The Alabama Board of Pharmacy issues the following types of business permits. Click on which business pertains to you for more information. Please note that all businesses applying for a permit must fill out the DEA Controlled Substance Waiver if facility does not perform activities requiring controlled substances.
Manufacturer
Wholesale Distributor
Repackager
Third Party Logistics (3PL)
Private Label Distributor
Precursor Chemicals
Retail Medical Oxygen
Manufacturer
Wholesale Distributor
Repackager
Third Party Logistics (3PL)
Private Label Distributor
Precursor Chemicals
Retail Medical Oxygen
MANUFACTURER
Definition: A person or entity, except a pharmacy, who prepares, derives, produces, researches, tests, labels, or packages any drug, medicine, chemical, or poison
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WHOLESALE DRUG DISTRIBUTOR
Definition: A person (other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or repackager) engaged in the business of distributing drugs and medicines for resale to pharmacies, hospitals, practitioners, government agencies, or other lawful outlets permitted to sell drugs or medicines. The sale, purchase, or trade of a drug by a retail pharmacy to another retail pharmacy or practitioner, for relief of temporary shortages, is exempt from this definition. Also exempt from this definition shall be
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- intracompany sales
- manufacturer and distributor sales representatives who distribute drug samples
- charitable organizations distributing to nonprofit affiliates of that organization
- certain purchases by hospitals or other health care entities that are members of a group purchasing organization, and
- the distributors of blood and blood components.
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REPACKAGER
Definition: A person who purchases or acquires from a manufacturer or distributor, a drug, medicine, chemical, or poison for the purpose of bottling, labeling, or otherwise repackaging for sale or distribution. This definition shall not apply to a physician licensed to practice medicine who as a part of his or her professional practice dispenses, administers, sells or otherwise distributes any drug to a patient.
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THIRD PARTY LOGISTICS (3PL)
Definition: An entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.
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PRIVATE LABEL DISTRIBUTOR
Private Label Distributor: A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else The private label distributor is responsible for the products it introduces into interstate commerce and for compliance with FDCA requirements and cGMP regulations.
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PRECURSOR CHEMICALS
Definition: Any individual, corporation, partnership, association or other entity who is a manufacturer, wholesaler, retailer or other person who sells, transfers, manufactures, purchases for resale or otherwise furnishes any listed precursor chemicals as defined or designated by any federal or state law or rule.
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RETAIL MEDICAL OXYGEN
Definition: Any person, company, agency, business, or entity of any kind which sells or provides medical oxygen directly or indirectly to patients or consumers and which bill the patient or consumer or their insurance, Medicare, Medicaid or other third party payor for the sale or providing of medical oxygen
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