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September 8, 2014
Earlier this month, the AUA shared with its members important information regarding BCG availability in the United States. Late last week, we received an update from Merck, who has advised us that production of this important drug has resumed and that product is once again being released from its manufacturing facility. BCG is expected to remain on a limited status until the supply pipeline has replenished.
Practices are encouraged to avoid over-ordering BCG at this time. If your practice is in dire need of BCG and is unable to obtain this drug through your distributor, sharing within your community may be an option. The AUA has received the following guidance from the Food & Drug Administration regarding transfers of BCG between entities:
Under Section 503(c)(3)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the sales restrictions for prescription drug marketing do not apply to the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons. As defined under 21 CFR 203.3(m), emergency medical reasons includes, but is not limited to, transfers of a prescription drug between health care entities or from a health care entity to a retail pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruption of regular distribution schedules.
Therefore, health care entities that experience a shortage arising from the current supply disruption of BCG Live (for intravesical use) in the U.S. would be permitted under the emergency medical reasons exclusion of the Prescription Drug Marketing Act (PDMA), and its regulations at 21 CFR 203.22(d), to sell, purchase, or trade or offer to sell, purchase or trade BCG Live to other health care entities, to the extent necessary to alleviate the temporary shortage.
All health care entities selling, purchasing or trading or offering to sell, purchase or trade BCG Live must document and maintain records of same, to include the following:
- The proprietary and established name of the drug;
- Dosage and presentation;
- Container size and doses;
- Number of containers involved;
- The drug's lot number(s);
- Where applicable, the entity the doses were received from, including name and address
- Where applicable, the entity the doses were transferred to, including name and address
In any such sale, purchase or trade of BCG, the parties must comply with FDA's current good manufacturing requirements, including proper storage, and distribution (see 21 CFR Part 211).
The AUA will continue to keep members apprised of new information on this issue as it becomes available. If you have questions or concerns, please contact us at communications@AUAnet.org.