USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices In general, manufacturing plants are not sub- ject to a separate authorisation from the related product approvals – although they must be reg- istered with the FDA (and the products produced at the facility must be listed as associated with the establishment). Moreover, in most cases, the FDA will review extensive manufacturing infor- mation in the product application and conduct a pre-approval inspection of the facility before approving a drug or device. Such establish- ments are also subject to both routine (typically every two years) and for-cause (eg, in response to a product defect and recall) inspections. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices In general, wholesale activities are subject to licensure requirements at the state level and registration as distributors at the federal level. The requirements and length of such licences vary by state. The FDA may inspect any facility holding drugs for shipments – although state inspection activi- ties and fees vary greatly. Significant additional requirements administered by the DEA and states apply to wholesale trade in controlled substances. The authorisation to trade in pharmaceuticals varies greatly by state; however, most pharma-
ceutical distributors must hold a state licence. Such requirements often do not apply to entities that are not physically handling drug products. 6.2 Different Classifications Applicable to Pharmaceuticals Drugs may be either prescription – ie, as defined under state law, generally subject to prescrip- tion by a designated healthcare practitioner and dispensing by a licensed pharmacist – or OTC (permitting sale without intervention by a healthcare practitioner or pharmacist). Certain products (eg, pseudoephedrine) must be kept behind the pharmacy counter, owing to specific statutory requirements. The FDA has issued a proposal that could expand direct OTC avail- ability of drug products – for example, through the use of mobile apps, as well as via kiosks in pharmacies that permit education and diagnos- tic screening. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies The FD&C Act and general import and export administration laws govern the import/export of pharmaceuticals and medical devices. Typically, imported medicines and medical devices must be subject to an approval or clearance (if appli- cable) in the USA. Only the original manufacturer of a drug may re-import a drug product back into the USA, subject to limited programmes – aimed at demonstrating how the importation of certain drugs can be accomplished in an attempt to reduce prices – that may nor may not proceed in the coming years. The importation of even
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