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Editorial: FDA Guidance Under 503B
This week we will continue our presentations of H.R. 3204 Drug Quality and Security Act and the FDA's actions in distributing Guidances for both Section 503A and 503B. Our focus this week is on Section 503B of the Act as it relates to sterile compounding, interstate shipment, FDA Registration, etc. Only selected portions are presented here to make it easier to read. For a full copy of the Guidance and how to respond, go to:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/
guidances/ucm377052.pdf
I. INTRODUCTION
This guidance is intended for outsourcing facilities that compound human drugs (outsourcing facilities). A facility that compounds sterile drugs may elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act (DQSA). This guidance focuses on electronic submission of establishment registration information.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. BACKGROUND
A. Drug Quality and Security Act
The DQSA adds new section 503B to the FD&C Act. Under section 503B(b) of the FD&C Act, a compounder may elect to become an outsourcing facility by registering with FDA. Each registered outsourcing facility must report to the Agency certain information about the products it compounds. Products compounded in a registered outsourcing facility can qualify for exemptions from the FDA approval requirements in section 505 of the FD&C Act (21 U.S.C. 355) and the requirement to label products with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if the requirements in section 503B are met.
Outsourcing facilities will be inspected by FDA and must comply with other provisions of the FD&C Act, such as current good manufacturing practice (cGMP) requirements. Information about these requirements will be provided separately at a later date. After the initial registration, under section 503B(b) of the FD&C Act, a facility that elects to register with FDA as an outsourcing facility must also do so annually between October 1 and December 31. Upon registration, the outsourcing facility must provide its name, place of business, a unique facility identifier, and a point of contact email address. The outsourcing facility must also indicate whether it intends to compound, within the next calendar year, a drug that appears on FDA's drug shortage list in effect under section 506E of the FD&C Act (21 50 U.S.C. 356e), and whether it compounds from bulk drug substances, and, if so, whether it compounds sterile drugs.
B. Scope of This Guidance
This guidance document describes the process for registering as an outsourcing facility under section 503B of the FD&C Act. A separate guidance provides instruction on how outsourcing facilities should report to FDA the products they compound. This guidance reflects current thinking in light of data standards, information technology, and information management resources. As these variables change over time, FDA may revisit this guidance and the specifications described in section III of this guidance.
III. REGISTERING WITH FDA AS AN OUTSOURCING FACILITY
A. Who Should Register
A facility that compounds sterile drugs may elect to register with FDA as an outsourcing facility. Each facility at a separate geographic location or address must register separately. The outsourcing facility is not required to be a licensed pharmacy, and may or may not obtain prescriptions for individual patients.
B. How to Register
1. Primary Method for Outsourcing Facility Registration
Facilities that elect to register with FDA as outsourcing facilities should submit registration information using the existing Structured Product Labeling (SPL) format. For detailed instructions on how to submit information using SPL, outsourcing facilities should refer to
• An indication of whether the facility intends to compound products on FDA's drug shortage list; and
• An indication of whether the facility compounds from bulk drug substances, and if so, whether it compounds sterile drugs from bulk drug substances.
FDA also encourages outsourcing facilities to include a phone number as part of their registration information.
This alternative interim registration method is only intended for use in the near term, while outsourcing facilities unfamiliar with registration familiarize themselves with the method described in section III.B.1. FDA encourages outsourcing facilities that choose to use this alternative interim method to begin using the method described in section III.B.1 no later than September 30, 2014.
3. Posting of Registration Information
The information collected from the outsourcing facility registration, as well as certain product information, will be published in a list on the Internet as required by section 503B(b)(1)(B)(ii) of the FD&C Act. This list will include the name of each registered outsourcing facility, the state in which it is located, whether the facility compounds from bulk drug substances, and whether any bulk drug substance compounding is for sterile or nonsterile drugs.
D. Registration Fees
Under the DQSA, an outsourcing facility is not considered registered until all registration fees owed by the facility have been paid (see section 503B(g)(3)(A) of the FD&C Act). However, an outsourcing facility can register without paying a fee until October 1, 2014, because under the DQSA fees will not be assessed or owed until after that date.
Next week, we will discuss various aspects of the new bill.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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