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2015-08-12 Lachman CONSULTANTS

根据《联邦食品、药品和化妆品法案》503B节，实体考虑是否注册为外包设施

关于“是否进行各种活动的实体（例如，只配制非无菌药品，只进行生物制品再包装）需要注册为外包设施”，FDA收到了很多问题。企业仍然对是否应该去注册感到迷惑，FDA发布了本定稿指南“根据《联邦食品、药品和化妆品法案》503B节，实体考虑是否注册为外包设施”来澄清这个问题。

根据FD&C Act 503B节，FDA列出了外包设施（outsourcing facility）的定义：
一个地理位置的设施 - (i)从事无菌药品的配制；(ii)决定注册为外包设施；(iii)符合本节的所有要求。
本指南列出了外包设施必须满足的11个条件，才能有资格实现本法规的标签要求。并且，FDA提醒注册人外包设施必须满足cGMP，必须接受FDA周期性的检查。最重要的事情是：外包设施必须生产无菌药品，才能满足上述定义。

指南也声明了：
如果注册人不期望设施内配制的所有的药品与FD&C Act 503B一致，并且符合CGMP要求，请不要注册为外包设施。并且，考虑注册为外包设施的实体应该考虑：

• 满足外包设施的定义，设施必须从事无菌人用药品配制。
  
• FD&C Act 503B(d)(1)节定义的配药（compounding）不包括再包装。
  
• FD&C Act 503B，药品，包括无菌药品不包括需要按照PHSA 351许可的生物制品，或按照 FD&CA 512 批准的兽用药。
  

FDA建议“如果设施内从事的活动仅是再包装，配制非无菌药品，或混合、稀释，或再包装需要按照PHSA 351许可的生物制品，那么不应将设施注册为外包设施”。因为设施内生产的任何药品都不符合 FD&CA 503B节规定的豁免。

请注意，注册为外包设施后，需要交纳年费，并且需要满足cGMP，接受FDA的监管。请根据企业的情况谨慎确认，因为错误的决定可能导致导致财产丧失，并且不会有返还。

Lachman CONSULTANTS - Bob Pollock先生 2015-08-11
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FDA Clarifies Issues Regarding Outsourcing Pharmacies
By Bob Pollock | August 11, 2015

The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.” Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act (here) was released from FDA today in hopes of clarifying this issue.

FDA outlines the definition of an outsourcing facility under 503B of the FD&C Act as follows:

A facility at one 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.

The Guidance delineates 11 conditions that must be met by outsourcing facilities and must be met to qualify for the exemptions afforded for adequate labeling requirements under the Act. In addition, FDA reminds registrants that an outsourcing facility is subject to current good manufacturing practices (cGMPs) and is subject to periodic inspection by the FDA. The key issue is that the outsourcing facility must produce sterile drug products in order to be defined as such.

The Guidance also states:

If you do not intend for all drugs compounded at your facility to be compounded in accordance with section 503B and comply with CGMP requirements, you should not register as an outsourcing facility under section 503B. In addition, entities considering registering as outsourcing facilities should consider the following:

• To meet the definition of an outsourcing facility, the facility must be engaged in the compounding of sterile human drugs.
• The definition of compounding in section 503B(d)(1) does not include repackaging.
• For purposes of section 503B, a drug, including a sterile drug, does not include a biological product subject to licensure under section 351 of the Public Health Service Act (PHS Act), or an animal drug subject to approval under section 512 of the FD&C Act.

The FDA advises, “you should not register a facility as an outsourcing facility if the only activities conducted at the facility are repackaging, compounding non-sterile drugs, compounding animal drugs, or mixing, diluting, or repackaging biological products subject to licensure under section 351 of the PHS Act, because none of the products produced at the facility would qualify for the exemptions provided in section 503B.”

Remember, outsourcing facilities need to pay a yearly fee to register. Be certain of your status and proceed with caution because the wrong decision can result in forfeiture of any fee paid (they are non-refundable) and you will be required to meet cGMPs and be subject to FDA inspection.