Quality

cGMP

Our commitment to patient safety combines utilization of the highest quality materials available, cutting edge technology, and quality assurance process controls that provides the right drug, right concentration, right route of administration for the right patient every time. As a national leader in sterile compounding, Empower Pharmacy has been committed for the last 11 years to developing quality processes that ensure the highest level of safety for patients.

Empower Pharmacy is designed and operated to meet cGMP standards. Furthermore, Empower Pharmacy adheres to the guidance provided by under section 503B of The Drug Quality and Security Act. We are regularly inspected by the State Boards of Pharmacy, DEA, and FDA to assure compliance. The key to providing safe sterile compounded products resides in using the principles of aseptic technique throughout the compounding process. This allows us to maintain the highest degree of supply chain integrity and compliance with state and federal regulations.

cGMP refers to the Current Good Manufacturing Practices enforced by the US Food and Drug Administration (FDA). cGMP provides for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to cGMP regulations assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining validated testing methods. This formal system of controls, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures and errors.

Drug Quality and Security Act

The Drug Quality and Security Act (DQSA) became law on November 27, 2013. The 80-page Act has direct consequences for compounding pharmacies and providers that use their services. The DQSA updated the Section 503A exemption. This exemption now applies only to small compounding pharmacies that produce medications in limited quantities, allowing them to continue their operations without having to use the most advanced quality and manufacturing techniques. State boards of pharmacy will continue to provide primary oversight of these pharmacies, and each pharmacy will only be allowed to have a small percentage of their medications shipped out-of-state, assuming valid licenses in those states. In addition, the prescriptions will need to be patient-specific for each compound.

DQSA also introduced a 503B exemption (designating Outsourcing Facilities) for larger sterile compounding pharmacies that requires the use of advanced manufacturing standards and imposes federal oversight.

All Outsourcing Facilities must comply with cGMP. These principles are designed to eliminate contamination of compounded medications, deviations from protocols or incorrect ingredients as well as other safety and quality issues. Under these requirements, a sample of each medication must be tested for the sterility and integrity of ingredients. Preparing compounded medications in a sophisticated, state-of-the-art cleanroom is also mandatory to adhere to cGMPs. Amongst other requirements, registered Outsourcing Facilities must:

  • Comply with cGMP requirements
  • Agree to maintain stringent reporting systems
  • Submit to unscheduled on-site inspections of their facilities
  • Adhere to FDA regulations regarding the bulk drug substances used to compound
  • Implement an adverse event reporting system

As a result, providers that use compounded and sterile medications can now easily identify a pharmacy partner that meets high standards around quality control and patient safety via the 503B Outsourcing Facility designation. While medications from pharmacies that do not register as an Outsourcing Facility may be less expensive, these facilities do not provide the same quality and safety assurance.

503B

In contrast to Section 503A, Section 503B is an entirely new section of the FDCA. Section 503B creates a new entry point for medications into the drug supply chain: the outsourcing facility. Outsourcing facilities can be used to fill the gap between traditional pharmacy compounding and industrial manufacturing where compounded products are needed for administration by health care facilities. The requirements that must be satisfied to qualify as a registered 503B facility, as well as implications of the provisions for both pharmacies considering obtaining 503B registration or contracting for services with a 503B facility, are discussed below. Registration and compliance with Section 503B exempts outsourcing facilities from the following FDCA requirements imposed on drug manufacturers:

Compliance with extensive product labeling materials (Section 502(f)(1)), Section 503B does, however, impose other outsourcing facility-specific labeling requirements; they are discussed below Proof of safety and efficacy of the drug product for its intended use through NDAs or ANDAs filed with FDA Compliance with track-and-trace requirements created by DQSA Title II

FDA inspects outsourcing facilities under a risk-based schedule, which includes consideration of the facility’s history, recall history, level of risk for drugs compounded, and if compounding from the drug shortage list.1

By June 2015, 53 outsourcing facilities had registered with FDA.2 As of July 1, 2016, 62 facilities had registered.3

Section 503B defines an outsourcing facility as "...a facility at 1 geographic location or address that—(i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section.”4 Any pharmacy or compounding physician may, therefore, elect to register as an outsourcing facility, but outsourcing facilities are not required to maintain any additional registration, such as a pharmacy license, under federal law. (State law may require them to acquire a pharmacy license.)

A compounding entity may have multiple locations, but an individual registration is required for each location; there is no corporate registration option. Unlike pharmacies that compound under Section 503A, outsourcing facilities may compound drug products without receipt of a valid, individual patient prescription. Outsourcing facilities may also accept prescriptions for individual patients, but are not required to do so.

Also, an entity engaged in compounding that is not governed by Section 503A may elect not to register as a 503B outsourcing facility, since registration is voluntary. Although outsourcing registration is voluntary, compounding prescription drugs other than pursuant to individual patient prescriptions is only legal if the facility doing so is a 503B outsourcing facility. (Note that there is concern that while compounding without meeting the requirements of 503A or registering as a 503B is illegal, registration is voluntary. Nothing about this prevents "bad actors" from compounding without registering. FDA is aware of this problem and has stated that they hope market forces will prevent this problem since pharmacies, physicians and other HC entities will only do business with 503B registered facilities.) Regulators anticipate that pharmacies, hospitals, physicians’ practices, and outpatient care centers that currently need or prepare products that are not patient-specific will now obtain them from registered 503B facilities. This is an important consideration for organizations and facilities that purchase compounded products. Purchasers must note that upon initial registration and payment of all applicable fees, an outsourcing facility can be listed on FDA’s Registered Outsourcing Facilities list. This means that a facility can be listed before it is inspected.5

Outsourcing facilities must comply with cGMPs applicable to drug manufacturers. This is an important distinction between Sections 503A and 503B. Recall that under Section 503A, pharmacies compounding products pursuant to valid, patient-specific prescriptions and satisfying other conditions are exempt from cGMP compliance and instead subject to USP compliance.

Compounded products from outsourcing facilities, while exempt from FDCA’s manufacturer labeling requirements, must nonetheless meet labeling requirements that go beyond those required of products from pharmacies in compliance with Section 503A. The labels of all products that are compounded by outsourcing facilities must include a statement that it is a compounded drug, and the lot or batch number of the drug, the established name of the drug, the dosage form and strength, the quantity or volume of drug, the date the drug was compounded, the expiration date, storage and handling instructions, the National Drug Code number (if available), the statement "Not for Resale," the statement "Office Use Only" (if applicable), and a list of active and inactive ingredients. The container of a compounded product must also include directions for use and instructions for reporting adverse events related to the compounded product.6

Outsourcing facilities may not sell or transfer compounded products to a wholesaler for redistribution. All products must be distributed within a health care setting (i.e., clinic, physician’s office, hospital) or dispensed directly to a patient or prescriber pursuant to a prescription. Outsourcing facilities cannot sell through wholesalers, but they can dispense to a practitioner for "office use." Again, a pharmacy compounding in compliance with Section 503A may not dispense compounded products except pursuant to a valid, patient specific prescription.4

An outsourcing facility must comply with any FDA-required Risk Evaluation and Mitigation Strategy (REMS) applicable to a product produced at the facility. Such reporting is voluntary for pharmacies that compound in compliance with Section 503A.4

Finally, an outsourcing facility must renew its registration with FDA annually. It must submit reports that list the drugs compounded by the facility twice a year. The outsourcing facility must also pay all applicable fees for registration—an annual establishment fee of $15,000 multiplied by an inflation adjustment factor, a small business adjustment factor, and reinspection fees.6 The annual registration period is October 1 through December 31 for the subsequent year. Failure to pay fees by December 31st of the year previous will result in loss of outsourcing facility status. Forms and information concerning outsourcing facility registration are available on FDA website.7

People

Empower Pharmacy’s commitment to quality begins with our rigorous hiring process to identify key individuals with a strong dedication to quality assurance and patient safety. These individuals undergo a thorough interview and background analysis to ensure they meet Empower’s standards.

All employees are required to complete our didactic and hands-on training programs before performing any duties as an Empower Pharmacy team member. Our robust training program consists of USP 797, cGMP, media fill testing, garbing practices, cleaning and disinfection practices, aseptic practices, and a thorough training on each standard operating procedure. After the completion of each training program, the employee is given an assessment to ensure complete understanding and knowledge in each subject area. Training is given to the employees on a routine basis to ensure overall quality and continuous development of our employees.

Dedication to quality can be seen throughout our entire organization. Our staff involved in quality control includes: Quality Assurance Director, Director of Compliance, Facility Manager, Director of Engineering, Director of Manufacturing, Director of Operations, Chief Information Officer, Chief Technology Officer, Director of Compliance and Regulations, Microbiologists, Pharmaceutical Engineers, Chemists, Pharmacists, and Pharmacy Technicians. Employees, equipment, facilities, training, processes, and compliance with state and federal regulations ensure that Empower Pharmacy will continue to be one of the leading 503B Outsourcing Facilities in the nation.

Facilities

The Drug Quality and Security Act adds a new section 503(b) to the FD&C Act. Under section 503(b), a compounder can register with the FDA as an outsourcing facility. Drug products compounded in a registered outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act and the requirement to label drug products with adequate directions for use under section 502(f)(1) if the requirements in section 503(b) are met. 503B Outsourcing facilities will be inspected by FDA and must comply with other provisions of the FD&C Act, including cGMP requirements under section 501(a).

21 CFR part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” sets out the requirements applicable to the design of facilities used in the manufacture of drug products. Certain elements of facility design are considered critical to ensuring the quality of compounded sterile drug products. Empower Pharmacy’s facilities were designed and constructed from the ground up with cGMP in mind. Our state-of-the-art facility built in 2016 includes the following features: 

  • 30,000 square foot building designed and operated with facility layout, room separation, and process flow considered in a manner to prevent the influx of contamination from adjacent areas and rooms of lower air quality
  • Class 100 ISO 5 Lyophilization Suite
  • Smoke studies of all our clean rooms and hoods are conducted under dynamic conditions to qualify them for use
  • Fully automated sterile processing line capable of cleaning, sterilizing, filling, stoppering, and capping up to 60 vials per minute with no human intervention
  • Steris Finn-Aqua BPS double door pit mounted steam sterilizer
  • Steris Finn-Aqua Pure Steam Generator creates pure pharmaceutical grade steam used for sterilization and cleanroom humidification
  • Steris Reliance Pharmaceutical Grade Washer that uses TOC monitoring, HEPA drying, purified water, and validated alkaline/acidic detergents to clean equipment and parts involved in the manufacturing process
  • Sterile and non-sterile hazardous drug compounding suites built to meet the new USP <800> requirements
  • Biannual certifications of cleanrooms and all HEPA filters
  • Daily viable air testing is performed in all areas where aseptic compounding occurs
  • Automated environmental control systems include built-in alarms to detect excursions with real time monitoring of pressure differentials, humidity, particulates, and temperatures
  • 35 foot ceiling shipping/receiving warehouse with controlled temperature and humidity for storage utilizing FedEx, UPS and USPS systems for shipments

Labeling

Empower Pharmacy is registered with the US Food and Drug Administration (FDA) as a 503B sterile compounding outsourcing facility under the recently enacted Drug Quality and Security Act (DQSA). The law, signed by the President on November 27, 2013, calls for entities engaged in office use anticipatory compounding to register with the FDA under the newly created section 503B.

Empower Pharmacy's registration as an outsourcing facility under the DQSA is based on draft guidance released by the FDA and listed in the Federal Register on December 4, 2013. Apart from new drug labeling and drug event reporting regulations, Section 503B also requires outsourcing facilities to compound all drugs utilizing current good manufacturing practices (cGMP), the same standards large pharmaceutical manufacturers use. Empower Pharmacy is actively engaged in complying with all requirements defined in the DQSA.

Part of this compliance strategy entailed a complete label redesign for our products to help enhance patient safety. In accordance with the DQSA, label changes or additions will include: The statement “compounded drug”, the name, address, and phone number of our outsourcing facility, the lot number of the compound, the established name of drug, the dosage form and strength, the statement of quantity or volume, the date that the drug was compounded, the beyond use date, the storage and handling instructions, the statement “not for resale” or “office use only” where applicable, and a list of active and inactive ingredients identified by established name and the quantity or proportion of each ingredient.

With respect to the container from which individual units are removed for dispensing or for administration Empower Pharmacy includes: information to facilitate adverse event reporting, and directions for use, including the appropriate dosage and route of administration.

Packaging of sterile drugs must be appropriate to the product and capable of ensuring the sterility and integrity of the product until it is administered to a patient. Packaging and labeling are critical to ensure the quality of compounded sterile drug products. We ensure through closure integrity testing that our container, closure, and packaging systems provide adequate protection against external factors in storage, shipment, and use that could cause contamination or deterioration of the finished product. Our labeling operations include adequate controls that have been established for issuing labels, examining issued labels, and reconciliation of used labels to prevent mix-ups. All labeled drug products are examined for accuracy and thoroughness before release.

Sterile Compounding

Empower Pharmacy houses Houston's premier state-of-the-art cleanroom constructed in 2016, which allows us the ability to offer a variety of customized sterile medications.

Empower Pharmacy skillfully and carefully follows the guidelines outlined by the United States Pharmacopeia's Chapter <797> and Federal Register title 21 CFR part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” for the compounding of sterile pharmaceutical preparations. Furthermore, Empower Pharmacy adheres to the guidance provided by the FDA’s Compliance Policy Guide (CPG) Sec. 460.200 “Pharmacy Compounding.” Federal, state and consultant agencies have performed detailed inspections of our facilities assuring compliance with the necessary regulations to ensure the safety of patients receiving sterile preparations.

Empower Pharmacy uses FDA approved drugs and aseptically adds them to sterile parenteral containers. The key to providing a safe admixture resides in using the principles of aseptic processing to maintain sterility of the FDA approved components throughout the compounding process. This allows us to maintain the highest degree of supply chain integrity and compliance with state and federal regulations.

Stability Studies

CGMP requires that a stability program must be established to assess the stability characteristics of finished drug products, and the results of stability testing must be used to determine appropriate storage conditions and beyond use dates. Stability studies are used to ensure that a drug product will retain its quality (e.g., strength) and remain sterile, through the labeled beyond use date. A beyond use date is established through the conduct of our stability program that includes testing to assess the product’s performance against specifications after aging to the desired beyond use date.

Quantitative analysis is performed per USP requirements on each batch to determine concentration of the active ingredient(s). Potency testing is performed by an independent FDA registered laboratory. Ingredients used in compounding procedures are determined to be stable, compatible, and appropriate for use, according to USP guidelines. Certificates of Analysis are received from manufacturers for ingredients used in compounded preparations. Tests are performed according to USP <51>, <71>, <85>, <788>, <790>, <791>, <797>, and <1207> guidelines. Components and finished preparations undergoing end-preparation testing, remain in quarantine until testing results are received and are reviewed by our quality control team and a compounding pharmacist before release. All our compounded sterile products undergo pH, particulate, appearance, preservative effectiveness, preservative content, method suitability, container-closure integrity, potency, endotoxin, and sterility testing as per USP.

Following cGMP & USP Guidelines

  • Test finished products - in-house & independent lab potency, endotoxin and sterility testing
  • Daily viable microbial sampling of air, surface and personnel within all clean rooms and hoods
  • Real time monitoring of the particle count of each clean room and hood's sterile environment 
  • Follow proper cleaning and maintenance 
  • Routinely have outside parties certify our cleanrooms and laminar flow hoods
  • Routinely assess pharmacy staff on their aseptic technique
  • Personnel must properly groom and gown before entering critical sterile areas

Empower Pharmacy's staff includes highly trained pharmacists, certified pharmacy technicians, quality control supervisors, and pharmaceutical engineers. All of these employees have had extensive training and years of experience in the area of sterile compounding, assuring our patients the highest level of quality and safety.

Freeze Drying

Freeze drying also known as lyophilization is an important process in sample preparation and for the preservation and storage of biologicals, pharmaceuticals and foods. Of the various methods of dehydration, freeze drying is especially suited for substances that are heat sensitive. Other than food processing (e.g., coffee, whole dinners), freeze drying has been extensively used in the development of pharmaceuticals (e.g., antibiotics) and preservation of biologicals (e.g., proteins, plasma, viruses and cell lines).

Freeze drying is a process whereby water or other solvent is removed from frozen material by converting the frozen water directly into vapor without the intermediate formation of liquid water. The basis for this sublimation process involves the absorption of heat by the frozen sample in order to vaporize the ice; the use of a vacuum pump to enhance the removal of water vapor from the surface of the sample; the transfer of water vapor to a collector; and the removal of heat by the collector in order to condense the water vapor. In essence, the freeze dry process is a balance between the heat absorbed by the sample to vaporize the ice and the heat removed from the collector to convert the water vapor into ice.

Why Freeze Dry?

Pharmaceutical companies often use freeze-drying to increase the shelf life of products, such as vaccines and other injectables. By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection.

  • The advantages of lyophilization include:
  • Ease of processing a liquid, which simplifies aseptic handling
  • Enhanced stability of a dry powder
  • Removal of water without excessive heating of the product
  • Enhanced product stability in a dry state
  • Rapid and easy dissolution of reconstituted product

Freeze Drying Process

Freeze drying is mainly used to remove the water from sensitive products, mostly of biological origin, without damaging them, so they can be preserved easily, in a permanently storable state and be reconstituted simply by adding water. Examples of freeze dried products are: antibiotics, bacteria, serum, vaccines, diagnostic medications, protein-containing and biotechnological products, cells and tissues, and chemicals.

The product to be dried is frozen under atmospheric pressure. Then, in an initial drying phase referred to as primary drying, the water (in form of ice) is removed by sublimation; in the second phase, called secondary drying, it is removed by desorption. Freeze drying is carried out under vacuum. The conditions under which the process takes place will determine the quality of the freeze dried product. Some important aspects to be considered during the freeze drying process are as follows:

Freezing

Freezing is a process used to transform the basic product by abstracting heat to create a state that is suitable for sublimation drying. When an aqueous product is cooled down, at first crystal nuclei are formed. The surrounding water will be taken up around these nucleation sites, resulting in crystals of different sizes and shapes. Freezing speed, composition of the basic product, water content, viscosity of the liquid, and the presence of non-crystallizing substance are all decisive factors in determining the crystal shape and size and in influencing the following sublimation process. Large crystals leave a relatively open lattice after sublimation, while small ice crystals leave narrow spaces in the dried product slowing down the removal of water vapour.

Primary Drying

At the beginning of the primary drying phase, sublimation of the ice takes place at the surface. As the process continues, the subliming surface withdraws into the product, and the evolving vapour must be conducted through the previously dried outer layers. This means that the drying process depends on the speed of vapour transfer and removal as well as on the necessary heat of sublimation. The heat required for sublimation is supplied to the product by convection and thermal conduction and in a small part by thermal radiation. Apart from heat transfer by thermal conduction and radiation, it is most important that the heat transfer by convection is optimized. It must be taken into account, however, that due to the reduction of pressure in the drying chamber, convection will practically cease at a pressure below 10 mbar. This is why, as a function of the required sublimation temperature, the pressure in the drying chamber is adjusted during primary drying to the highest permissible value.

The sublimation heat is not needed at the product surface, but at the boundary of the ice core that is withdrawing into the centre of the product as drying proceeds. Whilst the flow of water vapour is from within the product to the outside, the transfer of heat must be accomplished in the opposite direction from the outside to the inside. Due to the low thermal conductivity of the dried product layers, the temperature gradient required for heat transfer steadily increases. To avoid damage to the product, the maximum admissible temperature for the dried product must not be exceeded. On the other hand, care must be taken to maintain the required sublimation temperature throughout drying, keep the heat supply to the ice-core boundary in equilibrium with the heat requirement at that particular location, and avoid any overheating of the sublimation zone. The primary drying phase continues until all the ice contained in the product has been sublimated.

The freezing point of pure water is 0°C. Any other substances dissolved in the water will lower the freezing point; where inorganic salts are present it may be considerably lower. If a weak solution is frozen, at first pure ice will be separated, thereby increasing the concentration of dissolved substance in the residual solution making its freezing point lower still. The effect of such freezing concentration on the product is different from case to case and has to be taken into account when selecting the most appropriate freezing technique.

The most suitable freezing technique for a specific product should be determined and its parameters ascertained prior to sublimation drying. The freezing behaviour of the product may be investigated, for instance, using the resistance-measurement method.

Two different freezing methods are chiefly used for pharmaceutical products:

1. Freezing by contact with cooled surface.

2. Rotation or dynamic freezing in a coolant bath.

The first method is a static freezing technique where a versatile freeze dryer must be capable of adjusting the freezing rate to the specific product and should allow control of the freezing speed. A final temperature of -50°C will in many cases be sufficient to meet all requirements.

The second method is used wherever larger quantities of a liquid product are to be frozen and dried in flasks or large bottles.

The appropriate freezing technique will also be chosen to produce a layer thickness of the frozen product that is favourable for sublimation drying, i.e. not only uniform but also as thin as possible to achieve a short drying time.

Secondary Drying

In the secondary or final drying phase the aim is to reduce the residual moisture content in the product as much as necessary to ensure the product is in a permanently storable state. The water bound by adsorption at the internal surface of the product has to be removed. To achieve this, it is often necessary to overcome the capillary forces of the water, and freeze drying plant must therefore be designed to give a high pressure gradient during the secondary drying phase, as in most cases it is not possible to raise the product temperature without damaging the product. The secondary drying process must be precisely controlled so that any over drying of the product will be safely avoided.

After-Treatment

This section refers to the manner in which the dried products, often very hygroscopic owing to their large internal surface, can be protected after drying. If the product is dried in bottles, flasks or vials, it appears logical to close these containers immediately after drying before removal from the plant. For this purpose, special ribbed rubber stoppers are placed in the necks of the bottles or vials before charging the plant and, on termination of drying, are firmly pressed into the necks by a stoppering device. The containers may be sealed under vacuum or under protective gas atmosphere. The choice of method depends on the type of product. The drying chamber is then vented after termination of the drying cycle with dry sterile nitrogen or other inert gas up to atmospheric pressure.

Equipment

Empower Pharmacy utilizes a 24 sq ft cGMP lyophilizer to guarantee our customers a reliable validated cycle capable of producing a wide range of pharmaceutical products. We only employ production rated freeze driers as they offer many advantages over lab rated freeze driers.

Utilizing the knowledge of our engineering and cycle development groups differential scanning calorimetry, freeze dry microscopy analysis of eutectic points, critical temperatures and vapor pressures determine lyophilization conditions. Vials are filled and partially stoppered by way of an automated sterile filling line within an ISO Class 5 cleanroom before being transferred to the lyophilizer.

Clean-in-place (CIP) of the drying and condensing chambers is performed in between each batch using deionized purified water followed up with a steam-in-place (SIP) sterilization cycle. All piping and chamber materials are constructed of ASME 316L stainless steel. Sealing of vials is performed in process under inert gas back-fill with a hydraulic stoppering system. Empower Pharmacy performs full IQ/OQ/PQ validation and records cycle parameters employing a secure CFR 21 compliant data system. Complete project support from formulation through cycle development and scale up production is standard for all our products.

  • 1. 21 USC §353B(d)(10).
  • 2. U.S. Food and Drug Administration. Registered outsourcing facilities. Accessed at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm, June 25, 2015.
  • 3. U.S. Food and Drug Administration. Facilities registered as human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Accessed at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm, July 16, 2016.
  • 4. a. b. c. 21 USC §353b: Outsourcing Facilities. U.S. Code. Accessed at http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353b&num=0&edition=prelim, July 12, 2016.
  • 5. 21 USC §353B(d)(4).
  • 6. a. b. U.S. Food and Drug Administration. Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act. Rockville, MD: U.S. Dept of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2014. Accessed at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm391102.pdf, July 12, 2016.
  • 7. U.S. Food and Drug Administration. Information concerning outsourcing facility registration. Accessed at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm389118.htm, July 12, 2016.