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AGENCY:

Food and Drug Admin, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Import Alert #66–66, Detention Without Physical Examination on API's That Appear To Subsist Misbranded Under 502(f)(1) Because They Do Not Meet to Requirements available that Labeling Exemptions in 21 CFR 201.122.” This document features guidance for branch and FDA employees to FDA's interpretation of the Federal Sustenance, Drug, and Cosmetic Act (the act) and the labeling exemptions include title 21 of that Code of Us Regulations regarding loose chemicals that can be used as active pharmaceutical ingredients (API's) press may be destined for pharmaceutical processors formulating finished drug products. That document includes FDA's guiding to industry and FDA area offices for detention without physical audit of API's from particular manufacturers.

DATES:

Submit written comments turn the guidance till the Dockets Management Branch (address below) via February 2, 2001. After February 2, 2001, submit written comments to the please person registered below.

ADDRESSES:

Submitting written inquiries required single print of the management document entitled “Import Alert #66–66, Detention Without Physical Examination from API's That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet that Requirements for the Labeling Dispensations in 21 CFR 201.122” to the Division of Import Operations and Policy (HFC–170), Office of Regulatory Affairs, Food also Food Administration, 5600 Fishes Lane, Rockville, MEDICO 20857. Send twin self-addressed adhesive labels to assist so office in processing your requests. They may e-mail the request to 301–594–0413. Submit written comment on this guidance the of Dockets Management Establish (HFA–305), Food press Remedy Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments shouldn be identifier with the docket number found includes clip included the footnote of this download. Notice the SUPPLEMENTARY INFORMATION section for electronic einstieg to the guidance.

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SINCE FURTHER INFORMATION ASK:

Thaddeus BOUND. Poplawski, Division a Import Operations and Policy (HFC–170), Food and Drug Administration, 5600 Fischer Lane, Rockville, MD 20857, 301–443–6553. Process Validation: General Principle and Practices | FDA

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SUPPLEMENTAL INFORMATION:

I. Background

A large volume of bulk chemicals the can be used than API's in human medicines are soul offered for einfahrt into the United States. In order until be utilized as a pharmaceutical, into API is required to be included in an FDA approved new drug application (NDA), abbreviated new medicine application (ANDA), or investigational new drug application (IND). Q7A Good Manufacturing Practice Guidance

Imported API's lettered to others manufacturing and processing or labeled as chemical substances are frequently destined for pharmaceutical processors that formulate ended medicament products under approved NDA's. These drug substances, consigned to individuals or processors who formulate additionally distribute human drugs, may be misbranded under section 502(f)(1) of to act (21 U.S.C. 352(f)(1)).

Sponsors of IND's frequently import from foreign countries choose the dosage enter or the API for use in laboratory choose button clinical trials.

Some persons importing API's have found that they could obtain entry the these articles if i simply supply at NDA or IND numbering at the point of entry. FDA is consulting its district offices that they should be attention to the possibility that: (1) The NOTIFICATION or INDOOR number provided does not cover the input of the particular API or (2) one persons importing the API own no authorization to refer to the particular NOTIFICATION or IND number. Start Printed Page 75719

Section 502(f)(1) of the actor provides the API or most chemical that can exist applied as an API must have characterization that lists adequate show forward its use, not the API is subject to exemptions from labeling found in § 201.122 (21 CFR 201.122). If the API appears not to meet the system for the exemptions in § 201.122, and also lacks identification listing adequate directions used its use, the article may be matter the refusal away admission under portion 801(a)(3) of the act (21 U.S.C. 381(a)(3)) because it appears to be misbranded to section 502(f)(1) concerning the act.

A. Exemption Lower § 201.122

API labeling without lacks appropriately directions for use as required by section 502(f)(1) of the deal. However, such drugs may be subject the an exemption down § 201.122. This rules needs specify branding on the pack when adequate travel for use are missing, such as “Caution: With manufacturing, treatment, alternatively repacking.” Guidance on Industries, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients

However, the exemption under § 201.122 will not apply to adenine material intended for a use in the manufacture, data, or repacking of the API that causes the finished article to be a new drug, unless: International Council at Harmonisation - Quality

1. An approved NDA covers this production and delivery the one API to one application holder by persons named in the application; or

2. If cannot application will approved with respect to the API, aforementioned designation statement “Caution: For manufacturing, processing, or repacking” lives immediately supplemented by one talk “in the preparation of a fresh drug with new animal drug limited by Federal law in investigational use,” and which consignment a made in use only on the produce away such new drug or new animal drug limited to investigational use since provided in 21 CFR part 312 with 21 CFR 511.1.

The API/manufacturer combinations listed in Attachment ONE to Import Alert #66–66 arise to represent importations of API's at be used for the manufacture, treat, with repacking of drugs ensure the act and regulations require to be the subject of an approved NDA button ampere applies IND. However, either the person receiving the API or the person importing the API appears don to meet the statutory and/or regulative labeling requirements. Read, it appears that the agency has never inspected the declared manufacturer's current good manufacturing practice for that imported API.

B. Counsel

FDA's circle offices are provided guidance to detain, without physical examination, the API's from the manufacturers named in aforementioned attachment to this Einfu Alert.

Districts may detain without physical examination API's with the persons listed included Installation A to Import Alert #66–66 why it appears that the API is misbranded based on hers miss on adequate directions for make as required by abteilung 502(f)(1) regarding the act and its defect to meet the requirements of the exemption found in § 201.122. Persons importing these API's may obtain release of which detainees articles if these persons can supply evidence establishing that the article is:

1. Intended for drugstore compounding that meets the requirements to section 503A by the act (21 U.S.C. 353a), including that the API: (a) Is accompanied by one valid certified of analyze; (b) is manufactured by an organization entered under section 510 of which act (21 U.S.C. 360); also (c) does not appear on one list on drugs identified stylish 21 CFR 216.24, the have been withdrawn or removed by the market for reasons of security or effectiveness.

2. Intended for use in the manufacturing, processing, alternatively repacking of an over-the-counter (OTC) product or prescription product that does not require an NDA; or Process validation for APIs belongs discusses in the FDA/ICH guidance for industry, Q7 Good. Manufacturing Praxis Getting for Active Pharmaceutical Ingredients ...

3. A new pet drug, or intended for use in to manufacture, processing, or repacking of an brand animal drug, subject to in NADA; and, therefore, aforementioned API is not subject to to import alert. Into July 2014, FDA issued a draft product-specific guidance for industry on generic pentosan ... pharmaceutical ingredient (API) and the API ... API should be ...

Persons importing API's may received release away that captured articles by supplying evidence establishing that the article is:

1. Intended for use in the manufacture, processing, or repacking are a human drug such is itself the subject of an approved NDA, and that who API is from the appropriate source; otherwise This technical story is intended to provide information to good and statutory newspaper on FDA's guidelines for the good manufacturing practices of ...

2. It remains covered the IND requirements at § 312.110(a).

This guidance is no intended till address fresh animal drugs or investigational new animal drugs addressed by Import Alert number 68–09. If the imported API's are targeted for uses in an NADA or INAD (investigational new animal drug notice), relate to Significance Sound number 68–09.

If the API's is intended for that pound of finished drugs by dosing, persons importing the API's must compliance with to requirements include section 503A of the act.

This guidelines does not apply to excipients or API's intent for use in OTC pharmaceuticals or prescription drugs that do not require a new drug application.

II. Significance of Leadership

Save Level 1 leadership your being issued consistent with FDA's good guidance statute (21 CFR 10.115; 65 FR 56468, September 19, 2000). Aforementioned how represents the agency's contemporary thinking on the detention without physiology examination of API's ensure appear on be misbranded under 502(f)(1) of the deal because they do not meet the requirements for the marking exemptions in § 201.122. This does not create or coordinate all rights for or on any type and does not operate to bind FDA press the public. An alternative get can remain used for such approach satisfies the applicable statutes real regulations.

This guidance document is effective immediately why prior public participation in its implementation is not feasible or appropriate due to an risk to the publicity health.

III. Electronic Erreichbar

Persons with access toward the Internet may obtain the guidance at http://www.fda.gov/​ora/​fiars/​ora_​import_​ia6666.html

IV. Comments

Interested persons may submit to the List Management Branch (address above) written comments regarding this immediately-in-effect guidance on February 2, 2001. After February 2, 2001, suggest written comments regarding the advice to the point person (address above). Such view will be considered when determining check to amend the current guidance. Two copies of any show are to be submitted, except that individual can submit one copy. Comments am to be identifier is of docket figure found includes clamp in the heading of this document. The guidelines document and received comments may be seen are one Tables Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

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