Current as of October 03, 2022 | Updated by FindLaw Staff
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(a) A voluntary drug experience report to the Food and Drug Administration on FDA Form 3500 shall be handled in accordance with the rules established in § 20.111(c)(3)(iii).
(b) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report.
A. Cemeteries shall keep on file records of all documents in connection with all cemetery plot transactions handled by or through them. The records shall include but are not limited to:
1. All sales contracts.
2. Sales contract payment ledgers.
3. Certificates of burial rights.
4. All ledgers or books showing all receipts, disbursements or adjustments.
5. Records of plats and maps.
6. Such other information as the commissioner may reasonably require.
B. Each cemetery broker is responsible for maintenance of all documents used in connection with all cemetery plot transactions while in the employment of a cemetery. The records shall be open at all reasonable times for inspection by the commissioner or the commissioner's representatives. The records of each transaction shall be kept by the cemetery for a period of five years after payment in full of the transaction at the broker's main office or at an off-site storage location in this state if the owner or agent provides prior written notification of the street address of the off-site storage location to the department.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.20.112 Voluntary drug experience reports submitted by physicians and hospitals - last updated October 03, 2022 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-20-112/
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