DEPARTMENT OF HEALTH, STATE OF FLORIDA DEPARTMENT OF HEALTH PETITIONER, v. CASE NO. 2015-3148 HOME CARE PHARMACY OF PALM COAST, INC., RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and throug its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Home Care Pharmacy of Palm Coast, Inc., and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all times material to this Administrative Compl int, Respondent was a permitted special sterile compounding pharmacy w thin the state of Florida, having been issued permit number PH27614.
3. Respondent's address of record is 6 Florida Park Drive North palm Coast, Florida 32137. 4. At all times material to this Administrative Compl int, Respondent compounded high-risk level compounded sterile prepara ions ("CSPs"). 5. On or about October 28, 2015, the Department conduct d a routine inspection of Respondent. 6. On or about May 1, 2017, the Department conducted a ro tine inspection of Respondent. 7. From those inspections on or about October 28, 201$, and n or about May 1, 2017, the following deficiencies were found: a. The Department's inspection revealed that Responden s did not conduct pre-sterilization procedures for high-risk I vels CSP's in an environment with air quality no worse than ISO Class 8. b. The Department's inspection revealed that Respondent f iled to conduct surface sampling in all ISO classified areas n a periodic basis using TSA contact plates with lecithin and 2
polysorbate 80 and/or swabs and is done at the conclusi n of compounding. c. The Department's inspection revealed that Respondent did not have cleaning and disinfecting agents and method of application in accordance with written standard oper ting procedures and followed by custodial and/or compoun ing personnel. d. The Department's inspection revealed that Respondent f iled to have documentation indicating that compoun ing personnel have successfully completed didactic trai ing, password written competency assessments, undergone skill assessment using observational audit tools and media fill testing annually or semiannually and before any compoun ing personnel being to prepare CSPs. e. The Department's inspection revealed that Respondent did not have labels of CSPs contain name and addres of pharmacy, correct names and amounts or concehtratio s of ingredients, total volumes, beyond use dates, sto age conditions, and route(s) of administration. 3
f. The Department's inspection revealed that Respondent f iled to have documentation that procedures have been folio ed to ensure sterility, purity, correct identities and amoun us of ingredients, and stability. g. The Department's inspection revealed that Respondent f iled to have written procedures detail cleaning and disipfectin the sterile compounding areas including cleansers, disinfect nts, and non-shedding wipe and mop materials. 8. The Department's inspection on or about May 1, 2017, reveled the following additional deficiencies: a. The Respondent failed to have low risk CSPs pro i erly identified. Respondent dispenses GCP solution ith approximately 9 components into more than one unit and assigns a 14 day beyond use date. b. The Respondent failed to have medium risk CSPs pro erly identified. Respondent dispenses GCP solution ith approximately 9 components into more than one unit and assigns a 14 day beyond use date. 4
c. The Respondent failed to properly store medium risk CS 's in absence of passing sterility test, stored not more tha 30 hours at controlled room temperature, 9 days at old temperature, or 45 days in solid frozen state at -25 deg ees Celsius to -10 degrees Celsius or colder. d. The Respondent failed to use a certified membrane filter hat is chemically and physically compatible with the C$P. Filtr tion is completed rapidly without filter replacement. Steriliz tion method is verified to achieve sterility for the quantity and types of containers. e. The Respondent failed to show that the sterilization me hod used has documentation that acceptable strength and p rity of ingredients and integrity of containers is maintained. f. The Respondent failed to show that the manufact rer recommended filter integrity test is performed and documented for all sterilizing filters after filtering CSPs. g. The Respondent failed to use volumetric air sampling u ing malt extract agar or some other media that supports the 5
growth of fungi is used in high-risk level compoun environments. h. The Respondent failed to have cleaning materials suc as wipes, sponges, and mops that are non-shedding prefe.bly composed of synthetic micro fibers, and dedicated to u e in the buffer area, ante-area, and segregated compoun areas and are not removed from these areas except for disposal. i. The Respondent failed to have a written procedure in lace for cleaning and disinfecting the Direct Compounding Ar as. 9. Section 465.023(1)(c), Florida Statutes (2015-2016), pro ides that the department or the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or other ise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee violated any of the ules of the Board of Pharmacy. 10. Rule 64B16-27.797(1)(a), Florida Administrative Code, pro ides that all sterile compounding shall be performed in accordance with the minimum practice and quality standards of the following chapters of the 6
United States Pharmacopeia ("USP"): Chapter 797, Pharmaceu ical Compounding-Sterile Preparations. 11. USP Chapter 797 provides that for medium risk CSPs, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: before administration, the CSPs are properly st red and are exposed for not more than 30 hours at controlled room tempera 'ure, for not more than 9 days at a cold temperature, and for 45 days in Solid frozen state between -25 degrees Celsius and -10 degrees Celsius. 12. USP Chapter 797 provides that that presterilization proced res for high-risk CSPs, such as weighing and mixing, shall be completed i no worse than an ISO Class 8 environment. 13. USP Chapter 797 provides that sterilization of high-risk level t SPs by filtration shall be performed with a sterile 0.2-pm nominal pore size'filter entirely within an ISO Class 5 or superior air quality environment. 14. USP Chapter 797 provides that for high-risk level CSPs the sterilization method used has documentation that acceptable strength and purity of ingredients and integrity of containers is maintained. 7
15. USP Chapter 797 provides that filter units used to sterilize 4 SPs shall also be subjected to manufacturers' recommended integrity test, uch as the bubble point test. 16. USP Chapter 797 provides that evaluation of airb rne microorganisms using volumetric collection methods in the controlle air environments shall be performed by properly trained individuals fo all compounding risk levels. 17. USP Chapter 797 provides that malt extract agar or some ether media that supports the growth of fungi shall be used in high risk compounding environments. 18. USP Chapter 797 provides that surface sampling shall be performed in all ISO classified areas on a periodic basis and ca be accomplished using contact plates and/or swabs and shall be done at the conclusion of compounding. 19. USP Chapter 797 provides that cleaning and disinfecting ag nts, their schedules of use and methods of application shall be in accordance ith written standard operating procedures and followed by custodial an /or compounding personnel. 8
20. USP Chapter 797 provides that all cleaning materials, suc as wipers, sponges, and mops shall be non-shedding, preferably compos d of synthetic micro fibers and dedicated to use in the buffer area, or ante- rea, and segregated compounding areas and shall not be removed from t ese areas except for disposal. 21. USP Chapter 797 provides that prior to compounding perso nel preparing CSPs, shall have documentation indicating that campoun ing personnel have successfully completed didactic training, passed wr tten competency assessments, undergone skill assessment using observati nal audit tools (hand hygiene, garbing, aseptic technique) and media-fill testing annually or semiannually (high-risk). 22. USP Chapter 797 provides that compounding facility shall ave written procedures for verification that labels of CSPs bear correct na es and amounts or concentration of ingredients, total volumes, beyond use dates, storage conditions, and route(s) of administration. 23. USP Chapter 797 provides that facilities shall ave documentation that has procedures that have been followed, to enure sterility, purity, correct identities and amounts of ingredients, and stabili 9
24. USP Chapter 797 provides that written procedures detail clea ing and disinfecting the sterile compounding areas including cleansers, disinfectants, and non-shedding wipe and mop materials. 25. USP Chapter 797 provides that there is a written stan ard operating procedure for cleaning and disinfecting the Direct Compoun!rig Areas. 26. Respondent violated one or more of the aforementioned provisions of USP Chapter 797 through one or more of the deficiencies listed above in paragraphs seven (7) and eight (8) discovered during the Department's inspections of Respondent on or about October 28, 015 and/or on or about May 1, 2017. 27. Based on the foregoing, Respondent has violated Sei ion 465.023(1)(c), Florida Statutes (2015-2016), by and through a violati n of Rule 64B16-27.797(1)(a), Florida Administrative Code, which provides that all sterile compounding shall be performed in accordance with the mini urn practice and quality standards of the following chapters of the United S'.tes Pharmacopeia ("USP"): Chapter 797, Pharmaceutical Compounding-St-rile Preparations. 10
WHEREFORE, the Petitioner respectfully requests that the Boar of Pharmacy enter an order imposing one or more of the following penal ies: permanent revocation or suspension of Respondent's license, restricti n of practice, imposition of an administrative fine, issuance of a reprim nd, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Beard deems appropriate. SIGNED this 7th day of September 20 7. Celeste Philip, M.D., M.P.H. Surgeon General and Secretary CLERK DATE FILED DEPARTMENT OF HEALTH DEPUTY CLERK Ani ergandera sep 0 7 2011 /s/ Kate 11, Holmes Kate M. Holmes Assistant General Counsel Fla. Bar No. 115485 Florida Department of Health Office of the General Counsel 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Telephone: (850) 558-9849 Facsimile: (850) 245-4662 Email: kate.holmes2@flhealth.gov PCP Meeting: 9/7/17 PCP Members: Philip; Glass 11
NOTICE OF RIGHTS Respondent has the right to request a hearing to be condu ted in accordance with Section 120.569 and 120.57, Florida Statu es, to be represented by counsel or other qualified representativ to present evidence and argument, to call and cross-exa ine witnesses and to have subpoena and subpoena duces tecum iss ed on his or her behalf if a hearing is requested. A request or petition for an administrative hearing Must b in writing and must be received by the Department within 21 d ys from the day Respondent received the Administrative Compl int, pursuant to Rule 28-106.111(2), Florida Administrative Code If Respondent fails to request a hearing within 21 days of recei t of this Administrative Complaint, Respondent waives the righ to request a hearing on the facts alleged in this Administra ive Complaint pursuant to Rule 28-106.111(4), Florida Administra ive Code. Any request for an administrative proceeding to challe ge 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, Flo ida Statutes, is not available to resolve this Administrative Compla nt. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incu red costs related to the investigation and prosecution of this ma er. Pursuant to Section 456.072(4), Florida Statutes, the Board s all assess costs related to the investigation and prosecution f a disciplinary matter, which may include attorney hours and cots, on the Respondent in addition to any other discipline imposed. 12