DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, v. CASE NO. 2017-05245 SOUTHEAST COMPOUNDING PHARMACY, LLC, RESPON DENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Southeast Compounding Pharmacy, LLC, and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20A3, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Administrative Complaint, Respondent was a permitted special sterile compounding pharmacy within the state of Florida, having been issued permit number PH27164.
3. Respondent's address of record is 3906 Cragmont Drive, Tampa, Florida 33619. 4. On or about March 7, 2017, the Department presented to Respondent's address of record to conduct a sterile compounding inspection. 5. The sterile compounding inspection found one or more of the following deficiencies: a. One or more vials of MIC/Methy-B-12/B-6/Carn, a compounded sterile preparation (CSP) in a liquid state, was assigned a beyond-use date (BUD) of 90 days without passing a sterility test or documentation to justify chosen BUD; b. Respondent failed to maintain written documentation for dry heat depyrogenation cycle and duration for specific load items; c. A sample of 37 vials of glutathione 200mg/m1 sent to an outsourced facility for sterility testing did not have documentation whether the CSP passed or failed sterility testing before being dispensed; DOH v. Southeast Compounding Pharmacy, LLC 2
d. Respondent failed to conduct viable environmental air sampling of clean rooms semiannually (every six months); e. Respondent's environmental sampling plan did not e containing all elements of a sampling plan, such as the volume of air to be sampled depending on the number of colony-forming units of microorganisms identified in the compounding environments, or action levels; f. Surface sampling data collected on September 30, 2016, revealed existence of microorganisms, but Respondent failed to provide evidence of trended sampling data and speciation of microorganisms as a means of evaluating the overall state of control of the compounded environment; g. Respondent failed to maintain written procedures regarding verification of physical integrity, sterility, stability, and purity of CSPs. h. Compounding personnel at Respondent's pharmacy who were of reproductive capability had not confirmed in writing that they, understood the risks of handling hazardous drugs; DOH v. Southeast Compounding Pharmacy, LLC 3
i. One or more compounding worksheets for one or more CSPs were missing information, to include the quantity in units of finished products and/or the package size and number of units prepared. COUNT ONE 6. Petitioner realleges and incorporates paragraphs one through five as if fully set forth herein. 7. Section 465.023(1)(c), Florida Statutes (2016), provides that that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee violated any of the rules of the Board of Pharmacy. 8. Rule 64B16-27.797(1)(a), Florida Administrative Code, provides, in relevant part, that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the United States Pharmacopeia ("USP"), 36th revision, Second Supplement, incorporated and adopted by reference with DOH v. Southeast Compounding Pharmacy/ LLC 4
the effective chapter dates of December 1, 2013: Chapter 797, Pharmaceutical Compounding-Sterile Preparations. 9. USP Chapter 797 provides that for a sterilized high-risk level preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly stored and are exposed for not more than 24 hours at controlled room temperature, for not more than 3 days at a cold temperature and for 45 days in solid frozen state between -25 and -10. 10. USP Chapter 797 provides that the description of the dry heat depyrogenation cycle and duration for specific load items shall be included in written documentation in the compounding facility. 11. USP Chapter 797 provides that when sterility testing is outsourced, sterility testing reports are reviewed and appropriate actions taken and documented. 12. USP Chapter 797 provides that certification and testing of primary (LAFWs, BSCs, CAIs and CACIs) and secondary engineering controls (buffer and ante areas) have been performed by a qualified individual no less than every six months and whenever the device or room is relocated, altered, or major service to the facility is performed. DOH v. Southeast Compounding Pharmacy, LLC 5
13. USP Chapter 797 provides that sampling data shall be collected and reviewed on a periodic basis as a means of evaluating the overall control of the compounding environment. If an activity consistently shows elevated levels of microbial growth, competent microbiology personnel shall be consulted. 14. USP Chapter 797 provides that compounding facilities shall have at least the following written procedures for verifying the correct identity and quality of CSPs before they are dispensed and administered: 1. That labels of CSPs bear correct names and amounts or concentrations of ingredients, the total volume, the BUD, the appropriate route(s) of administration, the storage conditions, and other information for safe use. 2. That there are correct identities, purities, and amounts of ingredients by comparing the original written order with the written compounding record for the CSR 3. That correct fill volumes in CSPs and correct quantities of filled units of the CSPs were obtained. When the strength of finished CSPs cannot be confirmed to be accurate, based on the above three inspections, the CSPs shall be assayed by methods that are specific for the active ingredients. DOH v. Southeast Compounding Pharmacy, LLC 6
15. USP Chapter 797 provides that compounding personnel of reproductive capability confirm in writing that they understand the risks of handling hazardous drugs. 16. Respondent violated one or more of the aforementioned provisions of USP Chapter 797 through one or more of the deficiencies listed above in paragraph five discovered during the Department's inspection of Respondent on or about March 7, 2017. 17. Based on the foregoing, Respondent has violated Section 465.023(1)(c), Florida Statutes (2016), by and through a violation of Rule 64B16-27.797(1)(a), Florida Administrative Code. COUNT TWO 18. Petitioner realleges and incorporates paragraphs one through five as if fully set forth herein. 19. Section 465.023(1)(c), Florida Statutes (2016), provides that that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee violated any of the rules of the Board of Pharmacy. DOH v. Southeast Compounding Pharmacy; LLC 7
20. Rule 64B16-28.140(4)(g)(h), Florida Administrative Code provides that a written record shall be maintained for each batch/sub-batch of a compounded product under the provisions of Rule 64B16-27.700, Florida Administrative Code. This record shall include: (g) the quantity in units of finished products and (h) the package size and number of units prepared. 21. On or more of Respondent's compounding worksheets failed to include the quantity in units of finished products and/or the package size and number of units prepared. 22. Based on the foregoing, Respondent has violated Section 465.023(1)(c), Florida Statutes (2016), by and through a violation of Rule Rule 64616-28.140(4)(g)(h), Florida Administrative Code. DOH v. Southeast Compounding Pharmacy, LLC 8
WHEREFORE, the Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this 2 a day of 5ef-J--co\ 2017. Celeste Philip, M.D., M.P.H. Surgeon General and Secretary FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK Amber Greene DATE SFP 2 2 2017 I CHRISTOPHER A. ] CH Assistant General Counsel Fla. Bar No. 0099014 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9861 Facsimile: (850) 245-4662 Email: christopher.jurich@flhealth.gov PCP Meeting: September 22, 2017 PCP Members: Mark Mikhael, Debra Glass DOH v. Southeast Compounding Pharmacy, LLC 9
NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. A request or petition for an administrative hearing must be in writing and must be received by the Department within 21 days from the day Respondent received the Administrative Complaint, pursuant to Rule 28-106.111(2), Florida Administrative Code. If Respondent fails to request a hearing within 21 days of receipt of this Administrative Complaint, Respondent waives the right to request a hearing on the facts alleged in this Administrative Complaint pursuant to Rule 28-106.111(4), Florida Administrative Code. Any request for an administrative proceeding to challenge or contest the material facts or charges contained in the Administrative Complaint must conform to Rule 28-106.2015(5), Florida Administrative Code. Please note that mediation under Section 120.573, Florida Statutes, is not available to resolve this Administrative Complaint. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. DOH v. Southeast Compounding Pharmacy; LLC 10