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藥品召回是指藥品生產(chǎn)企業(yè)按照規(guī)定的程序收回已上市銷售的存在安全隱患的藥品。在cGMP以下問答指南中，F(xiàn)DA對于藥品召回的相關(guān)要求，以問題解答的方式給予了詳細(xì)的說明。

問1：什么是召回？

答：召回是指公司采取的行動，將任何違反FDA管制法律的產(chǎn)品從市場上撤出。召回藥品可以由公司自行發(fā)起，也可以應(yīng)FDA的要求進(jìn)行。違法的上市產(chǎn)品需要進(jìn)行移除或糾正，對此可以FDA可發(fā)起法院訴訟，而召回是一種替代方式。根據(jù)FDA關(guān)于制劑CGMP法規(guī)（21 CFR 211.150(b)），生產(chǎn)商必須建立并遵循書面程序，以促進(jìn)從市場上召回有缺陷的產(chǎn)品。

§211.150分銷程序

Sec. 211.150 Distribution procedures.

建立并遵循書面程序，描述藥品的分銷。應(yīng)包括：

Written procedures shall be established, and followed, describing the distribution of drug products. They shall include:

（b）一種系統(tǒng)：據(jù)此可以容易地確定每批藥品的分銷情況，以在必要時方便召回。

(b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary.

Q1. What is a recall?

A: Recalls are actions taken by a firm to remove from the market any product that is in violation of laws administered by FDA. Recalls of a drug may be conducted on a firm’s own initiative or by FDA request. A recall is an alternative to an FDA-initiated court action for removing or correcting violative, distributed products. Under FDA’s CGMP regulations for finished pharmaceuticals, manufacturers must establish and follow written procedures to facilitate the recall of defective products from the market (see 21 CFR 211.150(b)).

問2：FDA可以強制召回人藥嗎？ 

答：FDA無權(quán)強制召回人藥，但可以對那些堅持銷售有缺陷產(chǎn)品（例如扣押和禁令）的 生產(chǎn)商采取更權(quán)威的法律行動。召回是指公司對FDA認(rèn)為違反其管制法律的產(chǎn)品進(jìn)行移除或糾正，否則FDA將針對此產(chǎn)品采取更強有力的法律行動。因此，生產(chǎn)商通常會發(fā)現(xiàn)市場批次缺陷時主動發(fā)起自愿召回，以避免FDA可能采取更重大的執(zhí)法行動。

Q2. Can FDA mandate a recall of human drugs? 

A: FDA does not have authority to mandate a recall of a human drug, but it can take more authoritative legal actions against manufacturers that persist in marketing a defective product, such as seizure and injunction. A recall is a firm’s removal or correction of a marketed product that FDA considers to be in violation of the laws it administers, and against which FDA would otherwise initiate more powerful legal action. Thus, manufacturers typically initiate voluntary recalls when a defect is found within a marketed batch to avoid a potentially more significant enforcement action by FDA. 

問3：非處方藥是否與處方藥一樣，受召回規(guī)定的約束？ 

答：是的，F(xiàn)DA對藥品的召回期望同樣適用于非處方藥和處方藥。CGMP法規(guī)也適用于所有藥品，無論是非處方藥還是處方藥。 

Q3. Are over-the-counter (OTC) drugs subject to the same recall provisions as prescription drugs? 

A: Yes, FDA’s recall expectations for drugs apply equally to OTC and prescription. The CGMP regulations also apply to all drug products, whether OTC or prescription. 

問4：FDA是否期望企業(yè)對已放行和拒絕的批次進(jìn)行調(diào)查，以發(fā)現(xiàn)潛在的召回需求？

答：是的。根據(jù)21 CFR 211.180(e)，生產(chǎn)商必須建立并遵循書面程序，以定期回顧投訴、召回、退回或回收處理的藥品以，并對產(chǎn)品差異性問題進(jìn)行調(diào)查。公司還必須審查適當(dāng)數(shù)量的批次（無論已批準(zhǔn)還是已拒絕放行），以及與批次相關(guān)的記錄（如適用），以確保對所有可能受影響的產(chǎn)品進(jìn)行徹底調(diào)查，并采取適當(dāng)?shù)暮罄m(xù)措施（21 CFR 211.192）。 

Q4. Does FDA expect firms to investigate both released and rejected lots for potential recalls?

A: Yes. Under 21 CFR 211.180(e), manufacturers must establish and follow written procedures for periodically reviewing complaints, recalls, returned or salvaged drug products, and investigations of product discrepancies. Firms must also review an appropriate number of batches, whether approved or rejected, and, where applicable, records associated with the batches, to ensure that all potentially affected product is thoroughly investigated and appropriate follow-up action is taken (21 CFR 211.192). 

問5：如果公司不自愿召回有缺陷的產(chǎn)品怎么辦？

答：如果藥品有缺陷，對健康造成危害，F(xiàn)DA希望公司會自愿召回。當(dāng)公司拒絕執(zhí)行FDA要求的召回時，或FDA有理由認(rèn)為召回?zé)o效、確定召回?zé)o效或發(fā)現(xiàn)違反行為仍在繼續(xù)時，F(xiàn)DA將采取扣押、查封或其他法院行動。

Q5. What happens if a firm does not voluntarily recall a defective product?

A: FDA expects that a firm will voluntarily recall a drug that is defective or flawed if it could be hazardous to health. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by FDA, or where the Agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing (21 CFR 7.40(c)).