misleading advertising.

Link to Laws and Rules:          

• Section 499.01(2)(t), F.S.
• Section 499.0121(6), F.S.
• Chapter 621, F.S.
• Section 607.01401, F.S.
• Section 608.402, F.S.
• Rule 64F-12.012, Florida Administrative Code

If you need to communicate with the program staff, you are encouraged to email mqa_DDC@doh.state.fl.us.

(Note: Under Florida law, e-mail addresses are public records. If you do not want your e-mail address released in response to a public records request, do not send electronic mail to this entity. Instead, contact this office by phone or in writing.)

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

Actavis Totwa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey Facility.  This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The inspection at Little Falls revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices.  Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals.  The company has informed the FDA regarding this action.

Recall letters have been issued to wholesalers and retailers, instructing them to return product to Capital Returns, Milwaukee, WI.

Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf.  The voluntary action is limited only to Actavis Totowa products manufactured in the Little Falls, NJ facility listed below.  Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall.

The recalled products manufactured by the Little Falls facility are:

NEW!Governor Charlie Crist signed HB 7049 (pdf - 4mb)(2008) into law on June 17, 2008. This law becomes effective on July 1, 2008 unless otherwise provided in the bill language.

The Florida Drugs, Devices, and Cosmetics Program announces its new Web Board!  The Web Board will include important information and announcements for permitees and interested parties.

This message posting service is used to post information about meetings, new laws and regulations, and other useful information.

Using the Web Board is easy!  Just click the link above and click the “New User” button to register your email address (you design your own ID and password).  If you want to receive email notifications with the information attached to the email, you will need to log into the Web Board, click the “More” button at the top of the screen, and then select “My Watch Lists” and follow the instructions.

NEW! FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.

Read the complete MedWatch safety summary, including links to the Recall Notice and the "Dear Healthcare Professional" letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation

NEW! Computer-Based Testing (CBT) Vendor Transition for Certified Designated Representative (CDR) examination

The Florida Department of Health, Division of Medical Quality Assurance is committed to providing our customers with exemplary service.  In keeping with that commitment, we have made the decision that it is in the best interests of the State of Florida and its customers to contract with a new vendor, Prometric, Inc., for computer-based testing services.  

The contract with our current vendor, PSI, ends on Thursday, March 20, 2008.  Prometric's contract will begin on March 21, 2008, and candidates may begin scheduling with Prometric on Saturday, March 15, 2008, and begin testing on Thursday, March 21, 2008.

Please contact Testing Services Unit at 850-245-4252, if you have any questions or concerns.

NEW! FDA NEWS RELEASE: FDA Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes

On January 25, 2008, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed the recalled syringes have developed blood infections.

The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.

Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.

PRODUCT DESCRIPTION:
Heparin Lock Flush Solution USP, All Strengths and Sizes
Normal Saline IV Flush Solution USP, All Strengths and Sizes

Sierra Pre-Filled Inc. Products:

NDC#                         CATALOG #              Product         
64054-1003-02            1003-02           Heparin Lock Flush 100units/mL 5mL
64054-1003-01            1003-01          Heparin Lock Flush 100units/mL 3mL
64054-3005-02            3005-02          Heparin Lock Flush 10units/mL 5mL
64054-3003-02            3003-02          Heparin Lock Flush 10units/mL 3mL
64054-3003-06            3003-06          Heparin Lock Flush 10units/mL 3mL (6mL syringe)
64054-3005-06            3005-06          Heparin Lock Flush 10units/mL 5mL (6mL syringe)
64054-0910-2              0910-12          Normal Saline IV Flush 10mL
64054-0905-2              0905-12          Normal Saline IV Flush 5mL
64054-0903-2              0903-12          Normal Saline IV Flush 3mL

B. Braun Products:
NDC#                         CATALOG #              Product         
64054-3005-02            513610            Heparin Lock Flush 10units/mL 5mL
64054-1003-01            513611            Heparin Lock Flush 100units/mL 3mL
64054-1003-02            513612            Heparin Lock Flush 100units/mL 5mL
64054-0903-2              513584            Normal Saline IV Flush 3mL
64054-0905-2              513586            Normal Saline IV Flush 5mL
64054-0910-2              513587            Normal Saline IV Flush 10mL

New! On January 24, 2008, Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.

Read the complete MedWatch 2008 Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine

NEW! Advisory: Methadone Hydrochloride Tablets USP 40 mg (Dispersible)

As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. Manufacturers will instruct their wholesale distributors to discontinue supplying this formulation to any facility not meeting the above criteria.

Methadone is a long-lasting opioid medication used in the treatment of pain and narcotic addiction. The 5mg and 10 mg formulations indicated for the treatment of pain will continue to be available to all authorized registrants, including retail pharmacies. The 40 mg methadone formulation is indicated for the detoxification and maintenance treatment of opioid addiction. The 40 mg strength is not FDA approved for use in the management of pain. Thus, the distribution and availability of the 40 mg formulation will be limited to registrants in only those settings using the 40 mg formulation for the appropriate indication.

The DEA and pharmaceutical industry agree that the reported increase in methadone-related adverse events merits action and further agree to a united effort to assure that methadone is properly distributed, consistent with its approved uses. Industry and the federal entities involved commit to monitor the progress of this initiative.

For more information, please visit the DEA’s website at www.deadiversion.usdoj.gov

NEW! Transition Transition to New Certified Designated Representative (CDR) Laws & Rules Exam Vendor: Psychological Services, Inc. (PSI) (pdf - 37kb)

NEW! Rule Update: 64F-12.013 – Prescription Drugs; Receipt, Storage and Security

Changes to rule 64F-12.013, Florida Administrative Code will become effective November 8, 2007.  A clean and marked version of the rule are provided below.

• 64F-12.013 – Clean (pdf - 69kb)
• 64F-12.013 - Marked (pdf - 70kb)

Medicaid Tamper-Resistant Prescription Information (pdf -33kb)

The Florida Medicaid program, in accordance with section 409.912 (37)(a)5, Florida Statutes, requires medical practitioners to use a counterfeit-proof prescription blank produced by an approved vendor when writing hard copy prescription orders for Medicaid recipients for any covered service under the Florida Medicaid Prescribed Drug Services Program. All prescribers must use prescription blanks produced according to minimum requirements by one of the approved vendors. The requirement has been in effect in Florida since July 1, 2001, and meets the requirements of the new federal law becoming effective on October 1, 2007.

For more information, please refer to the Agency for Health Care Administration (AHCA) website: http://floridamedicaid.consultec-inc.com/index.jsp, then Click on Provider Support, then Click on Counterfeit Proof Prescriptions, then Click on Counterfeit Proof Prescription Vendor list. If you would like to speak directly to an individual, please contact the Bureau of Pharmacy Services at 487-4441

On Sept. 25, the Senate unanimously passed S. 2085, a bill to push back to April 1, 2008 the effective date for prescribers and pharmacists to comply with a provision requiring all Medicaid prescriptions to be written on tamper-resistant paper to avoid fraud. Acting quickly, the U.S. House approved a bill including a similar provision (HR 3668) the following day. To avoid a conference committee to reconcile the two slightly different bills and expedite final passage, the Senate took up the House-passed bill on last night, approved it and sent it to the President to be signed. If President Bush signs the measure, the transition to tamper resistant pads for written Medicaid prescription would be delayed for six months to next April 1st.

NEW! Drug Wholesaler Advisory Council Appointment Application
During the September 13, 2007 Drug Wholesale Advisory Council (DWAC) conference call, Ms. Rebecca Poston, Executive Director, thanked all of the current council members for their service, and announced that all of the membership slots are up for appointment/re-appointment on September 30, 2007.  The DWAC was created under section 499.01211, Florida Statutes (F.S.) , during the 2003 legislative session to review Chapter 499, F.S. and the rules adopted to administer Chapter 499, F.S., annually, provide input to the department regarding all proposed rules to administer Chapter 499, F.S., make recommendations to the department to improve the protection of the prescription drugs and public health, make recommendations to improve coordination with other states' regulatory agencies and the federal government concerning the wholesale distribution of drugs, and make recommendations to minimize the impact of regulation of the wholesale distribution industry while ensuring protection of the public health.

• Appointment Application (pdf - 46kb)
• Section 499.029, Florida Statutes (pdf - 70kb)

Cancer Drug Donation Program

Notice of Rule Development (pdf - 8kb)

Electronic Pedigree Certification Authority List

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older Prescription Remains Required for Those 17 and Under (pdf - 33kb)

FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual Enhancement (pdf - 39kb)

New Pedigree Requirements - Frequently Asked Questions - 7-13-2006

FDA Announces New Measures to Protect Americans from Counterfeit Drugs (pdf - 52kb)

The Florida Drug and Cosmetic Act: How It Affects Your Practice (For Practitioners)

Florida Board of Pharmacy

Administrative Complaints

Meetings and Minutes - Drug Wholesale Advisory Council

• Meeting Announcements
• Minutes
• Updates - Review Current legislative and rule issues, health product alerts, permit suspensions, and latest newsletters.

Permit Requirements, Applications & Forms:

ATTENTION: Please note that changes to rule 64F-12.018, Florida Administrative Code, became effective on September 5, 2007, and increased many of the permit fees.  All applications post-marked after September 5, 2007 will require the new permit fee.  Please visit our Permit Fees page for more information.

• Drug, Devices and Cosmetics Regulation Information and Application Resources

• 499 Applications and Other forms - Under Chapter 499, Florida Statutes

• Pedigree Paper Requirements - A pedigree paper traces the prior wholesale distributions of a prescription drug.

Examination Information:

• Certified Designated Representative Laws & Rules Examination (CBT)
  Candidate Information Booklet

Search for:

• Authorized Distributors of Record (ADR) - Effective July 1, 2006, the Authorized Distributor of Record (ADR) list is no longer a requirement.

• To search for companies, Certified Designated Representatives (CDR) with active permits and companies holding active Exemptions, use License Lookup.

Contact Information

• Chapter 499 Florida Statutes

• Florida Administrative Code (F.A.C. Online) -  Rule 64F-12 F.A.C.

• Related Laws, Rules and  Organizations

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