November 30, 2017 US. Food and Drug Administration 4040 North Central Expressway Suite #300 Dallas, Texas 75204 (214)253-5200 RE: Prescription Labs, Inc., dba Greenpark Compounding Pharmacy (FEIN 3009712882) Response to FDA form 483 issued 10/27/2017 The FDA conducted an inspection of Prescription Labs, Inc., dba Greenpark Compounding Pharmacy on 10/16/2017, 10/17/2017, 10/18/2017, 10/19/2017, 10/20/2017, 10/23/2017, 10/24/2017, 10/25/2017, 10/26/2017 and 10/27/2017, not accompanied by a Texas State Board of Pharmacy representative. At the start of the inspection, Greenpark Compounding Pharmacy was verbally informed that we were being inspected for an office use compounding complaint (office use compounding in Texas is authorized by the Texas State Board of Pharmacy). At the conclusion of the inspection, Greenpark Compounding Pharmacy was verbally informed that Greenpark Compounding Pharmacy was evaluated by the FDA and deemed 3 503a compounding pharmacy. Greenpark Compounding Pharmacy did receive an FDA Form 483 listing 6 observations. We are providing this response to the Form 483. We request this response be included with the Form 483 when the FDA provides a copy of the Form 483 to anyone outside the FDA and when/if the Form 483 is posted online. Before we respond to each of the observations listed in the Form 483, we believe it is important to address the inspection and application of the Form 483 to Prescription Labs, Inc., dba Greenpark Compounding Pharmacy. Greenpark Compounding Pharmacy has operated as a pharmacy licensed by and subject to the jurisdiction of the Texas State Board of Pharmacy. Currently, as well as at the time of the inspection, Greenpark Compounding Pharmacy engages in pharmacy-based compounding pursuant to and in compliance with the pharmacy practice and compounding guidelines set forth by the Texas State Board of Pharmacy. Greenpark Compounding Pharmacy respects and understands that the FDA maintains the necessary authority to regulate the manufacturer of drugs. However, Greenpark Compounding Pharmacy does not manufacture drugs. This distinction is important because the regulation of drug manufacturers and the Texas State Board of Pharmacy?s regulations of compounding pharmacies are not uniform and differ significantly. As a compounding pharmacy, Greenpark Compounding Pharmacy complies with regulations that govern Texas compounding pharmacies, not drug manufacturers. In addition to complying with the regulations of the Texas State Board of Pharmacy, Greenpark Compounding Pharmacy also complies with the quality control, quality assurance and quality improvement standards defined in the USP chapter <797>, which are specifically required by the Texas State Board of Pharmacy. It should be noted that the FDA inspection and response to the Form 483 has given us an opportunity to review our procedures and look for improvements. We provide this response and plan of action to Form 483. OBSERVATION On 10/17/17, an operator engaged in aseptic processing was observed with his upper torso inside the ISO 5 area with partially exposed skin while wearing a non-sterile mask, goggles, and hairnet. RESPONSE TO OBSERVATION Observation #1 documents Greenpark Compounding Pharmacy does comply with Texas State Board of Pharmacy requirements for wearing protective apparel while engaged in aseptic processing. Corrective Action: Greenpark Compounding Pharmacy does agree to conduct a more comprehensive observation of competency assessments: Aseptic Technique. Observations will be more closely monitored during employee assessments. OBSERVATION On 10/17/17, an operator was observed sanitizing his gloved hands with non-sterile (4) and then resuming aseptic processing in the ISO 5 area. RESPONSE TO OBERVATION Observation #2 documents that Greenpark Compounding Pharmacy does comply with the Texas State Board of Pharmacy requirements to frequently sanitize sterile gloved hands when engaged in aseptic processing. Corrective Action: Greenpark Compounding Pharmacy will review with sterile compounding personnel, that sterile (4) is the approved sanitizing solution to sanitize sterile gloved hands before resuming aseptic processing in an ISO 5 area. OBSERVATION The wipes used for disinfecting the interior of the ISO 5 hood are not sterile. RESPONSE TO OBSERVATION Observation #3 documents that Greenpark Compounding Pharmacy complies with the Texas State Board of Pharmacy requirement to use lint free wipes in the clean room. (4) dry clean room approved nonsterile (4) nonwoven wipers are manufactured for clean room solution application. Greenpark uses the dry wipes to spread sterile (4) in the ISO 5 area. The lint free wipe is not a disinfecting wipe. The sterile (4) is the sanitizer. Corrective Action: Greenpark Compounding Pharmacy complies with the Texas State Board of Pharmacy and USP <797> requirements, to use lint free wipes in the clean room. OBSERVATION The ISO 5 classi?ed areas were not certified under dynamic conditions. Speci?cally, unidirectional air ?ow was not verified under operational conditions. RESPONSE TO OBSERVATION Greenpark Compounding Pharmacy complies with the Texas State Board of Pharmacy requirements regarding air?ow smoke pattern Test. OBSERVATION There is no evidence that? testing is being performed for sterile products. For example, A. Tacrolimus Aqueous Ophthalmic 10ml 0.03% Suspension, lot #08312017@45 (Production date: 8/31/17 Beyond Use date3: 12/29/17 was sterilized using There was no evidence that the test was performed. RESPONSE TO OBSERVATION Greenpark Compounding Pharmacy complies with the Texas State Board of Pharmacy requirements regarding - sterilization of ophthalmic compounds and - - testing of - used in the sterilization process. Corrective Action: Greenpark Compounding Pharmacy will continue to review, with sterile compounding personnel, the importance of process documentation for all testing. OBSERVATION The use of sporicidal disinfectant,? in the ISO 5 areas is inadequate in that the contact time of. minutes has not been substantiated. RESPONSE TO Greenpark Compounding Pharmacy will purchase a proprietary sporicidal where contact time for sporicidal activity has been determined by the manufacturer. Speci?cally, Germicidal Wipes. Corrective Action: Greenpark Compounding Pharmacy will begin using Germicidal Wipes that are engineered as ready-to-use sporicidal cleaner-disinfectant system for healthcare facilities. Ken Hughes, Pharmacist in Charge Prescription Labs, Inc. dba: Greenpark Compounding Pharmacy