【正文】 that could be related to current good manufacturing practice. Examples of product plaints are: Foul odor, off taste, illness or injury, disintegration time, color variation, tablet size or size variation, underfilled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, subpotent, or contain the wrong ingredient, or contain a drug or other contaminant (eg, bacteria, pesticide, mycotoxin, glass, lead). 產(chǎn)品投訴的任何通信手段包含任何指控，書面，電子或口頭表示關(guān)注因任何原因，與一名膳食補(bǔ)充劑的質(zhì)量，這可能與目前的良好生產(chǎn)規(guī)范。 Pest means any objectionable insect or other animal including birds, rodents, flies, mites, and larvae. 害蟲是指任何不良昆蟲或其他動(dòng)物包括鳥類，老鼠，蒼蠅，螨蟲和幼蟲?；?(4) Otherwise may cause the ponent or dietary supplement to be adulterated. （4），否則可能會(huì)導(dǎo)致部分或營(yíng)養(yǎng)補(bǔ)充劑是摻假。 (3) Indicate that the ponent or dietary supplement is contaminated with filth。 (2) May cause a ponent or dietary supplement to depose。 This definition includes species that: 這個(gè)定義包括物種： (1) May have public health significance。或者，在連續(xù)過(guò)程中產(chǎn)生的飲食的補(bǔ)充，具體案件確定數(shù)額的方式生產(chǎn)在時(shí)間和數(shù)量的指定單位 ， 是一致的 ， 目的是要滿足的身份，純度，強(qiáng)度規(guī)格，和組成。 Lot means a batch, or a specific identified portion of a batch, that is uniform and that is intended to meet specifications for identity, purity, strength, and position。一種成分，包括但不一定限于，作為第201定義的膳食成分（法郎的行為）。 Examples of contact surfaces include containers, utensils, tables, contact surfaces of equipment, and packaging. 表面接觸的例子包括容器，用具，表，接觸的設(shè)備表面和包裝。組成部分包括膳食成分（如第201（后）的行為）和其他說(shuō)明材料。 Batch number, lot number, or control number means any distinctive group of letters, numbers, or symbols, or any bination of them, from which the plete history of the manufacturing, packaging, labeling, and/or holding of a batch or lot of dietary supplements can be determined. 批號(hào)，批號(hào)，或控制數(shù)是指任何字母，數(shù)字或符號(hào)，或任何組合，獨(dú)特的一群 ， 從其中的制造，包裝標(biāo)簽，完整的歷史，和/或批處理或很多持有膳食補(bǔ)充劑可確定。為此，下列定義也適用于： Actual yield means the quantity that is actually produced at any appropriate step of manufacture or packaging of a particular dietary supplement. 實(shí)際收益率是指實(shí)際上是在任何制造或包裝特殊膳食補(bǔ)充劑生產(chǎn)數(shù)量適當(dāng)?shù)牟襟E。 Sec. 秒。 (b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. （二）的要求舉行有關(guān)膳食補(bǔ)充劑并不適用于你是否保持在一個(gè)直接零售個(gè)人消費(fèi)者零售的唯一目的建立的膳食補(bǔ)充劑。 and （1）膳食補(bǔ)充劑 ， 但你制造的包裝物或由他人標(biāo)記。[聯(lián)邦法規(guī)] [Title 21, Volume 2] [標(biāo)題21，第2卷] [Revised as of April 1, 2008] [日期為2008年4月1日] [CITE: 21CFR111] [引用：21CFR111] TITLE 21FOOD AND DRUGS 標(biāo)題21 食品和藥物 CHAPTER IFOOD AND DRUG ADMINISTRATION 第一章食品和藥物管理局 DEPARTMENT OF HEALTH AND HUMAN SERVICES 部衛(wèi)生與公眾服務(wù) SUBCHAPTER BFOOD FOR HUMAN CONSUMPTION 子章節(jié)B組人類食用的食物 PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 現(xiàn)行良好操作規(guī)范在制造，包裝，標(biāo)簽，或?qū)κ称费a(bǔ)充劑控股作業(yè) Subpart AGeneral Provisions 子部分一般規(guī)定 Sec. 秒。 Who is subject to this part? ？ (a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including: （一）除提供段（二本節(jié)），你必須遵守 ， 如果你這部分的制造，包裝，標(biāo)簽，或持有飲食的補(bǔ)充，其中包括： (1) A dietary supplement you manufacture but that is packaged or labeled by another person。及 (2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. （2）膳食補(bǔ)充劑進(jìn)口或在任何國(guó)家或美國(guó)境內(nèi)的進(jìn)口提供，哥倫比亞特區(qū)，或波多黎各聯(lián)邦。 A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers. 阿零售的建立 ， 并不包括為零售商或倉(cāng)庫(kù)或其他存儲(chǔ)設(shè)施 ， 銷售直接向個(gè)人消費(fèi)者倉(cāng)庫(kù)或其他存儲(chǔ)設(shè)施。 What definitions apply to this part? ？ The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply: 的定義和節(jié)聯(lián)邦食品，藥品和化妝品法（該法）201條款的解釋適用于本部分時(shí) ， 使用的條款就本部分。 Batch means a specific quantity of a dietary supplement that is uniform, that is intended to meet specifications for identity, purity, strength, and position, and that is produced during a specified time period according to a single manufacturing record during the same cycle of manufacture. 批次指飲食補(bǔ)充劑是一致的，便是為了滿足身份，純度，強(qiáng)度規(guī)格，和組成，具體數(shù)量 ， 即在規(guī)定的時(shí)限內(nèi)根據(jù)一個(gè)單一的生產(chǎn)過(guò)程中產(chǎn)生的記錄的生產(chǎn)同一周期。 Component means any substance intended for use in the manufacture of a dietary supplement, including those that may not appear in the finished batch of the dietary supplement. Component includes dietary ingredients (as described in section 201(ff) of the act) and other ingredients. 組件是指任何人 ， 包括那些可能不會(huì)出現(xiàn)在膳食補(bǔ)充劑完成一批物質(zhì)在膳食補(bǔ)充劑的生產(chǎn)用途。 Contact surface means any surface that contacts a ponent or dietary supplement, and those surfaces from which drainage onto the ponent or dietary supplement, or onto surfaces that contact the ponent or dietary supplement, occurs during the normal course of operations. 接觸面指任何表面接觸組件或營(yíng)養(yǎng)補(bǔ)充劑，以及那些從表面上的排水組件或營(yíng)養(yǎng)補(bǔ)充劑，或接觸到的表面 ， 組件或營(yíng)養(yǎng)補(bǔ)充劑，在正常操作期間發(fā)生。 Ingredient means any substance that is used in the manufacture of a dietary supplement and that is intended to be present in the finished batch of the dietary supplement. An ingredient includes, but is not necessarily limited to, a dietary ingredient as defined in section 201(ff) of the act. 成分是指在一個(gè)膳食補(bǔ)充劑生產(chǎn)中使用的物質(zhì) ， 并擬在膳食補(bǔ)充劑完成一批存在。 Inprocess material means any material that is fabricated, pounded, blended, ground, extracted, sifted, sterilized, derived by chemical reaction, or processed in any other way for use in the manufacture of a dietary supplement. 在進(jìn)程的任何物質(zhì)手段是捏造的，復(fù)雜，混合，地面，提取，篩選，消毒，通過(guò)化學(xué)反應(yīng)，或以任何其他方式處理在膳食補(bǔ)充劑的生產(chǎn)使用得來(lái)的材料。 or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and position. 地段指一批，或特定確定了一個(gè)批處理部分，即是一致的