Are there any laws governing the distribution of sample drugs?
Yes, there are laws governing the distribution of sample drugs in California. In general, pharmaceutical manufacturers and distributors must obtain a permit from the California Board of Pharmacy to distribute or sell sample medications to health care practitioners or their representatives. This includes distribution of sample drugs to hospitals, pharmacies, or long-term care facilities. In addition, the California Board of Pharmacy requires that if manufacturers or distributors distribute sample drugs, they must restrict their distribution to licensed health care practitioners or their representatives. This includes distribution of samples to hospitals, pharmacies, or long-term care facilities. To meet this requirement, the manufacturers or distributors must maintain a record of the samples they have provided. Moreover, the Board of Pharmacy requires that the sample drugs must be affixed with a label that is designed to discourage inappropriate usage. The label must include the name of the drug, the expiration date, and a statement indicating that the medication is not to be used for any purpose other than to provide a sample to a practitioner or his/her representative. Finally, California’s Prescription Drug Law requires that all sample medications must be identified as such at the time of delivery and that the name of the receiving healthcare practitioner must be included. It is also important to note that these laws do not apply to samples provided by hospitals, pharmacies, or long-term care facilities to their patients.
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