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| TYLENOL PACKAGING & DISTRIBUTION  Tylenol Packaging and Distribution In 1982, Johnson & Johnson said that Tylenol was packaged in plastic shrink-wrap was wrapped around groups of six bottles at the manufacturing plant. After the 1986 Tylenol murder, Johnson & Johnson executives and FDA officials said Tylenol was bottled at J&J's distribution center and plastic shrink-wrap was wrapped around groups of six bottles at the distribution center.
Regarding the 1986 Tylenol tamperings, J&J spokesman Robert Kniffen said: “While the two tainted samples were handled at the same place only two weeks apart, the company considered it unlikely that the tainting had occurred there because each bottle was usually safeguarded by five seals.” Kniffin went on to say, “the bottles at the distribution center are typically covered by two additional sealed wrappings: a clear plastic binder that is heat-sealed around all sides of six bottles, and a shrink-wrapped plastic binding around groups of cartons, each of which contains 12 groups of six-packs.”
Also in 1986, FDA Commissioner Frank Young made a statement almost identical to Kniffen's. "The most plausible explanation is tampering at the local level. In addition to the triple seal on each bottle”, Young said, “the bottles at the distribution center are typically covered by two additional sealed wrappings: a clear plastic binder that is heat-sealed around all sides of six bottles, and a shrink-wrapped plastic binding around groups of cartons, each of which contains 12 groups of six-packs”
This phraseology by J&J and FDA officals confirms the obvious - some Tylenol was not bottled or sealed at the McNeil manufacturing plants. Some Tylenol was shipped from McNeil in bulk containers to repackageing facilities where it was actually bottled and package.
Some Tylenol shipped to Johnson & Johnson's distributors in 1982 and 1986 was not bottled or packaged at the McNeil's manufacturing plants. Some Tylenol was shipped to local repackagers that repackaged the Tylenol before it was sold to retail and institutional outlets. 
Typical Repackaging Facility Cheap Manual Capsule Filler
Bulk Pharmaceuticals Active pharmaceutical ingredients are typicaly shipped from manufacturing plants to repackagers in drums like the one below. Acetaminophen (known as paracetamol in europe) for sale at Alibaba.com 
Price per kilogram and sales by metric ton of bulk acetaminophen powder by two US manufacturing plants; Tyco Healthcare and Rhodia: 
Need more than 1 or 2 barrels of acetaminophen? Buy it by the truckload for the best price: Mallinckrodt Chemical Inc., the largest acetaminophen producer, raised its US price early in 1998 and its European price In July. The company quotes a price of $8.55 per kilo for truckload quantities of pure powder acetaminophen. FDA POLICY Sec. 410.100 Finished Dosage Form Drug Products In Bulk Containers - Applications Of Current Good Manufacturing Practice Regulations (CPG 7132a.06) BACKGROUND: Questions have arisen concerning the application of the "umbrella" CGMP regulations, 21 CFR Parts 210 and 211 to firms which prepare dosage form drug products in bulk containers, such as tablets in fiber drums, and sterile antibiotic powders in bulk containers. Drug products in such bulk quantities are usually intended for further repacking into conventional retail packages such as bottles of 100 tablets each or vials of an antibiotic powder for reconstitution. These questions of application have, on occasion mistakenly expanded the term "bulk drug" to mean not only ingredients of drug products but also finished dosage forms in large quantities. However, in order to apply Parts 210 and 211 it is important to distinguish drug products in finished dosage forms in bulk containers from bulk drug components (i.e. ingredients intended for use in manufacturing or processing of a drug product).
POLICY: The CGMP regulations set forth in 21 CFR Parts 210 and 211 apply to the preparation of finished dosage forms regardless of whether such drug products are in bulk containers or retail packaged form. This is set forth in 21 CFR 210.3(b)(4) and 211.3(a). Issued: 2/9/81
Revised: 9/4/87 
Healthcare Distribution Managemt Association (HDMA) Testimony to FDA 1. Definition of Relabeling
The FDA’s proposed definition of relabel in section 207.1 is defined very broadly to mean any change or addition to the label or labels on a drug or drug package. HDMA has grave concerns regarding the breadth of this definition. HDMA distributors ship millions of prescription drug products each day to customers nationwide. To do so efficiently, it is common practice for distributors to affix stickers, barcodes, tags or other identifiers to drug packages to track inventory location, identify product origins and/or to ensure proper returns from pharmacies.
2. Repackaging
HDMA members perform many forms of packaging. For example, a packaging company may simplify the last step in the manufacturing process for the supplier (contract packaging) or aid in dispensing the product to the patient for hospitals using a unit-dose system (unit-dose packaging). A retail service repackaging company purchases drug products from the manufacturer and repackages them into smaller quantities. The smaller packages are sold and delivered to retail pharmacy customers bearing the manufacturer’s applicable NDC for that package size. Retail service repackaging safely and effectively offers package sizes that increase inventory efficiencies, eliminate waste and provide enormous value to our members’ retail pharmacy customers. FDA Repackaging Guidelines POLICY: The CGMP regulations apply to all drug products, whether OTC or prescription.
REGULATORY GUIDANCE: Issued: 4/01/1982
Because of increased visibility and promotion of certain OTC preparations, there are periodic inquiries from district offices regarding whether or not the enforcement policy for CGMP regulations is the same for OTC drug products as it is for prescription (Rx) drug products.
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act requires drugs to be manufactured in conformance with current good manufacturing practice. This section does not differentiate between OTC and Rx products and it was not intended by Congress to do so.
A prescription drug may be toxic or have other potential for harm, which requires that it be administered only under the supervision of a licensed practitioner (section 503(b)(1) of the Act). For this reason, problems associated with its manufacture are generally more likely to cause serious problems.
22.1(3) Labeling requirements.
a. Labeling for single unit or unit dose packaging shall comply with the following:
(1) Doses packaged by the manufacturer or distributor shall be properly labeled according to federal Food and Drug Administration (FDA) requirements.
(2) Doses packaged by the pharmacy for use beyond a 24-hour period shall be labeled and packaged according to the prepackaging requirements established in sub-rule 22.3(2).
b. Labeling for unit of issue packages shall contain the following information:
(1) Name, strength, and expiration date of drug when the packages are utilized for floor stock in an institutional setting.
(2) Name and room or bed number of patient, the name of prescribing practitioner, the name and strength of drug, directions for use, and name and address of the dispensing pharmacy, when the packages are utilized for patients in an institutional setting. Room or bed number, the name of prescribing practitioner, and the name and address of the dispensing pharmacy are not required if this information appears on a medication administration record used by the institution.
(3) Unit of issue packages dispensed to patients on an outpatient basis or in a non-institutional setting shall be considered prescription containers and shall be labeled in accordance with 657—subrule 6.10(1).
c. If a pharmacist selects a generically equivalent drug product for a brand name drug product prescribed by a practitioner, the label must identify the generic drug and may identify the brand name drug for which the selection is made. The dual identification allowed under this paragraph must take the form of the following statement on the label: “(generic name) Generic for (brand name product)”.
d. The labeling requirements of paragraphs “a” and “b” of this sub-rule shall not apply to the special circumstances identified in rule 657—23.13(124,155A).
e. Those drugs not dispensed under a unit dose dispensing system shall be labeled in accordance with the requirements of sub-rule 22.5(5) or 657—subrule 6.10(1) as appropriate.
657—22.3(126) Prepackaging.
22.3(1) Control record. Pharmacies may prepackage and label drugs in convenient quantities for subsequent labeling and dispensing. Such drugs shall be prepackaged by or under the direct supervision of a pharmacist. The supervising pharmacist shall be responsible for the preparation and maintenance of a packaging control record containing the following information:
a. Date.
b. Identification of drug.
(1) Name of drug.
(2) Dosage form.
(3) Manufacturer.
(4) Manufacturer’s lot number.
(5) Strength.
(6) Expiration date.
c. Container specification.
d. Copy of a sample label.
e. Initials or unique identification of the packager.
f. Initials or unique identification of the supervising pharmacist.
g. Quantity per container.
h. Internal control number or date.
HOSPITAL DRUG DISTRIBUTION AND CONTROL
Developed by the ASHP Council on Professional Affairs - Approved by the ASHP Board of Directors, March 20, 1980 - Revised November 1981.
In-House Manufacturing, Bulk Compounding, Packaging, and Labeling
As with commercially marketed drug products, those produced by the pharmacy must be accurate in identity, strength, purity, and quality. Therefore, there must be adequate process and finished product controls for all manufacturing/bulk compounding and packaging operations. Written master formulas and batch records (including product test results) must be maintained. All technical personnel must be adequately trained and supervised. Packaging and labeling operations must have controls sufficient to prevent product/package/label mix-ups. A lot number to identify each finished product with its production and control history must be assigned to each batch.
(11) Medication containers, labeling, and dispensing: outpatient medications
Outpatient medications must be labeled in accordance with state board of pharmacy and federal regulations. As noted, medications given to patients as “discharge medication” must be labeled in the pharmacy (not by nursing personnel) as outpatient prescriptions. The source of the medication and initials of the dispenser should be noted on the prescription form at the time of dispensing. If feasible, the lot number also should be recorded. An identifying check system to ensure proper identification of outpatients should be established. Outpatient prescriptions should be packaged in accordance with the provisions of the Poison Prevention Packaging Act of 1970 and any regulations there-under. They must also meet any applicable requirements of the USP.
Nonprescription drugs, if used in the institution, should be labeled as any other medication.
Cheap Manual Capsule Filler American Journal of Law & Medicine, 32 (2006): 325-349 © 2006 American Society of Law, Medicine & Ethics Boston University School of Law Trojan Drugs: Counterfeit and Mislabeled Pharmaceuticals in the Legitimate Market Donald deKieffer
Repackers are also an integral part of the journey from the gray market to the pharmacists’ shelves. There are several hundred companies in the U.S. licensed to repackage pharmaceutical products. Unlike most consumer goods, drugs are almost always sold in packaging which was not produced by the maker of the goods therein. In many cases, the original manufacturer packs goods in institutionalsized bottles containing, for example, 1000 tablets. Repackers empty the original bottle, and sort the tablets into 50-tablet lots, filling smaller bottles with the goods, and re-labeling the new bottles. The original manufacturer is almost always indicated on the label, but additional distributors may be named as well. The original lot codes are often ink-jetted onto the finished product. This procedure is commercially justified by wholesalers who find it difficult to maintain inventories of huge quantities of medication. It is much easier to sell 10, 50 count bottles than 1 bottle of 500, for example. In other cases, a distributor (or retailer, for that matter) desires private label products which are merely the original goods in new packaging. As can be imagined, repackers are a godsend to diverters. There is often no need to replicate original packaging to disguise the circuitous route the pharmaceuticals have taken to reach the retailers. Even original goods, purchased directly from the manufacturer are routinely repackaged, so diverted goods are literally indistinguishable from those sold in the normal course of trade. As will be seen, repackaging is also one of the greatest vulnerabilities of the entire drug distribution chain in the case of counterfeits. The middle men mostly operate in the shadows of the drug industry, but sometimes furtively appear when absolutely necessary. When stiffer pedigreerequirements were being considered by the FDA, for example, these companies surfaced to defend themselves against what could have been crippling regulations. They formed an ad hoc organization, the Pharmaceutical Distributors Association (“PDA”), whose members were shrouded in secrecy. One member was selected as spokesman85 who bitterly attacked the proposed rules as unnecessary and burdensome. Quality King Distributors rules a gargantuan gray market empire. It buys US name-brand OTC pharmaceutical and branded personal care products that have been exported to overseas markets, re-imports them, then sells them below suggested retail prices. The practice, deeply disliked by US manufacturers, has been ruled legal by the Supreme Court. Quality King distributes its products to pharmacy and grocery chains, grocery distributors, and wholesale clubs throughout the US. Subsidiary QK Healthcare distributes branded and generic prescription pharmaceuticals. Bernard Nussdorf and his wife Ruth founded Quality King in 1961 in Long Island, New York. The Nussdorf family still owns the company.  § 211.130 Packaging and labeling operations. There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products; such written procedures shall be followed. These procedures shall incorporate the following features: (a) Prevention of mixups and cross-contamination by physical or spatial separation from operations on other drug products. (b) Identification and handling of filled drug product containers that are set aside and held in unlabeled condition for future labeling operations to preclude mislabeling of individual containers, lots, or portions of lots. Identification need not be applied to each individual container but shall be sufficient to determine name, strength, quantity of contents, and lot or control number of each container. (c) Identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and correctness before packaging operations, and documentation of such examination in the batch production record. (e) Inspection of the packaging and labeling facilities immediately before use to assure that all drug products have been removed from previous operations. Inspection shall also be made to assure that packaging and labeling materials not suitable for subsequent operations have been removed. Results of inspection shall be documented in the batch production records. [43 FR 45077, Sept. 29, 1978, as amended at 58 FR 41354, Aug. 3, 1993] § 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. (a) General. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products. An OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both. (b) Requirements for tamper-evident package. (1) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale. A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the term "distinctive by design'' means the packaging cannot be duplicated with commonly available materials or through commonly available processes. A tamper-evident package may involve an immediate-container and closure system or secondary- container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display. (2) In addition to the tamper-evident packaging feature described in paragraph (b)(1) of this section, any two-piece, hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology.
(c) Labeling. (1) In order to alert consumers to the specific tamper-evident feature(s) used, each retail package of an OTC drug product covered by this section (except ammonia inhalant in crushable glass ampules, containers of compressed medical oxygen, or aerosol products that depend upon the power of a liquefied or compressed gas to expel the contents from the container) is required to bear a statement that: (i) Identifies all tamper-evident feature(s) and any capsule sealing technologies used to comply with paragraph (b) of this section; (ii) Is prominently placed on the package; and (iii) Is so placed that it will be unaffected if the tamper-evident feature of the package is breached or missing.
(2) If the tamper-evident feature chosen to meet the requirements in paragraph (b) of this section uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling statement on a bottle with a shrink band could say "For your protection, this bottle has an imprinted seal around the neck."
(d) Request for exemptions from packaging and labeling requirements. A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a "Request for Exemption from the Tamper-Evident Packaging Rule.'' The petition is required to contain the following: (1) The name of the drug product or, if the petition seeks an exemption for a drug class, the name of the drug class, and a list of products within that class. (2) The reasons that the drug product's compliance with the tamper-evident packaging or labeling requirements of this section is unnecessary or cannot be achieved. (3) A description of alternative steps that are available, or that the petitioner has already taken, to reduce the likelihood that the product or drug class will be the subject of malicious adulteration. (4) Other information justifying an exemption.
(e) OTC drug products subject to approved new drug applications. Holders of approved new drug applications for OTC drug products are required under §314.70 of this chapter to provide the agency with notification of changes in packaging and labeling to comply with the requirements of this section. Changes in packaging and labeling required by this regulation may be made before FDA approval, as provided under § 314.70(c) of this chapter. Manufacturing changes by which capsules are to be sealed require prior FDA approval under § 314.70(b) of this chapter. (f) Poison Prevention Packaging Act of 1970. This section does not affect any requirements for "special packaging'' as defined under § 310.3(l) of this chapter and required under the Poison Prevention Packaging Act of 1970. (Approved by the Office of Management and Budget under OMB control number 0910-0149) [54 FR 5228, Feb. 2, 1989 as amended at 63 FR 59470, Nov. 4, 1998] Subpart H-Holding and Distribution § 211.142 Warehousing procedures.Written procedures describing the warehousing of drug products shall be established and followed. They shall include: (a) Quarantine of drug products before release by the quality control unit. (b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected. § 211.150 Distribution procedures.Written procedures shall be established, and followed, describing the distribution of drug products. They shall include: (a) A procedure whereby the oldest approved stock of a drug product is distributed first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. (b) A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary. Subpart J-Records and Reports § 211.180 General requirements. (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch. (b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling. (c) All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph. (d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. (e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for: (1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch. (2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under §211.192 for each drug product.
(f) Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under §§ 211.198, 211.204, or 211.208 of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4901, Jan. 20, 1995] Subpart J-Records and Reports § 211.180 General requirements. (a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the batch. (b) Records shall be maintained for all components, drug product containers, closures, and labeling for at least 1 year after the expiration date or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under § 211.137, 3 years after distribution of the last lot of drug product incorporating the component or using the container, closure, or labeling. (c) All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred. These records or copies thereof shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting the requirements of this paragraph. (d) Records required under this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Where reduction techniques, such as microfilming, are used, suitable reader and photocopying equipment shall be readily available. (e) Written records required by this part shall be maintained so that data therein can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures shall be established and followed for such evaluations and shall include provisions for: (1) A review of a representative number of batches, whether approved or rejected, and, where applicable, records associated with the batch. (2) A review of complaints, recalls, returned or salvaged drug products, and investigations conducted under §211.192 for each drug product.
(f) Procedures shall be established to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of any investigations conducted under §§ 211.198, 211.204, or 211.208 of these regulations, any recalls, reports of inspectional observations issued by the Food and Drug Administration, or any regulatory actions relating to good manufacturing practices brought by the Food and Drug Administration. [43 FR 45077, Sept. 29, 1978, as amended at 60 FR 4901, Jan. 20, 1995] § 211.182 Equipment cleaning and use log.A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order. § 211.184 Component, drug product container, closure, and labeling records.These records shall include the following: (a) The identity and quantity of each shipment of each lot of components, drug product containers, closures, and labeling; the name of the supplier; the supplier's lot number(s) if known; the receiving code as specified in §211.80; and the date of receipt. The name and location of the prime manufacturer, if different from the supplier, shall be listed if known. (b) The results of any test or examination performed (including those performed as required by §211.82(a), §211.84(d), or §211.122(a)) and the conclusions derived therefrom. (c) An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure. (d) Documentation of the examination and review of labels and labeling for conformity with established specifications in accord with §§ 211.122(c) and 211.130(c). (e) The disposition of rejected components, drug product containers, closure, and labeling. § 211.186 Master production and control records. (a) To assure uniformity from batch to batch, master production and control records for each drug product, including each batch size thereof, shall be prepared, dated, and signed (full signature, handwritten) by one person and independently checked, dated, and signed by a second person. The preparation of master production and control records shall be described in a written procedure and such written procedure shall be followed. (b) Master production and control records shall include: (1) The name and strength of the product and a description of the dosage form; (2) The name and weight or measure of each active ingredient per dosage unit or per unit of weight or measure of the drug product, and a statement of the total weight or measure of any dosage unit; (3) A complete list of components designated by names or codes sufficiently specific to indicate any special quality characteristic; (4) An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component. Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records; (5) A statement concerning any calculated excess of component; (6) A statement of theoretical weight or measure at appropriate phases of processing; (7) A statement of theoretical yield, including the maximum and minimum percentages of theoretical yield beyond which investigation according to §211.192 is required; (8) A description of the drug product containers, closures, and packaging materials, including a specimen or copy of each label and all other labeling signed and dated by the person or persons responsible for approval of such labeling; (9) Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations, and precautions to be followed.
§ 211.188 Batch production and control records. Batch production and control records shall be prepared for each batch of drug product produced and shall include complete information relating to the production and control of each batch. These records shall include: (a) An accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed; (b) Documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including: (1) Dates; (2) Identity of individual major equipment and lines used; (3) Specific identification of each batch of component or in-process material used; (4) Weights and measures of components used in the course of processing; (5) In-process and laboratory control results; (6) Inspection of the packaging and labeling area before and after use; (7) A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing; (8) Complete labeling control records, including specimens or copies of all labeling used; (9) Description of drug product containers and closures; (10) Any sampling performed; (11) Identification of the persons performing and directly supervising or checking each significant step in the operation; (12) Any investigation made according to §211.192. (13) Results of examinations made in accordance with §211.134.
§ 211.192 Production record review. All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup. § 211.196 Distribution records. Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers. (Approved by the Office of Management and Budget under control number 0910-0139) [49 FR 9865, Mar. 16, 1984] § 211.198 Complaint files.(a) Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and followed. Such procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with §211.192. Such procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the Food and Drug Administration in accordance with §§310.305 and 514.80 of this chapter. (b) A written record of each complaint shall be maintained in a file designated for drug product complaints. The file regarding such drug product complaints shall be maintained at the establishment where the drug product involved was manufactured, processed, or packed, or such file may be maintained at another facility if the written records in such files are readily available for inspection at that other facility. Written records involving a drug product shall be maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date that the complaint was received, whichever is longer. In the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under §211.137, such written records shall be maintained for 3 years after distribution of the drug product. (1) The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant. (2) Where an investigation under §211.192 is conducted, the written record shall include the findings of the investigation and followup. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred in accordance with §211.180(c). (3) Where an investigation under §211.192 is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.
[43 FR 45077, Sept. 29, 1978, as amended at 51 FR 24479, July 3, 1986; 68 FR 15364, March 31, 2003.] Subpart K-Returned and Salvaged Drug Products § 211.204 Returned drug products.Returned drug products shall be identified as such and held. If the conditions under which returned drug products have been held, stored, or shipped before or during their return, or if the condition of the drug product, its container, carton, or labeling, as a result of storage or shipping, casts doubt on the safety, identity, strength, quality or purity of the drug product, the returned drug product shall be destroyed unless examination, testing, or other investigations prove the drug product meets appropriate standards of safety, identity, strength, quality, or purity. A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristics. Records of returned drug products shall be maintained and shall include the name and label potency of the drug product dosage form, lot number (or control number or batch number), reason for the return, quantity returned, date of disposition, and ultimate disposition of the returned drug product. If the reason for a drug product being returned implicates associated batches, an appropriate investigation shall be conducted in accordance with the requirements of §211.192. Procedures for the holding, testing, and reprocessing of returned drug products shall be in writing and shall be followed. § 211.208 Drug product salvaging.Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age, or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is (a) evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and (b) evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accident. Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity. Records including name, lot number, and disposition shall be maintained for drug products subject to this section. Humco Holding Group, Inc. began operations in 1872 as Hutchison Medicine Company and generations of Americans came to know us as HUMCO, the name to trust for quality, traditional health care products. Humco is an Over-the-Counter medicines manufacturer and marketer supplying Humco Brands, private label and contract manufactured products to pharmacists, retailers and direct-to-consumers. Humco is a privately held corporation located in Texarkana Texas, offering national distribution from a central U.S. location. The company headquarters includes corporate offices, a product research and development lab, an FDA registered manufacturing facility along with warehousing and distribution space. Humco is proud of its long relationship with local pharmacies across America. Our products can be found in almost every community pharmacy across the country. Among our wholesale customers are McKesson Healthcare Solutions, Cardinal Health and AmerisourceBergen along with most regional wholesalers. In addition, Humco supplies products to Walgreens, CVS, Rite Aid and Wal-Mart. Our purpose is that everyone who comes in contact with Humco as a company will feel better for that contact. - When a consumer purchases our new Castiva™ Arthritis Pain Relief Lotion, our purpose is met when we hear comments like 81 year old Kenneth F. of Illinois recently sent to us: "I had a total hip replacement 16 months ago which left me with back and nerve irritation. I had shots and only felt about 10% relief. I have been using Castiva™ Warming for 8 days and get 10 hours of relief!"
- When a new employee joins us at Humco, our purpose is met when they take the opportunity to learn new things and they feel better about themselves.
- When our employees serve as mentors in Junior Achievement™ or work in area charities, our purpose is met when those in the community feel better because of our service.
In the products we create, the opportunities we provide and the service to our community, "We Help People Feel Better." BULK ACETAMINOPHEN / PARACETAMOL 
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