Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 33 No. 3, January 19, 2007 issue of the Florida Administrative Weekly.

62-730.186 Universal Pharmaceutical Waste

(1) through (2) No change.

(3) Hazardous waste pharmaceuticals are considered to be universal waste in Florida when managed in accordance with this section.) Hazardous waste pharmaceuticals not managed as universal waste in accordance with this section shall be managed in accordance with Chapter 62-730, F.A.C., and shall be disposed of at a permitted hazardous waste treatment, storage or disposal facility.

(4)(a) through (j) No change.

(k) “Reverse distributor” means a person engaged in the reverse distribution of prescription drugs who:

1. Operates a warehouse licensed by the Department of Health Bureau of Statewide Pharmaceutical Services under Chapter 499, F.S., as a reverse distributor; and

2. Has management systems in place to ensure compliance with applicable requirements of 40 CFR Parts 260 through 273 [as adopted in sections 62-730.021 and 62-730.183, and subsections 62-730.020(1), 62-730.030(1), 62-730.160(1), 62-730.170(1), 62-730.180(1) and & (2), 62-730.181(1), 62-730.185(1), and 62-730.220(1), F.A.C.] and Chapter 62-730, F.A.C.

NOTE: The Federal Drug Enforcement Administration has registration requirements for persons engaged in the reverse distribution of prescription drugs who handle controlled substances in Schedules II through V promulgated under United States Code, Title 21, Section 812.

(l) through (7)(a) No change.

(b) A handler shall clearly label those containers and tanks accumulating waste pharmaceuticals with the phrase “universal pharmaceutical waste” or “universal waste pharmaceuticals,” and with specific hazardous waste codes applicable to the universal pharmaceutical waste that is or may be placed in the container or tank.

(c) A handler may conduct the following activities as long as the innermost container of each individual pharmaceutical remains intact and closed, or if the innermost container is placed into another individual sealed container ~~and marked with the applicable hazardous waste code~~:

1. Sorting or mixing individual pharmaceuticals in one outer container, as long as the pharmaceuticals are compatible;

2. Disassembling packages containing several pharmaceuticals into individual pharmaceuticals; and

3. Removing pharmaceuticals from consumer packaging.

(7)(d) No change.

(e)1. A reverse distributor or wholesaler who meets the definition of “universal waste handler” in 40 CFR 273.9 [as adopted in subsection 62-730.185(1), F.A.C.] shall meet the requirements for “handlers” in subsections 62-730.186(6) through (12), F.A.C., of this section.

2. A reverse distributor or wholesaler that makes determinations as to whether pharmaceuticals are viable shall:

~~2. A reverse distributor or wholesaler that makes determinations as to whether pharmaceuticals are viable shall:~~

(e) 1.A reverse distributor or wholesaler who meets the definition of “universal waste handler” in 40 CFR 273.9 [as adopted in subsection 62-730.185(1), F.A.C.] shall meet the requirements for “handlers” in subsections 62-730.186(6) through (12), F.A.C., of this section.

a. Begin the process of distinguishing viable pharmaceuticals from universal pharmaceutical waste or hazardous waste within 14 days of receipt of a complete shipment of returns from a handler, and in no event more than 21 days from the receipt of the first installment of a partial shipment;

b. Complete the universal pharmaceutical waste or hazardous waste identification process within 21 days of receipt of the complete shipment, and in no event more than 30 days from receipt of the first installment of a partial shipment; and

c. Keep a record of each shipment of returns by any method that clearly demonstrates the date on which the shipment was received and the date on which the reverse distributor or wholesaler determined the universal pharmaceutical waste or hazardous waste status of all items in the shipment.

(7)(f) through (9) No change.

(10) A handler shall immediately contain all releases of universal pharmaceutical waste (including spills that occur indoors). A handler shall determine whether any material resulting from a release is hazardous waste. A handler shall manage any such hazardous waste in compliance with the requirements of 40 CFR Parts 260 through 272 [as adopted in sections 62-730.021, and 62-730.183, and subsections 62-730.020(1), 62-730.030(1), 62-730.160(1), 62-730.170(1), 62-730.180(1) and & (2), 62-730.181(1), and 62-730.220(1), F.A.C.] The handler is considered the generator of the material resulting from the release and shall manage the material in compliance with 40 CFR Part 262 [as adopted in subsection 62-730.160(1), F.A.C.] Material resulting from the release of universal pharmaceutical waste may not be managed as universal pharmaceutical waste.

(11)(a) through (e) No change.

(f) A handler that transports a universal pharmaceutical waste to a reverse distributor or another handler must provide the reverse distributor or handler with written information sufficient to allow the reverse distributor or other handler to make knowledgeable decisions about the safe handling and proper disposal of the universal pharmaceutical waste.

(g) through (13) No change.

Specific Authority 403.061, 403.151, 403.704, 403.72, 403.721 FS. Law Implemented 120.52, 120.54, 403.061, 403.151, 403.704, 403.72, and 403.721 FS. History–New_________.