Repacker

[Caleb Nelands]

UnderNew York State Law, the State Board of Pharmacy registers pharmacy, wholesaler, repacker and manufacturer establishments in New York State. New York is the home state for these establishments that are physically located in this state. For current registrant totals see License Statistics.

An initial application must be submitted for each instate establishment in order to do business in New York. A completed application must be submitted with the required registration fee (see Checklist MW109 (47 KB) for information on all forms required). Make checks payable to the New York State Education Department. Note: Your cancelled check is your receipt.

You must answer all questions and provide all information requested unless otherwise indicated. Failure to complete all required parts of the application will delay its review. Submit applications directly to the Office of the Professions at the mailing address at the end of the form.

If you are not sure about what is required, especially as it relates to corporate documents and filings, you may wish to consult with your attorney. You should also know that applications are processed in the order in which they are received. In the interest of fairness, we cannot deviate from this policy. Please submit your completed application at least 8 to 12 weeks before the planned opening or transfer of your pharmacy or establishment.

Applicants are urged to retain copies of all applications and documents submitted to the Pharmacy Board Office. Other agencies may require copies of applications for their registration. It is the applicant's responsibility to make and retain these copies. INCOMPLETE APPLICATIONS WILL BE RETURNED TO YOU FOR COMPLETION.

Note: All forms are in Adobe Portable Document Format (PDF). To view or print these documents, you will need to have the free Adobe Reader installed on your computer. Download times and print quality will depend on your connection speed and printer.

Registered establishments must notify the NYS Board of Pharmacy whenever there is a change of location, change of name or change of officers and/or owners. See Instructions below for information on filing and fee requirements. In each instance, the appropriate documents and fee, if required, must be submitted to the Office of the Professions at the mailing address at the end of the form whenever these changes occur.

Are you looking for a solution to automatically repack produced dry ice in small boxes?The CRYONOMIC dry ice repacker (DIR-550) is invented to repack bulk produced dry ice into smaller doses and replaces the heavy job of manually filling. This repacker has an integrated balance that weights the actual weight during filling (filling stops if the programmed weight is reached). One of the most important advantages of the CRYONOMIC dry ice repacker, besides the replacement of the manually filling job, is that the operator has the time to close and label other boxes while the second one is being filled. This results in more than 50% time saving and no more manual lifting for your staff.

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The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc., for significant violations of current good manufacturing practice (CGMP) requirements.

Generally, API repackers take bulk API (usually in powder form) from the container in which it was distributed by the original manufacturer and place it into a different container without further manipulation of the drug and distribute it to drug manufacturers, compounding pharmacies or outsourcing facilities. Improper repackaging or lack of supply chain oversight of API can cause serious vulnerabilities in the supply chain and may lead to adverse events in patients.

The warning letter issued to B&B Pharmaceuticals describes failures to conform to CGMPs, including failure to thoroughly investigate complaints regarding sub-potent API. The repacker also failed to conduct cleaning validation studies to demonstrate that their cleaning procedures for non-dedicated production equipment are adequate to prevent potential cross-contamination between repackaged API, including highly potent drugs such as testosterone, progesterone, estrogen and opioids. The repacker also failed to provide adequate certificates of analysis for API, by not including critical information about the quality and sourcing of drugs and their components. Omitting this vital information from a certificate of analysis compromises supply chain accountability and traceability and may put consumers at risk.

The warning letter issued to Enovachem notes, among other violations, failure to maintain traceability of the API throughout the supply chain, specifically warning that the company failed to obtain and retain documents with the identity of the original manufacturer and certificates of analysis from the original manufacturer. The company also distributed API, including opioids, to its customers with incomplete certificates of analysis, which compromises supply chain accountability and traceability and may put consumers at risk. The customers included compounding pharmacies which use the API for prescription compounding.

The FDA issued a warning letter to Spectrum for significant deviations from CGMPs. Spectrum repackages various opioid APIs but did not provide complete information in its certificates of analysis provided to its customers, including compounding pharmacies. Spectrum failed to properly investigate and resolve critical CGMP deviations, including cracked bottles of repackaged opioids, among other violations.

The Spectrum and Enovachem warning letters also state these companies list glycerin among the products they repackage. In 2007, the FDA issued final guidance intended to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison which may be deadly to patients. Lapses in supply chain oversight, including incomplete information on certificates of analysis, was one of the factors that allowed contaminated drugs to enter the supply chain in the past.

The FDA has requested responses from each repacker within 15 working days. The warning letters also state that failure to correct violations may result in legal action without further notice, including, without limitation, seizure, and injunction.

Additionally, the FDA has issued separate warning letters to other API repackers for similar violations, including Vipor Chemicals Private Ltd., Lumis Global Pharmaceuticals Co. Ltd., Sal Pharma, Huron Pharmaceuticals, Inc. and Fagron, Inc., and added Lumis Global Pharmaceuticals Co. Ltd. and Sal Pharma to import alerts, including 66-40 for failure to meeting CGMPs, to keep their API from ultimately reaching U.S. patients. The agency has also issued alerts about safety issues with repackaged porcine thyroid API and baclofen API.

The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:

Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Active pharmaceutical ingredient does not include intermediates used in the synthesis of the substance.

Commercial distribution means any distribution of a human drug, except for investigational use under part 312 of this chapter, and any distribution of an animal drug or an animal feed bearing or containing an animal drug, except for investigational use under part 511 of this chapter. The term does not include internal or interplant transfer between registered establishments under common ownership and control, including a parent, subsidiary, or affiliate company. For foreign establishments that manufacture, repack, relabel, or salvage, or for foreign private label distributors, the term "commercial distribution" has the same meaning except the term does not include distribution of any drug that is neither imported nor offered for import into the United States.

(4) For animal drugs (including, but not limited to, drugs that are subject to section 512 of the Federal Food, Drug, and Cosmetic Act): The content of the labeling that accompanies the drug that is necessary to enable safe and proper administration of the drug (e.g., the labeling applicable to veterinary drugs specified in part 201 of this chapter), including all text, tables, and figures.

Domestic for purposes of registration and listing under this part, when used to modify the term "registrant," "manufacturer," "repacker," "relabeler," "salvager," "private label distributor," or "establishment," refers to a registrant, manufacturer, repacker, relabeler, salvager, private label distributor, or establishment within any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

Establishment means a place of business under one management at one general physical location. The term includes, among others, independent laboratories that engage in control activities for a registered drug establishment (e.g., consulting laboratories), manufacturers of medicated feeds and of vitamin products that are drugs in accordance with section 201(g) of the Federal Food, Drug, and Cosmetic Act, human blood donor centers, and animal facilities used for the production or control testing of licensed biologicals, and establishments engaged in salvaging.

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