(a)General information required on the invoice. Each invoice of imported merchandise, must set forth the following information: (1) The port of entry to which the merchandise is destined; (2) The time when, the place where, and the person by whom and the person to whom the merchandise is sold or agreed to be sold, or if to be imported otherwise than in pursuance of a purchase, the place from which shipped, the time when and the person to whom and the person by whom it is shipped; (3) A detailed description

(a)Quarterly reports. A manufacturer must report product and pricing information for covered outpatient drugs to CMS not later than 30 days after the end of the rebate period. The quarterly pricing report must include the following: (1) AMP, calculated in accordance with § 447.504 . (2) Best price, calculated in accordance with § 447.505 . (3) Customary prompt pay discounts, which are reported as an aggregate dollar amount for each covered outpatient drug at the nine-digit NDC level, provided to

(a)Contents. Except as provided in paragraph (b) of this section, the entry documentation required to secure the release of merchandise must consist of the following: (1)Entry. CBP Form 3461 (appropriately modified), or its electronic equivalent, except that CBP Form 7533 (appropriately modified), or its electronic equivalent, in duplicate, may be used in place of CBP Form 3461 for merchandise imported from a contiguous country. The form used must be prepared in accordance with § 141.61(a)(1) of

(a)What is the NDC for a drug and what products must have unique NDCs ? The NDC for a drug is a numeric code. Each finished drug product or unfinished drug subject to the listing requirements of this part must have a unique NDC to identify its labeler, product, and package size and type. (b)What is the format of an NDC ? (1) Except as described in paragraph (b)(4) of this section, the NDC must consist of 10 or 11 digits, divided into three segments as follows: (i) The first segment of the NDC is

A pro forma invoice submitted in accordance with any provision of this chapter shall be in substantially the following form: Pro Forma Invoice Importers Statement Of Value Or The Price Paid In The Form Of An Invoice Not being in possession of a commercial seller's or shipper's invoice I request that you accept the statement of value or the price paid in the form of an invoice submitted below: Name of shipper address ________________________ Name of seller address ________________________;. Name of

(a) In order to assist manufacturers of prescription drugs in discharging their responsibilities under the act concerning such drugs that are distributed to pharmacies, the Consumer Product Safety Commission has codified this statement of its policy concerning which prescription drug packages supplied by manufacturers to pharmacies must comply with the "special" (child-resistant) packaging requirements contained in 16 CFR 1700.15 . (b) Manufacturers of prescription drugs may package such drugs for

(a) A product may be deemed to be misbranded if an NDC is used: (1) To represent a different drug than the drug for which the NDC has been assigned, as described in § 207.33 ; (2) To denote or imply FDA approval of a drug; or (3) On products that are not subject to parts 207, 607 of this chapter, or 1271 of this chapter, such as dietary supplements and medical devices. (b) If marketing is resumed for a discontinued drug, and no changes have been made to the drug that would require a new NDC under

(a) Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed. Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing is misleading and constitutes misbranding. (b) FDA's acceptance of registration and listing information, inclusion of a drug in our database